Long-term Observational Study of Subjects From Tanezumab... | NCT02674386 | Trialant
NCT02674386
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jul 30, 2020Actual
Enrollment
154Actual
Phase
Phase 3
Conditions
Osteoarthritis
Interventions
Investigational Medical Product (IMP) administered in parent study
Countries
United States
Australia
Canada
Germany
Hungary
Italy
Japan
Lithuania
New Zealand
Portugal
Russia
Serbia
Slovakia
Spain
Sweden
Protocol Section
Identification Module
NCT ID
NCT02674386
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A4091064
Secondary IDs
ID
Type
Description
Link
2013-002549-12
EudraCT Number
TJR FOLLOW-UP
Other Identifier
Alias Study Number
Brief Title
Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement
Official Title
A PHASE 3, MULTICENTER, LONG-TERM OBSERVATIONAL STUDY OF SUBJECTS FROM TANEZUMAB STUDIES WHO UNDERGO A TOTAL KNEE, HIP OR SHOULDER REPLACEMENT
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Jul 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 23, 2016Actual
Primary Completion Date
Jul 15, 2019Actual
Completion Date
Jul 15, 2019Actual
First Submitted Date
Nov 11, 2015
First Submission Date that Met QC Criteria
Feb 1, 2016
First Posted Date
Feb 4, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 6, 2020
Results First Submitted that Met QC Criteria
Jul 6, 2020
Results First Posted Date
Jul 30, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 6, 2020
Last Update Posted Date
Jul 30, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Name
Class
Eli Lilly and Company
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).
Detailed Description
A4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies A4091056, A4091057 or A4091058.
Conditions Module
Conditions
Osteoarthritis
Keywords
Not provided
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
154Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Other
long-term observational study of subjects from tanezumab parent study
Drug: Investigational Medical Product (IMP) administered in parent study
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Investigational Medical Product (IMP) administered in parent study
Drug
IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Surgeon's Assessment of Procedural Difficulty
Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Day 1
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint.
Week 24
Number of Participants With Post-Surgical Complications Upto Week 24
Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Baseline up to Week 24
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Personally signed and dated informed consent document.
Randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study.
Actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study.
Willing and able to comply with scheduled visits and other study procedures.
Mont MA, Carrino JA, Nemeth MA, Burr A, Yamabe T, Viktrup L, Brown MT, West CR, Verburg KM. Postoperative Outcome of Patients Who Underwent Total Joint Replacement During the Tanezumab Phase 3 Osteoarthritis Development Program: A 24-Week Observational Study. Surg Technol Int. 2021 May 20;38:467-477. doi: 10.52198/21.STI.38.OS1439.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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.
Pre-specified intent of this study was to compare results regardless of treatment group/doses in parent studies and also to report data for overall (combined participants from all parent studies).
Recruitment Details
This study included participants from studies A4091056 (NCT02697773), A4091057 (NCT02709486) and A4091058 (NCT02528188) who had undergone a total joint replacement (TJR) surgery of knee, hip, or shoulder. During this study, if participant underwent an additional TJR surgery, then data for that additional TJR surgery was also assessed.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 6, 2016
Jul 6, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Brazil
Bulgaria
Colombia
Croatia
Finland
France
Mexico
Peru
Philippines
Poland
Puerto Rico
Romania
South Korea
Taiwan
Ukraine
United Kingdom
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Other
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Cohort 1
Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Baseline up to Week 24
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Baseline up to Week 24
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Baseline, Week 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Baseline, Week 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
WOMAC: self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the replaced/to be replaced index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Baseline, Week 24
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in replaced/ to be replaced index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Baseline, Week 24
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 [for pain] and 80 [for disability]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition.
Baseline, Week 24
Number of Participants Who Used Concomitant Analgesic Medications
Baseline up to Week 24
Birmingham
Alabama
35235
United States
Alabama Orthopaedic Surgeons
Birmingham
Alabama
35235
United States
Cahaba Research Inc.
