Long-Term Analgesic Efficacy And Safety Of Tanezumab Alon... | NCT00809354 | Trialant
NCT00809354
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Jun 24, 2021Actual
Enrollment
2,720Actual
Phase
Phase 3
Conditions
Osteoarthritis
Arthritis
Interventions
NSAID
tanezumab
tanezumab
tanezumab
NSAID
tanezumab
NSAID
Countries
United States
Canada
Colombia
India
Mexico
Netherlands
Philippines
Russia
South Africa
South Korea
Spain
Ukraine
Protocol Section
Identification Module
NCT ID
NCT00809354
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4091025
Secondary IDs
ID
Type
Description
Link
2008-004815-37
EudraCT Number
OA CONTROLLED SAFETY STUDY
Other Identifier
Alias Study Number
Brief Title
Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip
Official Title
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jun 2021
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
See termination reason in detailed description.
Expanded Access Info
No
Start Date
Feb 12, 2009Actual
Primary Completion Date
Oct 28, 2010Actual
Completion Date
Jan 12, 2011Actual
First Submitted Date
Dec 16, 2008
First Submission Date that Met QC Criteria
Dec 16, 2008
First Posted Date
Dec 17, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 5, 2021
Results First Submitted that Met QC Criteria
Jun 2, 2021
Results First Posted Date
Jun 24, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 2, 2011
Certification/Extension First Submitted that Passed QC Review
Nov 2, 2011
Certification/Extension First Posted Date
Nov 7, 2011Estimated
Last Update Submitted Date
Jun 2, 2021
Last Update Posted Date
Jun 24, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to investigate the long-term analgesic efficacy and safety of tanezumab for patients with osteoarthritis (OA) of the knee or hip currently experiencing partial benefit from, and are tolerating, non-steroidal anti-inflammatory drug (NSAID) therapy.
Detailed Description
This study was terminated on 28 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Conditions Module
Conditions
Osteoarthritis
Arthritis
Keywords
monoclonal antibody
nerve growth factor (NGF)
anti-NGF
tanezumab
PF-04383119
RN624
osteoarthritis (OA)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,720Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
IV Placebo + NSAID
Active Comparator
Oral NSAID
Drug: NSAID
Tanezumab 5 mg
Experimental
IV tanezumab 5 mg every 8 weeks (through Week 48)
Biological: tanezumab
Tanezumab 10 mg
Experimental
IV tanezumab 10 mg every 8 weeks (through Week 48)
Biological: tanezumab
Tanezumab 5 mg + NSAID
Experimental
IV doses of tanezumab 5 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Biological: tanezumab
Drug: NSAID
Tanezumab 10 mg + NSAID
Experimental
IV doses of tanezumab 10 mg every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Biological: tanezumab
Drug: NSAID
Interventions
Name
Type
Description
Arm Group Labels
Other Names
NSAID
Drug
IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
IV Placebo + NSAID
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Baseline, Week 16
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Baseline, Week 16
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Anti-Drug Antibody (ADA) Response
Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence x-ray grade equal to, or greater than, 2.
Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.
Pain level and function levels as required by the protocol at Screening and Baseline.
Willing to discontinue all non-study pain medications for osteoarthritis except rescue medication (acetaminophen) and not use prohibited pain medications throughout the duration of the study except as permitted per protocol.
Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.
Exclusion Criteria:
Pregnant women.
BMI greater than 39.
Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to sever pain that may confound assessments or self-evaluation of the pain associated with OA.
Signs and symptoms of clinically significant cardiac disease with 6 months prior to screening.
Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
History, diagnosis, signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7 mg/dL (men) or 1.5 mg/dL (women).
Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to screening.
Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56
Tanezumab 5 mg
tanezumab
Biological
IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56
Tanezumab 10 mg
tanezumab
Biological
IV tanezumab 5 mg every 8 weeks (through Week 48)
Tanezumab 5 mg + NSAID
NSAID
Drug
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Tanezumab 5 mg + NSAID
tanezumab
Biological
IV tanezumab 10 mg every 8 weeks (through Week 48)
Tanezumab 10 mg + NSAID
NSAID
Drug
Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks
Tanezumab 10 mg + NSAID
Baseline, Week 16
Baseline, Weeks 2, 4, 8, 12, and 24
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Baseline, Weeks 2, 4, 8, 12, and 24
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
Baseline, Weeks 2, 4, 8, 12, and 24
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).
Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.
Baseline, Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
Baseline, Week 16
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
Baseline, Week 16
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.
Weeks 2, 4, 8, 12, 16, and 24
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Baseline, Weeks 2, 4, 8, 12, 16, and 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
Baseline, Weeks 12 and 24
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
Baseline, Weeks 12, 24, 40, and 56
Number of Participants Who Had Discontinued Study Due to Lack of Efficacy
Baseline up to Week 56
Time to Discontinuation Due to Lack of Efficacy
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.
Baseline up to Week 56
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Week 24
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Week 24 and 56
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Week 24
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Weeks 24 and 56
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Week 24
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Weeks 24 and 56
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Week 24
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
Baseline, Weeks 24, and 56
Percentage of Participants Who Used Rescue Medication: Observed Data
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized.
Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56
Baseline, Week 56
Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56
Baseline, Week 56
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Baseline up to Week 64
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
Plasma Trough (Pre-dose) Concentration of Tanezumab
Predose on Day 1, Weeks 16, 24, 40, and 56
Number of Participants With Intravenous (IV) Doses of Study Medication
Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.
Baseline up to Week 48
Baseline, Weeks 16, 40, 24, and 56
Number of Participants With Positive Urine or Serum Pregnancy Test
Female participants, who reported positive in urine or serum pregnancy test were reported.
Baseline up to Week 56
Birmingham
Alabama
35209
United States
Alliance Clinical Research
Birmingham
Alabama
35215
United States
Shades Mountain Imaging
Birmingham
Alabama
35216
United States
Rheumatology Associates of North Alabama, PC
Huntsville
Alabama
35801
United States
Saadat Ansari, MD Office
Huntsville
Alabama
35801
United States
Coastal Clinical Research, Inc.
Mobile
Alabama
36608
United States
Office of Vaughn H. Mancha, Jr., MD
Montgomery
Alabama
36117
United States
Radiant Research - Phoenix Southeast
Chandler
Arizona
85225
United States
Dedicated Clinical Research
Goodyear
Arizona
85395
United States
Eclipse Clinical Research
Green Valley
Arizona
85614
United States
Midwest Internal Medicine, PLLC
Lake Havasu City
Arizona
86403
United States
Arizona Arthritis & Rheumatology Associates, P.C.
Mesa
Arizona
85202
United States
Pivotal Research Centers
Mesa
Arizona
85210
United States
Arizona Arthritis & Rheumatology Research, PLLC
Paradise Valley
Arizona
85253
United States
Pivotal Research Centers
Peoria
Arizona
85381
United States
Elite Clinical Studies, LLC
Phoenix
Arizona
85018
United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix
Arizona
85037
United States
Cochise Clinical Research
Sierra Vista
Arizona
85635
United States
Premiere Phamaceutical Research, LLC
Tempe
Arizona
85282
United States
Radiant Research
Tucson
Arizona
85710
United States
Arizona Research Associates
Tucson
Arizona
85712-2142
United States
Quality of Life Medical and Research Center
Tucson
Arizona
85712
United States
Tucson Orthopaedic Institute
Tucson
Arizona
85712
United States
Little Rock Diagnostic Clinic, PA
Little Rock
Arkansas
72205
United States
Little Rock Family Practice Clinic
Little Rock
Arkansas
72205
United States
Advanced Clinical Research Institute
Anaheim
California
92801
United States
Orange County Clinical Trials, Inc.
Anaheim
California
92801
United States
Med Center
Carmichael
California
95608
United States
eStudySite
Chula Vista
California
91911
United States
Med Investigations, Inc.
Fair Oaks
California
95628
United States
Triwest Research
La Mesa
California
91942
United States
Lakewood Orthopedic Medical & Surgical Group
Lakewood
California
90712
United States
Premier Clinical Research LLC.
Lakewood
California
90712
United States
Prohealth Partners
Long Beach
California
90808
United States
Peak Health Medical Group, Inc.
Los Angeles
California
90025
United States
Synergy Clinical Research Center
National City
California
91950
United States
eStudySite
Oceanside
California
92056
United States
Desert Medical Group Inc., Desert Oasis Healthcare
Palm Springs
California
92262
United States
Advances in Medicine
Rancho Mirage
California
92270
United States
Mercy Imaging Center
Sacramento
California
95823
United States
Northern Clinical Research
Sacramento
California
95831
United States
California Research Foundation
San Diego
California
92103-6204
United States
San Diego Arthritis Medical Clinic
San Diego
California
92108
United States
Kaiser Permanente Medical Center
San Francisco
California
94118
United States
eStudySite
San Jose
California
95124
United States
Trinity Clinical Trials
Santa Ana
California
92701
United States
Apex Research Institute
Santa Ana
California
92705
United States
St. Joseph Medical Associates
Stockton
California
95204
United States
Westlake Medical Center
Westlake Village
California
91361
United States
Colorado Springs Family Practice
Colorado Springs
Colorado
80909
United States
Lynn Institute of the Rockies
Colorado Springs
Colorado
80909
United States
Colorado Arthritis Center, PC
Englewood
Colorado
80113
United States
Joao MA Nascimento, MD
Bridgeport
Connecticut
06606
United States
New England Research Associates, LLC
Trumbull
Connecticut
06611
United States
Rheumatology Consultants of Delaware/Delaware Arthritis
Lewes
Delaware
19958
United States
Arthritis and Rheumatic Disease Specialties
Aventura
Florida
33180
United States
International Physicans Research
Aventura
Florida
33180
United States
Surgery Center of Aventura
Aventura
Florida
33180
United States
HeartCare
Bradenton
Florida
34202
United States
Clinical Research of West Florida, Inc.
Clearwater
Florida
33765
United States
Nature Coast Clinical Research
Crystal River
Florida
34429
United States
Homestead Clinical Research Group, P.A.
Cutler Bay
Florida
33189
United States
Covance CRU, Inc.
Daytona Beach
Florida
32117
United States
Robert W. Levin MD
Dunedin
Florida
34698
United States
Internal Medicine Associates
Fort Myers
Florida
33912
United States
Clinical Physiology Associates, Clinical Study Center
Fort Myers
Florida
33916
United States
Research Consultants Group
Hialeah
Florida
33010
United States
Palm Springs Research Institute
Hialeah
Florida
33012
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Florida Arthritis
Lake Mary
Florida
32746
United States
Pharmax Research Clinic, Inc.
Miami
Florida
33126
United States
Community Research Foundation
Miami
Florida
33155
United States
International Research Associates, LLC
Miami
Florida
33183
United States
Jeffrey Alper MD Research
Naples
Florida
34102
United States
American Family Medicine
Ocala
Florida
34471
United States
Renstar Medical Research
Ocala
Florida
34471
United States
Sunshine Research Center
Opa-locka
Florida
33054-3818
United States
Arthritis Associates
Orlando
Florida
32804
United States
Arthritis Research of Florida, Inc.
Palm Harbor
Florida
34684
United States
University Clinical Research
Pembroke Pines
Florida
33024
United States
Pembroke Clinical Trials
Pemkbroke Pines
Florida
33028
United States
Advent Clinical Research Center Inc
Pinellas Park
Florida
33781
United States
Advent Clinical Research Centers
Pinellas Park
Florida
33781
United States
Berma Research Group
Plantation
Florida
33324
United States
Accord Clinical Research, LLC
Port Orange
Florida
32129
United States
HeartCare Research
Sarasota
Florida
34232
United States
Kennedy-White Orthopaedic Center
Sarasota
Florida
34232
United States
Sarasota Center for Clinical Research
Sarasota
Florida
34232
United States
Lovelace Scientific Resources
Sarasota
Florida
34233
United States
The Arthritis Specialty Centre
Sarasota
Florida
34233
United States
Dale G. Bramlet, MD, P.L.
St. Petersburg
Florida
33713
United States
Soutwest Florida Clinical Research Center
Tampa
Florida
33609-3018
United States
Stedman Clinical Trials
Tampa
Florida
33613
United States
Tampa Medical Group, PA
Tampa
Florida
33614
United States
Florida Medical Clinic, PA
Zephyrhills
Florida
33542
United States
Perimeter Institute for Clinical Reseach, Inc.
Atlanta
Georgia
30338
United States
Laureate Clinical Research Group
Atlanta
Georgia
30342
United States
ACCR/Internal Medicine
Roswell
Georgia
30075
United States
East-West Medical Research Institute
Honolulu
Hawaii
96814
United States
Institute of Arthritis Research
Idaho Falls
Idaho
83404
United States
Idaho Arthritis & Osteoporosis Center, PC
Meridian
Idaho
83642-6356
United States
Saltzer Medical Group PA
Nampa
Idaho
83686
United States
Rehabilitation Institute of Chicago
Chicago
Illinois
60611
United States
Rockford Orthopedic Associates
Rockford
Illinois
61107
United States
Springfield Clinic
Springfield
Illinois
62702
United States
Springfield Clinical Research Department
Springfield
Illinois
62703
United States
Deerbrook Medical Associates
Vernon Hills
Illinois
60061
United States
American Health Network of Indiana, LLC
Avon
Indiana
46123
United States
MediSphere Medical Research Center, LLC
Evansville
Indiana
47714
United States
Integrated Clinical Trial Services, Inc
West Des Moines
Iowa
50265
United States
Vince and Associates Clinical Research
Overland Park
Kansas
66211
United States
Vince and Associates Clinical Research
Overland Park
Kansas
66212
United States
Center for Arthritis and Osteoporosis
Elizabethtown
Kentucky
42701
United States
Pain Treatment Center of the Bluegrass
Lexington
Kentucky
40503
United States
Pasadena Pharmacy
Lexington
Kentucky
40503
United States
Commonwealth Biomedical Research, LLC
Madisonville
Kentucky
42431
United States
Multicare Specialists
Madisonville
Kentucky
42431
United States
Gulf Coast Research, LLC
Baton Rouge
Louisiana
70808
United States
The Bone and Joint Clinic
Baton Rouge
Louisiana
70808
United States
MD Medical Research
Oxon Hill
Maryland
20745
United States
Beacon Clinical Research
Brockton
Massachusetts
02301
United States
Berkshire Rheumatology
Pittsfield
Massachusetts
01201
United States
MedVadis Research Corporation
Watertown
Massachusetts
02472
United States
Quest Research Institute
Bingham Farms
Michigan
48025
United States
Rheumatology PC
Kalamazoo
Michigan
49009
United States
Justus J Fiechtner, MD
Lansing
Michigan
48910-8595
United States
PCM Medical Services
Lansing
Michigan
48917
United States
Medical Research Associates
Traverse City
Michigan
49684
United States
The Center for Clinical Trials
Biloxi
Mississippi
39531
United States
Olive Branch Family Medical Center
Olive Branch
Mississippi
38654
United States
Highland Community Hospital
Picayune
Mississippi
39466
United States
Mississippi Medical Research
Picayune
Mississippi
39466
United States
No. County Internal Medicine & Rheumatology
Florissant
Missouri
63031
United States
Dynamic Clinical Research, Inc.
Kansas City
Missouri
64114
United States
Joan Prouty Moore
Kansas City
Missouri
64114
United States
Orthopaedic & Occupational Medicine
Kansas City
Missouri
64114
United States
Medex Healthcare Research, Inc.
St Louis
Missouri
63117
United States
Rheumatology and Internal Medicine Associates of West County, P.C.
St Louis
Missouri
63131
United States
A & A Pain Institute
St Louis
Missouri
63141
United States
Arthritis Consultants Inc.
St Louis
Missouri
63141
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
Westroads Medical Group
Omaha
Nebraska
68114
United States
Anderson and Collins Clinical Research Inc.
Edison
New Jersey
08817
United States
Central Jersey Medical Research Center
Elizabeth
New Jersey
07202
United States
Arthritis & Osteoporosis Associates, P.A.
Freehold
New Jersey
07728
United States
Mark Fisher, MD, FACRUC
Haddon Heights
New Jersey
08035
United States
New Jersey Physicians, LLC
Passaic
New Jersey
07055
United States
Rheumatology Associates of North Jersey
Teaneck
New Jersey
07666
United States
Arthritis & Osteoporosis Associates
Toms River
New Jersey
08757
United States
Premier Research
Trenton
New Jersey
08611
United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township
New Jersey
08043
United States
The Center for Rheumatology, LLP
Albany
New York
12206
United States
Arthritis and Osteoporosis Associates of Brooklyn Heights
Brooklyn
New York
11201
United States
NYU Hospital for Joint Diseases
New York
New York
10003
United States
Prem C. Chatpar, MD, LLC
Plainview
New York
11803
United States
SPRI Bronx LLC
The Bronx
New York
10454
United States
Southgate Medical Group
West Seneca
New York
14224
United States
Physicians East P. A.
Greenville
North Carolina
27834
United States
Physicians East, PA
Greenville
North Carolina
27834
United States
Clinical Trials of America, Inc
Hickory
North Carolina
28601
United States
Piedmont Rheumatology
Hickory
North Carolina
28602
United States
Peters Medical Research
High Point
North Carolina
27262
United States
Wake Internal Medicine Consultants Inc
Raleigh
North Carolina
27612
United States
Wake Research Associates
Raleigh
North Carolina
27612
United States
Crescent Medical Research
Salisbury
North Carolina
28144
United States
Internal Medicine Associates
Fargo
North Dakota
58103
United States
Lillestol Research, LLC
Fargo
North Dakota
58103
United States
Daystar Clinical Research, Inc.
Akron
Ohio
44313
United States
New Horizons Clinical Research
Cincinnati
Ohio
45242
United States
Doctor's Urgent Care Offices
Cincinnati
Ohio
45246
United States
Sterling Research Group
Cincinnati
Ohio
45246
United States
Columbus Clinical Research, Inc.
Columbus
Ohio
43213
United States
Optimed Research, LTD
Columbus
Ohio
43235
United States
STAT Research, Inc.
Dayton
Ohio
45408
United States
Dayton Science Institute (DSI)
Dayton
Ohio
45415
United States
Hometown Urgent Care and Research
Dayton
Ohio
45432
United States
PHP - Center for Clinical Research
Dayton
Ohio
45439
United States
David R. Mandel, MD, Inc
Mayfield
Ohio
44143
United States
Southwest Rheumatology and Research Group, LLC
Middleburg Heights
Ohio
44130
United States
Integris Family Care of Norman
Norman
Oklahoma
73069
United States
LION Research
Norman
Oklahoma
73069
United States
Central Sooner Research
Norman
Oklahoma
73071
United States
Elise Wiesner, MD
Norman
Oklahoma
73071
United States
McBride Clinic, Inc
Norman
Oklahoma
73072
United States
McBride Clinic
Norman
Oklahoma
73072
United States
McBride Clinic, Inc
Oklahoma City
Oklahoma
73013
United States
Bone and Joint Hospital at St. Anthony
Oklahoma City
Oklahoma
73103
United States
Christine Codding, MD
Oklahoma City
Oklahoma
73103
United States
Health Research of Oklahoma
Oklahoma City
Oklahoma
73103
United States
Mc Bride Clinic
Oklahoma City
Oklahoma
73103
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Associated Orthopedics, Inc.
Oklahoma City
Oklahoma
73119
United States
Hillcrest Clinical Research
Oklahoma City
Oklahoma
73119
United States
Rheumatology Associates Inc
Tulsa
Oklahoma
74136
United States
Aquilo Clinical Research
Yukon
Oklahoma
73099
United States
Bend Memorial Clinic
Bend
Oregon
97701
United States
Bend Memorial Clinic
Bend
Oregon
97702
United States
Blair Orthopedics Associates
Altoona
Pennsylvania
16602
United States
Clinical Trials Research Services, LLC
Pittsburgh
Pennsylvania
15206
United States
Omega Medical Research
Warwick
Rhode Island
02886
United States
The Family Healthcare Center, PA
Clinton
South Carolina
29325
United States
Columbia Arthritis Center P.A.
Columbia
South Carolina
29204
United States
Southern Orthopaedic Sports Medicine
Columbia
South Carolina
29204
United States
Radiant Research Inc
Greer
South Carolina
29651
United States
The Carolina Center for Rheumatology and Arthritis Care, PA
Rock Hill
South Carolina
29732
United States
Regional Health Clinical Research
Rapid City
South Dakota
57701
United States
Regional Medical Clinical-Rheumatology
Rapid City
South Dakota
57701
United States
Arthritis Clinic
Jackson
Tennessee
38305
United States
Ramesh C. Gupta, M.D.
Memphis
Tennessee
38119
United States
Abilene Arthritis Center
Abilene
Texas
79601
United States
Tekton Research, Inc.
Austin
Texas
78745
United States
Dr. Paul K. Pickrell (Physician's Office)
Austin
Texas
78746
United States
Metroplex Clinical Research Center
Dallas
Texas
75231
United States
One Step Diagnostic
Houston
Texas
77030
United States
Accurate Clinical Research
Houston
Texas
77034
United States
Miracle Medical Center
Houston
Texas
77055
United States
DM Clinical Research
Houston
Texas
77070
United States
Gill Orthopedic Center
Lubbock
Texas
79410
United States
Robert R. King, M.D.
