## Protocol Section
### Identification Module
**NCT ID:** NCT03304379

**Acronym:** FACT OA2

**Brief Title:** Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

**Official Title:** Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip

#### Organization Study ID Info
**ID:** R475-OA-1688
#### Organization
**Class:** INDUSTRY
**Full Name:** Regeneron Pharmaceuticals
#### Secondary ID Infos
**ID:** 2017-001702-15
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2020-11-09

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2023-02-24

**Type:** ACTUAL

**Disp First Submit Date:** 2020-12-11
**Disp First Submit QC Date:** 2023-01-30

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-24

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-12-13

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-02-24

**Type:** ACTUAL

**Results First Submit Date:** 2022-12-09

**Results First Submit QC Date:** 2023-01-30

#### Start Date
**Date:** 2017-10-26

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2017-10-09
**Type:** ACTUAL
**Study First Submit Date:** 2017-10-02
**Study First Submit QC Date:** 2017-10-05
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Teva Pharmaceutical Industries, Ltd.

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Regeneron Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 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 to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
* To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip

### Conditions Module

**Conditions:**

- Osteoarthritis, Knee

- Osteoarthritis, Hip

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 1650

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Fasinumab

- Drug: Matching placebo

**Label:** Dosing regimen 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Diclofenac

- Drug: Matching placebo

**Label:** Dosing regimen 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Other: Celecoxib

- Drug: Matching placebo

**Label:** Dosing regimen 3

**Type:** EXPERIMENTAL

#### Arm Group 4

**Intervention Names:**

- Drug: Matching placebo

**Label:** Dosing regimen 4

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dosing regimen 1

**Description:** Solution for injection in pre-filled syringe

**Name:** Fasinumab

**Other Names:**

- REGN475

- MT-5547

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Dosing regimen 2

**Description:** NSAID active comparator (capsule)

**Name:** Diclofenac

**Other Names:**

- ZORVOLEX

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Dosing regimen 3

**Description:** NSAID active comparator (capsule)

**Name:** Celecoxib

**Other Names:**

- CELEBREX

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Dosing regimen 1

- Dosing regimen 2

- Dosing regimen 3

- Dosing regimen 4

**Description:** Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)

**Name:** Matching placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.

**Measure:** Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo

**Time Frame:** Baseline up to Week 24

**Description:** Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.

**Measure:** Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo

**Time Frame:** Baseline up to Week 24

#### Secondary Outcomes

**Description:** WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

**Measure:** Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo

**Time Frame:** Baseline up to Week 24

**Description:** The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

**Measure:** Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo

**Time Frame:** Baseline up to Week 24

**Description:** WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.

**Measure:** Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs

**Time Frame:** Baseline up to Week 24

**Description:** Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.

**Measure:** Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs

**Time Frame:** Baseline up to Week 24

**Description:** The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.

**Measure:** Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs

**Time Frame:** Baseline up to Week 24

**Description:** Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.

**Measure:** Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale

**Time Frame:** Baseline up to Week 24

**Description:** AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.

**Measure:** Number of Participants With Adjudicated Arthropathy (AA) Events

**Time Frame:** Baseline up to follow-up period (Week 44)

**Description:** DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

**Measure:** Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria

**Time Frame:** Baseline up to follow-up period (Week 44)

**Description:** An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.

**Measure:** Number of Participants With Treatment Emergent Adverse Events (TEAEs)

**Time Frame:** Baseline up to follow-up period (Week 44)

**Description:** Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.

**Measure:** Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events

**Time Frame:** Baseline up to follow-up period (Week 44)

**Description:** Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).

**Measure:** Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)

**Time Frame:** Baseline up to Week 44

**Description:** Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.

**Measure:** Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24

**Time Frame:** Baseline up to Week 24

**Description:** Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.

**Measure:** Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44

**Time Frame:** Baseline up to Week 44

**Description:** An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.

**Measure:** Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)

**Time Frame:** At Week 72

**Measure:** Serum Concentrations of Functional Fasinumab

**Time Frame:** At Weeks 0, 4, 8, 16, 24 and 44

**Description:** Immunogenicity was characterized by ADA responses \& titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, \>= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.

**Measure:** Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development

**Time Frame:** Baseline up to Week 44

### Eligibility Module

**Eligibility Criteria:** Key Inclusion Criteria (additional criteria may apply at screening):

1. A clinical diagnosis of osteoarthritis (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.
2. 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 \[countries where 325 mg strength tablets/capsules are available\])
3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip
4. Currently using a stable dose of NSAID
5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment

Key Exclusion Criteria (additional criteria may apply at screening):

1. Non-compliance with the numeric rating scale (NRS) recording during the pre-randomization period
2. 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
3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures
4. Trauma to the index joint within 3 months prior to the screening visit
5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
6. Patient is not a candidate for magnetic resonance imaging (MRI)
7. 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
8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)
10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
11. Use of systemic corticosteroids 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
12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
13. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 20 weeks after the last dose

