A Study to Determine the Safety and the Efficacy of Fasin... | NCT03161093 | Trialant
NCT03161093
Sponsor
Regeneron Pharmaceuticals
Status
Completed
Last Update Posted
Nov 14, 2022Actual
Enrollment
3,307Actual
Phase
Phase 3
Conditions
Osteoarthritis, Knee
Osteoarthritis, Hip
Interventions
Fasinumab
Naproxen
Fasinumab-matching placebo
Naproxen-matching placebo
Countries
United States
Denmark
Germany
Hungary
Lithuania
Poland
Romania
Russia
South Africa
Spain
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03161093
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R475-OA-1611
Secondary IDs
ID
Type
Description
Link
2016-005020-29
EudraCT Number
Brief Title
A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
Official Title
A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Acronym
FACT OA1
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Oct 2022
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 17, 2017Actual
Primary Completion Date
Sep 9, 2019Actual
Completion Date
Aug 27, 2021Actual
First Submitted Date
May 18, 2017
First Submission Date that Met QC Criteria
May 18, 2017
First Posted Date
May 19, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 25, 2022
Results First Submitted that Met QC Criteria
Oct 18, 2022
Results First Posted Date
Nov 14, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 8, 2020
Certification/Extension First Submitted that Passed QC Review
Oct 18, 2022
Certification/Extension First Posted Date
Nov 14, 2022Actual
Last Update Submitted Date
Oct 18, 2022
Last Update Posted Date
Nov 14, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Teva Pharmaceutical Industries, Ltd.
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
The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.
The secondary objectives of the study are:
To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip
To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip
To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip
To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks
To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks
To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Detailed Description
Not provided
Conditions Module
Conditions
Osteoarthritis, Knee
Osteoarthritis, Hip
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
3,307Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Fasinumab dosing regimen 1
Experimental
Fasinumab Subcutaneous (SC) dosing regimen 1 and naproxen-matching placebo oral
Drug: Fasinumab
Drug: Naproxen-matching placebo
Fasinumab dosing regimen 2
Experimental
Fasinumab SC dosing regimen 2 and naproxen-matching placebo oral
Drug: Fasinumab
Drug: Naproxen-matching placebo
Fasinumab-matching placebo and naproxen
Experimental
Drug: Naproxen
Drug: Fasinumab-matching placebo
Fasinumab-matching placebo and naproxen-matching placebo
Experimental
Drug: Fasinumab-matching placebo
Drug: Naproxen-matching placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Fasinumab
Drug
Solution for injection in pre-filled syringe
Fasinumab dosing regimen 1
Fasinumab dosing regimen 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Secondary Outcomes
Measure
Description
Time Frame
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria include, but are not limited to, the following:
Year 1:
Male and female patients, at least 18 years of age, at screening
A clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit
Moderate to severe pain in the index joint defined at both the screening and randomization visits
Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol) to be taken as needed with a maximum daily dose of 2500 mg (countries where 500 mg strength tablets/capsules are available) or 2600 mg (countries where 325 mg strength tablets/capsules are available)
A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:
Inadequate pain relief from acetaminophen/paracetamol AND
Intolerance to or inadequate pain relief from opioid or tramadol therapy, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol
Currently using a stable dose of NSAID.
Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment
Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period
Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator
Willing to maintain current activity and exercise levels throughout the study
Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study
Able to understand and complete study-related questionnaires
Year 2:
Note: Any Year 1 patient attending their week 52 visit on or after 26 March 2020 will no longer have the option to enroll into Year 2.
Completed the treatment period of Year 1
Did not permanently discontinue study drug during Year 1
Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1
Provide informed consent for Year 2
Willing to continue to maintain current activity and exercise levels throughout Year 2
Exclusion Criteria include, but are not limited to, the following:
Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period
History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures
Trauma to the index joint within 3 months prior to the screening visit
Signs or symptoms of carpal tunnel syndrome within 6 months of screening
Patient is not a candidate for MRI
Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications
Resting heart rate of <50 beats per minute (bpm) or >100 bpm at the screening or randomization visits
History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal Complex of Q, R, and S waves on an electrocardiogram (QRS) complex, or bifascicular block by ECG assessment at the screening visit
History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits
History of poorly controlled hypertension
Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
DiMartino SJ, Cicirello H, Magyar A, Eng S, Ho T, Manvelian G, Patel Y, Pervin K, Trinh N, Fetell M, Braunstein N, Geba GP, Dakin P. A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. 2026 Jan 16;12(1):e006436. doi: 10.1136/rmdopen-2025-006436.