Lubbock
Texas
79410
United States
Southwest Rheumatology, PA
Mesquite
Texas
75150
United States
Hill Country Medical Associates
New Braunfels
Texas
78130
United States
Neurology Clinic of Central Texas
New Braunfels
Texas
78130
United States
Philip Blum
Pasadena
Texas
77504
United States
Pearland Primary Care Associates
Pearland
Texas
77584
United States
Southwest Clinical Research Centers, LLC
Pearland
Texas
77584
United States
Plano Primary Care Clinic
Plano
Texas
75075
United States
Advanced Family Medical Care
Plano
Texas
75093
United States
Alamo Clinical Research Associates
San Antonio
Texas
78212
United States
Alamo Clinical Research Consultants
San Antonio
Texas
78212
United States
Texas Arthritis Research Center, PA
San Antonio
Texas
78217
United States
Clinical Trials of Texas, Inc.
San Antonio
Texas
78229
United States
Innovative Clinical Trials
San Antonio
Texas
78229
United States
Radiant Research San Antonio
San Antonio
Texas
78229
United States
SAM Clinical Research Center
San Antonio
Texas
78229
United States
San Antonio Preventive & Diagnostic Medicine, PA
San Antonio
Texas
78229
United States
South Texas Radiology Imaging Center
San Antonio
Texas
78229
United States
The Rehab Group
San Antonio
Texas
78229
United States
Sugar Land Med-Ped, PA
Sugar Land
Texas
77479
United States
Scott & White Healthcare
Temple
Texas
76508
United States
Martin Diagnostic Clinic
Tomball
Texas
77375
United States
Pivotal Research Centers
Midvale
Utah
84047
United States
Optimum Clinical Research, Inc.
Salt Lake City
Utah
84102
United States
Radiant Research, Inc.
Salt Lake City
Utah
84107
United States
Doris M. Rice, M.D., F.A.C.R.
Portsmouth
Virginia
23701
United States
National Clinical Research Richmond Inc.
Richmond
Virginia
23294
United States
Hypothe Test, LLC
Roanoke
Virginia
24018
United States
Northwest Clinical Research Center
Bellevue
Washington
98007
United States
Tacoma Center for Arthritis Research, PS
Tacoma
Washington
98405-2308
United States
Gundersen Clinic Ltd.
Onalaska
Wisconsin
54650
United States
Office of Diane Wilson
Lunenburg
Nova Scotia
B0J 2C0
Canada
MAC Research Inc.
Hamilton
Ontario
L8N 2B6
Canada
KW Musculoskeletal Research Inc.
Kitchener
Ontario
N2M 5N6
Canada
The Arthritis Program Research Group
Newmarket
Ontario
L3Y 3R7
Canada
SKDS Research Inc.
Newmarket
Ontario
L3Y 5G8
Canada
Dr. Saeed Shaikh
St. Catharines
Ontario
L2N 7E4
Canada
Dr. Anil Gupta
Toronto
Ontario
M9V 4B4
Canada
Groupe de Recherche en Rhumatologie et Maladies Osseuses
Québec
Quebec
G1V 3M7
Canada
Clinique Medicale St-Louis
Québec
Quebec
G1W 4R4
Canada
Polyclinique St. Eustache
Saint-Eustache
Quebec
J7P 4J2
Canada
Diex Research Sherbrooke Inc.
Sherbrooke
Quebec
J1H 1Z1
Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières
Quebec
G8Z 1Y2
Canada
Hospital Pablo Tobon Uribe
Medellín
Antioquia
Colombia
Centro Integral de Reumatologia e Inmunologia CIREI
Bogota
Cundinamarca
Colombia
Riesgo de Fractura S.A.
Bogota-Cundinamarca
Colombia
Clinica Las Americas
Medellín
Colombia
Reumatologya S.A.
Medellín
Colombia
Krishna Institute of Medical Sciences Ltd., Department of Rheumatology
Secunderabad
Andhra Pradesh
500003
India
St. Johns Medical College Hospital, Department of Orthopaedics
Bangalore
Karnataka
560034
India
M.S. Ramaiah Memorial Hospital, Department of Orthopaedics
Bangalore
Karnataka
560054
India
ChanRe Rheumatology & Immunology Center & Research
Bangalore
Karnataka
560079
India
KMC Hospital, Department of Orthopaedics
Mangalore
Karnataka
575 001
India
Sancheti Hospital
Pune
Maharashtra
411 005
India
PSG Institute of Medical Sciences and Research
Coimbatore
Tamil Nadu
641004
India
CSM Medical University, Department of Rheumatology
Lucknow
Uttar Pradesh
226018
India
URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de Guadalajara"Fray Antonio Alcalde"
Guadalajara
Jalisco
CP 44280
Mexico
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C.
Coahuila
27000
Mexico
Hospital General de Culiacan, S.S., "Dr. Bernardo Gastelum".
Culiacan Sinaloa
CP 80230
Mexico
Hospital Aranda de la Parra
Leon Gto
C.P. 37000
Mexico
Beneficencia Espanola de la Laguna
Torreon Coahuila
CP 27000
Mexico
READE
Amsterdam
1056 AB
Netherlands
UMC St. Radboud
Nijmegen
6525 GA
Netherlands
UMC Utrecht
Utrecht
3584 CX
Netherlands
Cebu Orthopedic Institute
Cebu City
6000
Philippines
Chong Hua Hospital, Medical Arts Center
Cebu City
6000
Philippines
Diaz Building
Cebu City
6000
Philippines
Asian Hospital and Medical Center
City of Muntinlupa
1780
Philippines
Davao Doctors Hospital, Medical Tower
Davao City
8000
Philippines
Davao Doctors Hospital
Davao City
8000
Philippines
Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center
Manila
1003
Philippines
Chinese General Hospital and Medical Center, Out Patient Department
Manila
Philippines
State Healthcare Institution Moscow City Clinical Hospital #4
Moscow
115093
Russia
State Healthcare Institution: Moscow City Clinical Hospital #7
Moscow
115446
Russia
Institution Of Russian Academy of Medical Sciences
Moscow
115522
Russia
Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov
Saint Petersburg
194291
Russia
Saint-Petersburg State Healthcare Institution "City Hospital #26"
Saint Petersburg
196247
Russia
Saint Petersburg State Medical University named after Pavlov
Saint Petersburg
197022
Russia
136 Panorama Medical Center
Panorama
CAPE TOWN
7500
South Africa
Phelang Private Hospital Research Unit
Mamelodi East
Pretoria
0122
South Africa
Tiervlei Trial Center
Bellville
South Africa
Worthwhile Clinical Trials
Benoni
1500
South Africa
Josha Research
Bloemfontein
9301
South Africa
Vincent Pallotti Hospital
Cape Town
7405
South Africa
Private Practice
Durban
4091
South Africa
Randles Road Medical Center
Durban
4091
South Africa
A. Briel
Durbanville
7550
South Africa
Origin Clinical Research
Johannesburg
2060
South Africa
Clinresco Centres (Pty) Ltd
Kempton Park
1619
South Africa
Paarl Research Center
Paarl
7646
South Africa
TREAD Research
Parrowvalley
7500
South Africa
Clinical Research Unit
Pretoria
0083
South Africa
Kyungpook National University Hospital
Daegu
700-721
South Korea
Inha University Hospital
Incheon
400-711
South Korea
Seoul National University Hospital
Seoul
110-744
South Korea
Hanyang University Hospital
Seoul
133-792
South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul
137-701
South Korea
Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia
Sabadell
Barcelona
08208
Spain
Hospital El Tomillar
Dos Hermanas
Sevilla
41700
Spain
Complejo Hospitalario Universitario de A Coruna
A Coruña
15006
Spain
Hospital de Cruces, Servicio de Reumatologia
Barakaldo (Vizcaya)
48903
Spain
Clinica CIMA
Barcelona
08034
Spain
Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA
Barcelona
08034
Spain
Hospital Universitario La Paz, Servicio de Reumatologia
Madrid
28046
Spain
Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia
Santiago de Compostela, A Coruna
15705
Spain
Hospital Nuestra Senora de Valme, Servicio de Reumatologia
Seville
41014
Spain
Chernivtsi Regional Clinical Hospital
Chernivtsi
58002
Ukraine
City Clinical Hospital #5
Donetsk
83000
Ukraine
V.K. Gusak Institute of Urgent and Recovery Surgery
Donetsk
83045
Ukraine
Kiev City Oleksandrivska Clinical Hospital
Kiev
01601
Ukraine
Kiev City Clinical Hospital #3
Kiev
02125
Ukraine
State Institution "Research Centre for Radiation Medicine AMS of Ukraine"
Kiev
03115
Ukraine
State Institution "Institute of Gerontology AMS of Ukraine"
Kiev
04114
Ukraine
Municipal institution :Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya
69600
Ukraine
Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
Schnitzer TJ, Ekman EF, Spierings EL, Greenberg HS, Smith MD, Brown MT, West CR, Verburg KM. Efficacy and safety of tanezumab monotherapy or combined with non-steroidal anti-inflammatory drugs in the treatment of knee or hip osteoarthritis pain. Ann Rheum Dis. 2015 Jun;74(6):1202-11. doi: 10.1136/annrheumdis-2013-204905. Epub 2014 Mar 13.
FG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
FG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
FG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
FG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
FG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
FG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
FG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
FG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
FG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
FG000288 subjects
FG001289 subjects
FG002286 subjects
FG003288 subjects
FG004288 subjects
FG005256 subjects
FG006255 subjects
FG007257 subjects
FG008256 subjects
FG009257 subjects
Treated
FG000285 subjects
FG001288 subjects
FG002280 subjects
FG003288 subjects
FG004283 subjects
FG005256 subjects
FG006254 subjects
FG007256 subjects
FG008254 subjects
FG009256 subjects
COMPLETED
FG00033 subjects
FG00131 subjects
FG00232 subjects
FG00332 subjects
FG00432 subjects
FG00531 subjects
FG00632 subjects
FG00719 subjects
FG00828 subjects
FG00931 subjects
NOT COMPLETED
FG000255 subjects
FG001258 subjects
FG002254 subjects
FG003256 subjects
FG004256 subjects
FG005225 subjects
FG006223 subjects
FG007238 subjects
FG008228 subjects
FG009226 subjects
Type
Comment
Reasons
Adverse Event
FG00032 subjects
FG00145 subjects
FG00237 subjects
FG00353 subjects
FG00426 subjects
FG00533 subjects
FG00644 subjects
FG00740 subjects
FG00846 subjects
FG00926 subjects
Lack of Efficacy
FG00023 subjects
FG00123 subjects
FG00222 subjects
FG00315 subjects
FG004
Lost to Follow-up
FG00010 subjects
FG00111 subjects
FG0028 subjects
FG00313 subjects
FG004
Protocol Violation
FG0007 subjects
FG00114 subjects
FG00214 subjects
FG00312 subjects
FG004
Withdrawal by Subject
FG00032 subjects
FG00127 subjects
FG00231 subjects
FG00333 subjects
FG004
Other
FG00010 subjects
FG0012 subjects
FG0027 subjects
FG00310 subjects
FG004
Study terminated by sponsor
FG000138 subjects
FG001134 subjects
FG002129 subjects
FG003120 subjects
FG004
Withdrawn due to pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized but not Treated
FG0003 subjects
FG0011 subjects
FG0026 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
BG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
BG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
BG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
BG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
BG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
BG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
BG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
BG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
BG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000285
BG001288
BG002280
BG003288
BG004283
BG005256
BG006254
BG007256
BG008254
BG009256
BG0102700
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
18 to 44 years
BG00020
BG00116
BG00218
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000200
BG001208
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using baseline observation carried forward (BOCF). Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.39± 1.61
OG0016.50± 1.57
OG0026.52± 1.65
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG003
OG004
Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
Least Square (LS) Mean Difference
-0.92
Standard Error of the Mean
0.18
2-Sided
95
-1.28
-0.57
Superiority or Other (legacy)
OG002
OG004
Primary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Primary
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Week 16
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using baseline BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 2, 4, 8, 12, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 2, 4, 8, 12, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip).The WOMAC physical function subscale was comprised of 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 2, 4, 8, 12, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF.
Posted
Number
percentage of participants
Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was >=50 percent and >=2 units in WOMAC pain subscale or WOMAC physical function subscale score, or at least 2 of the following 3 being true: improvement from baseline to week of interest was >=20 percent and >=1 unit in 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [worst possible pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = worse physical function) and PGA of osteoarthritis (score: 1 [very good] to 5 [very poor], higher score = worse condition).
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF.
Posted
Number
percentage of participants
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score From Baseline at Weeks 2, 4, 8, 12, 16, and 24: BOCF
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30%, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF.
Posted
Number
percentage of participants
Baseline, Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants who experienced an improvement (reduction) of >=30 percent, >=50%, >=70%, or >=90% in the WOMAC pain subscale scores from Baseline were reported.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF.
Posted
Number
percentage of participants
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline, Week 16
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Number of participants who experienced reduction (as percent) of >0% to >=100% from Baseline in WOMAC pain subscale scores at Week 16 were reported.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF.
Posted
Count of Participants
Participants
Baseline, Week 16
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants With Improvement of At Least 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, and 24: Baseline Observation Carried Forward (BOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF.
Posted
Number
percentage of participants
Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants With Improvement of Atleast 2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56: Last Observation Carried Forward (LOCF)
Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded by using a 5-point likert scale ranging from 1=very good (asymptomatic and no limitation of normal activities, 2= mild symptoms and no limitation of normal activities, 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (Very severe symptoms which are intolerable and inability to carry out all normal activities). Higher scores indicating worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants who showed an improvement of >=2 points on scale were reported.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF.
Posted
Number
percentage of participants
Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis of the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), with higher scores indicate more stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated more stiffness.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Each item is scored on a 0 to 10 NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score was calculated as the mean of 3 WOMAC subscale scores (pain, physical function and stiffness). Total score range was 0 (no response) to 10 (worse response), where higher score indicated worse response.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants responded about the amount of pain they experienced when walking on a flat surface by answering the question: "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using BOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 2, 4, 8, 12, 16, and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Participants responded about the amount of pain they experienced when going up or down stairs by answering the question: "How much pain have you had when going up or down the stairs?" Participants responded by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Missing values were imputed using LOCF. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using BOCF. 'Number analyzed' signifies participants evaluable at specified time points.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 12 and 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Weeks 12, 24, 40 and 56: Last Observation Carried Forward (LOCF)
The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher scores represent better health status.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (either tanezumab or matching placebo). Missing values were imputed using LOCF. 'Number analyzed' signifies participants evaluable at specified time points.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Weeks 12, 24, 40, and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Secondary
Number of Participants Who Had Discontinued Study Due to Lack of Efficacy
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
Posted
Count of Participants
Participants
Baseline up to Week 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Secondary
Time to Discontinuation Due to Lack of Efficacy
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of study drug administration up to the date of discontinuation of participant from study due to lack of efficacy.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
Posted
Mean
Standard Error
days
Baseline up to Week 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions (Q) are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent work time missed
Baseline, Week 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Percent Work Time Missed Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent work time missed due to health problem: Q2/(Q2+Q4). The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent work time missed
Baseline, Week 24 and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent impairment
Baseline, Week 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Percent Impairment While Working Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent impairment while working due to health problem: Q5/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent impairment
Baseline, Weeks 24 and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): BOCF
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent work impairment
Baseline, Week 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Percent Overall Work Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire- Specific Health Problem (WPAI-SHP): LOCF
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent overall work impairment due to health problem: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))*(Q5/10)]. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent work impairment
Baseline, Weeks 24 and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Baseline Observation Carried Forward (BOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent activity impairment
Baseline, Week 24
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in the Percent Activity Impairment Due to Osteoarthritis at Week 24 and 56 Assessed Using Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP): Last Observation Carried Forward (LOCF)
The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem affected work productivity and regular activities over the past 7 days. The questions are: Q1 = currently employed. Q2 = hours missed due to health problems. Q3 = hours missed other reasons. Q4 = hours actually worked. Q5 = degree health affected productivity while working (0-10 scale). Q6 = degree health affected regular activities (0-10 scale). Subscale scores are calculated: Percent activity impairment due to health problem: Q6/10. The computed percentage range for each sub-scale is 0-100, where higher numbers indicate greater impairment and less productivity.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Mean
Standard Deviation
change in percent activity impairment
Baseline, Weeks 24, and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants Who Used Rescue Medication: Observed Data
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Percentage of Participants Who Used Rescue Medication: Last Observation Carried Forward (LOCF)
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day for maximum of 3 days within a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during each study interval were summarized.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Amount of Rescue Medication Used
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified time intervals were summarized.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Medial Minimum Joint Space Width of the Index Knee at Week 56
Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort.
Posted
Mean
Standard Deviation
millimeter (mm)
Baseline, Week 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)
Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)
Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Minimum Joint Space Width of the Index Hip at Week 56
Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort.
Posted
Mean
Standard Deviation
millimeter
Baseline, Week 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)
Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)
Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 64 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
Posted
Count of Participants
Participants
Baseline up to Week 64
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Secondary
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Observed Data
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Last Observation Carried Forward (LOCF)
The Neuropathy Impairment Score is the sum of scores over all 37 items from both the left and right side. The neurological impairment score assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense, and pin prick) of index fingers and great toes through neurological examination. NIS calculated scoring muscle weakness (0=normal, 1=25% weak, 2=50% weak, 3=75% week, 3.25= move against gravity, 3.5=movement gravity eliminated, 3.75= muscle flicker no movement, 4=paralysis), scoring reflexes (0=normal, 1=reduced. 2=absent), scoring sensation (0=normal, 1=decreased, 2=absent). For NIS possible overall score (combined of both left and right sides of each domain), ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased/more neuropathic deficits.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). 'Number analyzed' signifies participants evaluable at specified time points.
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Other Pre-specified
Number of Participants With Anti-Drug Antibody (ADA) Response
Human serum ADA samples were analyzed for the presence or absence of anti--tanezumab antibodies by using a semi quantitative enzyme -linked immunosorbent assay (ELISA). Participants tested positive for ADA response on at least one post-baseline visit were reported. Participants with ADA titer level >=4.32 for tanezumab were considered ADA positive.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg).
Posted
Count of Participants
Participants
Baseline, Weeks 16, 40, 24, and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)
Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)
Secondary
Plasma Trough (Pre-dose) Concentration of Tanezumab
Analysis was performed on ITT analysis set. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure and Number analyzed' signifies participants evaluable at specified time points. Data was planned to be assessed and reported for combined population of naproxen and celecoxib cohort. This outcome measure was planned not to be analyzed for placebo reporting arms (Naproxen 500 mg and Celecoxib 100 mg).
Posted
Mean
Standard Deviation
nanogram/milliliter
Predose on Day 1, Weeks 16, 24, 40, and 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen or Celecoxib Exposure)
Participants were administered with tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen or Celecoxib Exposure)
Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
Other Pre-specified
Number of Participants With Positive Urine or Serum Pregnancy Test
Female participants, who reported positive in urine or serum pregnancy test were reported.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline up to Week 56
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Secondary
Number of Participants With Intravenous (IV) Doses of Study Medication
Number of participants are reported based on the maximum number of IV doses of either tanezumab or placebo received.
ITT analysis set included all randomized participants who received at least 1 dose of IV study medication (tanezumab or matching placebo).
