Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-02 @ 4:12 AM
Study NCT ID:
NCT03161093
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2017-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626997', 'term': 'fasinumab'}, {'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose up to week 124', 'description': 'As treated population', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)', 'otherNumAtRisk': 352, 'deathsNumAtRisk': 352, 'otherNumAffected': 215, 'seriousNumAtRisk': 352, 'deathsNumAffected': 5, 'seriousNumAffected': 49}, {'id': 'EG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID', 'otherNumAtRisk': 1056, 'deathsNumAtRisk': 1056, 'otherNumAffected': 687, 'seriousNumAtRisk': 1056, 'deathsNumAffected': 13, 'seriousNumAffected': 103}, {'id': 'EG002', 'title': 'Fasinumab 1mg Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID', 'otherNumAtRisk': 554, 'deathsNumAtRisk': 554, 'otherNumAffected': 382, 'seriousNumAtRisk': 554, 'deathsNumAffected': 12, 'seriousNumAffected': 81}, {'id': 'EG003', 'title': 'Fasinumab 1mg Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo PO, BID', 'otherNumAtRisk': 1052, 'deathsNumAtRisk': 1052, 'otherNumAffected': 727, 'seriousNumAtRisk': 1052, 'deathsNumAffected': 13, 'seriousNumAffected': 175}, {'id': 'EG004', 'title': 'Fasinumab 3mg Q4W', 'description': 'Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 41, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'Fasinumab 6mg Q8W', 'description': 'Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 58, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 117, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 357, 'numAffected': 232}, {'groupId': 'EG002', 'numAtRisk': 554, 'numEvents': 228, 'numAffected': 152}, {'groupId': 'EG003', 'numAtRisk': 1052, 'numEvents': 467, 'numAffected': 284}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 42, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 51, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 160, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 554, 'numEvents': 112, 'numAffected': 83}, {'groupId': 'EG003', 'numAtRisk': 1052, 'numEvents': 155, 'numAffected': 124}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 82, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 554, 'numEvents': 41, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 1052, 'numEvents': 88, 'numAffected': 65}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 41, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 554, 'numEvents': 29, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 1052, 'numEvents': 57, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Rapidly progressive osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG002', 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'numAtRisk': 1052, 'numEvents': 101, 'numAffected': 79}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 70, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 554, 'numEvents': 41, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 1052, 'numEvents': 85, 'numAffected': 70}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1052, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 352, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1056, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1052, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}], 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Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'PRIMARY', 'title': 'Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.71', 'spread': '0.161', 'groupId': 'OG000'}, {'value': '-2.42', 'spread': '0.096', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.046', 'ciUpperLimit': '-0.346', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.178', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'PRIMARY', 'title': 'Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.09', 'spread': '0.231', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '0.144', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.594', 'ciUpperLimit': '0.401', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.254', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'PRIMARY', 'title': 'Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.91', 'spread': '0.223', 'groupId': 'OG000'}, {'value': '-2.09', 'spread': '0.137', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4605', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.657', 'ciUpperLimit': '0.297', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.243', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.064', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.040', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0,040', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '394', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.074', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '0.043', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '56.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '644', 'groupId': 'OG000'}, {'value': '639', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000'}, {'value': '56.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.42', 'spread': '2.095', 'groupId': 'OG000'}, {'value': '-2.88', 'spread': '2.099', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.69', 'spread': '0.188', 'groupId': 'OG000'}, {'value': '-2.20', 'spread': '0.114', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.15', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '-2.20', 'spread': '0.114', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '595', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.37', 'spread': '0.137', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '0.088', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.172', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '0.113', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '485', 'groupId': 'OG000'}, {'value': '521', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.98', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '-2.42', 'spread': '0.096', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.186', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '0.109', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '378', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.00', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '0.109', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '596', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.46', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '-2.30', 'spread': '0.090', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '427', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.57', 'spread': '0.184', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '0.118', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The mFAS excluded additional participants from the Full Analysis Set (FAS) due to regional irregularities noted in some study sites; it was the main analysis population for efficacy endpoints for the fasinumab 1 mg Q4W group. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.057', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.057', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.1115', 'groupId': 'OG000'}, {'value': '-0.75', 'spread': '0.064', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.41', 'spread': '0.155', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '0.154', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.77', 'spread': '0.276', 'groupId': 'OG000'}, {'value': '-1.99', 'spread': '0.163', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.61', 'spread': '0.196', 'groupId': 'OG000'}, {'value': '-2.04', 'spread': '0.127', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.62', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '0.166', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.04', 'spread': '0.140', 'groupId': 'OG000'}, {'value': '-2.09', 'spread': '0.137', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.76', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '-1.90', 'spread': '0.157', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.73', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '0.131', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}, {'value': '52.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.69', 'spread': '0.271', 'groupId': 'OG000'}, {'value': '-1.80', 'spread': '0.169', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "mFAS Post Protocol Amendment 5 analysis set: For the analysis of fasinumab 1 mg Q8W group comparing to the control groups, only the subset of participants concurrently randomized (ie, after Protocol R475-OA-1611 Amendment 5 Global was implemented) were included. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '102', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With AA (as Confirmed by Adjudication) - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}, {'value': '371', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug in Year 2 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Year 2 safety analysis set (SAF - Year 2) includes all participants who received at least 1 dose of the Year 2 study drug; it is based on the treatment received during Year 2 (as treated); Here 'n' = Number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '553', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '152', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through week 104E (Extension)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With DA (as Confirmed by Adjudication) - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '402', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}, {'value': '371', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug in Year 2 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '553', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent Adverse Events (TEAEs) - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1063', 'groupId': 'OG000'}, {'value': '3641', 'groupId': 'OG001'}, {'value': '1985', 'groupId': 'OG002'}, {'value': '3901', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': "The Year 1 safety analysis set (SAF - Year 1) includes all randomized participants from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of TEAEs - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 2 Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm'}, {'id': 'OG001', 'title': 'Year 2 Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG002', 'title': 'Year 2 Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '973', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}, {'value': '808', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug in Year 2 through week 104E', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of TEAEs - Year 1 and Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '553', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1317', 'groupId': 'OG000'}, {'value': '4348', 'groupId': 'OG001'}, {'value': '2271', 'groupId': 'OG002'}, {'value': '4712', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through week 104E', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Year 1 safety analysis set (SAF - Year 1) includes all randomized patients from the FAS who received any study drug; it is based on the treatment received (as treated); Here 'n' = Number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 2 Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm'}, {'id': 'OG001', 'title': 'Year 2 Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG002', 'title': 'Year 2 Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug in Year 2 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '553', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Analysis Set (SAF) - Year 1 included participants randomized to fasinumab 1 mg Q4W, fasinumab 1 mg Q8W, naproxen, and placebo. Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 2 Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm'}, {'id': 'OG001', 'title': 'Year 2 Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG002', 'title': 'Year 2 Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug in Year 2 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '553', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '554', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 52', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (SAF)-Year 1. For participants with events, number of participant years is calculated up to the date of the first event; for participants without event, it corresponds to the length of the study participation in Year 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Type of All-Cause JR in Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Year 2 Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID; Year 2 naproxen arm contains participants from Year 1 Placebo arm and Year 1 naproxen arm'}, {'id': 'OG001', 'title': 'Year 2 Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG002', 'title': 'Year 2 Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study drug in Year 2 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; arm assignment was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}, {'value': '1056', 'groupId': 'OG001'}, {'value': '553', 'groupId': 'OG002'}, {'value': '1052', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'OG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'OG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'OG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through week 104E', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "SAF - Year 2: included all participants who received at least 1 dose of the Year 2 study drug; it was based on the treatment received during Year 2 (as treated). Here 'n' = Number of evaluable participants at the specified point in time."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'FG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'FG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'FG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}, {'id': 'FG004', 'title': 'Fasinumab 3mg Q4W', 'description': 'Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID'}, {'id': 'FG005', 'title': 'Fasinumab 6mg Q8W', 'description': 'Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '1063'}, {'groupId': 'FG002', 'numSubjects': '551'}, {'groupId': 'FG003', 'numSubjects': '1054'}, {'groupId': 'FG004', 'numSubjects': '145'}, {'groupId': 'FG005', 'numSubjects': '140'}]}, {'type': 'As Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '1056'}, {'groupId': 'FG002', 'numSubjects': '554'}, {'groupId': 'FG003', 'numSubjects': '1052'}, {'groupId': 'FG004', 'numSubjects': '145'}, {'groupId': 'FG005', 'numSubjects': '139'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '919'}, {'groupId': 'FG002', 'numSubjects': '465'}, {'groupId': 'FG003', 'numSubjects': '867'}, {'groupId': 'FG004', 'numSubjects': '102'}, {'groupId': 'FG005', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '187'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '73'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '97'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '13'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Unknown - Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 9157 participants were screened. Of those, 5850 were screen failures. 