A total of 9157 participants were screened. Of those, 5850 were screen failures. 3307 participants were randomized into the study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
FG001
Naproxen
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Aug 26, 2020
Aug 25, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
REGN475
Naproxen
Drug
Pharmaceutical form: Capsule
Fasinumab-matching placebo and naproxen
Fasinumab-matching placebo
Drug
Solution for injection in pre-filled syringe
Fasinumab-matching placebo and naproxen
Fasinumab-matching placebo and naproxen-matching placebo
Naproxen-matching placebo
Drug
Capsule
Fasinumab dosing regimen 1
Fasinumab dosing regimen 2
Fasinumab-matching placebo and naproxen-matching placebo
Baseline to Week 16
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 44
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Week 16
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 16
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
Baseline to Week 44
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 44
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 4, 8, 12 and 16
Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to Week 16
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Baseline to average score across weeks 36, 40 and 44
Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1
Baseline to Week 52
Number of Participants With AA (as Confirmed by Adjudication) - Year 2
First dose of study drug in Year 2 through week 104E
Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2
Day 1 through week 104E (Extension)
Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1
Baseline to Week 52
Number of Participants With DA (as Confirmed by Adjudication) - Year 2
First dose of study drug in Year 2 through week 104E
Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2
Day 1 through week 104E
Number of Treatment Emergent Adverse Events (TEAEs) - Year 1
Baseline to Week 52
Number of TEAEs - Year 2
First dose of study drug in Year 2 through week 104E
Number of TEAEs - Year 1 and Year 2
Day 1 through week 104E
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1
Baseline to Week 52
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2
First dose of study drug in Year 2 through week 104E
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2
Day 1 through week 104E
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1
Baseline to Week 52
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2
First dose of study drug in Year 2 through week 104E
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2
Day 1 through week 104E
Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1
Baseline to Week 52
Number of Participants With Any Type of All-Cause JR in Year 2
First dose of study drug in Year 2 through week 104E
Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2
Day 1 through week 104E
Phoenix
Arizona
85053
United States
Tucson Orthopaedic Research Center
Tucson
Arizona
85712
United States
Baptist Health Center for Clinical Research
Little Rock
Arkansas
72205
United States
Medvin Clinical Research
Covina
California
91722
United States
TriWest Research Associates, LLC
El Cajon
California
92020
United States
BioSolutions Clinical Research
La Mesa
California
91942
United States
Pacific Arthritis Care Center
Los Angeles
California
90045
United States
Artemis Institute for Clinical Research
San Diego
California
92103
United States
Artemis Clinical Research
San Marcos
California
92078
United States
Lynn Institute of Denver
Aurora
Colorado
80012
United States
Lynn Institute of the Rockies
Colorado Springs
Colorado
80920
United States
Panorama Orthopedics & Spine Center
Golden
Colorado
80401
United States
Arthritis and Rheumatic Disease Specialties
Aventura
Florida
33180
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Clinical Neuroscience Solutions, Inc.
Jacksonville
Florida
32256
United States
Sensible Healthcare
Ocoee
Florida
34761
United States
Clinical Neuroscience Solutions, Inc.
Orlando
Florida
32801
United States
Jewett Orthopaedic Clinic
Orlando
Florida
32825
United States
Lovelace Scientific Resources
Venice
Florida
34292
United States
Meridian Clinical Research
Savannah
Georgia
31406
United States
Advanced Clinical Research
Meridian
Idaho
83642
United States
Medex Healthcare Research, Inc.
Chicago
Illinois
60602
United States
Northwestern University
Chicago
Illinois
60611
United States
Healthcare Research Network II, LLC
Flossmoor
Illinois
60422
United States
Integrated Clinical Trial Services, Inc.
West Des Moines
Iowa
50265
United States
Klein & Associates, MD PA
Cumberland
Maryland
21502
United States
Klein & Associates, MD, PA
Hagerstown
Maryland
21740
United States
The Center for Rheumatology and Bone Research
Wheaton
Maryland
20902
United States
Clinical Pharmacology Study Group
Worcester
Massachusetts
01605
United States
The Center for Pharmaceutical Research
Kansas City
Missouri
64114
United States
Medex Healthcare Research, Inc.