Posted
Count of Participants
Participants
Baseline up to Week 48
ID
Title
Description
OG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
Time Frame
Not provided
Description
Cases of osteonecrosis (ON) reported in this and other studies conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Tanezumab 5 mg (Naproxen Exposure)
Participants received tanezumab 5 milligram (mg) intravenously (IV) infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
22
285
201
285
EG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
23
288
205
288
EG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
28
280
201
280
EG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
30
288
202
288
EG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
22
283
188
283
EG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
22
256
195
256
EG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
23
254
181
254
EG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
26
256
182
256
EG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
34
254
187
254
EG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
21
256
170
256
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG0030 affected288 at risk
EG0040 affected283 at risk
EG0050 affected256 at risk
EG0061 affected254 at risk
EG0070 affected256 at risk
EG0080 affected254 at risk
EG0090 affected256 at risk
Acute left ventricular failure
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0002 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Retinal detachment
Eye disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Chest pain
General disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Gallbladder pain
Hepatobiliary disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Gangrene
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Septic shock
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Viral infection
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Wound sepsis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Extradural haematoma
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0022 affected280 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0021 affected280 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Blood pressure increased
Investigations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0002 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Intervertebral disc disorder
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0005 affected285 at risk
EG0012 affected288 at risk
EG0029 affected280 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0022 affected280 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Gastric cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Hepatic neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Lung carcinoma cell type unspecified stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Aphasia
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Paralysis
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
VIIth nerve paralysis
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Depression
Psychiatric disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Hypertension
Vascular disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Peptic ulcer perforation
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Oedema peripheral
General disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0021 affected280 at risk
EG003
Bursitis infective
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0021 affected280 at risk
EG003
Influenza
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Localised infection
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Sepsis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Chemical peritonitis
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Lumbar vertebral fracture
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Bone disorder
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Knee deformity
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Central nervous system lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Cervical myelopathy
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Convulsion
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0021 affected280 at risk
EG003
Headache
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Nerve root compression
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0011 affected288 at risk
EG0020 affected280 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0004 affected285 at risk
EG0016 affected288 at risk
EG0027 affected280 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0006 affected285 at risk
EG0013 affected288 at risk
EG0027 affected280 at risk
EG0035 affected288 at risk
EG0044 affected283 at risk
EG0050 affected256 at risk
EG0060 affected254 at risk
EG0070 affected256 at risk
EG0080 affected254 at risk
EG0090 affected256 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0002 affected285 at risk
EG0011 affected288 at risk
EG0025 affected280 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0005 affected285 at risk
EG0014 affected288 at risk
EG0026 affected280 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0008 affected285 at risk
EG0012 affected288 at risk
EG0028 affected280 at risk
EG003
Fatigue
General disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0002 affected285 at risk
EG0014 affected288 at risk
EG0026 affected280 at risk
EG003
Oedema peripheral
General disorders
MedDRA (v13.1)
Non-systematic Assessment
EG00015 affected285 at risk
EG00114 affected288 at risk
EG00220 affected280 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0008 affected285 at risk
EG0015 affected288 at risk
EG0025 affected280 at risk
EG003
Influenza
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0008 affected285 at risk
EG0017 affected288 at risk
EG0026 affected280 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0007 affected285 at risk
EG0019 affected288 at risk
EG00212 affected280 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0006 affected285 at risk
EG0016 affected288 at risk
EG0026 affected280 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG00011 affected285 at risk
EG00111 affected288 at risk
EG00214 affected280 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (v13.1)
Non-systematic Assessment
EG0009 affected285 at risk
EG00114 affected288 at risk
EG00213 affected280 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0005 affected285 at risk
EG00110 affected288 at risk
EG00212 affected280 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0001 affected285 at risk
EG0016 affected288 at risk
EG0023 affected280 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (v13.1)
Non-systematic Assessment
EG0007 affected285 at risk
EG00110 affected288 at risk
EG00213 affected280 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG00032 affected285 at risk
EG00150 affected288 at risk
EG00237 affected280 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG00016 affected285 at risk
EG00112 affected288 at risk
EG0029 affected280 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0002 affected285 at risk
EG0016 affected288 at risk
EG0028 affected280 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0008 affected285 at risk
EG00117 affected288 at risk
EG0029 affected280 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0009 affected285 at risk
EG0016 affected288 at risk
EG0029 affected280 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG00010 affected285 at risk
EG0017 affected288 at risk
EG00214 affected280 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0005 affected285 at risk
EG00110 affected288 at risk
EG0023 affected280 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG00012 affected285 at risk
EG00111 affected288 at risk
EG00212 affected280 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0009 affected285 at risk
EG00122 affected288 at risk
EG0029 affected280 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0003 affected285 at risk
EG00111 affected288 at risk
EG0024 affected280 at risk
EG003
Decreased vibratory sense
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0008 affected285 at risk
EG0011 affected288 at risk
EG0022 affected280 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0008 affected285 at risk
EG0015 affected288 at risk
EG00211 affected280 at risk
EG003
Headache
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0009 affected285 at risk
EG00118 affected288 at risk
EG0027 affected280 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG00016 affected285 at risk
EG00117 affected288 at risk
EG00216 affected280 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG00014 affected285 at risk
EG00128 affected288 at risk
EG00217 affected280 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0002 affected285 at risk
EG0016 affected288 at risk
EG0022 affected280 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0006 affected285 at risk
EG0012 affected288 at risk
EG0022 affected280 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0006 affected285 at risk
EG0017 affected288 at risk
EG0022 affected280 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0003 affected285 at risk
EG0015 affected288 at risk
EG0027 affected280 at risk
EG003
Hypertension
Vascular disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0006 affected285 at risk
EG0019 affected288 at risk
EG00211 affected280 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Asthenia
General disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (v13.1)
Non-systematic Assessment
EG0000 affected285 at risk
EG0010 affected288 at risk
EG0020 affected280 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D010003
Osteoarthritis
D001168
Arthritis
D009477
Hereditary Sensory and Autonomic Neuropathies
Ancestor Terms
ID
Term
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D009421
Nervous System Malformations
D009422
Nervous System Diseases
D020271
Heredodegenerative Disorders, Nervous System
D019636
Neurodegenerative Diseases
D011115
Polyneuropathies
D010523
Peripheral Nervous System Diseases
D009468
Neuromuscular Diseases
D000013
Congenital Abnormalities
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D030342
Genetic Diseases, Inborn
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000894
Anti-Inflammatory Agents, Non-Steroidal
C549319
tanezumab
Ancestor Terms
ID
Term
D018712
Analgesics, Non-Narcotic
D000700
Analgesics
D018689
Sensory System Agents
D018373
Peripheral Nervous System Agents
D045505
Physiological Effects of Drugs
D020228
Pharmacologic Actions
D020164
Chemical Actions and Uses
D000893
Anti-Inflammatory Agents
D045506
Therapeutic Uses
D018501
Antirheumatic Agents
Browse Leaves
Not provided
Browse Branches
Not provided
40 subjects
FG00519 subjects
FG00621 subjects
FG00715 subjects
FG00818 subjects
FG00938 subjects
6 subjects
FG0052 subjects
FG0060 subjects
FG0075 subjects
FG0084 subjects
FG0090 subjects
14 subjects
FG0056 subjects
FG0064 subjects
FG0076 subjects
FG0089 subjects
FG0093 subjects
34 subjects
FG00529 subjects
FG00627 subjects
FG00719 subjects
FG00818 subjects
FG00920 subjects
5 subjects
FG0053 subjects
FG0062 subjects
FG0073 subjects
FG0084 subjects
FG0093 subjects
126 subjects
FG005133 subjects
FG006124 subjects
FG007148 subjects
FG008127 subjects
FG009135 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
5 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0082 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
18
BG00414
BG0058
BG0063
BG00711
BG0087
BG0093
BG010118
45 to 64 years
BG000168
BG001181
BG002157
BG003171
BG004195
BG005134
BG006117
BG007139
BG008133
BG009144
BG0101539
greater than or equal to (>=) 65 years
BG00097
BG00191
BG002105
BG00399
BG00474
BG005114
BG006134
BG007106
BG008114
BG009109
BG0101043
184
BG003192
BG004199
BG005192
BG006184
BG007179
BG008177
BG009189
BG0101904
Male
BG00085
BG00180
BG00296
BG00396
BG00484
BG00564
BG00670
BG00777
BG00877
BG00967
BG010796
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
286
OG004282
OG005254
OG006254
OG007256
OG008254
OG009255
6.33
± 1.65
OG0046.32± 1.64
OG0056.49± 1.55
OG0066.44± 1.53
OG0076.41± 1.66
OG0086.27± 1.64
OG0096.29± 1.60
Change at Week 16
Title
Measurements
OG000-1.80± 2.20
OG001-1.97± 2.35
OG002-2.09± 2.19
OG003-2.26± 2.31
OG004-1.34± 2.08
OG005-2.11± 2.51
OG006-2.12± 2.36
OG007-2.28± 2.43
OG008-2.41± 2.54
OG009-1.48± 2.07
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.70
Standard Error of the Mean
0.18
2-Sided
95
-1.06
-0.33
Superiority or Other (legacy)
OG001
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.001
LS Mean Difference
-0.58
Standard Error of the Mean
0.18
2-Sided
95
-0.94
-0.23
Superiority or Other (legacy)
OG000
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.015
LS Mean Difference
-0.45
Standard Error of the Mean
0.18
2-Sided
95
-0.81
-0.09
Superiority or Other (legacy)
OG000
OG001
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.453
LS Mean Difference
-0.14
Standard Error of the Mean
0.18
2-Sided
95
-0.49
0.22
Superiority or Other (legacy)
OG000
OG002
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.177
LS Mean Difference
-0.25
Standard Error of the Mean
0.18
2-Sided
95
-0.61
0.11
Superiority or Other (legacy)
OG001
OG003
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.062
LS Mean Difference
-0.34
Standard Error of the Mean
0.18
2-Sided
95
-0.70
0.02
Superiority or Other (legacy)
OG002
OG003
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.212
LS Mean Difference
-0.23
Standard Error of the Mean
0.18
2-Sided
95
-0.59
0.13
Superiority or Other (legacy)
OG008
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.94
Standard Error of the Mean
0.20
2-Sided
95
-1.34
-0.54
Superiority or Other (legacy)
OG007
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.75
Standard Error of the Mean
0.20
2-Sided
95
-1.15
-0.35
Superiority or Other (legacy)
OG006
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.004
LS Mean Difference
-0.58
Standard Error of the Mean
0.20
2-Sided
95
-0.98
-0.18
Superiority or Other (legacy)
OG005
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.007
LS Mean Difference
-0.55
Standard Error of the Mean
0.20
2-Sided
95
-0.95
-0.15
Superiority or Other (legacy)
OG005
OG006
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.879
LS Mean Difference
-0.03
Standard Error of the Mean
0.20
2-Sided
95
-0.43
0.37
Superiority or Other (legacy)
OG005
OG007
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.330
LS Mean Difference
-0.20
Standard Error of the Mean
0.20
2-Sided
95
-0.60
0.20
Superiority or Other (legacy)
OG006
OG008
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.083
LS Mean Difference
-0.35
Standard Error of the Mean
0.20
2-Sided
95
-0.75
0.05
Superiority or Other (legacy)
OG007
OG008
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.360
LS Mean Difference
-0.19
Standard Error of the Mean
0.20
2-Sided
95
-0.59
0.21
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000284
OG001287
OG002280
OG003286
OG004282
OG005255
OG006253
OG007255
OG008253
OG009254
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.46± 1.72
OG0016.47± 1.61
OG0026.57± 1.67
OG0036.39± 1.62
OG0046.32± 1.62
OG0056.67± 1.60
OG0066.58± 1.58
OG0076.57± 1.72
OG0086.39± 1.62
OG0096.47± 1.59
Change at Week 16
Title
Measurements
OG000-1.80± 2.15
OG001-1.84± 2.13
OG002-2.12± 2.19
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG003
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.88
Standard Error of the Mean
0.18
2-Sided
95
-1.23
-0.53
Superiority or Other (legacy)
OG002
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.78
Standard Error of the Mean
0.18
2-Sided
95
-1.13
-0.43
Superiority or Other (legacy)
OG001
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.003
LS Mean Difference
-0.52
Standard Error of the Mean
0.18
2-Sided
95
-0.87
-0.17
Superiority or Other (legacy)
OG000
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.007
LS Mean Difference
-0.48
Standard Error of the Mean
0.18
2-Sided
95
-0.83
-0.13
Superiority or Other (legacy)
OG000
OG001
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.824
LS Mean Difference
-0.04
Standard Error of the Mean
0.18
2-Sided
95
-0.39
0.31
Superiority or Other (legacy)
OG000
OG002
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.100
LS Mean Difference
-0.29
Standard Error of the Mean
0.18
2-Sided
95
-0.64
0.06
Superiority or Other (legacy)
OG001
OG003
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.044
LS Mean Difference
-0.36
Standard Error of the Mean
0.18
2-Sided
95
-0.70
-0.01
Superiority or Other (legacy)
OG002
OG003
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.565
LS Mean Difference
-0.10
Standard Error of the Mean
0.18
2-Sided
95
-0.45
0.25
Superiority or Other (legacy)
OG008
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.01
Standard Error of the Mean
0.20
2-Sided
95
-1.40
-0.62
Superiority or Other (legacy)
OG007
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.81
Standard Error of the Mean
0.20
2-Sided
95
-1.20
-0.42
Superiority or Other (legacy)
OG006
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.63
Standard Error of the Mean
0.20
2-Sided
95
-1.02
-0.24
Superiority or Other (legacy)
OG005
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.63
Standard Error of the Mean
0.20
2-Sided
95
-1.02
-0.24
Superiority or Other (legacy)
OG005
OG006
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.980
LS Mean Difference
0.01
Standard Error of the Mean
0.20
2-Sided
95
-0.39
0.40
Superiority or Other (legacy)
OG005
OG007
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.383
LS Mean Difference
-0.17
Standard Error of the Mean
0.20
2-Sided
95
-0.56
0.22
Superiority or Other (legacy)
OG006
OG008
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.057
LS Mean Difference
-0.38
Standard Error of the Mean
0.20
2-Sided
95
-0.77
0.01
Superiority or Other (legacy)
OG007
OG008
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.312
LS Mean Difference
-0.20
Standard Error of the Mean
0.20
2-Sided
95
-0.59
0.19
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000284
OG001288
OG002280
OG003285
OG004283
OG005256
OG006254
OG007255
OG008253
OG009254
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003.39± 0.63
OG0013.41± 0.62
OG0023.39± 0.63
OG0033.39± 0.66
OG0043.38± 0.63
OG0053.44± 0.65
OG0063.48± 0.63
OG0073.45± 0.67
OG0083.41± 0.64
OG0093.37± 0.59
Change at Week 16
Title
Measurements
OG000-0.54± 0.90
OG001-0.63± 0.91
OG002-0.61± 0.89
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG003
OG004
Analysis was based on analysis of co-variance (ANCOVA) model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.008
LS Mean Difference
-0.18
Standard Error of the Mean
0.07
2-Sided
95
-0.32
-0.05
Superiority or Other (legacy)
OG002
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.251
LS Mean Difference
-0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.22
0.06
Superiority or Other (legacy)
OG001
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.251
LS Mean Difference
-0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.22
0.06
Superiority or Other (legacy)
OG000
OG004
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.961
LS Mean Difference
-0.00
Standard Error of the Mean
0.07
2-Sided
95
-0.14
0.13
Superiority or Other (legacy)
OG000
OG001
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.272
LS Mean Difference
-0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.06
Superiority or Other (legacy)
OG000
OG002
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.271
LS Mean Difference
-0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.06
Superiority or Other (legacy)
OG001
OG003
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.128
LS Mean Difference
-0.11
Standard Error of the Mean
0.07
2-Sided
95
-0.24
0.03
Superiority or Other (legacy)
OG002
OG003
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.133
LS Mean Difference
-0.10
Standard Error of the Mean
0.07
2-Sided
95
-0.24
0.03
Superiority or Other (legacy)
OG008
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.21
Standard Error of the Mean
0.07
2-Sided
95
-0.35
-0.08
Superiority or Other (legacy)
OG007
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.004
LS Mean Difference
-0.20
Standard Error of the Mean
0.07
2-Sided
95
-0.34
-0.06
Superiority or Other (legacy)
OG006
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.414
LS Mean Difference
-0.06
Standard Error of the Mean
0.07
2-Sided
95
-0.20
0.08
Superiority or Other (legacy)
OG005
OG009
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.057
LS Mean Difference
-0.13
Standard Error of the Mean
0.07
2-Sided
95
-0.27
0.00
Superiority or Other (legacy)
OG005
OG006
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.277
LS Mean Difference
0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.06
0.21
Superiority or Other (legacy)
OG005
OG007
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.328
LS Mean Difference
-0.07
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.07
Superiority or Other (legacy)
OG006
OG008
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.026
LS Mean Difference
-0.16
Standard Error of the Mean
0.07
2-Sided
95
-0.30
-0.02
Superiority or Other (legacy)
OG007
OG008
Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.864
LS Mean Difference
-0.01
Standard Error of the Mean
0.07
2-Sided
95
-0.15
0.13
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003286
OG004282
OG005254
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-0.96± 1.98
OG001-1.00± 2.08
OG002-1.27± 2.03
OG003-0.89± 2.21
OG004-0.90± 1.81
OG005-1.01± 2.15
OG006-0.74± 2.08
OG007-1.08± 2.03
OG008-0.86± 2.22
OG009-0.93± 1.66
Change at Week 4
Title
Measurements
OG000-1.68± 2.05
OG001-1.87± 1.96
OG002-2.09± 2.13
OG003
Change at Week 8
Title
Measurements
OG000-1.68± 2.27
OG001-2.08± 2.14
OG002-2.10± 2.25
OG003
Change at Week 12
Title
Measurements
OG000-1.86± 2.32
OG001-1.95± 2.21
OG002-2.26± 2.21
OG003
Change at Week 24
Title
Measurements
OG000-1.65± 2.33
OG001-1.82± 2.32
OG002-1.83± 2.19
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG003
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.927
LS Mean Difference
0.01
Standard Error of the Mean
0.16
2-Sided
95
-0.31
0.34
Superiority or Other (legacy)
OG002
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.057
LS Mean Difference
-0.31
Standard Error of the Mean
0.17
2-Sided
95
-0.64
0.01
Superiority or Other (legacy)
OG001
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.779
LS Mean Difference
-0.05
Standard Error of the Mean
0.16
2-Sided
95
-0.37
0.28
Superiority or Other (legacy)
OG000
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.798
LS Mean Difference
-0.04
Standard Error of the Mean
0.16
2-Sided
95
-0.36
0.28
Superiority or Other (legacy)
OG000
OG001
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.980
LS Mean Difference
-0.00
Standard Error of the Mean
0.16
2-Sided
95
-0.33
0.32
Superiority or Other (legacy)
OG000
OG002
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.098
LS Mean Difference
-0.27
Standard Error of the Mean
0.16
2-Sided
95
-0.60
0.05
Superiority or Other (legacy)
OG001
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.709
LS Mean Difference
0.06
Standard Error of the Mean
0.16
2-Sided
95
-0.26
0.38
Superiority or Other (legacy)
OG002
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.045
LS Mean Difference