Birmingham
Alabama
35242
United States
Noble Clinical Research
Tucson
Arizona
85704
United States
Baptist Health Center for Clinical Research
Little Rock
Arkansas
72205
United States
Advanced Research Center, Inc.
Anaheim
California
92805
United States
Hope Clinical Research
Canoga Park
California
91303
United States
Marvel Clinical Research, LLC
Huntington Beach
California
92647
United States
Advances in Medicine
Palm Desert
California
92260
United States
Clinical Trials Research
Sacramento
California
95821
United States
California Research Foundation
San Diego
California
92123
United States
CITrials
Santa Ana
California
92705
United States
Stamford Therapeutics Consortium
Stamford
Connecticut
06905
United States
JEM Research Institute
Atlantis
Florida
33462
United States
Orthopedic Research Institute
Boynton Beach
Florida
33472
United States
Orthopaedic Associates of West Florida
Clearwater
Florida
33756
United States
Clinical Neuroscience Solutions, Inc.
Jacksonville
Florida
32256
United States
Clintex Research Group
Miami
Florida
33135
United States
Renstar Medical Research
Ocala
Florida
34470
United States
American Family Medical
Ocala
Florida
34471
United States
Sunshine Research Center
Opa-locka
Florida
33054
United States
Gulfcoast Research Institute, LLC
Sarasota
Florida
34232-6028
United States
Kennedy White Orthopaedic Center
Sarasota
Florida
34232
United States
Stedman Clinical Trials
Tampa
Florida
33613
United States
Masters of Clinical Research, Inc.
Augusta
Georgia
30909
United States
North Georgia Clinical Research
Woodstock
Georgia
30189
United States
North Georgia Internal Medicine
Woodstock
Georgia
30189
United States
Injury Care Research
Boise
Idaho
83713
United States
Chicago Clinical Research Institute, Inc.
Chicago
Illinois
60607
United States
Northwestern University
Chicago
Illinois
60611
United States
Professional Research Network of Kansas, LLC
Wichita
Kansas
67205-1138
United States
Best Clinical Trials, LLC
New Orleans
Louisiana
70115
United States
George Stanley Walker, MD
New Orleans
Louisiana
70115
United States
Great Lakes Research Group, Incorporated
Bay City
Michigan
48706
United States
Orthopaedic Associates of Michigan, PC
Grand Rapids
Michigan
49525
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
Drug Trials America
Hartsdale
New York
10530
United States
Remington-Davis, Incorporated
Columbus
Ohio
43215
United States
Optimed Research LTD
Columbus
Ohio
43235
United States
AC Clinical Research
Tiffin
Ohio
44883
United States
Founders Research Corporation
Philadelphia
Pennsylvania
19114
United States
Abigail R. Neiman, MD, PA
Houston
Texas
77024
United States
Advances In Health
Houston
Texas
77030
United States
Mercury Clinical Research, Inc.
Houston
Texas
77036
United States
BI Research Center
Houston
Texas
77084
United States
ClinRx Research
Richardson
Texas
75080
United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio
Texas
78258
United States
Mercury Clinical Research
Webster
Texas
77598
United States
Spectrum Medical, Inc.