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Anniston

**Country:** United States

**Facility:** Pinnacle Research Group, Llc

**State:** Alabama

**Zip:** 36207

**Location 2:**

**City:** Mobile

**Country:** United States

**Facility:** Horizon Research Partners

**State:** Alabama

**Zip:** 36608

**Location 3:**

**City:** Chandler

**Country:** United States

**Facility:** Clinical Research Advantage, Inc./Warner Family Practice, PC

**State:** Arizona

**Zip:** 85224

**Location 4:**

**City:** Phoenix

**Country:** United States

**Facility:** Synexus Central Phoenix Medical Clinic

**State:** Arizona

**Zip:** 85020

**Location 5:**

**City:** Tempe

**Country:** United States

**Facility:** Clinical Research Consortium Arizona

**State:** Arizona

**Zip:** 85283

**Location 6:**

**City:** Anaheim

**Country:** United States

**Facility:** Advance Research Center

**State:** California

**Zip:** 92805

**Location 7:**

**City:** El Cajon

**Country:** United States

**Facility:** TriWest Research Associates, LLC

**State:** California

**Zip:** 92020

**Location 8:**

**City:** Garden Grove

**Country:** United States

**Facility:** Paragon Rx Clinical Research, Inc.

**State:** California

**Zip:** 92840

**Location 9:**

**City:** Montclair

**Country:** United States

**Facility:** Catalina Research Institute, LLC

**State:** California

**Zip:** 91763

**Location 10:**

**City:** Roseville

**Country:** United States

**Facility:** Sierra Clinical Research

**State:** California

**Zip:** 95661

**Location 11:**

**City:** Sacramento

**Country:** United States

**Facility:** UC Davis Center for Musculoskeletal Health

**State:** California

**Zip:** 95817

**Location 12:**

**City:** San Diego

**Country:** United States

**Facility:** Advanced Research Center, Inc

**State:** California

**Zip:** 92103

**Location 13:**

**City:** San Diego

**Country:** United States

**Facility:** California Research Foundation

**State:** California

**Zip:** 92123

**Location 14:**

**City:** Santa Ana

**Country:** United States

**Facility:** Paragon Rx Clinical Research, Inc

**State:** California

**Zip:** 92703

**Location 15:**

**City:** Spring Valley

**Country:** United States

**Facility:** Encompass Clinical Research

**State:** California

**Zip:** 91978

**Location 16:**

**City:** Thousand Oaks

**Country:** United States

**Facility:** Westlake Medical Research

**State:** California

**Zip:** 91360

**Location 17:**

**City:** Vista

**Country:** United States

**Facility:** Synexus Clinical Research US, Inc.

**State:** California

**Zip:** 92083

**Location 18:**

**City:** Denver

**Country:** United States

**Facility:** Mountain View Clinical Research

**State:** Colorado

**Zip:** 80209

**Location 19:**

**City:** Bridgeport

**Country:** United States

**Facility:** New England Research Associates, LLC

**State:** Connecticut

**Zip:** 06606

**Location 20:**

**City:** Hamden

**Country:** United States

**Facility:** CRM of Greater New Haven, LLC

**State:** Connecticut

**Zip:** 06157

**Location 21:**

**City:** Stamford

**Country:** United States

**Facility:** Stamford Therapeutics Consortium

**State:** Connecticut

**Zip:** 06905

**Location 22:**

**City:** DeLand

**Country:** United States

**Facility:** Avail Clinical Research, LLC

**State:** Florida

**Zip:** 32720

**Location 23:**

**City:** Miami Lakes

**Country:** United States

**Facility:** Lakes Research, LLC

**State:** Florida

**Zip:** 33014

**Location 24:**

**City:** Miami

**Country:** United States

**Facility:** AMB Research Center, Inc

**State:** Florida

**Zip:** 33144

**Location 25:**

**City:** Miami

**Country:** United States

**Facility:** Allied Biomedical Research Institute

**State:** Florida

**Zip:** 33155

**Location 26:**

**City:** Orlando

**Country:** United States

**Facility:** Bioclinica Research

**State:** Florida

**Zip:** 32806

**Location 27:**

**City:** Pensacola

**Country:** United States

**Facility:** Gulf Region Clinical Research institute

**State:** Florida

**Zip:** 32514

**Location 28:**

**City:** Plantation

**Country:** United States

**Facility:** Integral Rheumatology & Immunology Specialists (IRIS)

**State:** Florida

**Zip:** 33324

**Location 29:**

**City:** Port Orange

**Country:** United States

**Facility:** Progressive Medical Research

**State:** Florida

**Zip:** 32127

**Location 30:**

**City:** Marietta

**Country:** United States

**Facility:** Drug Studies America

**State:** Georgia

**Zip:** 30060

**Location 31:**

**City:** Marietta

**Country:** United States

**Facility:** Georgia Institute For Clinical Research LLC

**State:** Georgia

**Zip:** 30060

**Location 32:**

**City:** Woodstock

**Country:** United States

**Facility:** North Georgia Clinical Research

**State:** Georgia

**Zip:** 30189

**Location 33:**

**City:** Chicago

**Country:** United States

**Facility:** Chicago Clinical Research Institute, Inc

**State:** Illinois

**Zip:** 60607

**Location 34:**

**City:** Oak Lawn

**Country:** United States

**Facility:** Affinity Clinical Research Institute

**State:** Illinois

**Zip:** 60453

**Location 35:**

**City:** Evansville

**Country:** United States

**Facility:** Clinical Research Advantage, Inc.