0.33
Standard Error of the Mean
0.16
2-Sided
95
0.01
0.65
Superiority or Other (legacy)
OG008
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.710
LS Mean Difference
0.06
Standard Error of the Mean
0.17
2-Sided
95
-0.28
0.41
Superiority or Other (legacy)
OG007
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.504
LS Mean Difference
-0.12
Standard Error of the Mean
0.17
2-Sided
95
-0.46
0.23
Superiority or Other (legacy)
OG006
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.183
LS Mean Difference
0.23
Standard Error of the Mean
0.17
2-Sided
95
-0.11
0.58
Superiority or Other (legacy)
OG005
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.919
LS Mean Difference
-0.02
Standard Error of the Mean
0.17
2-Sided
95
-0.36
0.33
Superiority or Other (legacy)
OG005
OG006
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.152
LS Mean Difference
0.25
Standard Error of the Mean
0.17
2-Sided
95
-0.09
0.59
Superiority or Other (legacy)
OG005
OG007
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.572
LS Mean Difference
-0.10
Standard Error of the Mean
0.17
2-Sided
95
-0.44
0.24
Superiority or Other (legacy)
OG006
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.337
LS Mean Difference
-0.17
Standard Error of the Mean
0.17
2-Sided
95
-0.51
0.18
Superiority or Other (legacy)
OG007
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.299
LS Mean Difference
0.18
Standard Error of the Mean
0.17
2-Sided
95
-0.16
0.52
Superiority or Other (legacy)
OG003
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.84
Standard Error of the Mean
0.17
2-Sided
95
-1.17
-0.50
Superiority or Other (legacy)
OG002
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.89
Standard Error of the Mean
0.17
2-Sided
95
-1.22
-0.55
Superiority or Other (legacy)
OG001
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.68
Standard Error of the Mean
0.17
2-Sided
95
-1.01
-0.34
Superiority or Other (legacy)
OG000
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.003
LS Mean Difference
-0.52
Standard Error of the Mean
0.17
2-Sided
95
-0.85
-0.18
Superiority or Other (legacy)
OG000
OG001
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.341
LS Mean Difference
-0.16
Standard Error of the Mean
0.17
2-Sided
95
-0.50
0.17
Superiority or Other (legacy)
OG000
OG002
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.031
LS Mean Difference
-0.37
Standard Error of the Mean
0.17
2-Sided
95
-0.71
-0.03
Superiority or Other (legacy)
OG001
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.349
LS Mean Difference
-0.16
Standard Error of the Mean
0.17
2-Sided
95
-0.49
0.17
Superiority or Other (legacy)
OG002
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.780
LS Mean Difference
0.05
Standard Error of the Mean
0.17
2-Sided
95
-0.29
0.38
Superiority or Other (legacy)
OG008
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.95
Standard Error of the Mean
0.19
2-Sided
95
-1.31
-0.58
Superiority or Other (legacy)
OG007
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.93
Standard Error of the Mean
0.18
2-Sided
95
-1.29
-0.56
Superiority or Other (legacy)
OG006
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.63
Standard Error of the Mean
0.19
2-Sided
95
-0.99
-0.26
Superiority or Other (legacy)
OG005
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.005
LS Mean Difference
-0.52
Standard Error of the Mean
0.19
2-Sided
95
-0.88
-0.15
Superiority or Other (legacy)
OG005
OG006
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.562
LS Mean Difference
-0.11
Standard Error of the Mean
0.19
2-Sided
95
-0.47
0.26
Superiority or Other (legacy)
OG005
OG007
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.028
LS Mean Difference
-0.41
Standard Error of the Mean
0.19
2-Sided
95
-0.77
-0.04
Superiority or Other (legacy)
OG006
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.084
LS Mean Difference
-0.32
Standard Error of the Mean
0.19
2-Sided
95
-0.68
0.04
Superiority or Other (legacy)
OG007
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.910
LS Mean Difference
-0.02
Standard Error of the Mean
0.19
2-Sided
95
-0.38
0.34
Superiority or Other (legacy)
OG003
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.05
Standard Error of the Mean
0.18
2-Sided
95
-1.40
-0.69
Superiority or Other (legacy)
OG002
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.91
Standard Error of the Mean
0.18
2-Sided
95
-1.27
-0.56
Superiority or Other (legacy)
OG001
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.90
Standard Error of the Mean
0.18
2-Sided
95
-1.25
-0.55
Superiority or Other (legacy)
OG000
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.003
LS Mean Difference
-0.53
Standard Error of the Mean
0.18
2-Sided
95
-0.88
-0.17
Superiority or Other (legacy)
OG000
OG001
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.039
LS Mean Difference
-0.37
Standard Error of the Mean
0.18
2-Sided
95
-0.72
-0.02
Superiority or Other (legacy)
OG000
OG002
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.032
LS Mean Difference
-0.39
Standard Error of the Mean
0.18
2-Sided
95
-0.74
-0.03
Superiority or Other (legacy)
OG001
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.409
LS Mean Difference
-0.15
Standard Error of the Mean
0.18
2-Sided
95
-0.50
0.20
Superiority or Other (legacy)
OG002
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.461
LS Mean Difference
-0.13
Standard Error of the Mean
0.18
2-Sided
95
-0.49
0.22
Superiority or Other (legacy)
OG008
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.21
Standard Error of the Mean
0.19
2-Sided
95
-1.59
-0.84
Superiority or Other (legacy)
OG007
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.03
Standard Error of the Mean
0.19
2-Sided
95
-1.40
-0.65
Superiority or Other (legacy)
OG006
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.80
Standard Error of the Mean
0.19
2-Sided
95
-1.17
-0.43
Superiority or Other (legacy)
OG005
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.59
Standard Error of the Mean
0.19
2-Sided
95
-0.97
-0.22
Superiority or Other (legacy)
OG005
OG006
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.281
LS Mean Difference
-0.21
Standard Error of the Mean
0.19
2-Sided
95
-0.58
0.17
Superiority or Other (legacy)
OG005
OG007
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.023
LS Mean Difference
-0.43
Standard Error of the Mean
0.19
2-Sided
95
-0.81
-0.06
Superiority or Other (legacy)
OG006
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.031
LS Mean Difference
-0.41
Standard Error of the Mean
0.19
2-Sided
95
-0.79
-0.04
Superiority or Other (legacy)
OG007
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.331
LS Mean Difference
-0.19
Standard Error of the Mean
0.19
2-Sided
95
-0.56
0.19
Superiority or Other (legacy)
OG003
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.11
Standard Error of the Mean
0.18
2-Sided
95
-1.47
-0.75
Superiority or Other (legacy)
OG002
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.97
Standard Error of the Mean
0.18
2-Sided
95
-1.33
-0.60
Superiority or Other (legacy)
OG001
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.67
Standard Error of the Mean
0.18
2-Sided
95
-1.03
-0.31
Superiority or Other (legacy)
OG000
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.62
Standard Error of the Mean
0.18
2-Sided
95
-0.98
-0.26
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.781
LS Mean Difference
-0.05
Standard Error of the Mean
0.18
2-Sided
95
-0.41
0.31
Superiority or Other (legacy)
OG000
OG002
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.057
LS Mean Difference
-0.35
Standard Error of the Mean
0.18
2-Sided
95
-0.71
0.01
Superiority or Other (legacy)
OG001
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.016
LS Mean Difference
-0.44
Standard Error of the Mean
0.18
2-Sided
95
-0.80
-0.08
Superiority or Other (legacy)
OG002
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.450
LS Mean Difference
-0.14
Standard Error of the Mean
0.18
2-Sided
95
-0.50
0.22
Superiority or Other (legacy)
OG008
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.08
Standard Error of the Mean
0.20
2-Sided
95
-1.47
-0.69
Superiority or Other (legacy)
OG007
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.81
Standard Error of the Mean
0.20
2-Sided
95
-1.20
-0.42
Superiority or Other (legacy)
OG006
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.73
Standard Error of the Mean
0.20
2-Sided
95
-1.12
-0.34
Superiority or Other (legacy)
OG005
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.001
LS Mean Difference
-0.65
Standard Error of the Mean
0.20
2-Sided
95
-1.04
-0.26
Superiority or Other (legacy)
OG005
OG006
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.699
LS Mean Difference
-0.08
Standard Error of the Mean
0.20
2-Sided
95
-0.47
0.31
Superiority or Other (legacy)
OG005
OG007
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.408
LS Mean Difference
-0.16
Standard Error of the Mean
0.20
2-Sided
95
-0.55
0.22
Superiority or Other (legacy)
OG006
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.077
LS Mean Difference
-0.35
Standard Error of the Mean
0.20
2-Sided
95
-0.74
0.04
Superiority or Other (legacy)
OG007
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.182
LS Mean Difference
-0.26
Standard Error of the Mean
0.20
2-Sided
95
-0.65
0.12
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003286
OG004282
OG005254
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-0.96± 1.98
OG001-1.00± 2.08
OG002-1.27± 2.03
OG003-0.89± 2.21
OG004-0.90± 1.81
OG005-1.01± 2.15
OG006-0.74± 2.08
OG007-1.08± 2.03
OG008-0.86± 2.22
OG009-0.93± 1.66
Change at Week 4
Title
Measurements
OG000-1.66± 2.09
OG001-1.92± 1.96
OG002-2.12± 2.13
OG003
Change at Week 8
Title
Measurements
OG000-1.76± 2.34
OG001-2.20± 2.17
OG002-2.26± 2.25
OG003
Change at Week 12
Title
Measurements
OG000-2.04± 2.40
OG001-2.14± 2.24
OG002-2.45± 2.18
OG003
Change at Week 16
Title
Measurements
OG000-2.00± 2.29
OG001-2.19± 2.37
OG002-2.36± 2.20
OG003
Change at Week 24
Title
Measurements
OG000-2.04± 2.44
OG001-2.12± 2.37
OG002-2.20± 2.26
OG003
Change at Week 32
Title
Measurements
OG000-1.94± 2.51
OG001-2.08± 2.40
OG002-2.10± 2.32
OG003
Change at Week 40
Title
Measurements
OG000-1.90± 2.54
OG001-1.94± 2.50
OG002-1.88± 2.38
OG003
Change at Week 48
Title
Measurements
OG000-1.86± 2.54
OG001-1.93± 2.51
OG002-1.86± 2.44
OG003
Change at Week 56
Title
Measurements
OG000-1.84± 2.54
OG001-1.86± 2.49
OG002-1.84± 2.44
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.798
LS Mean Difference
-0.04
Standard Error of the Mean
0.16
2-Sided
95
-0.36
0.28
Superiority or Other (legacy)
OG001
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.779
LS Mean Difference
-0.05
Standard Error of the Mean
0.16
2-Sided
95
-0.37
0.28
Superiority or Other (legacy)
OG002
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.057
LS Mean Difference
-0.31
Standard Error of the Mean
0.17
2-Sided
95
-0.64
0.01
Superiority or Other (legacy)
OG003
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.927
LS Mean Difference
0.01
Standard Error of the Mean
0.16
2-Sided
95
-0.31
0.34
Superiority or Other (legacy)
OG000
OG001
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.980
LS Mean Difference
-0.00
Standard Error of the Mean
0.16
2-Sided
95
-0.33
0.32
Superiority or Other (legacy)
OG000
OG002
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.098
LS Mean Difference
-0.27
Standard Error of the Mean
0.16
2-Sided
95
-0.60
0.05
Superiority or Other (legacy)
OG001
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.709
LS Mean Difference
0.06
Standard Error of the Mean
0.16
2-Sided
95
-0.26
0.38
Superiority or Other (legacy)
OG002
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.045
LS Mean Difference
0.33
Standard Error of the Mean
0.16
2-Sided
95
0.01
0.65
Superiority or Other (legacy)
OG005
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.919
LS Mean Difference
-0.02
Standard Error of the Mean
0.17
2-Sided
95
-0.36
0.33
Superiority or Other (legacy)
OG006
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.183
LS Mean Difference
0.23
Standard Error of the Mean
0.17
2-Sided
95
-0.11
0.58
Superiority or Other (legacy)
OG007
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.504
LS Mean Difference
-0.12
Standard Error of the Mean
0.17
2-Sided
95
-0.46
0.23
Superiority or Other (legacy)
OG008
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.710
LS Mean Difference
0.06
Standard Error of the Mean
0.17
2-Sided
95
-0.28
0.41
Superiority or Other (legacy)
OG005
OG006
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.152
LS Mean Difference
0.25
Standard Error of the Mean
0.17
2-Sided
95
-0.09
0.59
Superiority or Other (legacy)
OG005
OG007
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.572
LS Mean Difference
-0.10
Standard Error of the Mean
0.17
2-Sided
95
-0.44
0.24
Superiority or Other (legacy)
OG006
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.337
LS Mean Difference
-0.17
Standard Error of the Mean
0.17
2-Sided
95
-0.51
0.18
Superiority or Other (legacy)
OG007
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.299
LS Mean Difference
0.18
Standard Error of the Mean
0.17
2-Sided
95
-0.16
0.52
Superiority or Other (legacy)
OG000
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.005
LS Mean Difference
-0.48
Standard Error of the Mean
0.17
2-Sided
95
-0.82
-0.14
Superiority or Other (legacy)
OG001
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.71
Standard Error of the Mean
0.17
2-Sided
95
-1.05
-0.38
Superiority or Other (legacy)
OG002
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.91
Standard Error of the Mean
0.17
2-Sided
95
-1.25
-0.57
Superiority or Other (legacy)
OG003
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.90
Standard Error of the Mean
0.17
2-Sided
95
-1.23
-0.56
Superiority or Other (legacy)
OG000
OG001
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.177
LS Mean Difference
-0.23
Standard Error of the Mean
0.17
2-Sided
95
-0.57
0.10
Superiority or Other (legacy)
OG000
OG002
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.014
LS Mean Difference
-0.42
Standard Error of the Mean
0.17
2-Sided
95
-0.76
-0.09
Superiority or Other (legacy)
OG001
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.286
LS Mean Difference
-0.18
Standard Error of the Mean
0.17
2-Sided
95
-0.52
0.15
Superiority or Other (legacy)
OG002
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.952
LS Mean Difference
0.01
Standard Error of the Mean
0.17
2-Sided
95
-0.33
0.35
Superiority or Other (legacy)
OG005
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.58
Standard Error of the Mean
0.19
2-Sided
95
-0.95
-0.21
Superiority or Other (legacy)
OG006
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.003
LS Mean Difference
-0.57
Standard Error of the Mean
0.19
2-Sided
95
-0.94
-0.20
Superiority or Other (legacy)
OG007
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.89
Standard Error of the Mean
0.19
2-Sided
95
-1.26
-0.52
Superiority or Other (legacy)
OG008
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.92
Standard Error of the Mean
0.19
2-Sided
95
-1.29
-0.55
Superiority or Other (legacy)
OG005
OG006
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.972
LS Mean Difference
0.01
Standard Error of the Mean
0.19
2-Sided
95
-0.36
0.38
Superiority or Other (legacy)
OG005
OG007
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.096
LS Mean Difference
-0.31
Standard Error of the Mean
0.19
2-Sided
95
-0.69
0.06
Superiority or Other (legacy)
OG006
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.069
LS Mean Difference
-0.34
Standard Error of the Mean
0.19
2-Sided
95
-0.72
0.03
Superiority or Other (legacy)
OG007
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.902
LS Mean Difference
-0.02
Standard Error of the Mean
0.19
2-Sided
95
-0.39
0.35
Superiority or Other (legacy)
OG000
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.57
Standard Error of the Mean
0.18
2-Sided
95
-0.93
-0.22
Superiority or Other (legacy)
OG001
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.97
Standard Error of the Mean
0.18
2-Sided
95
-1.33
-0.61
Superiority or Other (legacy)
OG002
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.02
Standard Error of the Mean
0.18
2-Sided
95
-1.38
-0.66
Superiority or Other (legacy)
OG003
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.19
Standard Error of the Mean
0.18
2-Sided
95
-1.55
-0.84
Superiority or Other (legacy)
OG000
OG001
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.028
LS Mean Difference
-0.40
Standard Error of the Mean
0.18
2-Sided
95
-0.75
-0.04
Superiority or Other (legacy)
OG000
OG002
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.013
LS Mean Difference
-0.45
Standard Error of the Mean
0.18
2-Sided
95
-0.81
-0.09
Superiority or Other (legacy)
OG001
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.217
LS Mean Difference
-0.22
Standard Error of the Mean
0.18
2-Sided
95
-0.58
0.13
Superiority or Other (legacy)
OG002
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.351
LS Mean Difference
-0.17
Standard Error of the Mean
0.18
2-Sided
95
-0.53
0.19
Superiority or Other (legacy)
OG005
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.66
Standard Error of the Mean
0.20
2-Sided
95
-1.05
-0.28
Superiority or Other (legacy)
OG006
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.83
Standard Error of the Mean
0.20
2-Sided
95
-1.22
-0.45
Superiority or Other (legacy)
OG007
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.00
Standard Error of the Mean
0.20
2-Sided
95
-1.38
-0.62
Superiority or Other (legacy)
OG008
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.19
Standard Error of the Mean
0.20
2-Sided
95
-1.57
-0.80
Superiority or Other (legacy)
OG005
OG006
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.389
LS Mean Difference
-0.17
Standard Error of the Mean
0.20
2-Sided
95
-0.55
0.22
Superiority or Other (legacy)
OG005
OG007
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.087
LS Mean Difference
-0.34
Standard Error of the Mean
0.20
2-Sided
95
-0.72
0.05
Superiority or Other (legacy)
OG006
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.072
LS Mean Difference
-0.35
Standard Error of the Mean
0.20
2-Sided
95
-0.74
0.03
Superiority or Other (legacy)
OG007
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.340
LS Mean Difference
-0.19
Standard Error of the Mean
0.20
2-Sided
95
-0.57
0.20
Superiority or Other (legacy)
OG000
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.69
Standard Error of the Mean
0.19
2-Sided
95
-1.06
-0.33
Superiority or Other (legacy)
OG001
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.75
Standard Error of the Mean
0.19
2-Sided
95
-1.11
-0.39
Superiority or Other (legacy)
OG002
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.05
Standard Error of the Mean
0.19
2-Sided
95
-1.42
-0.69
Superiority or Other (legacy)
OG003
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.23
Standard Error of the Mean
0.19
2-Sided
95
-1.59
-0.87
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.762
LS Mean Difference
-0.06
Standard Error of the Mean
0.18
2-Sided
95
-0.42
0.31
Superiority or Other (legacy)
OG000
OG002
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.056
LS Mean Difference
-0.36
Standard Error of the Mean
0.19
2-Sided
95
-0.72
0.01
Superiority or Other (legacy)
OG001
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.010
LS Mean Difference
-0.48
Standard Error of the Mean
0.18
2-Sided
95
-0.84
-0.12
Superiority or Other (legacy)
OG002
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.335
LS Mean Difference
-0.18
Standard Error of the Mean
0.19
2-Sided
95
-0.54
0.19
Superiority or Other (legacy)
OG005
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.78
Standard Error of the Mean
0.20
2-Sided
95
-1.18
-0.38
Superiority or Other (legacy)
OG006
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.84
Standard Error of the Mean
0.20
2-Sided
95
-1.24
-0.44
Superiority or Other (legacy)
OG007
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.85
Standard Error of the Mean
0.20
2-Sided
95
-1.25
-0.46
Superiority or Other (legacy)
OG008
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.13
Standard Error of the Mean
0.20
2-Sided
95
-1.52
-0.73
Superiority or Other (legacy)
OG005
OG006
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.782
LS Mean Difference
-0.06
Standard Error of the Mean
0.20
2-Sided
95
-0.46
0.34
Superiority or Other (legacy)
OG005
OG007
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.719
LS Mean Difference
-0.07
Standard Error of the Mean
0.20
2-Sided
95
-0.47
0.33
Superiority or Other (legacy)
OG006
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.158
LS Mean Difference
-0.29
Standard Error of the Mean
0.20
2-Sided
95
-0.69
0.11
Superiority or Other (legacy)
OG007
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.183
LS Mean Difference
-0.27
Standard Error of the Mean
0.20
2-Sided
95
-0.67
0.13
Superiority or Other (legacy)
OG000
OG004
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.004
LS Mean difference
-0.54
Standard Error of the Mean
0.18
2-Sided
95
-0.90
-0.18
Superiority or Other (legacy)
OG001
OG004
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean difference
-0.69
Standard Error of the Mean
0.18
2-Sided
95
-1.05
-0.33
Superiority or Other (legacy)
OG002
OG004
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean difference
-0.84
Standard Error of the Mean
0.18
2-Sided
95
-1.20
0.48
Superiority or Other (legacy)
OG003
OG004
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean difference
-1.12
Standard Error of the Mean
0.18
2-Sided
95
-1.48
-0.76
Superiority or Other (legacy)
OG000
OG001
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.408
LS mean difference
-0.15
Standard Error of the Mean
0.18
2-Sided
95
-0.51
0.21
Superiority or Other (legacy)
OG000
OG002
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.097
LS mean difference
-0.31
Standard Error of the Mean
0.18
2-Sided
95
-0.67
0.06
Superiority or Other (legacy)
OG001
OG003
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.018
LS mean difference
-0.43
Standard Error of the Mean
0.18
2-Sided
95
-0.79
-0.07
Superiority or Other (legacy)
OG002
OG003
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.132
LS mean difference
-0.28
Standard Error of the Mean
0.18
2-Sided
95
-0.64
0.08
Superiority or Other (legacy)
OG005
OG009
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
0.001
LS Mean Difference
-0.67
Standard Error of the Mean
0.21
2-Sided
95
-1.08
-0.26
Superiority or Other (legacy)
OG006
OG009
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
0.002
LS Mean Difference
-0.66
Standard Error of the Mean
0.21
2-Sided
95
-1.07
-0.25
Superiority or Other (legacy)
OG007
OG009
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
<0.001
LS Mean Difference
-0.78
Standard Error of the Mean
0.21
2-Sided
95
-1.19
-0.37
Superiority or Other (legacy)
OG008
OG009
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
<0.001
LS Mean Difference
-0.96
Standard Error of the Mean
0.21
2-Sided
95
-1.37
-0.55
Superiority or Other (legacy)
OG005
OG006
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
0.959
LS Mean Difference
0.01
Standard Error of the Mean
0.21
2-Sided
95
-0.40
0.42
Superiority or Other (legacy)
OG005
OG007
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
