Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-03-13 @ 6:29 AM
Study NCT ID:
NCT00863304
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2009-03-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tanezumab in Osteoarthritis of the Hip or Knee (2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549319', 'term': 'tanezumab'}, {'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.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.', 'otherNumAtRisk': 209, 'otherNumAffected': 38, 'seriousNumAtRisk': 209, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.', 'otherNumAtRisk': 211, 'otherNumAffected': 69, 'seriousNumAtRisk': 211, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.', 'otherNumAtRisk': 209, 'otherNumAffected': 62, 'seriousNumAtRisk': 209, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.', 'otherNumAtRisk': 211, 'otherNumAffected': 58, 'seriousNumAtRisk': 211, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Small intestine ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Breast cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Drug exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 211, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 209, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 211, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.41', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '7.27', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '7.37', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '7.30', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'Change at week 16', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '-3.32', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-3.03', 'spread': '3.05', 'groupId': 'OG002'}, {'value': '-2.61', 'spread': '2.70', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '-0.62', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.29', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.090', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '0.07', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '-0.17', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.175', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.04', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '7.09', 'spread': '1.52', 'groupId': 'OG002'}, {'value': '6.95', 'spread': '1.64', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-1.75', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-3.01', 'spread': '2.64', 'groupId': 'OG001'}, {'value': '-2.86', 'spread': '2.98', 'groupId': 'OG002'}, {'value': '-2.25', 'spread': '2.51', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.23', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '-0.75', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-1.48', 'ciUpperLimit': '-0.51', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.067', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '-0.29', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.031', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': "WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.46', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '3.36', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '3.40', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '3.48', 'spread': '0.61', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '-0.66', 'spread': '0.90', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '-0.18', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.078', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.02', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '-0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.029', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '-0.02', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.11', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-2.64', 'spread': '2.48', 'groupId': 'OG001'}, {'value': '-2.42', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '-2.92', 'spread': '2.42', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.29', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-3.48', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '-3.27', 'spread': '2.82', 'groupId': 'OG002'}, {'value': '-2.98', 'spread': '2.33', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.23', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-3.46', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '-3.06', 'spread': '2.81', 'groupId': 'OG002'}, {'value': '-2.85', 'spread': '2.39', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.12', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '-3.40', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-3.24', 'spread': '3.02', 'groupId': 'OG002'}, {'value': '-2.78', 'spread': '2.63', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.214', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '-0.32', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.234', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.72', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.034', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '-0.70', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-1.42', 'ciUpperLimit': '-0.49', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '-0.18', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.029', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.193', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '-0.73', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '-0.32', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '-0.14', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.017', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.10', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.464', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.30', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-1.72', 'ciUpperLimit': '-0.72', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.54', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '-0.13', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.023', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.08', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.114', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.10', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, and 12', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.41', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '7.27', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '7.37', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '7.30', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.11', 'spread': '2.15', 'groupId': 'OG000'}, {'value': '-2.64', 'spread': '2.48', 'groupId': 'OG001'}, {'value': '-2.42', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '-2.92', 'spread': '2.42', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.42', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '-3.57', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '-3.35', 'spread': '2.79', 'groupId': 'OG002'}, {'value': '-3.04', 'spread': '2.35', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.48', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '-3.59', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '-3.39', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '-3.05', 'spread': '2.39', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.58', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '-3.73', 'spread': '2.84', 'groupId': 'OG002'}, {'value': '-3.12', 'spread': '2.56', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.64', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-3.80', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '-3.58', 'spread': '2.87', 'groupId': 'OG002'}, {'value': '-3.07', 