**State:** Indiana

**Zip:** 47714

**Location 36:**

**City:** Evansville

**Country:** United States

**Facility:** MediSphere Medical Research Center, LLC

**State:** Indiana

**Zip:** 47714

**Location 37:**

**City:** Louisville

**Country:** United States

**Facility:** L-MARC Research Center

**State:** Kentucky

**Zip:** 40213

**Location 38:**

**City:** Marrero

**Country:** United States

**Facility:** Tandem Clinical Research

**State:** Louisiana

**Zip:** 70072

**Location 39:**

**City:** Boston

**Country:** United States

**Facility:** Tufts Medical Center, Inc.

**State:** Massachusetts

**Zip:** 02111

**Location 40:**

**City:** Bay City

**Country:** United States

**Facility:** Great Lakes Research Group, Inc.

**State:** Michigan

**Zip:** 48706

**Location 41:**

**City:** Caro

**Country:** United States

**Facility:** Onyx Clinical Research

**State:** Michigan

**Zip:** 48723

**Location 42:**

**City:** Richfield

**Country:** United States

**Facility:** Synexus Clinical Research US, Inc.

**State:** Minnesota

**Zip:** 55423

**Location 43:**

**City:** Elkhorn

**Country:** United States

**Facility:** Skyline Medical Center /Radiant Research, Inc.

**State:** Nebraska

**Zip:** 68022

**Location 44:**

**City:** Omaha

**Country:** United States

**Facility:** Meridian Clinical Research Associates, LLC

**State:** Nebraska

**Zip:** 68134

**Location 45:**

**City:** Las Vegas

**Country:** United States

**Facility:** Robert Kaplan, D.O.

**State:** Nevada

**Zip:** 89144

**Location 46:**

**City:** Raritan

**Country:** United States

**Facility:** Amici Clinical Research, LLC

**State:** New Jersey

**Zip:** 08869

**Location 47:**

**City:** Albuquerque

**Country:** United States

**Facility:** Albuquerque Clinical Trials, Inc.

**State:** New Mexico

**Zip:** 87102

**Location 48:**

**City:** Brooklyn

**Country:** United States

**Facility:** Drug Trial Brooklyn

**State:** New York

**Zip:** 11230

**Location 49:**

**City:** Great Neck

**Country:** United States

**Facility:** Northwell Health

**State:** New York

**Zip:** 11021

**Location 50:**

**City:** Hartsdale

**Country:** United States

**Facility:** Drug Trials America

**State:** New York

**Zip:** 10530

**Location 51:**

**City:** Williamsville

**Country:** United States

**Facility:** Upstate Clinical Research Associates, LLC

**State:** New York

**Zip:** 14221

**Location 52:**

**City:** Shelby

**Country:** United States

**Facility:** Carolina Research Center

**State:** North Carolina

**Zip:** 28150

**Location 53:**

**City:** Wilmington

**Country:** United States

**Facility:** PMG Research of Wilmington LLC

**State:** North Carolina

**Zip:** 28401

**Location 54:**

**City:** Winston-Salem

**Country:** United States

**Facility:** The Center For Clinical Research

**State:** North Carolina

**Zip:** 27103

**Location 55:**

**City:** Cincinnati

**Country:** United States

**Facility:** New Horizons Clinical Research

**State:** Ohio

**Zip:** 45242

**Location 56:**

**City:** Columbus

**Country:** United States

**Facility:** Aventiv Research Inc

**State:** Ohio

**Zip:** 43213

**Location 57:**

**City:** Dayton

**Country:** United States

**Facility:** DOC Clinical Research

**State:** Ohio

**Zip:** 45432

**Location 58:**

**City:** Indiana

**Country:** United States

**Facility:** Center for Orthopaedics and Sports Medicine

**State:** Pennsylvania

**Zip:** 15701

**Location 59:**

**City:** Anderson

**Country:** United States

**Facility:** Radiant Research, Inc.

**State:** South Carolina

**Zip:** 29621

**Location 60:**

**City:** Greenville

**Country:** United States

**Facility:** Piedmont Comprehensive Pain Management Group

**State:** South Carolina

**Zip:** 29601

**Location 61:**

**City:** Greer

**Country:** United States

**Facility:** Radiant Research, Inc.