Danville
Virginia
24541
United States
Northwest Clinical Research Center
Bellevue
Washington
98007
United States
CMAX Clinical Research Pty Ltd
Adelaide
South Australia
5000
Australia
Dawson Road Medical Centre
Guelph
Ontario
N1H 1B1
Canada
Rebecca Medical Associates
Oakville
Ontario
L6K 1J6
Canada
Recherche Clinique Sigma inc
Québec
Quebec
G1G 3Y8
Canada
Centre de recherche Saint-Louis
Québec
Quebec
G1W 4R4
Canada
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan
18209
Germany
Tolna Megyei Balassa Janos Korhaz, Ortopediai Osztaly
Szekszárd
7100
Hungary
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
Rome
00161
Italy
Omuro Orthopedic Clinic
Himeji
Hyōgo
670-0976
Japan
Nakajo Orthopedic Clinic
Sendai
Miyagi
983-0862
Japan
Marunouchi Hospital
Matsumoto
Nagano
390-8601
Japan
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano
Osaka
586-8521
Japan
Osaka University Hospital
Suita
Osaka
565-0871
Japan
Saules seimos medicinos centras
Kaunas
LT-49449
Lithuania
South Pacific Clinical Trials
Auckland
0610
New Zealand
Star Unit, North Shore Hospital, Waitemata District Health Board
Auckland
0622
New Zealand
Southern Clinical Trials- Waitemata Ltd
Auckland
0626
New Zealand
Clinical Horizons NZ Ltd
Tauranga
3112
New Zealand
Hospital Conde de Bertiandos
Ponte de Lima
Viana do Castelo District
4990-041
Portugal
Medical Technologies Ltd.
Saint Petersburg
191025
Russia
Institute of Rheumatology
Belgrade
11000
Serbia
Kompan, s.r.o.
Dolný Kubín
02601
Slovakia
Slovak Research Center Team Member, MUDr. Viliam Cibik, PhD, s.r.o.
Pruské
018 52
Slovakia
Instituto de Ciencias Medicas
Alicante
03004
Spain
Hospital del Mar
Barcelona
08003
Spain
Ladulaas Kliniska Studier
Boras, Sweden
SE-506 30
Sweden
ProbarE I Lund AB
Lund
222 22
Sweden
ProbarE i Stockholm AB
Stockholm
111 37
Sweden
FG001
Tanezumab Combined
Participants who received tanezumab subcutaneous (SC) injection of 2.5 milligram (mg) or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
FG002
NSAID
Participants who received non-steroidal anti-inflammatory drug (NSAID) tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
FG00020 subjects
FG001117 subjects
FG00217 subjects
Safety Analysis Set
FG00020 subjects
FG001113 subjects
FG00217 subjects
COMPLETED
FG00020 subjects
FG001107 subjects
FG00216 subjects
NOT COMPLETED
FG0000 subjects
FG00110 subjects
FG0021 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
Withdrawal by Subject
FG0000 subjects
FG0014 subjects
FG0020 subjects
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
Enrolled but not evaluated
FG0000 subjects
FG0014 subjects
FG0020 subjects
Safety analysis set: all enrolled participants of this study who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying i.e. total (not partial) joint replacement surgery.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
BG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
BG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00020
BG001113
BG00217
BG003150
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00065.26± 8.77
BG00164.57± 8.18
BG00262.94± 9.13
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Male
BG0006
BG00150
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Number of Participants With Surgeon's Assessment of Procedural Difficulty
Following the TJR surgery on Day 1, the orthopedic surgeon was asked to answer the following question: "taking into consideration the participant's medical history and physical condition prior to surgery would you classify the operative procedure as Uneventful, Minor complications or Major complications." Participants were reported based on these categories for knee, hip and shoulder joint. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set analyzed. Here, 'Overall number of participants analyzed (N)' = only those participants who had data available for this outcome measure (OM). 'Number analyzed (n)' = participants evaluable for this OM at specified categories.