0.618
LS Mean Difference
-0.10
Standard Error of the Mean
0.21
2-Sided
95
-0.51
0.31
Superiority or Other (legacy)
OG006
OG008
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
0.149
LS Mean Difference
-0.30
Standard Error of the Mean
0.21
2-Sided
95
-0.71
0.11
Superiority or Other (legacy)
OG007
OG008
Change at Week 16: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates
ANCOVA
0.370
LS Mean Difference
-0.19
Standard Error of the Mean
0.21
2-Sided
95
-0.60
0.22
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003286
OG004282
OG005255
OG006253
OG007255
OG008253
OG009254
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-1.10± 1.88
OG001-1.13± 1.90
OG002-1.44± 2.02
OG003-1.06± 2.07
OG004-0.90± 1.69
OG005-1.18± 2.01
OG006-0.95± 1.99
OG007-1.21± 1.96
OG008-1.02± 2.13
OG009-0.90± 1.67
Change at Week 4
Title
Measurements
OG000-1.71± 2.00
OG001-1.79± 1.88
OG002-2.04± 2.16
OG003
Change at Week 8
Title
Measurements
OG000-1.62± 2.19
OG001-2.01± 2.04
OG002-2.05± 2.26
OG003
Change at Week 12
Title
Measurements
OG000-1.85± 2.25
OG001-1.87± 2.06
OG002-2.18± 2.17
OG003
Change at Week 24
Title
Measurements
OG000-1.66± 2.28
OG001-1.76± 2.16
OG002-1.76± 2.11
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.887
LS mean difference
-0.02
Standard Error of the Mean
0.16
2-Sided
95
-0.33
0.28
Superiority or Other (legacy)
OG000
OG002
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.046
LS mean difference
-0.31
Standard Error of the Mean
0.16
2-Sided
95
-0.62
-0.01
Superiority or Other (legacy)
OG001
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.771
LS mean difference
0.05
Standard Error of the Mean
0.16
2-Sided
95
-0.26
0.35
Superiority or Other (legacy)
OG002
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.032
LS mean difference
0.34
Standard Error of the Mean
0.16
2-Sided
95
0.03
0.64
Superiority or Other (legacy)
OG005
OG006
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.223
LS mean difference
0.21
Standard Error of the Mean
0.17
2-Sided
95
-0.13
0.54
Superiority or Other (legacy)
OG005
OG007
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.718
LS mean difference
-0.06
Standard Error of the Mean
0.17
2-Sided
95
-0.39
0.27
Superiority or Other (legacy)
OG006
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.495
LS mean difference
-0.12
Standard Error of the Mean
0.17
2-Sided
95
-0.45
0.22
Superiority or Other (legacy)
OG007
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.371
LS mean difference
0.15
Standard Error of the Mean
0.17
2-Sided
95
-0.18
0.49
Superiority or Other (legacy)
OG000
OG001
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.647
LS mean difference
-0.08
Standard Error of the Mean
0.16
2-Sided
95
-0.40
0.25
Superiority or Other (legacy)
OG000
OG002
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.073
LS mean difference
-0.30
Standard Error of the Mean
0.16
2-Sided
95
-0.62
0.03
Superiority or Other (legacy)
OG001
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.161
LS mean difference
-0.23
Standard Error of the Mean
0.16
2-Sided
95
-0.55
0.09
Superiority or Other (legacy)
OG002
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.961
LS mean difference
-0.01
Standard Error of the Mean
0.16
2-Sided
95
-0.33
0.32
Superiority or Other (legacy)
OG005
OG006
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.697
LS mean difference
-0.07
Standard Error of the Mean
0.18
2-Sided
95
-0.42
0.28
Superiority or Other (legacy)
OG005
OG007
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.139
LS mean difference
-0.27
Standard Error of the Mean
0.18
2-Sided
95
-0.62
0.09
Superiority or Other (legacy)
OG006
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.120
LS mean difference
-0.28
Standard Error of the Mean
0.18
2-Sided
95
-0.64
0.07
Superiority or Other (legacy)
OG007
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.637
LS mean difference
-0.09
Standard Error of the Mean
0.18
2-Sided
95
-0.44
0.27
Superiority or Other (legacy)
OG000
OG001
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.028
LS mean difference
-0.38
Standard Error of the Mean
0.17
2-Sided
95
-0.72
-0.04
Superiority or Other (legacy)
OG000
OG002
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.024
LS mean difference
-0.39
Standard Error of the Mean
0.17
2-Sided
95
-0.74
-0.05
Superiority or Other (legacy)
OG001
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.339
LS mean difference
-0.17
Standard Error of the Mean
0.17
2-Sided
95
-0.51
0.17
Superiority or Other (legacy)
OG002
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.381
LS mean difference
-0.15
Standard Error of the Mean
0.17
2-Sided
95
-0.50
0.19
Superiority or Other (legacy)
OG005
OG006
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.438
LS mean difference
-0.14
Standard Error of the Mean
0.19
2-Sided
95
-0.51
0.22
Superiority or Other (legacy)
OG005
OG007
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.111
LS mean difference
-0.30
Standard Error of the Mean
0.19
2-Sided
95
-0.66
0.07
Superiority or Other (legacy)
OG006
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.059
LS mean difference
-0.35
Standard Error of the Mean
0.19
2-Sided
95
-0.72
0.01
Superiority or Other (legacy)
OG007
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.282
LS mean difference
-0.20
Standard Error of the Mean
0.19
2-Sided
95
-0.57
0.17
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.927
LS mean difference
-0.02
Standard Error of the Mean
0.18
2-Sided
95
-0.37
0.33
Superiority or Other (legacy)
OG000
OG002
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.094
LS mean difference
-0.30
Standard Error of the Mean
0.18
2-Sided
95
-0.65
0.05
Superiority or Other (legacy)
OG001
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.012
LS mean difference
-0.45
Standard Error of the Mean
0.18
2-Sided
95
-0.80
-0.10
Superiority or Other (legacy)
OG002
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.363
LS mean difference
-0.16
Standard Error of the Mean
0.18
2-Sided
95
-0.51
0.19
Superiority or Other (legacy)
OG005
OG006
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.742
LS mean difference
0.06
Standard Error of the Mean
0.20
2-Sided
95
-0.32
0.45
Superiority or Other (legacy)
OG005
OG007
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.436
LS mean difference
-0.15
Standard Error of the Mean
0.19
2-Sided
95
-0.53
0.23
Superiority or Other (legacy)
OG006
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.038
LS mean difference
-0.41
Standard Error of the Mean
0.20
2-Sided
95
-0.79
-0.02
Superiority or Other (legacy)
OG007
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.332
LS mean difference
-0.19
Standard Error of the Mean
0.20
2-Sided
95
-0.57
0.19
Superiority or Other (legacy)
OG000
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.284
LS Mean Difference
-0.17
Standard Error of the Mean
0.16
2-Sided
95
-0.47
0.14
Superiority or Other (legacy)
OG001
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.224
LS Mean Difference
-0.19
Standard Error of the Mean
0.16
2-Sided
95
-0.50
0.12
Superiority or Other (legacy)
OG002
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.48
Standard Error of the Mean
0.16
2-Sided
95
-0.79
-0.17
Superiority or Other (legacy)
OG003
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.355
LS Mean Difference
-0.14
Standard Error of the Mean
0.16
2-Sided
95
-0.45
0.16
Superiority or Other (legacy)
OG005
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.172
LS Mean Difference
-0.23
Standard Error of the Mean
0.17
2-Sided
95
-0.57
0.10
Superiority or Other (legacy)
OG006
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.882
LS Mean Difference
-0.03
Standard Error of the Mean
0.17
2-Sided
95
-0.36
0.31
Superiority or Other (legacy)
OG007
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.084
LS Mean Difference
-0.29
Standard Error of the Mean
0.17
2-Sided
95
-0.63
0.04
Superiority or Other (legacy)
OG008
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.405
LS Mean Difference
-0.14
Standard Error of the Mean
0.17
2-Sided
95
-0.47
0.19
Superiority or Other (legacy)
OG000
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.67
Standard Error of the Mean
0.16
2-Sided
95
-0.99
-0.34
Superiority or Other (legacy)
OG001
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.74
Standard Error of the Mean
0.16
2-Sided
95
-1.06
-0.42
Superiority or Other (legacy)
OG002
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.96
Standard Error of the Mean
0.16
2-Sided
95
-1.29
-0.64
Superiority or Other (legacy)
OG003
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.97
Standard Error of the Mean
0.16
2-Sided
95
-1.29
-0.65
Superiority or Other (legacy)
OG005
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.60
Standard Error of the Mean
0.18
2-Sided
95
-0.95
-0.25
Superiority or Other (legacy)
OG006
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.67
Standard Error of the Mean
0.18
2-Sided
95
-1.02
-0.32
Superiority or Other (legacy)
OG007
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.87
Standard Error of the Mean
0.18
2-Sided
95
-1.22
-0.51
Superiority or Other (legacy)
OG008
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.95
Standard Error of the Mean
0.18
2-Sided
95
-1.31
-0.60
Superiority or Other (legacy)
OG000
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.003
LS Mean Difference
-0.52
Standard Error of the Mean
0.17
2-Sided
95
-0.86
-0.18
Superiority or Other (legacy)
OG001
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.90
Standard Error of the Mean
0.17
2-Sided
95
-1.24
-0.56
Superiority or Other (legacy)
OG002
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.92
Standard Error of the Mean
0.18
2-Sided
95
-1.26
-0.57
Superiority or Other (legacy)
OG003
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.07
Standard Error of the Mean
0.17
2-Sided
95
-1.41
-0.73
Superiority or Other (legacy)
OG005
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.70
Standard Error of the Mean
0.19
2-Sided
95
-1.06
-0.33
Superiority or Other (legacy)
OG006
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.84
Standard Error of the Mean
0.19
2-Sided
95
-1.21
-0.47
Superiority or Other (legacy)
OG007
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.99
Standard Error of the Mean
0.19
2-Sided
95
-1.36
-0.63
Superiority or Other (legacy)
OG008
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.19
Standard Error of the Mean
0.19
2-Sided
95
-1.56
-0.83
Superiority or Other (legacy)
OG000
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.001
LS Mean Difference
-0.58
Standard Error of the Mean
0.18
2-Sided
95
-0.93
-0.23
Superiority or Other (legacy)
OG001
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.88
Standard Error of the Mean
0.18
2-Sided
95
-1.24
-0.53
Superiority or Other (legacy)
OG002
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.88
Standard Error of the Mean
0.18
2-Sided
95
-1.24
-0.53
Superiority or Other (legacy)
OG003
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.05
Standard Error of the Mean
0.18
2-Sided
95
-1.40
-0.70
Superiority or Other (legacy)
OG005
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.79
Standard Error of the Mean
0.20
2-Sided
95
-1.17
-0.40
Superiority or Other (legacy)
OG006
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.72
Standard Error of the Mean
0.20
2-Sided
95
-1.11
-0.34
Superiority or Other (legacy)
OG007
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.94
Standard Error of the Mean
0.19
2-Sided
95
-1.32
-0.56
Superiority or Other (legacy)
OG008
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.13
Standard Error of the Mean
0.20
2-Sided
95
-1.51
-0.75
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000284
OG001287
OG002280
OG003286
OG004282
OG005255
OG006253
OG007255
OG008253
OG009254
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.46± 1.72
OG0016.47± 1.61
OG0026.57± 1.67
OG0036.39± 1.62
OG0046.32± 1.62
OG0056.67± 1.60
OG0066.58± 1.58
OG0076.57± 1.72
OG0086.39± 1.62
OG0096.47± 1.59
Change at Week 2
Title
Measurements
OG000-1.10± 1.88
OG001-1.13± 1.90
OG002-1.44± 2.02
OG003
Change at Week 4
Title
Measurements
OG000-1.70± 2.02
OG001-1.84± 1.87
OG002-2.08± 2.15
OG003
Change at Week 8
Title
Measurements
OG000-1.69± 2.23
OG001-2.13± 2.06
OG002-2.23± 2.26
OG003
Change at Week 12
Title
Measurements
OG000-2.02± 2.31
OG001-2.08± 2.12
OG002-2.40± 2.15
OG003
Change at Week 24
Title
Measurements
OG000-2.04± 2.37
OG001-2.08± 2.22
OG002-2.22± 2.21
OG003
Change at Week 32
Title
Measurements
OG000-1.87± 2.40
OG001-2.01± 2.29
OG002-2.15± 2.32
OG003
Change at Week 40
Title
Measurements
OG000-1.87± 2.37
OG001-1.90± 2.40
OG002-1.95± 2.34
OG003
Change at Week 48
Title
Measurements
OG000-1.82± 2.36
OG001-1.93± 2.43
OG002-1.90± 2.41
OG003
Change at Week 56
Title
Measurements
OG000-1.82± 2.36
OG001-1.84± 2.41
OG002-1.88± 2.41
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.887
LS Mean Difference
-0.02
Standard Error of the Mean
0.16
2-Sided
95
-0.33
0.28
Superiority or Other (legacy)
OG000
OG002
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.046
LS Mean Difference
-0.31
Standard Error of the Mean
0.16
2-Sided
95
-0.62
-0.01
Superiority or Other (legacy)
OG001
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.771
LS mean difference
0.05
Standard Error of the Mean
0.16
2-Sided
95
-0.26
0.35
Superiority or Other (legacy)
OG002
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.032
LS mean difference
0.34
Standard Error of the Mean
0.16
2-Sided
95
0.03
0.64
Superiority or Other (legacy)
OG005
OG006
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.223
LS mean difference
0.21
Standard Error of the Mean
0.17
2-Sided
95
-0.13
0.54
Superiority or Other (legacy)
OG005
OG007
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.718
LS mean difference
-0.06
Standard Error of the Mean
0.17
2-Sided
95
-0.39
0.27
Superiority or Other (legacy)
OG006
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.495
LS mean difference
-0.12
Standard Error of the Mean
0.17
2-Sided
95
-0.45
0.22
Superiority or Other (legacy)
OG000
OG001
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.389
LS mean difference
-0.14
Standard Error of the Mean
0.16
2-Sided
95
-0.47
0.18
Superiority or Other (legacy)
OG000
OG002
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.035
LS mean difference
-0.35
Standard Error of the Mean
0.17
2-Sided
95
-0.68
-0.02
Superiority or Other (legacy)
OG001
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.155
LS mean difference
-0.23
Standard Error of the Mean
0.16
2-Sided
95
-0.56
0.09
Superiority or Other (legacy)
OG002
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.876
LS mean difference
-0.03
Standard Error of the Mean
0.17
2-Sided
95
-0.35
0.30
Superiority or Other (legacy)
OG005
OG006
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.864
LS mean difference
0.03
Standard Error of the Mean
0.18
2-Sided
95
-0.33
0.39
Superiority or Other (legacy)
OG005
OG007
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.338
LS mean difference
-0.18
Standard Error of the Mean
0.18
2-Sided
95
-0.54
0.18
Superiority or Other (legacy)
OG006
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.101
LS mean difference
-0.30
Standard Error of the Mean
0.18
2-Sided
95
-0.66
0.06
Superiority or Other (legacy)
OG007
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.605
LS mean difference
-0.09
Standard Error of the Mean
0.18
2-Sided
95
-0.46
0.27
Superiority or Other (legacy)
OG000
OG001
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.013
LS mean difference
-0.43
Standard Error of the Mean
0.17
2-Sided
95
-0.78
-0.09
Superiority or Other (legacy)
OG000
OG002
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.005
LS mean difference
-0.50
Standard Error of the Mean
0.18
2-Sided
95
-0.84
-0.15
Superiority or Other (legacy)
OG001
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.199
LS mean difference
-0.22
Standard Error of the Mean
0.17
2-Sided
95
-0.57
0.12
Superiority or Other (legacy)
OG002
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.363
LS mean difference
-0.16
Standard Error of the Mean
0.18
2-Sided
95
-0.50
0.18
Superiority or Other (legacy)
OG005
OG006
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.613
LS Mean difference
-0.10
Standard Error of the Mean
0.19
2-Sided
95
-0.47
0.28
Superiority or Other (legacy)
OG005
OG007
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.416
LS mean difference
-0.16
Standard Error of the Mean
0.19
2-Sided
95
-0.53
0.22
Superiority or Other (legacy)
OG006
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.143
LS mean difference
-0.28
Standard Error of the Mean
0.19
2-Sided
95
-0.66
0.09
Superiority or Other (legacy)
OG007
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.245
LS mean difference
-0.22
Standard Error of the Mean
0.19
2-Sided
95
-0.60
0.15
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.745
LS mean difference
-0.06
Standard Error of the Mean
0.18
2-Sided
95
-0.41
0.29
Superiority or Other (legacy)
OG000
OG002
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.062
LS mean difference
-0.34
Standard Error of the Mean
0.18
2-Sided
95
-0.69
0.02
Superiority or Other (legacy)
OG001
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.014
LS mean difference
-0.44
Standard Error of the Mean
0.18
2-Sided
95
-0.80
-0.09
Superiority or Other (legacy)
OG002
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.367
LS mean difference
-0.16
Standard Error of the Mean
0.18
2-Sided
95
-0.52
0.19
Superiority or Other (legacy)
OG005
OG006
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.995
LS mean difference
-0.00
Standard Error of the Mean
0.20
2-Sided
95
-0.39
0.39
Superiority or Other (legacy)
OG005
OG007
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.735
LS mean difference
-0.07
Standard Error of the Mean
0.20
2-Sided
95
-0.46
0.32
Superiority or Other (legacy)
OG006
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.169
LS mean difference
-0.28
Standard Error of the Mean
0.20
2-Sided
95
-0.67
0.12
Superiority or Other (legacy)
OG007
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.295
LS mean difference
-0.21
Standard Error of the Mean
0.20
2-Sided
95
-0.60
0.18
Superiority or Other (legacy)
OG000
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.284
LS Mean Difference
-0.17
Standard Error of the Mean
0.16
2-Sided
95
-0.47
0.14
Superiority or Other (legacy)
OG001
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.224
LS Mean Difference
-0.19
Standard Error of the Mean
0.16
2-Sided
95
-0.50
0.12
Superiority or Other (legacy)
OG002
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.48
Standard Error of the Mean
0.16
2-Sided
95
-0.79
-0.17
Superiority or Other (legacy)
OG003
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.355
LS Mean Difference
-0.14
Standard Error of the Mean
0.16
2-Sided
95
-0.45
0.16
Superiority or Other (legacy)
OG005
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.172
LS Mean Difference
-0.23
Standard Error of the Mean
0.17
2-Sided
95
-0.57
0.10
Superiority or Other (legacy)
OG006
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.882
LS Mean Difference
-0.03
Standard Error of the Mean
0.17
2-Sided
95
-0.36
0.31
Superiority or Other (legacy)
OG007
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.084
LS Mean Difference
-0.29
Standard Error of the Mean
0.17
2-Sided
95
-0.63
0.04
Superiority or Other (legacy)
OG008
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.405
LS Mean Difference
-0.14
Standard Error of the Mean
0.17
2-Sided
95
-0.47
0.19
Superiority or Other (legacy)
OG000
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.62
Standard Error of the Mean
0.17
2-Sided
95
-0.94
-0.30
Superiority or Other (legacy)
OG001
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.76
Standard Error of the Mean
0.17
2-Sided
95
-1.09
-0.44
Superiority or Other (legacy)
OG002
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.97
Standard Error of the Mean
0.17
2-Sided
95
-1.30
-0.64
Superiority or Other (legacy)
OG003
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.00
Standard Error of the Mean
0.17
2-Sided
95
-1.32
-0.67
Superiority or Other (legacy)
OG005
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.66
Standard Error of the Mean
0.18
2-Sided
95
-1.02
-0.30
Superiority or Other (legacy)
OG006
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.63
Standard Error of the Mean
0.18
2-Sided
95
-0.99
-0.27
Superiority or Other (legacy)
OG007
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.83
Standard Error of the Mean
0.18
2-Sided
95
-1.19
-0.48
Superiority or Other (legacy)
OG008
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.93
Standard Error of the Mean
0.18
2-Sided
95
-1.29
-0.57
Superiority or Other (legacy)
OG000
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS Mean Difference
-0.54
Standard Error of the Mean
0.18
2-Sided
95
-0.89
-0.20
Superiority or Other (legacy)
OG001
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.98
Standard Error of the Mean
0.18
2-Sided
95
-1.32
-0.63
Superiority or Other (legacy)
OG002
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.04
Standard Error of the Mean
0.18
2-Sided
95
-1.39
-0.70
Superiority or Other (legacy)
OG003
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.20
Standard Error of the Mean
0.18
2-Sided
95
-1.55
-0.86
Superiority or Other (legacy)
OG005
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.80
Standard Error of the Mean
0.19
2-Sided
95
-1.18
-0.43
Superiority or Other (legacy)
OG006
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.90
Standard Error of the Mean
0.19
2-Sided
95
-1.28
-0.53
Superiority or Other (legacy)
OG007
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.96
Standard Error of the Mean
0.19
2-Sided
95
-1.33
-0.58
Superiority or Other (legacy)
OG008
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.18
Standard Error of the Mean
0.19
2-Sided
95
-1.56
-0.81
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.66
Standard Error of the Mean
0.18
2-Sided
95
-1.02
-0.31
Superiority or Other (legacy)
OG001
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.72
Standard Error of the Mean
0.18
2-Sided
95
-1.08
-0.37
Superiority or Other (legacy)
OG002
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.00
Standard Error of the Mean
0.18
2-Sided
95
-1.36
-0.65
Superiority or Other (legacy)
OG003
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-1.17
Standard Error of the Mean
0.18
2-Sided
95
-1.52
-0.81
Superiority or Other (legacy)
OG005
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.90
Standard Error of the Mean
0.20
2-Sided
95
-1.29
-0.51
Superiority or Other (legacy)
OG006
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.90
Standard Error of the Mean
0.20
2-Sided
95
-1.30
-0.51
Superiority or Other (legacy)
OG007
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.97
Standard Error of the Mean
0.20
2-Sided
95
-1.36
-0.58
Superiority or Other (legacy)
OG008
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.01
LS Mean Difference
-1.18
Standard Error of the Mean
0.20
2-Sided
95
-1.57
-0.79
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000284
OG001288
OG002280
OG003285
OG004283
OG005256
OG006254
OG007255
OG008253
OG009254
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-0.45± 0.80
OG001-0.42± 0.83