**State:** South Carolina

**Zip:** 29651

**Location 62:**

**City:** Indian Land

**Country:** United States

**Facility:** Piedmont Research Partners, LLC

**State:** South Carolina

**Zip:** 29707

**Location 63:**

**City:** North Charleston

**Country:** United States

**Facility:** Coastal Carolina Research Center at LowCountry Orthopaedics

**State:** South Carolina

**Zip:** 29406

**Location 64:**

**City:** Orangeburg

**Country:** United States

**Facility:** ACME Research, LLC

**State:** South Carolina

**Zip:** 29118

**Location 65:**

**City:** Memphis

**Country:** United States

**Facility:** Office of Dr.Ramesh C. Gupta MD

**State:** Tennessee

**Zip:** 38119

**Location 66:**

**City:** Lubbock

**Country:** United States

**Facility:** West Texas Clinical Research

**State:** Texas

**Zip:** 79410

**Location 67:**

**City:** Plano

**Country:** United States

**Facility:** Clinical Investigations Of Texas

**State:** Texas

**Zip:** 75075

**Location 68:**

**City:** Plano

**Country:** United States

**Facility:** Synexus USA

**State:** Texas

**Zip:** 75093

**Location 69:**

**City:** Charlottesville

**Country:** United States

**Facility:** Charlottesville Medical Research Center LLC

**State:** Virginia

**Zip:** 22911

**Location 70:**

**City:** Newport News

**Country:** United States

**Facility:** Health Research of Hampton Roads, Inc

**State:** Virginia

**Zip:** 23606

**Location 71:**

**City:** Spokane

**Country:** United States

**Facility:** Spokane Joint Replacement Center

**State:** Washington

**Zip:** 99218

#### Overall Officials

**Official 1:**

**Affiliation:** Regeneron Pharmaceuticals

**Name:** Clinical Trial Management

**Role:** STUDY_DIRECTOR

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-07-11

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1024724

- Type Abbrev: Prot

- Upload Date: 2022-12-09T14:25

- Date: 2020-04-16

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 716112

- Type Abbrev: SAP

- Upload Date: 2022-12-09T14:25

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Osteoarthritis, Knee

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M17912

- Name: Osteoarthritis, Hip

- Relevance: HIGH

- As Found: Osteoarthritis, Hip

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

- ID: D000015207

- Term: Osteoarthritis, Hip

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000052246

- Term: Cyclooxygenase 2 Inhibitors

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7197

- Name: Diclofenac

- Relevance: HIGH

- As Found: Personalized

- ID: M277

- Name: Celecoxib

- Relevance: HIGH

- As Found: Air

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M293679

- Name: Fasinumab

- Relevance: HIGH

- As Found: Exercise habits

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M27009

- Name: Cyclooxygenase 2 Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068579

- Term: Celecoxib

- ID: D000004008

- Term: Diclofenac

- ID: C000626997

- Term: Fasinumab

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2023-01-06

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 309

**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.

**ID:** EG000

**Other Num Affected:** 121

**Other Num at Risk:** 309

**Serious Number Affected:** 20

**Serious Number At Risk:** 309

**Title:** Placebo

**Group ID:** EG001

**Title:** NSAIDs

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 609

**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.

**ID:** EG001

**Other Num Affected:** 263

**Other Num at Risk:** 609

**Serious Number Affected:** 45

**Serious Number At Risk:** 609

**Title:** NSAIDs

**Group ID:** EG002

**Title:** Fasinumab 1mg Q4W

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 609

**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID

**ID:** EG002

**Other Num Affected:** 261

**Other Num at Risk:** 609

**Serious Number Affected:** 35

**Serious Number At Risk:** 609

**Title:** Fasinumab 1mg Q4W

**Group ID:** EG003

**Title:** Fasinumab 3mg Q4W

**Deaths Num At Risk:** 58

**Description:** Participants received SC injection of Fasinumab at a dose of 3 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID

**ID:** EG003

**Other Num Affected:** 17

**Other Num at Risk:** 58

**Serious Number Affected:** 5

**Serious Number At Risk:** 58

**Title:** Fasinumab 3mg Q4W

**Group ID:** EG004

**Title:** Fasinumab 6mg Q8W

**Deaths Num At Risk:** 59

**Description:** Participants received SC injection of Fasinumab at a dose of 6 mg Q8W up to 24 weeks, alternating with Q8W placebo injections. Participants received placebo injections at the Q4W study visits where study drug was not administered and NSAID-matching placebo oral, BID

**ID:** EG004

**Other Num Affected:** 15

**Other Num at Risk:** 59

**Serious Number Affected:** 2

**Serious Number At Risk:** 59

**Title:** Fasinumab 6mg Q8W

**Frequency Threshold:** 5

#### Other Events

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.1)

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (23.1)

**Term:** Ligament sprain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

**Term:** Muscle strain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

#### Serious Events

**Term:** Arteriosclerosis coronary artery

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 609

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Vertigo positional

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Retinal detachment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 609