Posted
Count of Participants
Participants
Day 1
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00017
OG00192
OG00213
OG003
Title
Denominators
Categories
Knee
ParticipantsOG0009
ParticipantsOG00151
ParticipantsOG0028
ParticipantsOG003
Primary
Number of Participants With Overall Satisfaction With Surgery as Assessed by the Self-Administered Patient Satisfaction (SAPS) Scale at Week 24
SAPS contained four questions; How satisfied are you with the 1) results of your surgery 2) results of surgery for improving pain 3) results of surgery for improving ability to do home or yard work, and 4) results of surgery for improving your ability to do recreational activities. Items scored on a 4-point Likert scale with response of 'very satisfied' (100 points), 'somewhat satisfied' (75 points), 'somewhat dissatisfied' (50 points), and 'very dissatisfied' (25 points). The scale score calculated as mean of the scores of individual items, ranging from 25 to 100, with higher scores indicating greater satisfaction. Here, number of participants are summarized as, satisfied (very satisfied and somewhat satisfied categories combined) and dissatisfied (somewhat dissatisfied and very dissatisfied categories combined). Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
Posted
Count of Participants
Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
Primary
Number of Participants With Post-Surgical Complications Upto Week 24
Post-surgical complications are adverse events occurring after TJR surgery that were considered clinically significant as assessed by investigator and attributable to the total joint replacement procedure. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
Primary
Number of Participants With Additional or Corrective Procedures Related to Total Joint Replacement Upto Week 24
Participants were asked whether they had been told by their orthopedic surgeon that additional or corrective procedures were necessary for their total joint replacement. Participants, who responded as yes have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
Primary
Number of Participants Who Participated in Physical Rehabilitation Activities Related to Total Joint Replacement Upto Week 24
Participants responded with a yes or no to the following question ''are you participating in physical rehabilitation activities related to your replaced joint''. Participants responded with a yes, have been reported here. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. 'n' = participants evaluable for this OM at specified categories.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
Primary
Change From Baseline in Average Pain Score in to be Replaced or Replaced Joints at Week 24
Participants assessed their average pain in to be replaced (pre-surgery) knee/ hip joint or in the replaced joint (post-surgery) in the past 24 hours using an 11-point numerical rating scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'n' = participants evaluable for this OM at specified categories.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
total joint replacements
total joint replacements
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of to be replaced/replaced index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
total joint replacements
total joint replacements
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 24
WOMAC: self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the replaced/to be replaced index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness. Change from baseline was calculated using the difference between post-baseline weekly mean and the baseline mean score. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
total joint replacements
total joint replacements
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
Primary
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24
WOMAC: Self-administered, disease-specific questionnaire, which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in replaced/ to be replaced index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Participants may have been counted more than once if they had TJR surgery in more than one joint.
Safety analysis set: enrolled participants who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery. Here, 'N' signifies only those participants who had data available for this OM. 'n' = participants evaluable for this OM at specified categories.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
total joint replacements
total joint replacements
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
Primary
Change From Baseline in Shoulder Pain and Disability Index (SPADI) Score at Week 24
SPADI: self-administered questionnaire to measure pain and disability associated with shoulder pathology in participants with shoulder pain. It consists of two dimensions pain and function. Pain dimension:5 questions regarding severity of pain, scores ranged from 0=no pain to 10=worst pain imaginable, higher scores indicated extreme pain. Functional activities:8 questions to measure degree of difficulty with various activities of daily living that require upper extremity use, scores ranged from 0=no difficulty to 10=so difficult it requires help, higher scores=extreme difficulty. Pain and disability dimension score was calculated as the sum of non-missing scores divided by the maximum possible score (50 [for pain] and 80 [for disability]) multiplied by 100. A total score was calculated as the mean of two dimensions, ranged from 0=best to 100=worst, higher scores indicated worsening of condition.
Enrolled participants who received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had qualifying shoulder replacement. "N"=those participants who had data available for this OM, hence data for Placebo and Tanezumab reporting groups were not collected as no participants were evaluable for this OM.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
total joint replacements
total joint replacements
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
Primary
Number of Participants Who Used Concomitant Analgesic Medications
Safety analysis set: all enrolled participants of this study who had received at least one dose of SC study medication during studies A4091056, A4091057 or A4091058, and who had a qualifying TJR surgery.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
Time Frame
Baseline up to Week 24
Description
Same event may appear as both an adverse event (AE) and serious AE. What is presented are distinct events. An event may be categorized as serious in one and as non-serious in another or one participant may have experienced both serious and non-serious event. Safety set analyzed. AEs for tanezumab were collected and reported dose wise and combined.