St Louis
Missouri
63117
United States
Sundance Clinical Research, LLC
St Louis
Missouri
63141
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
Lovelace Scientific Resources, Inc.
Albuquerque
New Mexico
87108
United States
United Medical Associates
Binghamton
New York
13901
United States
Regional Clinical Research, Inc.
Endwell
New York
13760
United States
Medex Healthcare Research
New York
New York
10036
United States
Buffalo Rheumatology and Medicine, PLLC
Orchard Park
New York
14127
United States
Orchard Park Family Practice
Orchard Park
New York
14127
United States
PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
Cary
North Carolina
27518
United States
DJL Clinical Research, PLLC
Charlotte
North Carolina
28210
United States
Hickory Family Practice Associates
Hickory
North Carolina
28601
United States
Peters Medical Research LLC
High Point
North Carolina
27262
United States
PMG Research of Salisbury, LLC
Salisbury
North Carolina
28144
United States
PMG Research of Winston-Salem, LLC
Winston-Salem
North Carolina
27103
United States
Sterling Research Group, Ltd.
Cincinnati
Ohio
45219
United States
Hillcrest Clinical Research
Oklahoma City
Oklahoma
73119
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Low Country Rheumatology, PA
Charleston
South Carolina
29406
United States
PMG Research of Charleston, LLC
Mt. Pleasant
South Carolina
29464
United States
Clinical Research Solutions
Franklin
Tennessee
37067
United States
PMG Research of Knoxville
Knoxville
Tennessee
37912
United States
Clinical Neuroscience Solutions, Inc.
Memphis
Tennessee
38119
United States
Pioneer Research Solutions, Inc.
Cypress
Texas
77429
United States
Southwest Rheumatology Research, LLC
Mesquite
Texas
75150
United States
Center for Arthritis and Rheumatic Diseases
Chesapeake
Virginia
23320
United States
Rheumatology & Pulmonary Clinic
Beckley
West Virginia
25801
United States
CCBR Vejle
Vejle
DK 7100
Denmark
Synexus Clinical Research GmbH
Leipzig
Saxony
04103
Germany
Synexus Clinical Research GmbH
Berlin
12627
Germany
Synexus Clinical Research GmbH
Bochum
44787
Germany
Synexus Clinical Research GmbH
Frankfurt
60313
Germany
Qualiclinic Kft.
Budapest
1036
Hungary
Synexus Magyarorszag Kft
Budapest
1036
Hungary
Synexus Magyarorszag Kft.
Debrecen
4025
Hungary
Synexus Magyarorszag Kft.
Gyula
5700
Hungary
BKS Research Kft.
Hatvan
3000
Hungary
Hevizgyogyfurdo es Szent Andraes ReumaKorhaz
Hévíz
8380
Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak Josa Andras Oktatokorhaza Klinikai Kutatasi Osztaly
Nyíregyháza
4400
Hungary
Synexus Magyarorszag Egeszsegugyi Kft.
Zalaegerszeg
8900
Hungary
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas
LT35144
Lithuania
Saules Seimos Medicinos Centras, Jsc
Kaunas
LT50009
Lithuania
Republican Panevezys Hospital
Panevezys
LT01117
Lithuania
Center Outpation Clinic, Public Institution
Vilnius
LT01117
Lithuania
Synexus Polska Sp. z o.o Oddzial w Poznaniu
Poznan
Greater Poland Voivodeship
60-702
Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow
Lesser Poland Voivodeship
31-501
Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw
Lower Silesian Voivodeship
59-381
Poland
MCBK Sc lwona Czajkowska Monika Barney
Grodzisk Mazowiecki
Masovian Voivodeship
05-825
Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw
Masovian Voivodeship
01-192
Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o.
Warsaw
Masovian Voivodeship
04-730
Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdynia
Pomeranian Voivodeship
81-537
Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia
Pomeranian Voivodeship
81-537
Poland
ClinicMed Daniluk, Nowak Sp.j.
Bialystok
15-879
Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice
40-040
Poland
Malopolskie Centrum Kliniczne
Krakow
30-149
Poland
CLINMEDICA RESEARCH OMC, Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa
Skierniewice
96-100
Poland
Etg Zgierz
Zgierz
95-100
Poland
Specjalistyczny Osrodek Medycyny Wieku Dojrzalego Sp. z o.o. Jednostka 02 - SOMED - Lodzkie Centrum Osteoporozy
Lodz
Łódź Voivodeship
90-368
Poland
Clinica Medicala Synexus Ltd.