'spread': '2.66', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.214', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '-0.32', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.234', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.72', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.034', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.93', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '-0.67', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '-0.45', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.13', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.023', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '-0.07', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.175', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '0.14', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.09', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.63', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.88', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '-0.41', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.017', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.10', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.027', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.06', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.190', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '0.15', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '-0.68', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-1.55', 'ciUpperLimit': '-0.60', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.04', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '9', 'paramValue': '-0.64', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.023', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '-0.08', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.12', 'ciLowerLimit': '-1.60', 'ciUpperLimit': '-0.64', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-1.35', 'ciUpperLimit': '-0.39', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.092', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.07', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.004', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.23', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.064', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.04', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '7.09', 'spread': '1.52', 'groupId': 'OG002'}, {'value': '6.95', 'spread': '1.64', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-2.34', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '-2.33', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '-2.52', 'spread': '2.40', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.77', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '-3.04', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '-2.94', 'spread': '2.80', 'groupId': 'OG002'}, {'value': '-2.55', 'spread': '2.36', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.76', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '-3.00', 'spread': '2.61', 'groupId': 'OG001'}, {'value': '-2.83', 'spread': '2.79', 'groupId': 'OG002'}, {'value': '-2.40', 'spread': '2.29', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.71', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '-3.06', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '-2.95', 'spread': '2.95', 'groupId': 'OG002'}, {'value': '-2.47', 'spread': '2.45', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '-0.27', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.23', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '-0.39', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.572', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.55', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.467', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.59', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.28', 'ciLowerLimit': '-1.74', 'ciUpperLimit': '-0.83', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.12', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '-0.66', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.27', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '-0.09', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.101', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.08', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '-0.78', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.00', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '-0.54', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.008', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.101', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.08', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '-0.83', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.63', 'ciUpperLimit': '-0.67', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.72', 'ciLowerLimit': '-1.21', 'ciUpperLimit': '-0.24', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.016', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.11', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.082', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.06', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, and 12', 'description': "WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-2.34', 'spread': '2.37', 'groupId': 'OG001'}, {'value': '-2.33', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '-2.52', 'spread': '2.40', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.84', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-3.09', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '-3.05', 'spread': '2.78', 'groupId': 'OG002'}, {'value': '-2.58', 'spread': '2.37', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.92', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '-3.10', 'spread': '2.76', 'groupId': 'OG002'}, {'value': '-2.56', 'spread': '2.34', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.03', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-3.36', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '-3.36', 'spread': '2.85', 'groupId': 'OG002'}, {'value': '-2.70', 'spread': '2.49', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.08', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '-3.38', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '-3.30', 'spread': '2.87', 'groupId': 'OG002'}, {'value': '-2.60', 'spread': '2.59', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '-0.27', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.23', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '-0.39', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.572', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.55', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.467', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.59', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-1.73', 'ciUpperLimit': '-0.82', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.15', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '-0.70', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.24', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.015', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.11', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.053', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.01', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '-0.75', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.11', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '-0.65', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.011', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.14', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.035', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '-0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.32', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '-0.85', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '-0.76', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '-0.21', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.013', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.12', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 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'dispersionValue': '0.24', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.050', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '-0.00', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '-0.34', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.11', 'ciUpperLimit': '-0.16', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': "WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '0.99', 