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
Placebo
Participants who received placebo matched to tanezumab in studies A4091056 (NCT02697773) and A4091057 (NCT02709486) and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 (NCT02528188) or when the site notified of a planned TJR surgery.
0
20
0
20
0
20
EG001
Tanezumab 2.5 mg
Participants who received tanezumab 2.5 mg SC injection in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
0
52
5
52
9
52
EG002
Tanezumab 2.5/5 mg
Participants who received tanezumab 2.5/5 mg SC injection in study A4091056 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
0
8
3
8
3
8
EG003
Tanezumab 5 mg
Participants who received tanezumab 5 mg SC injection in studies A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
0
53
7
53
9
53
EG004
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
0
113
15
113
21
113
EG005
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
0
17
2
17
4
17
EG006
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
0
150
17
150
25
150
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Coronary artery occlusion
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG0030 affected53 at risk
EG0041 affected113 at risk
EG0050 affected17 at risk
EG0061 affected150 at risk
Colitis ischaemic
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0021 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0021 affected8 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Device related infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0021 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Periprosthetic fracture
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0021 affected8 at risk
EG003
Parkinson's disease
Nervous system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Device dislocation
Product Issues
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Haematoma
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrioventricular block second degree
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG0030 affected53 at risk
EG0040 affected113 at risk
EG0051 affected17 at risk
EG0061 affected150 at risk
Coronary artery stenosis
Cardiac disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Chest pain
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Peripheral swelling
General disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0013 affected52 at risk
EG0020 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0021 affected8 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0013 affected52 at risk
EG0020 affected8 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0021 affected8 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0011 affected52 at risk
EG0020 affected8 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0021 affected8 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA v22.0
Non-systematic Assessment
EG0000 affected20 at risk
EG0010 affected52 at risk
EG0020 affected8 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.
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00020
OG001113
OG00217
OG003150
Title
Denominators
Categories
Knee
ParticipantsOG00010
ParticipantsOG00166
ParticipantsOG0029
ParticipantsOG00385
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hip
ParticipantsOG00010
ParticipantsOG00148
ParticipantsOG0027
ParticipantsOG00365
Shoulder
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00020
OG001113
OG00217
OG003150
Title
Denominators
Categories
Knee
ParticipantsOG00010
ParticipantsOG00166
ParticipantsOG0029
ParticipantsOG00385
Title
Measurements
OG0000
OG0014
OG0020
OG003
Hip
ParticipantsOG00010
ParticipantsOG00148
ParticipantsOG0027
ParticipantsOG00365
Shoulder
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00020
OG001113
OG00217
OG003150
Title
Denominators
Categories
Knee
ParticipantsOG00010
ParticipantsOG00166
ParticipantsOG0029
ParticipantsOG00385
Title
Measurements
OG00010
OG00155
OG0027
OG003
Hip
ParticipantsOG00010
ParticipantsOG00148
ParticipantsOG0027
ParticipantsOG00365
Shoulder
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0031