Bucharest
021611
Romania
SC Policlinica CCBR SRL
Bucharest
030463
Romania
"SBEIHPE ""Kazan State Medical University"" of MHSD of Russia"
"State Autonomous Healthcare Institution of Yaroslavl Oblast ""Clinical Hospital #3"""
Yaroslavl
150007
Russia
Tread Research-Tygerberg Hospital
Parow
Cape Town
7500
South Africa
Welkom Clinical trial Centre
Welkom
Free State
9460
South Africa
Wits Clinical Research
Johannesburg
Gauteng
2013
South Africa
University of Pretoria
Pretoria
Gauteng
0002
South Africa
Global Clinical Trials
Pretoria
Gauteng
0083
South Africa
Synexus SA Stanza Clinical Research Centre
Pretoria
Gauteng
0122
South Africa
Synexus Watermeyer Clinical Research Centre
Pretoria
Gauteng
0184
South Africa
Roodepoort Medicross Clinical Research Centre
Roodepoort
Gauteng
1724
South Africa
Soweto Clinical Trials Centre (CTC)
Soweto
Johannesburg
1818
South Africa
Synapta Clinical Research Center
Durban
KwaZulu-Natal
4001
South Africa
Enhancing Care
Durban
KwaZulu-Natal
4091
South Africa
Aliwal Shoal Medical Centre
eMkhomazi
KwaZulu-Natal
4170
South Africa
Mzansi Ethical Research Centre Middleburg
Middelburg
Mpumalanga
1055
South Africa
Langeberg Medicross Medical Centre
Kraaifontein
Western Cape
7570
South Africa
Paarl Research Centre
Paarl
Western Cape
7646
South Africa
Synexus Helderberg Clinical Trial Centre
Somerset West
Western Cape
7130
South Africa
TASK Applied Science
Cape Town
7530
South Africa
Mzansi Ethical Research Centre Cape Town
Cape Town
7764
South Africa
Newtown Clinical Research
Johannesburg
2113
South Africa
CETA Leganes
Leganés
Madrid
28915
Spain
Complejo Hospitalario Universitario A Coruna
A Coruña
15006
Spain
MeDiNova Investigacion y Desarrollo
Madrid
28100
Spain
Centro De Investigacion Clinica En Enfermedades Cronicas - Cicec
Santiago de Compostela
15705
Spain
Clínica Nuevas Tecnologias en Diabetes y Endocrinologia (NTDE)
Seville
41003
Spain
Hospital Quiron Salud Infanta Luisa
Seville
41010
Spain
"Municipal Establishment ""Cherkasy Regional Hospital of Cherkasy Oblast Council"""
Cherkasy
18009
Ukraine
Kharkiv City Multispecialty Hospital #18
Kharkiv
61029
Ukraine
Medical center of Private High Educational Institute Institute of General Practice-Family Medicine
Kyiv
02002
Ukraine
"Subsidiary Company ""Medical Research and Practice Center Medbud of the Public Joint Stock ""Holding Company ""Kyivmiskbud"""
Kyiv
03037
Ukraine
"Kyiv Railway Clinical Hospital No.2 of branch ""Health Center "" of the PJSC ""Ukrainian Railway"""
Kyiv
03049
Ukraine
Lviv Regional Hospital for veterans of the war and former political prisoners
Lviv
79495
Ukraine
Synexus Thames Valley Clinical Research Centre
Reading
Berkshire
RG2 0TG
United Kingdom
Synexus Scotland Clinical Research Centre
Glasgow
Lanarkshire
G20 0SP
United Kingdom
Synexus Lancashire Clinical Research Centre
Chorley
Lancashire
PR7 7NA
United Kingdom
MediNova North London Dedicated Research Centre, Mount Vernon Hospital
Northwood
Middlesex
HA6 2RN
United Kingdom
Synexus North East Clinical Research Centre - Hexham General Hospital
Hexham
Northumberland
NE46 1QJ
United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham
West Midlands
B15 2SQ
United Kingdom
Synexus Wales Clinical Research Centre
Cardiff
CF15 9SS
United Kingdom
Synexus Merseyside Clinical Research Centre
Liverpool
L22 0LG
United Kingdom
Synexus Manchester Clinical Research Centre-Manchester Science Park
Manchester
M15 6SX
United Kingdom
Medinova Research East London Clinical Studies Centre
Romford
RM1 3PJ
United Kingdom
MeDiNova Research Yorkshire Clinical Studies Centre
Shipley
BD18 3SA
United Kingdom
MediNova South London Dedicated Research Centre
Sidcup
DA14 6LT
United Kingdom
Derived
DiMartino SJ, Gao H, Neogi T, Fuerst T, Zaim S, Eng S, Ho T, Manvelian G, Braunstein N, Geba GP, Dakin P. Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging. Osteoarthritis Cartilage. 2024 Dec;32(12):1601-1609. doi: 10.1016/j.joca.2024.07.001. Epub 2024 Jul 14.