OG002-0.50± 0.81
OG003-0.40± 0.92
OG004-0.39± 0.71
OG005-0.46± 0.89
OG006-0.33± 0.88
OG007-0.45± 0.89
OG008-0.26± 0.85
OG009-0.37± 0.75
Change at Week 4
Title
Measurements
OG000-0.60± 0.78
OG001-0.69± 0.81
OG002-0.74± 0.86
OG003
Change at Week 8
Title
Measurements
OG000-0.58± 0.89
OG001-0.70± 0.84
OG002-0.69± 0.87
OG003
Change at Week 12
Title
Measurements
OG000-0.60± 0.89
OG001-0.68± 0.85
OG002-0.69± 0.88
OG003
Change at Week 24
Title
Measurements
OG000-0.58± 0.97
OG001-0.54± 0.93
OG002-0.50± 0.82
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.469
LS mean difference
0.04
Standard Error of the Mean
0.06
2-Sided
95
-0.08
0.17
Superiority or Other (legacy)
OG000
OG002
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.387
LS mean difference
-0.05
Standard Error of the Mean
0.06
2-Sided
95
-0.18
0.07
Superiority or Other (legacy)
OG001
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.887
LS mean difference
0.01
Standard Error of the Mean
0.06
2-Sided
95
-0.11
0.13
Superiority or Other (legacy)
OG002
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.084
LS mean difference
0.11
Standard Error of the Mean
0.06
2-Sided
95
-0.01
0.23
Superiority or Other (legacy)
OG005
OG006
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.018
LS mean difference
0.16
Standard Error of the Mean
0.07
2-Sided
95
0.03
0.29
Superiority or Other (legacy)
OG005
OG007
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.783
LS mean difference
0.02
Standard Error of the Mean
0.07
2-Sided
95
-0.11
0.15
Superiority or Other (legacy)
OG006
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.762
LS mean difference
0.02
Standard Error of the Mean
0.07
2-Sided
95
-0.11
0.15
Superiority or Other (legacy)
OG007
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.017
LS mean difference
0.16
Standard Error of the Mean
0.07
2-Sided
95
0.03
0.29
Superiority or Other (legacy)
OG000
OG001
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.207
LS mean difference
-0.08
Standard Error of the Mean
0.06
2-Sided
95
-0.20
0.04
Superiority or Other (legacy)
OG000
OG002
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.020
LS mean difference
-0.15
Standard Error of the Mean
0.06
2-Sided
95
-0.27
-0.02
Superiority or Other (legacy)
OG001
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.941
LS mean difference
-0.00
Standard Error of the Mean
0.06
2-Sided
95
-0.13
0.12
Superiority or Other (legacy)
OG005
OG006
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.494
LS mean difference
-0.05
Standard Error of the Mean
0.07
2-Sided
95
-0.18
0.09
Superiority or Other (legacy)
OG005
OG007
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.089
LS mean difference
-0.11
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.02
Superiority or Other (legacy)
OG006
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.467
LS mean difference
-0.05
Standard Error of the Mean
0.07
2-Sided
95
-0.18
0.08
Superiority or Other (legacy)
OG007
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.774
LS mean difference
0.02
Standard Error of the Mean
0.07
2-Sided
95
-0.11
0.15
Superiority or Other (legacy)
OG002
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.315
LS mean difference
0.06
Standard Error of the Mean
0.06
2-Sided
95
-0.06
0.19
Superiority or Other (legacy)
OG000
OG001
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.088
LS mean difference
-0.11
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.02
Superiority or Other (legacy)
OG000
OG002
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.084
LS mean difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.02
Superiority or Other (legacy)
OG001
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.066
LS mean difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.01
Superiority or Other (legacy)
OG002
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.073
LS mean difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.01
Superiority or Other (legacy)
OG005
OG006
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.682
LS mean difference
-0.03
Standard Error of the Mean
0.07
2-Sided
95
-0.16
0.10
Superiority or Other (legacy)
OG005
OG007
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.014
LS mean difference
-0.17
Standard Error of the Mean
0.07
2-Sided
95
-0.30
-0.03
Superiority or Other (legacy)
OG006
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.027
LS mean difference
-0.15
Standard Error of the Mean
0.07
2-Sided
95
-0.28
-0.02
Superiority or Other (legacy)
OG007
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.871
LS mean difference
-0.01
Standard Error of the Mean
0.07
2-Sided
95
-0.14
0.12
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.301
LS mean difference
-0.07
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.06
Superiority or Other (legacy)
OG000
OG002
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.181
LS mean difference
-0.09
Standard Error of the Mean
0.07
2-Sided
95
-0.23
0.04
Superiority or Other (legacy)
OG001
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.013
LS mean difference
-0.17
Standard Error of the Mean
0.07
2-Sided
95
-0.30
-0.04
Superiority or Other (legacy)
OG002
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.031
LS mean difference
-0.15
Standard Error of the Mean
0.07
2-Sided
95
-0.28
-0.01
Superiority or Other (legacy)
OG005
OG006
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.874
LS mean difference
-0.01
Standard Error of the Mean
0.07
2-Sided
95
-0.15
0.13
Superiority or Other (legacy)
OG005
OG007
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.447
LS mean difference
-0.05
Standard Error of the Mean
0.07
2-Sided
95
-0.19
0.08
Superiority or Other (legacy)
OG006
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.059
LS mean difference
-0.13
Standard Error of the Mean
0.07
2-Sided
95
-0.27
0.01
Superiority or Other (legacy)
OG007
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.196
LS mean difference
-0.09
Standard Error of the Mean
0.07
2-Sided
95
-0.23
0.05
Superiority or Other (legacy)
OG000
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.360
LS mean difference
-0.06
Standard Error of the Mean
0.06
2-Sided
95
-0.18
0.06
Superiority or Other (legacy)
OG001
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.845
LS mean difference
-0.01
Standard Error of the Mean
0.06
2-Sided
95
-0.13
0.11
Superiority or Other (legacy)
OG002
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.076
LS mean difference
-0.11
Standard Error of the Mean
0.06
2-Sided
95
-0.23
0.01
Superiority or Other (legacy)
OG003
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.957
LS mean difference
-0.00
Standard Error of the Mean
0.06
2-Sided
95
-0.12
0.12
Superiority or Other (legacy)
OG005
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.404
LS mean difference
-0.06
Standard Error of the Mean
0.07
2-Sided
95
-0.19
0.08
Superiority or Other (legacy)
OG006
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.128
LS mean difference
0.10
Standard Error of the Mean
0.07
2-Sided
95
-0.03
0.23
Superiority or Other (legacy)
OG007
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.577
LS mean difference
-0.04
Standard Error of the Mean
0.07
2-Sided
95
-0.17
0.09
Superiority or Other (legacy)
OG008
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.068
LS mean difference
0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.01
0.25
Superiority or Other (legacy)
OG000
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.011
LS mean difference
-0.16
Standard Error of the Mean
0.06
2-Sided
95
-0.28
-0.04
Superiority or Other (legacy)
OG001
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.24
Standard Error of the Mean
0.06
2-Sided
95
-0.36
-0.11
Superiority or Other (legacy)
OG002
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.30
Standard Error of the Mean
0.06
2-Sided
95
-0.43
-0.18
Superiority or Other (legacy)
OG003
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.24
Standard Error of the Mean
0.06
2-Sided
95
-0.36
-0.12
Superiority or Other (legacy)
OG005
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.043
LS mean difference
-0.14
Standard Error of the Mean
0.07
2-Sided
95
-0.27
-0.00
Superiority or Other (legacy)
OG006
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.007
LS Mean Difference
-0.18
Standard Error of the Mean
0.07
2-Sided
95
-0.31
-0.05
Superiority or Other (legacy)
OG007
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.25
Standard Error of the Mean
0.07
2-Sided
95
-0.38
-0.12
Superiority or Other (legacy)
OG008
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.23
Standard Error of the Mean
0.07
2-Sided
95
-0.36
-0.10
Superiority or Other (legacy)
OG000
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.074
LS Mean Difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.01
Superiority or Other (legacy)
OG001
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.23
Standard Error of the Mean
0.07
2-Sided
95
-0.37
-0.10
Superiority or Other (legacy)
OG002
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.24
Standard Error of the Mean
0.07
2-Sided
95
-0.37
-0.10
Superiority or Other (legacy)
OG003
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.36
Standard Error of the Mean
0.07
2-Sided
95
-0.49
-0.23
Superiority or Other (legacy)
OG005
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.236
LS Mean Difference
-0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.05
Superiority or Other (legacy)
OG006
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.112
LS Mean Difference
-0.11
Standard Error of the Mean
0.07
2-Sided
95
-0.24
0.02
Superiority or Other (legacy)
OG007
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.24
Standard Error of the Mean
0.07
2-Sided
95
-0.38
-0.11
Superiority or Other (legacy)
OG008
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.26
Standard Error of the Mean
0.07
2-Sided
95
-0.39
-0.12
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.059
LS Mean Difference
-0.13
Standard Error of the Mean
0.07
2-Sided
95
-0.26
0.01
Superiority or Other (legacy)
OG001
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.003
LS Mean Difference
-0.20
Standard Error of the Mean
0.07
2-Sided
95
-0.33
-0.07
Superiority or Other (legacy)
OG002
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.001
LS Mean Difference
-0.22
Standard Error of the Mean
0.07
2-Sided
95
-0.36
-0.09
Superiority or Other (legacy)
OG003
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.37
Standard Error of the Mean
0.07
2-Sided
95
-0.51
-0.24
Superiority or Other (legacy)
OG005
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.055
LS Mean Difference
-0.13
Standard Error of the Mean
0.07
2-Sided
95
-0.27
0.00
Superiority or Other (legacy)
OG006
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.038
LS Mean Difference
-0.15
Standard Error of the Mean
0.07
2-Sided
95
-0.28
-0.01
Superiority or Other (legacy)
OG007
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.007
LS Mean Difference
-0.19
Standard Error of the Mean
0.07
2-Sided
95
-0.33
-0.05
Superiority or Other (legacy)
OG008
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS Mean Difference
-0.28
Standard Error of the Mean
0.07
2-Sided
95
-0.42
-0.14
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000284
OG001288
OG002280
OG003285
OG004283
OG005256
OG006254
OG007255
OG008253
OG009254
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-0.45± 0.80
OG001-0.42± 0.83
OG002-0.50± 0.81
OG003-0.40± 0.92
OG004-0.39± 0.71
OG005-0.46± 0.89
OG006-0.33± 0.88
OG007-0.45± 0.89
OG008-0.26± 0.85
OG009-0.37± 0.75
Change at Week 4
Title
Measurements
OG000-0.60± 0.80
OG001-0.72± 0.82
OG002-0.76± 0.86
OG003
Change at Week 8
Title
Measurements
OG000-0.63± 0.91
OG001-0.77± 0.87
OG002-0.75± 0.88
OG003
Change at Week 12
Title
Measurements
OG000-0.67± 0.91
OG001-0.79± 0.89
OG002-0.78± 0.90
OG003
Change at Week 16
Title
Measurements
OG000-0.63± 0.93
OG001-0.74± 0.95
OG002-0.72± 0.92
OG003
Change at Week 24
Title
Measurements
OG000-0.69± 1.02
OG001-0.68± 1.00
OG002-0.64± 0.87
OG003
Change at Week 32
Title
Measurements
OG000-0.60± 0.97
OG001-0.66± 0.95
OG002-0.60± 0.93
OG003
Change at Week 40
Title
Measurements
OG000-0.58± 0.98
OG001-0.60± 0.98
OG002-0.53± 0.93
OG003
Change at Week 48
Title
Measurements
OG000-0.53± 0.99
OG001-0.60± 0.98
OG002-0.51± 0.92
OG003
Change at Week 56
Title
Measurements
OG000-0.53± 1.00
OG001-0.55± 0.95
OG002-0.49± 0.94
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.469
LS mean difference
0.04
Standard Error of the Mean
0.06
2-Sided
95
-0.08
0.17
Superiority or Other (legacy)
OG000
OG007
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.387
LS mean difference
-0.05
Standard Error of the Mean
0.06
2-Sided
95
-0.18
0.07
Superiority or Other (legacy)
OG001
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.887
LS mean difference
0.01
Standard Error of the Mean
0.06
2-Sided
95
-0.11
0.13
Superiority or Other (legacy)
OG002
OG003
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.084
LS mean difference
0.11
Standard Error of the Mean
0.06
2-Sided
95
-0.01
0.23
Superiority or Other (legacy)
OG005
OG006
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.018
LS mean difference
0.16
Standard Error of the Mean
0.07
2-Sided
95
0.03
0.29
Superiority or Other (legacy)
OG000
OG002
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.783
LS mean difference
0.02
Standard Error of the Mean
0.07
2-Sided
95
-0.11
0.15
Superiority or Other (legacy)
OG006
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.762
LS mean difference
0.02
Standard Error of the Mean
0.07
2-Sided
95
-0.11
0.15
Superiority or Other (legacy)
OG007
OG008
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.017
LS mean difference
0.16
Standard Error of the Mean
0.07
2-Sided
95
0.03
0.29
Superiority or Other (legacy)
OG000
OG001
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.091
LS mean difference
-0.11
Standard Error of the Mean
0.06
2-Sided
95
-0.23
0.02
Superiority or Other (legacy)
OG000
OG002
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.009
LS mean difference
-0.16
Standard Error of the Mean
0.06
2-Sided
95
-0.29
-0.04
Superiority or Other (legacy)
OG001
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.835
LS mean difference
-0.01
Standard Error of the Mean
0.06
2-Sided
95
-0.13
0.11
Superiority or Other (legacy)
OG002
OG003
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.463
LS mean difference
0.05
Standard Error of the Mean
0.06
2-Sided
95
-0.08
0.17
Superiority or Other (legacy)
OG005
OG006
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.713
LS mean difference
-0.02
Standard Error of the Mean
0.07
2-Sided
95
-0.16
0.11
Superiority or Other (legacy)
OG005
OG007
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.267
LS mean difference
-0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.06
Superiority or Other (legacy)
OG006
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.552
LS mean difference
-0.04
Standard Error of the Mean
0.07
2-Sided
95
-0.17
0.09
Superiority or Other (legacy)
OG007
OG008
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.885
LS mean difference
0.01
Standard Error of the Mean
0.07
2-Sided
95
-0.12
0.14
Superiority or Other (legacy)
OG000
OG001
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.47
LS mean difference
-0.13
Standard Error of the Mean
0.07
2-Sided
95
-0.26
-0.00
Superiority or Other (legacy)
OG000
OG002
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.056
LS mean difference
-0.13
Standard Error of the Mean
0.07
2-Sided
95
-0.26
0.00
Superiority or Other (legacy)
OG001
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.117
LS mean difference
-0.10
Standard Error of the Mean
0.07
2-Sided
95
-0.24
0.03
Superiority or Other (legacy)
OG002
OG003
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.106
LS mean difference
-0.11
Standard Error of the Mean
0.07
2-Sided
95
-0.24
0.02
Superiority or Other (legacy)
OG005
OG006
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.673
LS mean difference
-0.03
Standard Error of the Mean
0.07
2-Sided
95
-0.16
0.10
Superiority or Other (legacy)
OG005
OG007
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.089
LS mean difference
-0.11
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.02
Superiority or Other (legacy)
OG006
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.065
LS mean difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.26
0.01
Superiority or Other (legacy)
OG007
OG008
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.567
LS mean difference
-0.04
Standard Error of the Mean
0.07
2-Sided
95
-0.17
0.09
Superiority or Other (legacy)
OG000
OG001
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.135
LS mean difference
-0.10
Standard Error of the Mean
0.07
2-Sided
95
-0.24
0.03
Superiority or Other (legacy)
OG000
OG002
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.094
LS mean difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.02
Superiority or Other (legacy)
OG001
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.055
LS mean difference
-0.13
Standard Error of the Mean
0.07
2-Sided
95
-0.27
0.00
Superiority or Other (legacy)
OG002
OG003
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.087
LS mean difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.02
Superiority or Other (legacy)
OG005
OG006
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.542
LS mean difference
-0.04
Standard Error of the Mean
0.07
2-Sided
95
-0.18
0.10
Superiority or Other (legacy)
OG005
OG007
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.643
LS mean difference
-0.03
Standard Error of the Mean
0.07
2-Sided
95
-0.17
0.11
Superiority or Other (legacy)
OG006
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.301
LS mean difference
-0.07
Standard Error of the Mean
0.07
2-Sided
95
-0.21
0.07
Superiority or Other (legacy)
OG007
OG008
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.237
LS mean difference
-0.08
Standard Error of the Mean
0.07
2-Sided
95
-0.22
0.05
Superiority or Other (legacy)
OG000
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.360
LS mean difference
-0.06
Standard Error of the Mean
0.06
2-Sided
95
-0.18
0.06
Superiority or Other (legacy)
OG001
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.854
LS mean difference
-0.01
Standard Error of the Mean
0.06
2-Sided
95
-0.13
0.11
Superiority or Other (legacy)
OG002
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.076
LS mean difference
-0.11
Standard Error of the Mean
0.06
2-Sided
95
-0.23
0.01
Superiority or Other (legacy)
OG003
OG004
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.957
LS mean difference
-0.00
Standard Error of the Mean
0.06
2-Sided
95
-0.12
0.12
Superiority or Other (legacy)
OG005
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.404
LS mean difference
-0.06
Standard Error of the Mean
0.07
2-Sided
95
-0.19
0.08
Superiority or Other (legacy)
OG006
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.128
LS mean difference
0.10
Standard Error of the Mean
0.07
2-Sided
95
-0.03
0.23
Superiority or Other (legacy)
OG007
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.577
LS mean difference
-0.04
Standard Error of the Mean
0.07
2-Sided
95
-0.17
0.09
Superiority or Other (legacy)
OG008
OG009
Change at Week 2: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.068
LS mean difference
0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.01
0.25
Superiority or Other (legacy)
OG000
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.016
LS mean difference
-0.15
Standard Error of the Mean
0.06
2-Sided
95
-0.27
-0.03
Superiority or Other (legacy)
OG001
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.26
Standard Error of the Mean
0.06
2-Sided
95
-0.38
-0.13
Superiority or Other (legacy)
OG002
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.31
Standard Error of the Mean
0.06
2-Sided
95
-0.44
-0.19
Superiority or Other (legacy)
OG003
OG004
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.27
Standard Error of the Mean
0.06
2-Sided
95
-0.39
-0.15
Superiority or Other (legacy)
OG005
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.037
LS mean difference
-0.14
Standard Error of the Mean
0.07
2-Sided
95
-0.27
-0.01
Superiority or Other (legacy)
OG006
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.015
LS mean difference
-0.17
Standard Error of the Mean
0.07
2-Sided
95
-0.30
-0.03
Superiority or Other (legacy)
OG007
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.001
0.07
-0.22
2-Sided
95
-0.35
-0.08
Superiority or Other (legacy)
OG008
OG009
Change at Week 4: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS mean difference
-0.21
Standard Error of the Mean
0.07
2-Sided
95
-0.34
-0.07
Superiority or Other (legacy)
OG000
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.042
LS mean difference
-0.14
Standard Error of the Mean
0.07
2-Sided
95
-0.27
-0.00
Superiority or Other (legacy)
OG001
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.27
Standard Error of the Mean
0.07
2-Sided
95
-0.40
-0.14
Superiority or Other (legacy)
OG002
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.26
Standard Error of the Mean
0.07
2-Sided
95
-0.40
-0.13
Superiority or Other (legacy)
OG003
OG004
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.37
Standard Error of the Mean
0.07
2-Sided
95
-0.50
-0.24
Superiority or Other (legacy)
OG005
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.182
LS mean difference
-0.09
Standard Error of the Mean
0.07
2-Sided
95
-0.22
0.04
Superiority or Other (legacy)
OG006
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.080
LS mean difference
-0.12
Standard Error of the Mean
0.07
2-Sided
95
-0.25
0.01
Superiority or Other (legacy)
OG007
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.002
LS mean difference
-0.20
Standard Error of the Mean
0.07
2-Sided
95
-0.34
-0.07
Superiority or Other (legacy)
OG008
OG009
Change at Week 8: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.24
Standard Error of the Mean
0.07
2-Sided
95
-0.37
-0.11
Superiority or Other (legacy)
OG000
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.016
LS mean difference
-0.17
Standard Error of the Mean
0.07
2-Sided
95
-0.30
-0.03
Superiority or Other (legacy)
OG001
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.27
Standard Error of the Mean
0.07
2-Sided
95
-0.40
-0.13
Superiority or Other (legacy)
OG002
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.28
Standard Error of the Mean
0.07
2-Sided
95
-0.42
-0.15
Superiority or Other (legacy)
OG003
OG004
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.40
Standard Error of the Mean
0.07
2-Sided
95
-0.53
-0.27
Superiority or Other (legacy)
OG005
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.032
LS mean difference
-0.15
Standard Error of the Mean
0.07
2-Sided
95
-0.29
-0.01
Superiority or Other (legacy)
OG006
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.006
LS mean difference
-0.19
Standard Error of the Mean
0.07
2-Sided
95
-0.33
-0.06
Superiority or Other (legacy)
OG007
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
0.009
LS mean difference
-0.18
Standard Error of the Mean
0.07
2-Sided
95
-0.32
-0.05
Superiority or Other (legacy)
OG008
OG009
Change at Week 12: Analysis was based on ANCOVA model with treatment, baseline value, index joint (knee or hip) as covariates.