3307 participants were randomized into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'BG000'}, {'value': '1063', 'groupId': 'BG001'}, {'value': '551', 'groupId': 'BG002'}, {'value': '1054', 'groupId': 'BG003'}, {'value': '145', 'groupId': 'BG004'}, {'value': '140', 'groupId': 'BG005'}, {'value': '3307', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Fasinumab-matching placebo administered by subcutaneous (SC) injection, every 4 weeks (Q4W) and naproxen-matching placebo orally (PO), twice a day (BID)'}, {'id': 'BG001', 'title': 'Naproxen', 'description': 'Fasinumab-matching placebo SC Q4W and naproxen 500 mg PO, BID'}, {'id': 'BG002', 'title': 'Fasinumab 1 mg SC Q8W', 'description': 'Fasinumab 1 mg SC Q8W and naproxen-matching placebo, orally, BID'}, {'id': 'BG003', 'title': 'Fasinumab 1 mg SC Q4W', 'description': 'Fasinumab 1 mg SC Q4W and naproxen-matching placebo, PO, BID'}, {'id': 'BG004', 'title': 'Fasinumab 3mg Q4W', 'description': 'Fasinumab 3 mg SC Q4W and naproxen-matching placebo PO, BID'}, {'id': 'BG005', 'title': 'Fasinumab 6mg Q8W', 'description': 'Fasinumab 6 mg SC Q8W and naproxen-matching placebo PO, BID'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-64 years', 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '608', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}, {'value': '584', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}, {'value': '81', 'groupId': 'BG005'}, {'value': '1876', 'groupId': 'BG006'}]}]}, {'title': '65 - 84 years', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '449', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}, {'value': '463', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}, {'value': '1409', 'groupId': 'BG006'}]}]}, {'title': '85 years and over', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '807', 'groupId': 'BG001'}, {'value': '419', 'groupId': 'BG002'}, {'value': '793', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}, {'value': '2478', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '261', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '829', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '339', 'groupId': 'BG000'}, {'value': '1032', 'groupId': 'BG001'}, {'value': '537', 'groupId': 'BG002'}, {'value': '1015', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}, {'value': '134', 'groupId': 'BG005'}, {'value': '3196', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '116', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '308', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '992', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '211', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}, {'value': '630', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}, {'value': '86', 'groupId': 'BG005'}, {'value': '1956', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '241', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-26', 'size': 1141326, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-25T01:21', 'hasProtocol': True}, {'date': '2020-07-01', 'size': 1857292, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-25T01:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3307}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2020-09-08', 'completionDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2017-05-18', 'dispFirstSubmitQcDate': '2022-10-18', 'resultsFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2017-05-18', 'dispFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-18', 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q4W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in the WOMAC Pain Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg SC Q8W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in the WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}], 'secondaryOutcomes': [{'measure': 'Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).'}, {'measure': 'Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).'}, {'measure': 'Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That Of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 44', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).'}, {'measure': 'Percentage Of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Percentage of Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores', 'timeFrame': 'Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1 mg Q4W, Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q4W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q4W, Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q4W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in the Patient Global Assessment (PGA) Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).'}, {'measure': 'Change in the PGA Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 16', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).'}, {'measure': 'Change In The PGA Scores From Baseline To Week 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That Of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 44', 'description': 'The Patient Global Assessment of OA (PGA) is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).'}, {'measure': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 16 In Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Pain Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 4, 8, 12 and 16, in Participants Treated With Fasinumab 1 mg Q8W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to the Average Score Across Weeks 36, 40 and 44 in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 16 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Naproxen', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Physical Function Subscale Scores From Baseline to Week 44 in Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to Week 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change In WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 4, 8, 12 And 16, in Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 4, 8, 12 and 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Percentage Of Participants Treated With Fasinumab 1mg Q8W, Compared With That of Participants Treated With Placebo, Who Had A Response At Week 16, With Response Defined As An Improvement By ≥30% In The WOMAC Pain Subscale Scores', 'timeFrame': 'Baseline to Week 16', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Change in WOMAC Pain Subscale Scores From Baseline To The Average Score Across Weeks 36, 40 And 44 In Participants Treated With Fasinumab 1mg Q8W Compared With That of Participants Treated With Placebo', 'timeFrame': 'Baseline to average score across weeks 36, 40 and 44', 'description': 'The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.'