'groupId': 'OG002'}, {'value': '-0.88', 'spread': '0.85', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-0.93', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '-0.85', 'spread': '0.83', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-0.85', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '-0.71', 'spread': '0.86', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '-0.80', 'spread': '0.93', 'groupId': 'OG002'}, {'value': '-0.65', 'spread': '0.83', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '-0.04', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.18', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.076', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.29', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.37', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '-0.24', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '-0.26', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.11', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.102', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.066', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.01', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '-0.28', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.21', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.027', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '-0.02', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.10', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline 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pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '-0.11', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.328', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.08', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.09', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.022', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '-0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, and 12', 'description': 'Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '0.99', 'groupId': 'OG002'}, {'value': '-0.88', 'spread': '0.85', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '-0.92', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '-0.86', 'spread': '0.85', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-0.52', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '-0.88', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '-0.78', 'spread': '0.87', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '-0.95', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '-0.88', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '-0.78', 'spread': '0.86', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '-0.89', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '-0.79', 'spread': '0.92', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '-0.04', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.18', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 2: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.076', 'groupIds': ['OG001', 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'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.13', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 4: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.120', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 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'paramValue': '-0.22', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.052', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.00', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 8: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.25', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '-0.15', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.051', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.00', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.08', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.069', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.01', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 12: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.24', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.20', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '-0.05', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.020', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '-0.03', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.064', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.01', 'pValueComment': 'P-value was based on pairwise comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'groupDescription': 'Week 16: ANCOVA was performed with treatment as main effects, baseline value, index joint as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000'}, {'value': '59.7', 'groupId': 'OG001'}, {'value': '55.3', 'groupId': 'OG002'}, {'value': '68.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '45.9', 'groupId': 'OG000'}, {'value': '72.5', 'groupId': 'OG001'}, {'value': '63.9', 'groupId': 'OG002'}, {'value': '67.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000'}, {'value': '72.0', 'groupId': 'OG001'}, {'value': '60.6', 'groupId': 'OG002'}, {'value': '64.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '64.5', 'groupId': 'OG001'}, {'value': '59.6', 'groupId': 'OG002'}, {'value': '58.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '64.9', 'groupId': 'OG001'}, {'value': '55.8', 'groupId': 'OG002'}, {'value': '53.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\\>=) 50 percent and \\>=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was \\>=20 percent and \\>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \\[no pain\\] to 10 \\[worst possible pain\\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \\[minimum difficulty\\] to 10 \\[maximum difficulty\\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \\[very good\\] to 5 \\[very poor\\], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000'}, {'value': '59.7', 'groupId': 'OG001'}, {'value': '55.3', 'groupId': 'OG002'}, {'value': '68.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '74.4', 'groupId': 'OG001'}, {'value': '65.9', 'groupId': 'OG002'}, {'value': '69.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000'}, {'value': '74.9', 'groupId': 'OG001'}, {'value': '66.8', 'groupId': 'OG002'}, {'value': '69.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '53.6', 'groupId': 'OG000'}, {'value': '73.5', 'groupId': 'OG001'}, {'value': '69.7', 'groupId': 'OG002'}, {'value': '68.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000'}, {'value': '74.9', 'groupId': 'OG001'}, {'value': '68.8', 'groupId': 'OG002'}, {'value': '64.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was \\>=50 percent and \\>=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was \\>=20 percent and \\>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \\[no pain\\] to 10 \\[worst possible pain\\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \\[minimum difficulty\\] to 10 \\[maximum difficulty\\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \\[very good\\] to 5 \\[very poor\\], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2: >=30 percent reduction', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '50.2', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}, {'value': '56.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: >=50 percent reduction', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}, {'value': '28.4', 'groupId': 'OG002'}, {'value': '37.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=30 percent reduction', 'categories': [{'measurements': [{'value': '46.4', 'groupId': 'OG000'}, {'value': '68.7', 'groupId': 'OG001'}, {'value': '58.2', 'groupId': 'OG002'}, {'value': '57.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=50 percent reduction', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}, {'value': '44.2', 'groupId': 'OG002'}, {'value': '39.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=30 percent reduction', 'categories': [{'measurements': [{'value': '39.7', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}, {'value': '54.8', 'groupId': 'OG002'}, {'value': '57.