ANCOVA
<0.001
LS mean difference
-0.27
Standard Error of the Mean
0.07
2-Sided
95
-0.41
-0.13
Superiority or Other (legacy)
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Week 2
Title
Measurements
OG00040.4
OG00135.5
OG00243.2
OG00336.1
OG00431.8
OG00539.6
OG00633.9
OG00739.5
OG00833.1
OG00932.4
Week 4
Title
Measurements
OG00053.0
OG00157.6
OG00260.7
OG003
Week 8
Title
Measurements
OG00049.5
OG00158.9
OG00260.4
OG003
Week 12
Title
Measurements
OG00054.0
OG00156.1
OG00261.4
OG003
Week 16
Title
Measurements
OG00052.3
OG00153.0
OG00256.8
OG003
Week 24
Title
Measurements
OG00048.1
OG00150.9
OG00251.4
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Week 2
Title
Measurements
OG00040.4
OG00135.5
OG00243.2
OG00336.1
OG00431.8
OG00539.6
OG00633.9
OG00739.5
OG00833.1
OG00932.4
Week 4
Title
Measurements
OG00053.7
OG00159.0
OG00262.5
OG003
Week 8
Title
Measurements
OG00053.3
OG00162.2
OG00265.7
OG003
Week 12
Title
Measurements
OG00060.4
OG00161.8
OG00268.2
OG003
Week 16
Title
Measurements
OG00059.3
OG00159.7
OG00265.7
OG003
Week 24
Title
Measurements
OG00060.4
OG00160.1
OG00263.2
OG003
Week 32
Title
Measurements
OG00060.7
OG00157.6
OG00261.4
OG003
Week 40
Title
Measurements
OG00057.9
OG00156.3
OG00258.9
OG003
Week 48
Title
Measurements
OG00058.2
OG00157.6
OG00257.9
OG003
Week 56
Title
Measurements
OG00057.2
OG00154.9
OG00257.5
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Week 2: >=30% Reduction
Title
Measurements
OG00028.4
OG00126.8
OG00235.0
OG00324.9
OG00422.7
OG00528.0
OG00622.8
OG00730.6
OG00826.0
OG00924.7
Week 2: >=50% Reduction
Title
Measurements
OG00017.5
OG00117.1
OG00220.4
OG003
Week 2: >=70% Reduction
Title
Measurements
OG0005.6
OG0018.7
OG0026.4
OG003
Week 2: >=90% Reduction
Title
Measurements
OG0001.1
OG0011.4
OG0022.9
OG003
Week 4: >=30% Reduction
Title
Measurements
OG00040.7
OG00145.6
OG00252.1
OG003
Week 4: >=50% Reduction
Title
Measurements
OG00024.6
OG00130.0
OG00227.5
OG003
Week 4: >=70% Reduction
Title
Measurements
OG00011.9
OG00112.5
OG00215.0
OG003
Week 4: >=90% Reduction
Title
Measurements
OG0002.1
OG0013.1
OG0026.8
OG003
Week 8: >=30% Reduction
Title
Measurements
OG00043.9
OG00149.8
OG00249.3
OG003
Week 8: >=50% Reduction
Title
Measurements
OG00027.7
OG00133.8
OG00229.6
OG003
Week 8: >=70% Reduction
Title
Measurements
OG00013.7
OG00116.4
OG00218.2
OG003
Week 8: >=90% Reduction
Title
Measurements
OG0004.2
OG0013.8
OG0026.4
OG003
Week 12: >=30% Reduction
Title
Measurements
OG00045.6
OG00146.3
OG00253.2
OG003
Week 12: >=50% Reduction
Title
Measurements
OG00030.2
OG00132.8
OG00232.1
OG003
Week 12: >=70% Reduction
Title
Measurements
OG00014.4
OG00116.0
OG00218.6
OG003
Week 12: >=90% Reduction
Title
Measurements
OG0006.3
OG0016.3
OG0026.8
OG003
Week 16: >=30% Reduction
Title
Measurements
OG00044.6
OG00147.0
OG00249.6
OG003
Week 16: >=50% Reduction
Title
Measurements
OG00027.4
OG00132.8
OG00234.3
OG003
Week 16: >=70% Reduction
Title
Measurements
OG00015.1
OG00117.4
OG00215.0
OG003
Week 16: >=90% Reduction
Title
Measurements
OG0006.0
OG0016.3
OG0026.8
OG003
Week 24: >=30% Reduction
Title
Measurements
OG00040.4
OG00144.9
OG00244.3
OG003
Week 24: >=50% Reduction
Title
Measurements
OG00027.7
OG00131.7
OG00228.2
OG003
Week 24: >=70% Reduction
Title
Measurements
OG00014.0
OG00117.4
OG00216.4
OG003
Week 24: >=90% Reduction
Title
Measurements
OG0006.7
OG0017.3
OG0026.4
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Week 2: >=30% Reduction
Title
Measurements
OG00028.4
OG00126.8
OG00235.0
OG00324.9
OG00422.7
OG00528.0
OG00622.8
OG00730.6
OG00826.0
OG00924.7
Week 2: >=50% Reduction
Title
Measurements
OG00017.5
OG00117.1
OG00220.4
OG003
Week 2: >=70% Reduction
Title
Measurements
OG0005.6
OG0018.7
OG0026.4
OG003
Week 2: >=90% Reduction
Title
Measurements
OG0001.1
OG0011.4
OG0022.9
OG003
Week 4: >=30% Reduction
Title
Measurements
OG00041.1
OG00146.3
OG00253.2
OG003
Week 4: >=50% Reduction
Title
Measurements
OG00024.6
OG00130.7
OG00227.9
OG003
Week 4: >=70% Reduction
Title
Measurements
OG00011.9
OG00112.5
OG00215.0
OG003
Week 4: >=90% Reduction
Title
Measurements
OG0002.1
OG0013.1
OG0026.8
OG003
Week 8: >=30% Reduction
Title
Measurements
OG00046.3
OG00151.9
OG00253.9
OG003
Week 8: >=50% Reduction
Title
Measurements
OG00029.1
OG00135.2
OG00231.4
OG003
Week 8: >=70% Reduction
Title
Measurements
OG00014.4
OG00116.7
OG00219.3
OG003
Week 8: >=90% Reduction
Title
Measurements
OG0004.2
OG0014.2
OG0026.4
OG003
Week 12: >=30% Reduction
Title
Measurements
OG00049.8
OG00150.9
OG00259.3
OG003
Week 12: >=50% Reduction
Title
Measurements
OG00032.6
OG00135.5
OG00234.3
OG003
Week 12: >=70% Reduction
Title
Measurements
OG00015.4
OG00116.4
OG00219.6
OG003
Week 12: >=90% Reduction
Title
Measurements
OG0006.3
OG0016.6
OG0027.1
OG003
Week 16: >=30% Reduction
Title
Measurements
OG00049.1
OG00152.3
OG00256.8
OG003
Week 16: >=50% Reduction
Title
Measurements
OG00030.2
OG00135.9
OG00237.5
OG003
Week 16: >=70% Reduction
Title
Measurements
OG00016.1
OG00118.1
OG00216.8
OG003
Week 16: >=90% Reduction
Title
Measurements
OG0006.0
OG0016.6
OG0027.5
OG003
Week 24: >=30% Reduction
Title
Measurements
OG00049.5
OG00153.0
OG00254.3
OG003
Week 24: >=50% Reduction
Title
Measurements
OG00034.0
OG00136.2
OG00233.2
OG003
Week 24: >=70% Reduction
Title
Measurements
OG00016.8
OG00118.5
OG00219.6
OG003
Week 24: >=90% Reduction
Title
Measurements
OG0007.4
OG0017.7
OG0027.5
OG003
Week 32: >=30% Reduction
Title
Measurements
OG00049.5
OG00152.3
OG00253.6
OG003
Week 32: >=50% Reduction
Title
Measurements
OG00030.2
OG00133.8
OG00233.9
OG003
Week 32: >=70% Reduction
Title
Measurements
OG00018.2
OG00117.8
OG00216.1
OG003
Week 32: >=90% Reduction
Title
Measurements
OG0005.6
OG0017.0
OG0025.4
OG003
Week 40: >=30% Reduction
Title
Measurements
OG00049.5
OG00150.9
OG00251.8
OG003
Week 40: >=50% Reduction
Title
Measurements
OG00031.9
OG00131.7
OG00230.4
OG003
Week 40: >=70% Reduction
Title
Measurements
OG00016.1
OG00117.4
OG00215.7
OG003
Week 40: >=90% Reduction
Title
Measurements
OG0005.3
OG0015.6
OG0024.6
OG003
Week 48: >=30% Reduction
Title
Measurements
OG00048.8
OG00151.6
OG00251.4
OG003
Week 48: >=50% Reduction
Title
Measurements
OG00030.9
OG00130.7
OG00230.4
OG003
Week 48: >=70% Reduction
Title
Measurements
OG00017.2
OG00116.0
OG00215.4
OG003
Week 48: >=90% Reduction
Title
Measurements
OG0005.6
OG0015.9
OG0024.6
OG003
Week 56: >=30% Reduction
Title
Measurements
OG00047.7
OG00150.2
OG00251.4
OG003
Week 56: >=50% Reduction
Title
Measurements
OG00030.2
OG00128.9
OG00228.6
OG003
Week 56: >=70% Reduction
Title
Measurements
OG00016.5
OG00115.3
OG00216.1
OG003
Week 56: >=90% Reduction
Title
Measurements
OG0006.0
OG0015.2
OG0024.6
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003285
OG004282
OG005254
OG006254
OG007255
OG008254
OG009255
Title
Denominators
Categories
>0%
Title
Measurements
OG000198
OG001201
OG002199
OG003203
OG004172
OG005177
OG006182
OG007193
OG008194
OG009170
>=10%
Title
Measurements
OG000179
OG001184
OG002183
OG003
>=20%
Title
Measurements
OG000148
OG001162
OG002158
OG003
>=30%
Title
Measurements
OG000127
OG001135
OG002139
OG003
>=40%
Title
Measurements
OG000103
OG001117
OG002118
OG003
>=50%
Title
Measurements
OG00078
OG00194
OG00296
OG003
>=60%
Title
Measurements
OG00053
OG00175
OG00261
OG003
>=70%
Title
Measurements
OG00043
OG00150
OG00242
OG003
>=80%
Title
Measurements
OG00029
OG00129
OG00231
OG003
>=90%
Title
Measurements
OG00017
OG00118
OG00219
OG003
100%
Title
Measurements
OG0004
OG00111
OG00212
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
>0%
Title
Measurements
OG000228
OG001234
OG002233
OG003245
OG004201
OG005197
OG006202
OG007208
OG008208
OG009188
>=10%
Title
Measurements
OG000203
OG001210
OG002215
OG003
>=20%
Title
Measurements
OG000167
OG001183
OG002181
OG003
>=30%
Title
Measurements
OG000140
OG001150
OG002159
OG003
>=40%
Title
Measurements
OG000114
OG001129
OG002132
OG003
>=50%
Title
Measurements
OG00086
OG001103
OG002105
OG003
>=60%
Title
Measurements
OG00058
OG00179
OG00268
OG003
>=70%
Title
Measurements
OG00046
OG00152
OG00247
OG003
>=80%
Title
Measurements
OG00031
OG00130
OG00236
OG003
>=90%
Title
Measurements
OG00017
OG00119
OG00221
OG003
100%
Title
Measurements
OG0004
OG00112
OG00214
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Week 2
Title
Measurements
OG0009.9
OG00110.1
OG0028.2
OG00310.9
OG0046.4
OG00511.3
OG0069.4
OG00712.5
OG0085.9
OG0096.3
Week 4
Title
Measurements
OG00010.2
OG00113.5
OG00217.5
OG003
Week 8
Title
Measurements
OG00014.1
OG00118.4
OG00218.2
OG003
Week 12
Title
Measurements
OG00015.5
OG00117.4
OG00218.2
OG003
Week 16
Title
Measurements
OG00014.8
OG00119.1
OG00216.4
OG003
Week 24
Title
Measurements
OG00017.6
OG00118.1
OG00212.1
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Week 2
Title
Measurements
OG0009.9
OG00110.1
OG0028.2
OG00310.9
OG0046.4
OG00511.3
OG0069.4
OG00712.5
OG0085.9
OG0096.3
Week 4
Title
Measurements
OG00010.6
OG00114.2
OG00217.9
OG003
Week 8
Title
Measurements
OG00015.1
OG00120.5
OG00219.3
OG003
Week 12
Title
Measurements
OG00016.9
OG00120.8
OG00220.4
OG003
Week 16
Title
Measurements
OG00016.5
OG00122.6
OG00218.9
OG003
Week 24
Title
Measurements
OG00020.1
OG00122.2
OG00215.4
OG003
Week 32
Title
Measurements
OG00014.4
OG00118.8
OG00216.4
OG003
Week 40
Title
Measurements
OG00014.8
OG00117.4
OG00213.9
OG003
Week 48
Title
Measurements
OG00014.4
OG00116.7
OG00212.9
OG003
Week 56
Title
Measurements
OG00014.4
OG00115.3
OG00213.6
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000284
OG001287
OG002280
OG003286
OG004281
OG005255
OG006254
OG007255
OG008254
OG009255
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.50± 2.00
OG0016.66± 1.85
OG0026.70± 1.88
OG0036.42± 2.05
OG0046.60± 1.73
OG0056.62± 2.14
OG0066.58± 2.04
OG0076.47± 2.14
OG0086.33± 2.01
OG0096.39± 1.89
Change at Week 2
Title
Measurements
OG000-1.35± 2.43
OG001-1.32± 2.18
OG002-1.65± 2.44
OG003
Change at Week 4
Title
Measurements
OG000-1.85± 2.46
OG001-2.10± 2.34
OG002-2.31± 2.51
OG003
Change at Week 8
Title
Measurements
OG000-1.76± 2.60
OG001-2.26± 2.38
OG002-2.26± 2.66
OG003
Change at Week 12
Title
Measurements
OG000-1.98± 2.64
OG001-2.14± 2.38
OG002-2.49± 2.52
OG003
Change at Week 16
Title
Measurements
OG000-1.93± 2.55
OG001-2.15± 2.40
OG002-2.31± 2.57
OG003
Change at Week 24
Title
Measurements
OG000-1.80± 2.62
OG001-1.96± 2.52
OG002-1.98± 2.57
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000284
OG001287
OG002280
OG003286
OG004281
OG005255
OG006254
OG007255
OG008254
OG009255
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-1.35± 2.43
OG001-1.32± 2.18
OG002-1.65± 2.44
OG003-1.19± 2.29
OG004-1.02± 1.98
OG005-1.35± 2.52
OG006-1.21± 2.40
OG007-1.41± 2.31
OG008-1.11± 2.44
OG009-0.82± 2.04
Change at Week 4
Title
Measurements
OG000-1.88± 2.49
OG001-2.17± 2.33
OG002-2.34± 2.50
OG003
Change at Week 8
Title
Measurements
OG000-1.88± 2.67
OG001-2.43± 2.38
OG002-2.44± 2.66
OG003
Change at Week 12
Title
Measurements
OG000-2.18± 2.71
OG001-2.39± 2.38
OG002-2.71± 2.50
OG003
Change at Week 16
Title
Measurements
OG000-2.16± 2.62
OG001-2.44± 2.38
OG002-2.64± 2.58
OG003
Change at Week 24
Title
Measurements
OG000-2.22± 2.75
OG001-2.36± 2.50
OG002-2.48± 2.65
OG003
Change at Week 32
Title
Measurements
OG000-2.07± 2.86
OG001-2.23± 2.51
OG002-2.36± 2.62
OG003
Change at Week 40
Title
Measurements
OG000-2.05± 2.85
OG001-2.15± 2.63
OG002-2.13± 2.63
OG003
Change at Week 48
Title
Measurements
OG000-2.03± 2.90
OG001-2.23± 2.71
OG002-2.11± 2.71
OG003
Change at Week 56
Title
Measurements
OG000-1.99± 2.86
OG001-2.10± 2.66
OG002-2.07± 2.72
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003286
OG004283
OG005255
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.45± 1.62
OG0016.54± 1.53
OG0026.60± 1.58
OG0036.38± 1.63
OG0046.41± 1.51
OG0056.60± 1.58
OG0066.54± 1.54
OG0076.48± 1.70
OG0086.33± 1.59
OG0096.38± 1.55
Change at Week 2
Title
Measurements
OG000-1.13± 1.90
OG001-1.15± 1.86
OG002-1.46± 2.03
OG003
Change at Week 4
Title
Measurements
OG000-1.74± 2.04
OG001-1.92± 1.91
OG002-2.15± 2.15
OG003
Change at Week 8
Title
Measurements
OG000-1.68± 2.21
OG001-2.11± 2.05
OG002-2.14± 2.27
OG003
Change at Week 12
Title
Measurements
OG000-1.90± 2.26
OG001-1.98± 2.08
OG002-2.31± 2.18
OG003
Change at Week 16
Title
Measurements
OG000-1.84± 2.17
OG001-1.98± 2.17
OG002-2.17± 2.19
OG003
Change at Week 24
Title
Measurements
OG000-1.70± 2.29
OG001-1.84± 2.19
OG002-1.87± 2.17
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003286
OG004283
OG005255
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-1.13± 1.90
OG001-1.15± 1.86
OG002-1.46± 2.03
OG003-1.04± 2.03
OG004-0.93± 1.69
OG005-1.17± 2.05
OG006-0.98± 2.01
OG007-1.23± 1.94
OG008-0.99± 2.12
OG009-0.89± 1.65
Change at Week 4
Title
Measurements
OG000-1.74± 2.06
OG001-1.98± 1.90
OG002-2.18± 2.13
OG003
Change at Week 8
Title
Measurements
OG000-1.78± 2.26
OG001-2.25± 2.05
OG002-2.31± 2.26
OG003
Change at Week 12
Title
Measurements
OG000-2.08± 2.31
OG001-2.20± 2.09
OG002-2.52± 2.14
OG003
Change at Week 16
Title
Measurements
OG000-2.05± 2.22
OG001-2.24± 2.16
OG002-2.48± 2.17
OG003
Change at Week 24
Title
Measurements
OG000-2.10± 2.37
OG001-2.18± 2.19
OG002-2.30± 2.22
OG003
Change at Week 32
Title
Measurements
OG000-1.96± 2.44
OG001-2.10± 2.24
OG002-2.20± 2.26
OG003
Change at Week 40
Title
Measurements
OG000-1.94± 2.43
OG001-1.99± 2.35
OG002-1.99± 2.31
OG003
Change at Week 48
Title
Measurements
OG000-1.91± 2.44
OG001-2.02± 2.39
OG002-1.96± 2.36
OG003
Change at Week 56
Title
Measurements
OG000-1.89± 2.43
OG001-1.93± 2.36
OG002-1.93± 2.36
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003286
OG004282
OG005254
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Baseline
Title
Measurements
OG0006.22± 1.83
OG0016.37± 1.97
OG0026.34± 1.87
OG0036.13± 1.96
OG0046.12± 2.08
OG0056.28± 1.83
OG0066.30± 1.88
OG0076.21± 1.97
OG0086.14± 1.97
OG0096.10± 1.83
Change at Week 2
Title
Measurements
OG000-1.05± 2.24
OG001-1.02± 2.43
OG002-1.31± 2.24
OG003
Change at Week 4
Title
Measurements
OG000-1.67± 2.37
OG001-1.88± 2.39
OG002-1.98± 2.19
OG003
Change at Week 8
Title
Measurements
OG000-1.57± 2.64
OG001-1.95± 2.51
OG002-1.93± 2.53
OG003
Change at Week 12
Title
Measurements
OG000-1.74± 2.53
OG001-1.78± 2.38
OG002-2.15± 2.38
OG003
Change at Week 16
Title
Measurements
OG000-1.71± 2.40
OG001-1.77± 2.61
OG002-1.95± 2.49
OG003
Change at Week 24
Title
Measurements
OG000-1.56± 2.49
OG001-1.65± 2.47
OG002-1.64± 2.47
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003286
OG004282
OG005254
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-1.05± 2.24
OG001-1.02± 2.43
OG002-1.31± 2.24
OG003-0.87± 2.43
OG004-0.80± 2.08
OG005-1.04± 2.34
OG006-0.68± 2.49
OG007-1.01± 2.24
OG008-0.86± 2.51
OG009-0.86± 2.04
Change at Week 4
Title
Measurements
OG000-1.65± 2.40
OG001-1.92± 2.41
OG002-2.01± 2.18
OG003
Change at Week 8
Title
Measurements
OG000-1.65± 2.69
OG001-2.09± 2.62
OG002-2.08± 2.53
OG003
Change at Week 12
Title
Measurements
OG000-1.93± 2.62
OG001-1.98± 2.53
OG002-2.32± 2.38
OG003
Change at Week 16
Title
Measurements
OG000-1.93± 2.50
OG001-2.00± 2.74
OG002-2.20± 2.55
OG003
Change at Week 24
Title
Measurements
OG000-1.95± 2.64
OG001-1.94± 2.68
OG002-1.98± 2.61
OG003
Change at Week 32
Title
Measurements
OG000-1.78± 2.72
OG001-1.80± 2.85
OG002-1.91± 2.61
OG003
Change at Week 40
Title
Measurements
OG000-1.69± 2.76
OG001-1.78± 2.92
OG002-1.69± 2.69
OG003
Change at Week 48
Title
Measurements
OG000-1.63± 2.81
OG001-1.72± 2.92
OG002-1.68± 2.76
OG003
Change at Week 56
Title
Measurements
OG000-1.65± 2.79
OG001-1.64± 2.92
OG002-1.68± 2.76
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003286
OG004282
OG005254
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Baseline
Title
Measurements
OG0007.55± 1.80
OG0017.68± 1.78
OG0027.72± 1.69
OG0037.50± 1.73
OG0047.40± 1.87
OG0057.80± 1.71
OG0067.59± 1.77
OG0077.55± 1.77
OG0087.54± 1.78
OG0097.52± 1.70
Change at Week 2
Title
Measurements
OG000-1.29± 2.23
OG001-1.34± 2.33
OG002-1.67± 2.39
OG003
Change at Week 4
Title
Measurements
OG000-1.78± 2.31
OG001-2.13± 2.30
OG002-2.46± 2.55
OG003
Change at Week 8
Title
Measurements
OG000-1.79± 2.50
OG001-2.32± 2.49
OG002-2.41± 2.62
OG003
Change at Week 12
Title
Measurements
OG000-2.09± 2.69
OG001-2.16± 2.59
OG002-2.49± 2.57
OG003
Change at Week 16
Title
Measurements
OG000-1.99± 2.60
OG001-2.20± 2.65
OG002-2.35± 2.47
OG003
Change at Week 24
Title
Measurements
OG000-1.82± 2.66
OG001-2.01± 2.67
OG002-2.02± 2.52
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001287
OG002280
OG003286
OG004282
OG005254
OG006254
OG007256
OG008254
OG009255
Title
Denominators
Categories
Change at Week 2
Title
Measurements
OG000-1.29± 2.23
OG001-1.34± 2.33
OG002-1.67± 2.39
OG003-1.36± 2.42
OG004-0.94± 2.19
OG005-1.41± 2.39
OG006-1.23± 2.31
OG007-1.45± 2.43
OG008-1.37± 2.18
OG009-1.05± 2.08
Change at Week 4
Title
Measurements
OG000-1.80± 2.31
OG001-2.20± 2.31
OG002-2.51± 2.55
OG003
Change at Week 8
Title
Measurements
OG000-1.90± 2.55
OG001-2.48± 2.52
OG002-2.62± 2.61
OG003
Change at Week 12
Title
Measurements
OG000-2.29± 2.70
OG001-2.40± 2.60
OG002-2.76± 2.52
OG003
Change at Week 16
Title
Measurements
OG000-2.23± 2.63
OG001-2.47± 2.65
OG002-2.70± 2.45
OG003
Change at Week 24
Title
Measurements
OG000-2.26± 2.73
OG001-2.38± 2.71
OG002-2.48± 2.55
OG003
Change at Week 32
Title
Measurements
OG000-2.12± 2.75
OG001-2.28± 2.74
OG002-2.43± 2.72
OG003
Change at Week 40
Title
Measurements
OG000-2.06± 2.66
OG001-2.21± 2.73
OG002-2.09± 2.59
OG003
Change at Week 48
Title
Measurements
OG000-1.99± 2.69
OG001-2.17± 2.74
OG002-2.10± 2.74
OG003
Change at Week 56
Title
Measurements
OG000-2.00± 2.70
OG001-2.08± 2.76
OG002-2.10± 2.72
OG003
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
General health at baseline
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
ParticipantsOG004279
ParticipantsOG005254
ParticipantsOG006254
ParticipantsOG007255
ParticipantsOG008253
ParticipantsOG009255
Title
Measurements
OG00056.76± 20.74
OG00157.41± 21.03
OG00260.66± 20.88
OG003
Physical function at baseline
ParticipantsOG000282
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Role physical at baseline
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Bodily pain at baseline
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003285
Vitality at baseline
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Social function at baseline
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Role emotional at baseline
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Mental health at baseline
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: General health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Physical function