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00020
OG001113
OG00217
OG003150
total joint replacements
OG00020
OG001113
OG00217
OG003150
Title
Denominators
Categories
Baseline: Knee
ParticipantsOG00010
ParticipantsOG00171
ParticipantsOG00210
ParticipantsOG00391
total joint replacementsOG00010
total joint replacementsOG00171
total joint replacementsOG00210
total joint replacementsOG00391
Title
Measurements
OG0006.00± 2.31
OG0016.86± 2.14
OG0026.80± 2.20
OG003
Baseline: Hip
ParticipantsOG00010
ParticipantsOG00148
ParticipantsOG0027
ParticipantsOG00365
Change at Week 24: Knee
ParticipantsOG0009
ParticipantsOG00163
ParticipantsOG0027
ParticipantsOG00379
Change at Week 24: Hip
ParticipantsOG00010
ParticipantsOG00142
ParticipantsOG0026
ParticipantsOG00358
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00020
OG001113
OG00215
OG003148
total joint replacements
OG00020
OG001113
OG00215
OG003148
Title
Denominators
Categories
Baseline: Knee
ParticipantsOG00010
ParticipantsOG00168
ParticipantsOG0029
ParticipantsOG00387
total joint replacementsOG00010
total joint replacementsOG00168
total joint replacementsOG0029
total joint replacementsOG00387
Title
Measurements
OG0004.66± 3.05
OG0015.62± 2.33
OG0026.11± 2.31
OG003
Baseline: Hip
ParticipantsOG00010
ParticipantsOG00146
ParticipantsOG0026
ParticipantsOG00362
Change at Week 24: Knee
ParticipantsOG0009
ParticipantsOG00161
ParticipantsOG0027
ParticipantsOG00377
Change at Week 24: Hip
ParticipantsOG00010
ParticipantsOG00140
ParticipantsOG0025
ParticipantsOG00355
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00020
OG001113
OG00215
OG003148
total joint replacements
OG00020
OG001113
OG00215
OG003148
Title
Denominators
Categories
Baseline: Knee
ParticipantsOG00010
ParticipantsOG00168
ParticipantsOG0029
ParticipantsOG00387
total joint replacementsOG00010
total joint replacementsOG00168
total joint replacementsOG0029
total joint replacementsOG00387
Title
Measurements
OG0004.80± 2.78
OG0015.75± 2.52
OG0026.44± 2.58
OG003
Baseline: Hip
ParticipantsOG00010
ParticipantsOG00146
ParticipantsOG0026
ParticipantsOG00362
Change at Week 24: Knee
ParticipantsOG0009
ParticipantsOG00161
ParticipantsOG0027
ParticipantsOG00377
Change at Week 24: Hip
ParticipantsOG00010
ParticipantsOG00140
ParticipantsOG0025
ParticipantsOG00355
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG00020
OG001113
OG00215
OG003148
total joint replacements
OG00020
OG001113
OG00215
OG003148
Title
Denominators
Categories
Baseline: Knee
ParticipantsOG00010
ParticipantsOG00168
ParticipantsOG0029
ParticipantsOG00387
total joint replacementsOG00010
total joint replacementsOG00168
total joint replacementsOG0029
total joint replacementsOG00387
Title
Measurements
OG0004.83± 2.99
OG0015.82± 2.11
OG0026.63± 1.98
OG003
Baseline: Hip
ParticipantsOG00010
ParticipantsOG00146
ParticipantsOG0026
ParticipantsOG00362
Change at Week 24: Knee
ParticipantsOG0009
ParticipantsOG00161
ParticipantsOG0027
ParticipantsOG00377
Change at Week 24: Hip
ParticipantsOG00010
ParticipantsOG00140
ParticipantsOG0025
ParticipantsOG00355
OG001
Tanezumab Combined
Participants who received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG002
NSAID
Participants who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery, were followed up for a maximum duration of 24 weeks in this study. Baseline for this study was the last visit in study A4091056, A4091057 or A4091058 or when the site notified of a planned TJR surgery.
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0031
total joint replacements
OG0000
OG0010
OG0021
OG0031
Title
Denominators
Categories
Baseline
Title
Measurements
OG00289.88
OG00389.88
Change at Week 24
Title
Measurements
OG002-89.88
OG003-89.88
OG003
All Participants
All participants who received placebo matched to tanezumab in studies A4091056 and A4091057; received tanezumab SC injection of 2.5 mg or 2.5 mg/5 mg or 5 mg in studies A4091056, A4091057 or A4091058 and who received NSAID tablets (naproxen 500 mg, celecoxib 100 mg, or diclofenac extended release 75 mg) in study A4091058 and who had undergone a TJR surgery.