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
FG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
FG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
FG004
Fasinumab 3mg Q4W
Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID
FG005
Fasinumab 6mg Q8W
Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID
FG000354 subjects
FG0011063 subjects
FG002551 subjects
FG0031054 subjects
FG004145 subjects
FG005140 subjects
As Treated
FG000352 subjects
FG0011056 subjects
FG002554 subjects
FG0031052 subjects
FG004145 subjects
FG005139 subjects
COMPLETED
FG000299 subjects
FG001919 subjects
FG002465 subjects
FG003867 subjects
FG004102 subjects
FG00599 subjects
NOT COMPLETED
FG00055 subjects
FG001144 subjects
FG00286 subjects
FG003187 subjects
FG00443 subjects
FG00541 subjects
Type
Comment
Reasons
Protocol Violation
FG00011 subjects
FG00114 subjects
FG0026 subjects
FG00313 subjects
FG0041 subjects
FG0050 subjects
Adverse Event
FG0005 subjects
FG00121 subjects
FG00216 subjects
FG00335 subjects
FG004
Lack of Efficacy
FG0009 subjects
FG00113 subjects
FG0029 subjects
FG00324 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG00024 subjects
FG00173 subjects
FG00244 subjects
FG00397 subjects
FG004
Lost to Follow-up
FG0003 subjects
FG00112 subjects
FG0024 subjects
FG0037 subjects
FG004
Death
FG0003 subjects
FG0019 subjects
FG0027 subjects
FG0039 subjects
FG004
Unknown - Not reported
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
BG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
BG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
BG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
BG004
Fasinumab 3mg Q4W
Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID
BG005
Fasinumab 6mg Q8W
Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000354
BG0011063
BG002551
BG0031054
BG004145
BG005140
BG0063307
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
18-64 years
Title
Measurements
BG000212
BG001608
BG002300
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000265
BG001807
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00012
BG00126
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0011
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 in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
Modified Full Analysis Set (mFAS) analysis population; The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
OG000155
OG001522
Title
Denominators
Categories
Title
Measurements
OG000-1.82± 0.162
OG001-2.49± 0.098
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
Mixed Models Analysis
0.0002
Least Squares Mean
-0.68
Standard Error of the Mean
0.180
2-Sided
95
-1.028
-0.324
Superiority
Primary
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Primary
Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
Primary
Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID
Secondary
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Number
Percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Mean
Standard Deviation
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 4, 8, 12 and 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 36, 40 and 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 4, 8, 12 and 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 36, 40 and 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
Units
Counts
Participants
Secondary
Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo
The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
Secondary
Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 4, 8, 12 and 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 36, 40 and 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 16
ID
Title
Description
OG000
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
Secondary
Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to Week 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
Secondary
Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 4, 8, 12 and 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Secondary
Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Number
Percentage of participants
Baseline to Week 16
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID
Secondary
Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo
The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.
mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Least Squares Mean
Standard Error
Score on a scale
Baseline to average score across weeks 36, 40 and 44
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Fasinumab 1 mg SC Q8W
Secondary
Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1
The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
Posted
Count of Participants
Participants
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With AA (as Confirmed by Adjudication) - Year 2
The Year 2 safety analysis set (SAF - Year 2) includes all participants who received at least 1 dose of the Year 2 study drug; it is based on the treatment received during Year 2 (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
Posted
Count of Participants
Participants
First dose of study drug in Year 2 through week 104E
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
Day 1 through week 104E (Extension)
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1
The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
Posted
Count of Participants
Participants
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With DA (as Confirmed by Adjudication) - Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
First dose of study drug in Year 2 through week 104E
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
Day 1 through week 104E
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Treatment Emergent Adverse Events (TEAEs) - Year 1
The Year 1 safety analysis set (SAF - Year 1) includes all randomized participants from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
Posted
Number
Events
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of TEAEs - Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Number
Events
First dose of study drug in Year 2 through week 104E
ID
Title
Description
OG000
Year 2 Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm
OG001
Year 2 Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG002
Year 2 Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Number of TEAEs - Year 1 and Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Number
Events
Day 1 through week 104E
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1
The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time.