}, {'measure': 'Number of Participants With Adjudicated Arthropathy (AA) (as Confirmed by Adjudication) - Year 1', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Number of Participants With AA (as Confirmed by Adjudication) - Year 2', 'timeFrame': 'First dose of study drug in Year 2 through week 104E'}, {'measure': 'Number of Participants With AA (as Confirmed by Adjudication) - Year 1 and Year 2', 'timeFrame': 'Day 1 through week 104E (Extension)'}, {'measure': 'Number of Participants With Destructive Arthropathy (DA) (as Confirmed by Adjudication) - Year 1', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Number of Participants With DA (as Confirmed by Adjudication) - Year 2', 'timeFrame': 'First dose of study drug in Year 2 through week 104E'}, {'measure': 'Number of Participants With DA (as Confirmed by Adjudication) - Year 1 and Year 2', 'timeFrame': 'Day 1 through week 104E'}, {'measure': 'Number of Treatment Emergent Adverse Events (TEAEs) - Year 1', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Number of TEAEs - Year 2', 'timeFrame': 'First dose of study drug in Year 2 through week 104E'}, {'measure': 'Number of TEAEs - Year 1 and Year 2', 'timeFrame': 'Day 1 through week 104E'}, {'measure': 'Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 2', 'timeFrame': 'First dose of study drug in Year 2 through week 104E'}, {'measure': 'Number of Participants With at Least 1 Sympathetic Nervous System (SNS) Dysfunction Adverse Event of Special Interest (AESI) - Year 1 and Year 2', 'timeFrame': 'Day 1 through week 104E'}, {'measure': 'Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 2', 'timeFrame': 'First dose of study drug in Year 2 through week 104E'}, {'measure': 'Number of Participants With at Least 1 Peripheral Sensory Neuropathy AESI That Require a Neurology or Other Specialty Consultation - Year 1 and Year 2', 'timeFrame': 'Day 1 through week 104E'}, {'measure': 'Number of Participants With Any Type of All-Cause Joint Replacement (JR) in Year 1', 'timeFrame': 'Baseline to Week 52'}, {'measure': 'Number of Participants With Any Type of All-Cause JR in Year 2', 'timeFrame': 'First dose of study drug in Year 2 through week 104E'}, {'measure': 'Number of Participants With Any Type of All-Cause Joint Replacement (JR) - Year 1 and Year 2', 'timeFrame': 'Day 1 through week 104E'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee', 'Osteoarthritis, Hip']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip.\n\nThe secondary objectives of the study are:\n\n1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip\n2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip\n3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip\n4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip\n5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip\n6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks\n7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks\n8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks\n9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks\n10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria include, but are not limited to, the following:\n\nYear 1:\n\n1. Male and female patients, at least 18 years of age, at screening\n2. A clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit\n3. Moderate to severe pain in the index joint defined at both the screening and randomization visits\n4. 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)\n5. A history of at least 12 weeks of analgesics use for pain due to OA of the knee or hip, as defined by:\n\n 1. Inadequate pain relief from acetaminophen/paracetamol AND\n 2. Intolerance to or inadequate pain relief from opioid or tramadol therapy, unwillingness to take opioid or tramadol therapy for a medically acceptable reason, or lack of access to an opioid or to tramadol\n6. Currently using a stable dose of NSAID.\n7. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the initial 16 weeks of treatment\n8. Stable treatment with glucosamine sulfate and chondroitin sulfate treatments must be stopped during the pre-randomization period\n9. Consent to allow all radiographs and medical/surgical/hospitalization records of care received elsewhere prior to and during the study period to be shared with the investigator\n10. Willing to maintain current activity and exercise levels throughout the study\n11. Willing and able to comply with clinic visits and study-related procedures and willing to provide follow-up information related to any JR surgery that occurs within the period of time covered by their intended participation in the study\n12. Able to understand and complete study-related questionnaires\n\nYear 2:\n\nNote: Any Year 1 patient attending their week 52 visit on or after 26 March 2020 will no longer have the option to enroll into Year 2.\n\n1. Completed the treatment period of Year 1\n2. Did not permanently discontinue study drug during Year 1\n3. Received no less than 10 of the 13 planned doses of SC study drug during the treatment period of Year 1\n4. Provide informed consent for Year 2\n5. Willing to continue to maintain current activity and exercise levels throughout Year 2\n\nExclusion Criteria include, but are not limited to, the following:\n\n1. Non-compliance with the Numeric Rating Scale (NRS) recording during the pre-randomization period\n2. 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\n3. History or presence on imaging of arthropathy, neuropathic joint arthropathy, hip or knee dislocation, extensive subchondral cysts, significant bone collapse or bone loss, or pathologic fractures\n4. Trauma to the index joint within 3 months prior to the screening visit\n5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening\n6. Patient is not a candidate for MRI\n7. 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\n8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy\n9. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy\n10. History of naproxen intolerance, or existence of a medical condition that is high risk for naproxen-associated complications\n11. Resting heart rate of \\<50 beats per minute (bpm) or \\>100 bpm at the screening or randomization visits\n12. History or presence of 2nd or 3rd degree heart block, 1st degree heart block with abnormal Complex of Q, R, and S waves on an electrocardiogram (QRS) complex, or bifascicular block by ECG assessment at the screening visit\n13. History or presence of orthostatic hypotension at the screening, prerandomization, or randomization visits\n14. History of poorly controlled hypertension\n15. Use of systemic corticosteroid within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit\n16. Exposure to an anti-Nerve growth factor (NGF) antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies"}, 'identificationModule': {'nctId': 'NCT03161093', 'acronym': 'FACT OA1', 'briefTitle': 'A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip', 'orgStudyIdInfo': {'id': 'R475-OA-1611'}, 'secondaryIdInfos': [{'id': '2016-005020-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasinumab dosing regimen 1', 'description': 'Fasinumab Subcutaneous (SC) dosing regimen 1 and 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