**Num Events:** 2

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Hiatus hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Pancreatitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Cholecystitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 609

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Peritonsillar abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Wound infection staphylococcal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Concussion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Femur fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Fractured sacrum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Multiple injuries

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Radius fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 2

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Intervertebral disc protrusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 309

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 609

**Num Events:** 6

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Osteoporotic fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Rapidly progressive osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 309

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 8

**Num At Risk:** 609

**Num Events:** 9

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 58

**Num Events:** 2

**Group ID:** EG004

**Num Affected:** 2

**Num At Risk:** 59

**Num Events:** 2

**Term:** Rotator cuff syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 609

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Spinal synovial cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Tendonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Prostate cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 609

**Num Events:** 2

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Amnesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 609

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Presyncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Trigeminal neuralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Device loosening

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Product Issues

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Endometrial hyperplasia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Uterine prolapse

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Joint arthroplasty

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 609

**Num Events:** 3

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Knee arthroplasty

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 609

**Num Events:** 4

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 609

**Num Events:** 3

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Arteriosclerosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Hypertensive crisis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Varicose vein

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Atrioventricular block complete

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Diverticulum intestinal haemorrhagic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Large intestine polyp

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Impaired healing

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Cholelithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Atypical pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** COVID-19 pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Meningitis viral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Accidental overdose

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Tendon injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Tendon rupture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Bursitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Joint range of motion decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Lumbar spinal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Spinal osteoarthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Spinal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Subchondral insufficiency fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Invasive papillary breast carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Pseudostroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Device dislocation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Product Issues

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Depressed mood

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Nephrolithiasis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num At Risk:** 609

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Breast cyst

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Hip arthroplasty

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 309

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 609

**Num Events:** 3

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (23.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 309

**Group ID:** EG001

**Num At Risk:** 609

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 609

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 58

**Group ID:** EG004

**Num At Risk:** 59

**Time Frame:** First dose to week 44

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 308

**Group ID:** BG001

**Value:** 612

**Group ID:** BG002

**Value:** 612

**Group ID:** BG003

**Value:** 59

**Group ID:** BG004

**Value:** 59

**Group ID:** BG005

**Value:** 1650

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.

### Group

**ID:** BG001

**Title:** NSAIDs

**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.

### Group

**ID:** BG002

**Title:** Fasinumab 1 mg

**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID

### Group

**ID:** BG003

**Title:** Fasinumab 3 mg

**Description:** Participants received SC injection of Fasinumab at a dose of 3 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID

### Group

**ID:** BG004

**Title:** Fasinumab 6 mg

**Description:** Participants received SC injection of Fasinumab at a dose of 6 mg Q8W up to 24 weeks, alternating with Q8W placebo injections. Participants received placebo injections at the Q4W study visits where study drug was not administered and NSAID-matching placebo oral, BID