Posted
Count of Participants
Participants
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
First dose of study drug in Year 2 through week 104E
ID
Title
Description
OG000
Year 2 Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm
OG001
Year 2 Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG002
Year 2 Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
Day 1 through week 104E
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1
Safety Analysis Set (SAF) - Year 1 included participants randomized to fasinumab 1 mg Q4W, fasinumab 1 mg Q8W, naproxen, and placebo. Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
First dose of study drug in Year 2 through week 104E
ID
Title
Description
OG000
Year 2 Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm
OG001
Year 2 Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG002
Year 2 Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
Day 1 through week 104E
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1
Safety Analysis Set (SAF)-Year 1. For participants with events, number of participant years is calculated up to the date of the first event; for participants without event, it corresponds to the length of the study participation in Year 1.
Posted
Count of Participants
Participants
Baseline to Week 52
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Secondary
Number of Participants With Any Type of All-Cause JR in Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
First dose of study drug in Year 2 through week 104E
ID
Title
Description
OG000
Year 2 Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm
OG001
Year 2 Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG002
Year 2 Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Units
Counts
Participants
Secondary
Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2
SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time.
Posted
Count of Participants
Participants
Day 1 through week 104E
ID
Title
Description
OG000
Placebo
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
OG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
OG002
Fasinumab 1 mg SC Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID
OG003
Fasinumab 1 mg SC Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID
Time Frame
From first dose up to week 124
Description
As treated population
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
Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)
5
352
49
352
215
352
EG001
Naproxen
Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID
13
1,056
103
1,056
687
1,056
EG002
Fasinumab 1mg Q8W
Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID
12
554
81
554
382
554
EG003
Fasinumab 1mg Q4W
Fasinumab 1 mg SC Q4W and naproxen-matching placebo PO, BID
13
1,052
175
1,052
727
1,052
EG004
Fasinumab 3mg Q4W
Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID
0
145
7
145
41
145
EG005
Fasinumab 6mg Q8W
Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID
0
139
6
139
58
139
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0004 events4 affected352 at risk
EG00111 events11 affected1,056 at risk
EG00211 events10 affected554 at risk
EG0039 events8 affected1,052 at risk
EG004
Rapidly progressive osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0017 events4 affected1,056 at risk
EG00213 events13 affected554 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0003 events3 affected352 at risk
EG0013 events3 affected1,056 at risk
EG0023 events3 affected554 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Haemarthrosis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Limb mass
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Spinal synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Subchondral insufficiency fracture
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Vertebral foraminal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0002 events2 affected352 at risk
EG0013 events3 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
COVID-19
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Sepsis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Arthritis infective
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Empyema
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Gastric ulcer helicobacter
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Pneumonia klebsiella
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Infected bite
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Lung abscess
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Meningitis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Meningitis pneumococcal
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Post procedural cellulitis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
MedDRA (23.1)
Systematic Assessment
EG0007 events7 affected352 at risk
EG0017 events7 affected1,056 at risk
EG0024 events4 affected554 at risk
EG003
Hip arthroplasty
Surgical and medical procedures
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0016 events5 affected1,056 at risk
EG0025 events5 affected554 at risk
EG003
Joint arthroplasty
Surgical and medical procedures
MedDRA (23.1)
Systematic Assessment
EG0002 events2 affected352 at risk
EG0013 events3 affected1,056 at risk
EG0024 events4 affected554 at risk
EG003
Joint resurfacing surgery
Surgical and medical procedures
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Knee operation
Surgical and medical procedures
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0023 events2 affected554 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0012 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Extrasystoles
Cardiac disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Oedematous pancreatitis
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Peptic ulcer
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0013 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Intestinal haemorrhage
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Volvulus of small bowel
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Gun shot wound
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Meniscus injury
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Thoracic vertebral fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Deep vein thrombosis postoperative
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Ligament rupture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Tendon injury