ParticipantsOG000282
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Role physical
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Bodily pain
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Vitality
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Social function
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Role emotional
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Mental health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: General health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Physical function
ParticipantsOG000282
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Role physical
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Bodily pain
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Vitality
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Social function
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Role emotional
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Mental health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Change at Week 12: General health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
ParticipantsOG004279
ParticipantsOG005254
ParticipantsOG006254
ParticipantsOG007255
ParticipantsOG008253
ParticipantsOG009255
Title
Measurements
OG0003.29± 14.32
OG0014.66± 15.19
OG0023.66± 15.27
OG003
Change at Week 12: Physical function
ParticipantsOG000282
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Role physical
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Bodily pain
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Vitality
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Social function
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Role emotional
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 12: Mental health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: General health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Physical function
ParticipantsOG000282
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Role physical
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Bodily pain
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Vitality
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Social function
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Role emotional
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 24: Mental health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 40: General health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 40: Physical function
ParticipantsOG000282
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 40: Role physical
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 40: Bodily pain
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003285
Change at Week 40: Vitality
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Social function at Week 40
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 40: Role emotional
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 40: Mental health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: General health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: Physical function
ParticipantsOG000282
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: Role physical
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: Bodily pain
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: Vitality
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: Social function
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: Role emotional
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Change at Week 56: Mental health
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003285
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Title
Measurements
OG00023
OG00123
OG00222
OG00315
OG00440
OG00519
OG00621
OG00715
OG00818
OG00938
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Title
Measurements
OG000319.87± 3.74
OG001331.69± 3.65
OG002394.80± 5.08
OG003271.89± 2.66
OG004306.11± 4.94
OG005329.79± 3.68
OG006314.16± 4.15
OG007334.84± 3.08
OG008324.25± 3.32
OG009303.08± 5.10
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000101
OG001103
OG00299
OG003121
OG004114
OG00576
OG00677
OG00792
OG00884
OG00990
Title
Denominators
Categories
Title
Measurements
OG000-0.88± 11.54
OG0010.04± 8.16
OG0020.63± 6.23
OG003-0.77± 15.75
OG0041.11± 12.55
OG005-2.85± 10.19
OG006-0.42± 12.87
OG0071.51± 11.21
OG008-1.64± 9.60
OG009-0.61± 8.36
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000101
OG001103
OG00299
OG003121
OG004114
OG00576
OG00677
OG00792
OG00884
OG00990
Title
Denominators
Categories
Change at Week 24
Title
Measurements
OG000-0.88± 11.54
OG0010.04± 8.16
OG0020.63± 6.23
OG0030.77± 15.75
OG0041.11± 12.55
OG005-2.85± 10.19
OG006-0.42± 12.87
OG0071.51± 11.21
OG008-1.64± 9.60
OG009-0.61± 8.36
Change at Week 56
Title
Measurements
OG000-1.10± 11.30
OG001-0.39± 9.29
OG0021.08± 7.57
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000100
OG001101
OG00298
OG003120
OG004113
OG00573
OG00673
OG00789
OG00880
OG00986
Title
Denominators
Categories
Title
Measurements
OG000-11.90± 22.32
OG001-11.68± 24.74
OG002-5.51± 26.33
OG003-13.00± 27.34
OG004-7.35± 29.03
OG005-17.81± 22.00
OG006-13.01± 25.91
OG007-9.33± 22.40
OG008-9.63± 23.68
OG009-5.81± 22.62
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000100
OG001101
OG00298
OG003120
OG004113
OG00573
OG00673
OG00789
OG00880
OG00986
Title
Denominators
Categories
Change at Week 24
Title
Measurements
OG000-11.90± 22.32
OG001-11.68± 24.74
OG002-5.51± 26.33
OG003-13.00± 27.34
OG004-7.35± 29.03
OG005-17.81± 22.00
OG006-13.01± 25.91
OG007-9.33± 22.40
OG008-9.63± 23.68
OG009-5.81± 22.62
Change at Week 56
Title
Measurements
OG000-10.30± 23.11
OG001-11.88± 24.85
OG002-4.08± 25.92
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000101
OG001103
OG00299
OG003121
OG004114
OG00577
OG006254
OG00792
OG00884
OG00990
Title
Denominators
Categories
Title
Measurements
OG000-5.40± 31.08
OG001-1.46± 24.95
OG002-0.75± 18.60
OG003-1.35± 29.85
OG0042.09± 28.55
OG005-10.17± 26.46
OG006-0.22± 22.51
OG0071.25± 26.81
OG008-4.30± 24.16
OG009-2.29± 23.87
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000101
OG001103
OG00299
OG003121
OG004114
OG00576
OG00677
OG00792
OG00884
OG00990
Title
Denominators
Categories
Change at Week 24
Title
Measurements
OG000-5.40± 31.08
OG001-1.46± 24.95
OG002-0.75± 18.60
OG003-1.35± 29.85
OG0042.09± 28.55
OG005-10.17± 26.46
OG006-0.22± 22.51
OG0071.25± 26.81
OG008-4.30± 24.16
OG009-2.29± 23.87
Change at Week 56
Title
Measurements
OG000-6.08± 30.20
OG001-1.88± 26.61
OG0020.77± 22.05
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000283
OG001287
OG002279
OG003284
OG004280
OG005254
OG006250
OG007255
OG008249
OG009253
Title
Denominators
Categories
Title
Measurements
OG000-12.30± 25.61
OG001-15.51± 26.17
OG002-13.55± 26.42
OG003-14.96± 26.74
OG004-10.00± 25.92
OG005-17.24± 25.11
OG006-17.84± 25.81
OG007-18.04± 25.47
OG008-17.31± 26.28
OG009-11.90± 26.06
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000283
OG001287
OG002279
OG003284
OG004280
OG005254
OG006250
OG007255
OG008249
OG009253
Title
Denominators
Categories
Change at Week 24
Title
Measurements
OG000-12.30± 25.61
OG001-15.51± 26.17
OG002-13.55± 26.42
OG003-14.96± 26.74
OG004-10.00± 25.92
OG005-17.24± 25.11
OG006-17.84± 25.81
OG007-18.04± 25.47
OG008-17.31± 26.28
OG009-11.90± 26.06
Change at Week 56
Title
Measurements
OG000-12.12± 25.37
OG001-14.77± 26.72
OG002-12.19± 27.03
OG003
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Weeks 1-2
ParticipantsOG000266
ParticipantsOG001275
ParticipantsOG002264
ParticipantsOG003267
ParticipantsOG004273
ParticipantsOG005241
ParticipantsOG006240
ParticipantsOG007241
ParticipantsOG008240
ParticipantsOG009250
Title
Measurements
OG00060.5
OG00159.3
OG00257.6
OG003
Weeks 3-4
ParticipantsOG000256
ParticipantsOG001262
ParticipantsOG002256
ParticipantsOG003254
Weeks 5-8
ParticipantsOG000251
ParticipantsOG001249
ParticipantsOG002243
ParticipantsOG003240
Weeks 9-12
ParticipantsOG000242
ParticipantsOG001245
ParticipantsOG002229
ParticipantsOG003236
Weeks 13-16
ParticipantsOG000231
ParticipantsOG001234
ParticipantsOG002224
ParticipantsOG003225
Weeks 17-24
ParticipantsOG000206
ParticipantsOG001209
ParticipantsOG002207
ParticipantsOG003206
Weeks 25-32
ParticipantsOG000162
ParticipantsOG001153
ParticipantsOG002159
ParticipantsOG003156
Weeks 33-40
ParticipantsOG00090
ParticipantsOG00182
ParticipantsOG00291
ParticipantsOG00376
Weeks 41-48
ParticipantsOG00051
ParticipantsOG00140
ParticipantsOG00249
ParticipantsOG00346
Weeks 49-56
ParticipantsOG00091
ParticipantsOG00190
ParticipantsOG00289
ParticipantsOG00389
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Weeks 1-2
ParticipantsOG000278
ParticipantsOG001286
ParticipantsOG002274
ParticipantsOG003284
ParticipantsOG004281
ParticipantsOG005253
ParticipantsOG006250
ParticipantsOG007253
ParticipantsOG008249
ParticipantsOG009255
Title
Measurements
OG00060.4
OG00159.4
OG00256.9
OG003
Weeks 3-4
ParticipantsOG000281
ParticipantsOG001287
ParticipantsOG002278
ParticipantsOG003285
Weeks 5-8
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003287
Weeks 9-12
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 13-16
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 17-24
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 25-32
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 33-40
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 41-48
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 49-56
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Weeks 1-2
ParticipantsOG000278
ParticipantsOG001286
ParticipantsOG002274
ParticipantsOG003284
ParticipantsOG004281
ParticipantsOG005253
ParticipantsOG006250
ParticipantsOG007253
ParticipantsOG008249
ParticipantsOG009255
Title
Measurements
OG0003144.66± 6878.90
OG0013365.46± 8829.47
OG0022739.96± 7060.72
OG003
Weeks 3-4
ParticipantsOG000281
ParticipantsOG001287
ParticipantsOG002278
ParticipantsOG003285
Weeks 5-8
ParticipantsOG000284
ParticipantsOG001287
ParticipantsOG002280
ParticipantsOG003287
Weeks 9-12
ParticipantsOG000284
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 13-16
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 17-24
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 25-32
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 33-40
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 41-48
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
Weeks 49-56
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
OG002
Tanezumab 5 mg + NSAID
Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
OG003
Tanezumab 10 mg + NSAID
Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
OG004
NSAID
Placebo matched to tanezumab infusion, IV once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000448
OG001449
OG002446
OG003452
OG004446
Title
Denominators
Categories
Baseline
ParticipantsOG000371
ParticipantsOG001370
ParticipantsOG002369
ParticipantsOG003368
ParticipantsOG004375
Title
Measurements
OG0002.769± 2.077
OG0012.850± 2.077
OG0023.005± 2.068
OG003
Change at Week 56
ParticipantsOG000255
ParticipantsOG001256
ParticipantsOG002262
ParticipantsOG003239
OG002
Tanezumab 5 mg + NSAID
Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
OG003
Tanezumab 10 mg + NSAID
Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
OG004
NSAID
Placebo matched to tanezumab infusion, IV once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG00092
OG00193
OG00290
OG00390
OG00493
Title
Denominators
Categories
Baseline
ParticipantsOG00091
ParticipantsOG00192
ParticipantsOG00287
ParticipantsOG00387
ParticipantsOG00490
Title
Measurements
OG0002.447± 1.364
OG0012.372± 1.433
OG0022.346± 1.424
OG003
Change at Week 56
ParticipantsOG00069
ParticipantsOG00167
ParticipantsOG00265
ParticipantsOG00359
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
AEs
Title
Measurements
OG000203
OG001211
OG002205
OG003207
OG004192
OG005202
OG006188
OG007185
OG008193
OG009172
SAEs
Title
Measurements
OG00022
OG00123
OG00228
OG003
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Baseline
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
ParticipantsOG004282
ParticipantsOG005256
ParticipantsOG006254
ParticipantsOG007256
ParticipantsOG008253
ParticipantsOG009255
Title
Measurements
OG0002.64± 5.96
OG0012.56± 5.82
OG0021.93± 4.34
OG003
Change at Week 2
ParticipantsOG000278
ParticipantsOG001284
ParticipantsOG002272
ParticipantsOG003274
Change at Week 4
ParticipantsOG000269
ParticipantsOG001274
ParticipantsOG002263
ParticipantsOG003268
Change at Week 8
ParticipantsOG000257
ParticipantsOG001257
ParticipantsOG002251
ParticipantsOG003248
Change at Week 12
ParticipantsOG000248
ParticipantsOG001253
ParticipantsOG002248
ParticipantsOG003236
Change at Week 16
ParticipantsOG000246
ParticipantsOG001244
ParticipantsOG002233
ParticipantsOG003231
Change at Week 24
ParticipantsOG000224
ParticipantsOG001224
ParticipantsOG002219
ParticipantsOG003223
Change at Week 32
ParticipantsOG000208
ParticipantsOG001195
ParticipantsOG002200
ParticipantsOG003201
Change at Week 40
ParticipantsOG000186
ParticipantsOG001174
ParticipantsOG002179
ParticipantsOG003175
Change at Week 48
ParticipantsOG000151
ParticipantsOG001143
ParticipantsOG002144
ParticipantsOG003138
Change at Week 56
ParticipantsOG00083
ParticipantsOG00183
ParticipantsOG00283
ParticipantsOG00370
OG001
Tanezumab 10 mg (Naproxen Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg tablet orally twice daily on Days 1-7, naproxen 500 mg tablet orally once daily in the morning of Days 8-14 and placebo matching to naproxen tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000285
OG001288
OG002280
OG003288
OG004283
OG005256
OG006254
OG007256
OG008254
OG009256
Title
Denominators
Categories
Baseline
ParticipantsOG000285
ParticipantsOG001288
ParticipantsOG002280
ParticipantsOG003287
ParticipantsOG004282
ParticipantsOG005256
ParticipantsOG006254
ParticipantsOG007256
ParticipantsOG008253
ParticipantsOG009255
Title
Measurements
OG0002.64± 5.96
OG0012.56± 5.82
OG0021.93± 4.34
OG003
Change at Week 2
ParticipantsOG000278
ParticipantsOG001284
ParticipantsOG002272
ParticipantsOG003274
Change at Week 4
ParticipantsOG000282
ParticipantsOG001287
ParticipantsOG002275
ParticipantsOG003284
Change at Week 8
ParticipantsOG000282
ParticipantsOG001287
ParticipantsOG002277
ParticipantsOG003284
Change at Week 12
ParticipantsOG000282
ParticipantsOG001287
ParticipantsOG002277
ParticipantsOG003284
Change at Week 16
ParticipantsOG000283
ParticipantsOG001287
ParticipantsOG002277
ParticipantsOG003284
Change at Week 24
ParticipantsOG000283
ParticipantsOG001287
ParticipantsOG002277
ParticipantsOG003284
Change at Week 32
ParticipantsOG000283
ParticipantsOG001287
ParticipantsOG002277
ParticipantsOG003284
Change at Week 40
ParticipantsOG000283
ParticipantsOG001287
ParticipantsOG002278
ParticipantsOG003284
Change at Week 48
ParticipantsOG000283
ParticipantsOG001283
ParticipantsOG002278
ParticipantsOG003284
Change at Week 56
ParticipantsOG000283
ParticipantsOG001287
ParticipantsOG002278
ParticipantsOG003284
Participants were administered with tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received naproxen 500 mg/celecoxib 100 mg tablet orally twice daily on Days 1-7 followed by naproxen 500 mg/celecoxib 100 mg tablet orally once daily in the morning along with placebo matching to naproxen/celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to naproxen 500 mg/celecoxib 100 mg tablet orally twice daily up to Week 48.
OG002
Tanezumab 5 mg + NSAID
Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
OG003
Tanezumab 10 mg + NSAID
Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000541
OG001542
OG002536
OG003542
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003
OG0012
OG0024
OG0032
Week 16
Title
Measurements
OG0005
OG0013
OG0024
OG003
Week 24
Title
Measurements
OG0004
OG0012
OG0021
OG003
Week 40
Title
Measurements
OG0002
OG0012
OG0025
OG003
Week 56
Title
Measurements
OG0003
OG0012
OG0021
OG003
OG002
Tanezumab 5 mg + NSAID
Tanezumab 5 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
OG003
Tanezumab 10 mg + NSAID
Tanezumab 10 mg IV infusion, once every 8 weeks plus NSAID (naproxen 500 mg or celecoxib 100 mg) tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000512
OG001517
OG002502
OG003507
Title
Denominators
Categories
Day 1
ParticipantsOG000512
ParticipantsOG001517
ParticipantsOG002502
ParticipantsOG003507
Title
Measurements
OG00048.4570± 241.4173
OG001164.068± 1045.628
OG002102.398± 543.2856
OG003
Week 16
ParticipantsOG000426
ParticipantsOG001413
ParticipantsOG002421
ParticipantsOG003410
Week 24
ParticipantsOG000395
ParticipantsOG001387
ParticipantsOG002398
ParticipantsOG003391
Week 40
ParticipantsOG000295
ParticipantsOG001259
ParticipantsOG002272
ParticipantsOG003257
Week 56
ParticipantsOG000391
ParticipantsOG001390
ParticipantsOG002389
ParticipantsOG003370
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.
Units
Counts
Participants
OG000200
OG001208
OG002184
OG003192
OG004199
OG005192
OG006184
OG007179
OG008177
OG009189
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG002
Tanezumab 5 mg + Naproxen 500 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG003
Tanezumab 10 mg + Naproxen 500 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG004
Naproxen 500 mg
Participants received naproxen 500 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48 and placebo matched to tanezumab infusion, IV once every 8 weeks up to Week 48, beginning from Day 1 of Week 1.
OG005
Tanezumab 5 mg (Celecoxib Exposure)
Participants received tanezumab 5 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG006
Tanezumab 10 mg (Celecoxib Exposure)
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1. Additionally, participants received celecoxib 100 mg tablet orally twice daily on Days 1-7, celecoxib 100 mg tablet orally once daily in the morning of Days 8-14 and placebo matched to celecoxib tablet once daily in the evening of Days 8-14. From Day 15, participants received placebo matched to celecoxib 100 mg tablet orally twice daily up to Week 48.
OG007
Tanezumab 5 mg + Celecoxib 100 mg
Participants received tanezumab 5 mg IV infusion, once every 8 weeks, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG008
Tanezumab 10 mg + Celecoxib 100 mg
Participants received tanezumab 10 mg IV infusion, once every 8 weeks up to Week 48, beginning from Day 1 of Week 1 and celecoxib 100 mg tablet orally twice daily from Day 1 of Week 1 up to Week 48.
OG009
Celecoxib 100 mg
Placebo matched to tanezumab infusion, IV once every 8 weeks plus celecoxib 100 mg tablet orally twice daily up to Week 48.