### Group

**ID:** BG005

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.30

**Value:** 62.0

#### Measurement

**Group ID:** BG001

**Spread:** 9.41

**Value:** 62.3

#### Measurement

**Group ID:** BG002

**Spread:** 9.13

**Value:** 62.1

#### Measurement

**Group ID:** BG003

**Spread:** 9.38

**Value:** 62.8

#### Measurement

**Group ID:** BG004

**Spread:** 9.55

**Value:** 61.5

#### Measurement

**Group ID:** BG005

**Spread:** 9.28

**Value:** 62.2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 308

**Group ID:** BG001

**Value:** 612

**Group ID:** BG002

**Value:** 612

**Group ID:** BG003

**Value:** 59

**Group ID:** BG004

**Value:** 59

**Group ID:** BG005

**Value:** 1650

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 222

#### Measurement

**Group ID:** BG001

**Value:** 418

#### Measurement

**Group ID:** BG002

**Value:** 436

#### Measurement

**Group ID:** BG003

**Value:** 36

#### Measurement

**Group ID:** BG004

**Value:** 34

#### Measurement

**Group ID:** BG005

**Value:** 1146

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 86

#### Measurement

**Group ID:** BG001

**Value:** 194

#### Measurement

**Group ID:** BG002

**Value:** 176

#### Measurement

**Group ID:** BG003

**Value:** 23

#### Measurement

**Group ID:** BG004

**Value:** 25

#### Measurement

**Group ID:** BG005

**Value:** 504

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 308

**Group ID:** BG001

**Value:** 612

**Group ID:** BG002

**Value:** 612

**Group ID:** BG003

**Value:** 59

**Group ID:** BG004

**Value:** 59

**Group ID:** BG005

**Value:** 1650

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 20

#### Measurement

**Group ID:** BG001

**Value:** 44

#### Measurement

**Group ID:** BG002

**Value:** 31

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 10

#### Measurement

**Group ID:** BG005

**Value:** 110

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 285

#### Measurement

**Group ID:** BG001

**Value:** 568

#### Measurement

**Group ID:** BG002

**Value:** 581

#### Measurement

**Group ID:** BG003

**Value:** 54

#### Measurement

**Group ID:** BG004

**Value:** 49

#### Measurement

**Group ID:** BG005

**Value:** 1537

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 3

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 308

**Group ID:** BG001

**Value:** 612

**Group ID:** BG002

**Value:** 612

**Group ID:** BG003

**Value:** 59

**Group ID:** BG004

**Value:** 59

**Group ID:** BG005

**Value:** 1650

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 2

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 33

#### Measurement

**Group ID:** BG001

**Value:** 57

#### Measurement

**Group ID:** BG002

**Value:** 54

#### Measurement

**Group ID:** BG003

**Value:** 8

#### Measurement

**Group ID:** BG004

**Value:** 3

#### Measurement

**Group ID:** BG005

**Value:** 155

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 2

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 60

#### Measurement

**Group ID:** BG001

**Value:** 134

#### Measurement

**Group ID:** BG002

**Value:** 132

#### Measurement

**Group ID:** BG003

**Value:** 12

#### Measurement

**Group ID:** BG004

**Value:** 16

#### Measurement

**Group ID:** BG005

**Value:** 354

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 202

#### Measurement

**Group ID:** BG001

**Value:** 396

#### Measurement

**Group ID:** BG002

**Value:** 405

#### Measurement

**Group ID:** BG003

**Value:** 39

#### Measurement

**Group ID:** BG004

**Value:** 40

#### Measurement

**Group ID:** BG005

**Value:** 1082

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 11

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 18

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 53

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 2

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 308

**Group ID:** BG001

**Value:** 612

**Group ID:** BG002

**Value:** 612

**Group ID:** BG003

**Value:** 59

**Group ID:** BG004

**Value:** 59

**Group ID:** BG005

**Value:** 1650

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.394

**Value:** 6.42

#### Measurement

**Group ID:** BG001

**Spread:** 1.344

**Value:** 6.38

#### Measurement

**Group ID:** BG002

**Spread:** 1.321

**Value:** 6.46

#### Measurement

**Group ID:** BG003

**Spread:** 1.401

**Value:** 6.43

#### Measurement

**Group ID:** BG004

**Spread:** 1.279

**Value:** 6.54

#### Measurement

**Group ID:** BG005

**Spread:** 1.344

**Value:** 6.42

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 308

**Group ID:** BG001

**Value:** 611

**Group ID:** BG002

**Value:** 612

**Group ID:** BG003

**Value:** 58

**Group ID:** BG004

**Value:** 59

**Group ID:** BG005

**Value:** 1648

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.495

**Value:** 6.40

#### Measurement

**Group ID:** BG001

**Spread:** 1.418

**Value:** 6.32

#### Measurement

**Group ID:** BG002

**Spread:** 1.462

**Value:** 6.39

#### Measurement

**Group ID:** BG003

**Spread:** 1.350

**Value:** 6.50

#### Measurement

**Group ID:** BG004

**Spread:** 1.392

**Value:** 6.34

#### Measurement

**Group ID:** BG005

**Spread:** 1.445

**Value:** 6.37

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 304

**Group ID:** BG001

**Value:** 609

**Group ID:** BG002

**Value:** 610

**Group ID:** BG003

**Value:** 58

**Group ID:** BG004

**Value:** 57

**Group ID:** BG005

**Value:** 1638

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 5
**Description:** WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Here 'n' = number of evaluable participants at the specified time point
**Title:** Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
**Unit of Measure:** Score on a scale
### Measure 6
**Description:** WOMAC physical function subscale:17-item questionnaire used to assess degree of difficulty experienced due to OA in index joint during past 48 hours. It was calculated as mean of scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** Here 'n' = number of evaluable participants at the specified time point
**Title:** WOMAC Physical Function Subscale Scores
**Unit of Measure:** Score on a scale
## Results Section - More Information Module
### Certain Agreement
**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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** clinicaltrials@regeneron.com
**Organization:** Regeneron Pharmaceuticals, Inc.
**Phone:** 844-734-6643
**Title:** Clinical Trials Administrator
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -0.971
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.286
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.0003
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Least Square (LS) Mean Difference
**Parameter Value:** -0.63
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.154
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.383
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** (mFAS)

Analyses were based on a multiple imputation approach using a MMRM model with baseline, randomization strata, baseline, treatment, visit and treatment by-visit interaction
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** > 0.0001
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -0.77
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -0.981
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.290
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.0003
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -0.64
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** -1.198
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.443
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** (mFAS)