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Bladder neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Chronic myeloid leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Hepatic cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Osteosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Prostate cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Benign ovarian tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Benign soft tissue neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Breast cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Hepatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Intraductal proliferative breast lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Non-small cell lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Pancreatic carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Pancreatic neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Renal hamartoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Retroperitoneal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Squamous cell carcinoma of lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Uterine cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Carotid artery aneurysm
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Vascular encephalopathy
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0022 events1 affected554 at risk
EG003
Cerebrospinal fistula
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Hemiplegic migraine
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Muscle tone disorder
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Radiculopathy
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Sciatica
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Syncope
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Sudden death
General disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0013 events3 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Death
General disorders
MedDRA (23.1)
Systematic Assessment
EG0002 events2 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Adverse drug reaction
General disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Chest pain
General disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Oedema peripheral
General disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (23.1)
Systematic Assessment
EG0004 events2 affected352 at risk
EG0014 events4 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Hepatitis alcoholic
Hepatobiliary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0012 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0012 events2 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Bladder prolapse
Renal and urinary disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Diabetic nephropathy
Renal and urinary disorders
MedDRA (23.1)
Systematic Assessment
EG0002 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Prerenal failure
Renal and urinary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Aortic stenosis
Vascular disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Hypertension
Vascular disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cataract
Eye disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Eyelid ptosis
Eye disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Device dislocation
Product Issues
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Device loosening
Product Issues
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Substance abuse
Psychiatric disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Pseudodementia
Psychiatric disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0011 events1 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Apnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (23.1)
Systematic Assessment
EG0001 events1 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0022 events2 affected554 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Hydrocele
Congenital, familial and genetic disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Cervical polyp
Reproductive system and breast disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0020 events0 affected554 at risk
EG003
Endometrial hyperplasia
Reproductive system and breast disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA (23.1)
Systematic Assessment
EG0000 events0 affected352 at risk
EG0010 events0 affected1,056 at risk
EG0021 events1 affected554 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG000117 events76 affected352 at risk
EG001357 events232 affected1,056 at risk
EG002228 events152 affected554 at risk
EG003467 events284 affected1,052 at risk
EG00416 events13 affected145 at risk
EG00542 events30 affected139 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG00051 events39 affected352 at risk
EG001160 events117 affected1,056 at risk
EG002112 events83 affected554 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG00027 events20 affected352 at risk
EG00182 events62 affected1,056 at risk
EG00241 events34 affected554 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG00023 events18 affected352 at risk
EG00141 events34 affected1,056 at risk
EG00229 events22 affected554 at risk
EG003
Rapidly progressive osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (23.1)
Systematic Assessment
EG0006 events5 affected352 at risk
EG00128 events27 affected1,056 at risk
EG00245 events38 affected554 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG00037 events28 affected352 at risk
EG001122 events92 affected1,056 at risk
EG00264 events54 affected554 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG00027 events25 affected352 at risk
EG001106 events90 affected1,056 at risk
EG00251 events41 affected554 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG00029 events24 affected352 at risk
EG001105 events86 affected1,056 at risk
EG00245 events41 affected554 at risk
EG003
Influenza
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG00030 events24 affected352 at risk
EG00170 events55 affected1,056 at risk
EG00241 events31 affected554 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (23.1)
Systematic Assessment
EG00020 events19 affected352 at risk
EG00161 events50 affected1,056 at risk
EG00234 events30 affected554 at risk
EG003
Headache
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG000109 events67 affected352 at risk
EG001548 events216 affected1,056 at risk
EG002308 events127 affected554 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA (23.1)
Systematic Assessment
EG00016 events15 affected352 at risk
EG00123 events20 affected1,056 at risk
EG00232 events26 affected554 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG0008 events8 affected352 at risk
EG00175 events65 affected1,056 at risk
EG00212 events12 affected554 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (23.1)
Systematic Assessment
EG00012 events12 affected352 at risk
EG00172 events54 affected1,056 at risk
EG00235 events27 affected554 at risk
EG003
Hypertension
Vascular disorders
MedDRA (23.1)
Systematic Assessment
EG00034 events31 affected352 at risk
EG00188 events77 affected1,056 at risk
EG00241 events36 affected554 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
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.