Analyses were based on a multiple imputation approach using an Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** Threshold for significance at 0.05 level
**Parameter Type:** LS Mean Difference
**Parameter Value:** -0.82
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 1.195
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.092
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on Cochran-Mantel-Haenszel model.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.0013
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 1.581
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.28
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** -0.009
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on a multiple imputation approach using Mixed-Effect Model With Repeated Measure (MMRM) model.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** = 0.0365
**P-Value Comment:** Threshold for significance at 0.05 level.
**Parameter Type:** LS Mean Difference
**Parameter Value:** -0.14
**Statistical Comment:** 
**Statistical Method:** MMRM
**Tested Non-Inferiority:** 
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.165
- **Upper Limit:** 
- **Value:** -2.21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.127
- **Upper Limit:** 
- **Value:** -2.84
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 208
- **Group ID:** OG001
- **Value:** 439
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.182
- **Upper Limit:** 
- **Value:** -2.01
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.141
- **Upper Limit:** 
- **Value:** -2.78
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 173
- **Group ID:** OG001
- **Value:** 372
**Units:** Participants
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.164
- **Upper Limit:** 
- **Value:** -2.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.125
- **Upper Limit:** 
- **Value:** -2.65
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 207
- **Group ID:** OG001
- **Value:** 439
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.180
- **Upper Limit:** 
- **Value:** -1.80
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.138
- **Upper Limit:** 
- **Value:** -2.62
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 172
- **Group ID:** OG001
- **Value:** 372
**Units:** Participants
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.8
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.063
- **Upper Limit:** 
- **Value:** -0.66
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.047
- **Upper Limit:** 
- **Value:** -0.81
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.128
- **Upper Limit:** 
- **Value:** -2.60
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.127
- **Upper Limit:** 
- **Value:** -2.84
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 426
- **Group ID:** OG001
- **Value:** 439
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.140
- **Upper Limit:** 
- **Value:** -2.48
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.141
- **Upper Limit:** 
- **Value:** -2.78
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 363
- **Group ID:** OG001
- **Value:** 372
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.127
- **Upper Limit:** 
- **Value:** -2.33
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.125
- **Upper Limit:** 
- **Value:** -2.65
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 426
- **Group ID:** OG001
- **Value:** 439
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.140
- **Upper Limit:** 
- **Value:** -2.26
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.138
- **Upper Limit:** 
- **Value:** -2.62
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 364
- **Group ID:** OG001
- **Value:** 372
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.048
- **Upper Limit:** 
- **Value:** -0.75
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.047
- **Upper Limit:** 
- **Value:** -0.81
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.130
- **Upper Limit:** 
- **Value:** -1.85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.101
- **Upper Limit:** 
- **Value:** -2.13
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.100
- **Upper Limit:** 
- **Value:** -2.51
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 186
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 406
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 403
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.002
- **Upper Limit:** 
- **Value:** 0.000155
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 586
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0179
- **Upper Limit:** 
- **Value:** 0.0469
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 570
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0275
- **Upper Limit:** 
- **Value:** 0.0644
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 543
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0380
- **Upper Limit:** 
- **Value:** 0.0738
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 502
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.0379
- **Upper Limit:** 
- **Value:** 0.0713
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 465
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.00476
- **Upper Limit:** 
- **Value:** 0.000349
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 186
**Units:** Participants
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint. Modified full analysis set (mFAS) includes all randomized participants in FAS but excludes participants from 4 sites for which there were potential concerns regarding data quality, identified prior to database lock.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
**Type:** PRIMARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG001
**Title:** Fasinumab 1 mg
#### Outcome Measure 2
**Description:** Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
**Type:** PRIMARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG001
**Title:** Fasinumab 1 mg
#### Outcome Measure 3
**Description:** WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
**Parameter Type:** NUMBER
**Population Description:** The FAS included all randomized participants excluding participants affected by the urgent safety measure and was based on the treatment allocated (as randomized). As pre-specified in the protocol, efficacy data from participants randomized to Fasinumab 1 mg Q4W and placebo was only included in the analysis for this outcome measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo
**Type:** SECONDARY
**Unit of Measure:** Percentage of Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG001
**Title:** Fasinumab 1 mg
#### Outcome Measure 4
**Description:** The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG001
**Title:** Fasinumab 1 mg
#### Outcome Measure 5
**Description:** WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG000
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG001
**Title:** Fasinumab 1 mg
#### Outcome Measure 6
**Description:** Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, "Number of Subjects Analysed" signifies those subjects who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG000
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG001
**Title:** Fasinumab 1 mg
#### Outcome Measure 7
**Description:** The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG000
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG001
**Title:** Fasinumab 1 mg
#### Outcome Measure 8
**Description:** Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.
**Dispersion Type:** Standard Error
**Parameter Type:** LEAST_SQUARES_MEAN
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this endpoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale
**Type:** SECONDARY
**Unit of Measure:** Score on a Scale
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Pooled Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 9
**Description:** AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Safety Analysis set (SAF) included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to follow-up period (Week 44)
**Title:** Number of Participants With Adjudicated Arthropathy (AA) Events
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Pooled Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 10
**Description:** DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. Here, "Number of Participants Analyzed" signifies those participants who had positive AA.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to follow-up period (Week 44)
**Title:** Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Pooled Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 11
**Description:** An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to follow-up period (Week 44)
**Title:** Number of Participants With Treatment Emergent Adverse Events (TEAEs)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Pooled Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 12
**Description:** Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to follow-up period (Week 44)
**Title:** Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Pooled Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 13
**Description:** Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 44
**Title:** Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 14
**Description:** Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 24
**Title:** Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 15
**Description:** Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 44
**Title:** Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 16
**Description:** An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.
**Reporting Status:** POSTED
**Time Frame:** At Week 72
**Title:** Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
#### Outcome Measure 17
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic (PK) analysis set included all treated participants who received any study drug and who had at least 1 non-missing drug concentration result following the first study dose. Here, "Overall Number of Participants Analyzed" = participants who were evaluable for this outcome measure and "Number Analyzed" = participants who were evaluable at specified time points. Data was planned to be collected and analyzed for Fasinumab 1 mg Q4W arm only.
**Reporting Status:** POSTED
**Time Frame:** At Weeks 0, 4, 8, 16, 24 and 44
**Title:** Serum Concentrations of Functional Fasinumab
**Type:** SECONDARY
**Unit of Measure:** Milligrams per Liter (mg/L)
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG000
**Title:** Fasinumab 1 mg
#### Outcome Measure 18
**Description:** Immunogenicity was characterized by ADA responses \& titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, \>= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. The ADA analysis set included all participants who received any study drug and had at least 1 non-missing ADA result following the first dose of study drug.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 44
**Title:** Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** OG001
**Title:** NSAIDs
##### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** OG002
**Title:** Fasinumab 1 mg
### Participant Flow Module
#### Group
**Description:** Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.
**ID:** FG001
**Title:** NSAIDs
#### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** FG002
**Title:** Fasinumab 1 mg
#### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 3 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID
**ID:** FG003
**Title:** Fasinumab 3 mg
#### Group
**Description:** Participants received SC injection of Fasinumab at a dose of 6 mg Q8W up to 24 weeks, alternating with Q8W placebo injections. Participants received placebo injections at the Q4W study visits where study drug was not administered and NSAID-matching placebo oral, BID
**ID:** FG004
**Title:** Fasinumab 6 mg
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 10
###### Reason
**Group ID:** FG002
**Number of Subjects:** 5
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 2
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 20
###### Reason
**Group ID:** FG002
**Number of Subjects:** 17
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 17
###### Reason
**Group ID:** FG001
**Number of Subjects:** 16
###### Reason
**Group ID:** FG002
**Number of Subjects:** 20
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
###### Reason
**Group ID:** FG001
**Number of Subjects:** 10
###### Reason
**Group ID:** FG002
**Number of Subjects:** 6
###### Reason
**Group ID:** FG003
**Number of Subjects:** 9
###### Reason
**Group ID:** FG004
**Number of Subjects:** 10
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 26
###### Reason
**Group ID:** FG001
**Number of Subjects:** 58
###### Reason
**Group ID:** FG002
**Number of Subjects:** 66
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
###### Reason
**Group ID:** FG004
**Number of Subjects:** 5
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 24
###### Reason
**Group ID:** FG002
**Number of Subjects:** 35
###### Reason
**Group ID:** FG003
**Number of Subjects:** 4
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 308
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 612
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 612
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 59
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 59
##### Milestone
**Type:** Full Analysis Set (FAS)
**Comment:** FAS included all randomized participants excluding participants affected by the urgent safety measure and was based on the treatment allocated (as randomized)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 308
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 612
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 612
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** Safety Analysis Set (SAF)
**Comment:** SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 309
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 609
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 609
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** Urgent Safety Measure Set (USMS)
**Comment:** USMS included all participants randomized to Fasinumab 3 mg Q4W or 6 mg Q8W and was based on the treatment allocated (as randomized)
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 59
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 59
##### Milestone
**Type:** Completed Treatment
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 218
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 436
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 454
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 238
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 471
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 463
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 42
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 42
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 70
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 141
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 149
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 17
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 17
**Pre-Assignment Details:** In May 2018, the sponsor implemented an urgent safety measure to stop dosing for participants randomized to Fasinumab (6 mg and 3 mg), to prevent further randomization to these regimens across the Fasinumab program based on review of unblinded data in an ongoing study R475-PN-1523 (NCT02683239). Participants from Fasinumab 3 mg and 6 mg group were moved directly into the 20-week follow-up period.
**Recruitment Details:** A total of 4531 participants were screened in this study. Out of which, 1650 participants were randomized to 1 of the following arms: Fasinumab (1 milligram \[mg\]), non-steroidal anti-inflammatory drug (NSAIDs), matched placebo, Fasinumab 3 and 6 mg. Screen failure was mostly due to inclusion criteria not met/exclusion criteria met. Eligible participants were randomized to receive placebo matched to Fasinumab/NSAIDs, NSAIDs (Diclofenac and Celecoxib) and Fasinumab 1 mg.
**Has Results:** True