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=50 percent reduction', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '54.0', 'groupId': 'OG001'}, {'value': '42.8', 'groupId': 'OG002'}, {'value': '41.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=30 percent reduction', 'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}, {'value': '64.0', 'groupId': 'OG001'}, {'value': '56.3', 'groupId': 'OG002'}, {'value': '52.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=50 percent reduction', 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000'}, {'value': '53.1', 'groupId': 'OG001'}, {'value': '48.6', 'groupId': 'OG002'}, {'value': '41.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 16: >=30 percent reduction', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}, {'value': '52.9', 'groupId': 'OG002'}, {'value': '51.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 16: >=50 percent reduction', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}, {'value': '44.7', 'groupId': 'OG002'}, {'value': '41.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2: >=30 percent reduction', 'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000'}, {'value': '50.2', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}, {'value': '56.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: >=50 percent reduction', 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000'}, {'value': '37.0', 'groupId': 'OG001'}, {'value': '28.4', 'groupId': 'OG002'}, {'value': '37.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=30 percent reduction', 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}, {'value': '70.1', 'groupId': 'OG001'}, {'value': '59.6', 'groupId': 'OG002'}, {'value': '58.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=50 percent reduction', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '53.1', 'groupId': 'OG001'}, {'value': '45.2', 'groupId': 'OG002'}, {'value': '40.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=30 percent reduction', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}, {'value': '70.6', 'groupId': 'OG001'}, {'value': '61.5', 'groupId': 'OG002'}, {'value': '60.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=50 percent reduction', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '56.4', 'groupId': 'OG001'}, {'value': '47.1', 'groupId': 'OG002'}, {'value': '44.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=30 percent reduction', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '71.6', 'groupId': 'OG001'}, {'value': '65.9', 'groupId': 'OG002'}, {'value': '58.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=50 percent reduction', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '58.3', 'groupId': 'OG001'}, {'value': '53.8', 'groupId': 'OG002'}, {'value': '45.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16:>=30 percent reduction', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '64.4', 'groupId': 'OG002'}, {'value': '58.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16:>=50 percent reduction', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}, {'value': '51.0', 'groupId': 'OG002'}, {'value': '46.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '16.8', 'groupId': 'OG002'}, {'value': '23.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '24.2', 'groupId': 'OG001'}, {'value': '26.4', 'groupId': 'OG002'}, {'value': '21.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '26.5', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}, {'value': '15.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}, {'value': '22.1', 'groupId': 'OG002'}, {'value': '15.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '21.8', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}, {'value': '19.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}, {'value': '16.8', 'groupId': 'OG002'}, {'value': '23.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}, {'value': '26.9', 'groupId': 'OG002'}, {'value': '22.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '27.0', 'groupId': 'OG001'}, {'value': '28.8', 'groupId': 'OG002'}, {'value': '17.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}, {'value': '25.5', 'groupId': 'OG002'}, {'value': '17.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}, {'value': '26.0', 'groupId': 'OG002'}, {'value': '21.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': '>0% reduction', 'categories': [{'measurements': [{'value': '54.1', 'groupId': 'OG000'}, {'value': '71.6', 'groupId': 'OG001'}, {'value': '64.9', 'groupId': 'OG002'}, {'value': '67.1', 'groupId': 'OG003'}]}]}, {'title': '>=10% reduction', 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}, {'value': '69.7', 'groupId': 'OG001'}, {'value': '61.5', 'groupId': 'OG002'}, {'value': '61.4', 'groupId': 'OG003'}]}]}, {'title': '>=20% reduction', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}, {'value': '66.4', 'groupId': 'OG001'}, {'value': '57.2', 'groupId': 'OG002'}, {'value': '55.1', 'groupId': 'OG003'}]}]}, {'title': '>=30% reduction', 'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}, {'value': '52.9', 'groupId': 'OG002'}, {'value': '51.7', 'groupId': 'OG003'}]}]}, {'title': '>=40% reduction', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}, {'value': '47.6', 'groupId': 'OG002'}, {'value': '43.5', 'groupId': 'OG003'}]}]}, {'title': '>=50% reduction', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}, {'value': '44.7', 'groupId': 'OG002'}, {'value': '41.1', 'groupId': 'OG003'}]}]}, {'title': '>=60% reduction', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000'}, {'value': '44.5', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}, {'value': '32.9', 'groupId': 'OG003'}]}]}, {'title': '>=70% reduction', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}, {'value': '29.3', 'groupId': 'OG002'}, {'value': '23.7', 'groupId': 'OG003'}]}]}, {'title': '>=80% reduction', 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}, {'value': '22.6', 'groupId': 'OG002'}, {'value': '19.3', 'groupId': 'OG003'}]}]}, {'title': '>=90% reduction', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '13.3', 'groupId': 'OG001'}, {'value': '13.9', 'groupId': 'OG002'}, {'value': '9.2', 'groupId': 'OG003'}]}]}, {'title': '=100% reduction', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '3.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent \\[%\\]; \\>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': '>0% reduction', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}, {'value': '89.6', 'groupId': 'OG001'}, {'value': '86.5', 'groupId': 'OG002'}, {'value': '85.0', 'groupId': 'OG003'}]}]}, {'title': '>=10% reduction', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}, {'value': '83.4', 'groupId': 'OG001'}, {'value': '79.8', 'groupId': 'OG002'}, {'value': '75.4', 'groupId': 'OG003'}]}]}, {'title': '>=20% reduction', 'categories': [{'measurements': [{'value': '59.3', 'groupId': 'OG000'}, {'value': '78.7', 'groupId': 'OG001'}, {'value': '72.6', 'groupId': 'OG002'}, {'value': '65.7', 'groupId': 'OG003'}]}]}, {'title': '>=30% reduction', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '64.4', 'groupId': 'OG002'}, {'value': '58.9', 'groupId': 'OG003'}]}]}, {'title': '>=40% reduction', 'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000'}, {'value': '64.5', 'groupId': 'OG001'}, {'value': '56.3', 'groupId': 'OG002'}, {'value': '50.7', 'groupId': 'OG003'}]}]}, {'title': '>=50% reduction', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}, {'value': '51.0', 'groupId': 'OG002'}, {'value': '46.9', 'groupId': 'OG003'}]}]}, {'title': '>=60% reduction', 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '49.8', 'groupId': 'OG001'}, {'value': '44.2', 'groupId': 'OG002'}, {'value': '37.7', 'groupId': 'OG003'}]}]}, {'title': '>=70% reduction', 'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '42.2', 'groupId': 'OG001'}, {'value': '32.2', 'groupId': 'OG002'}, {'value': '26.6', 'groupId': 'OG003'}]}]}, {'title': '>=80% reduction', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}, {'value': '24.5', 'groupId': 'OG002'}, {'value': '21.7', 'groupId': 'OG003'}]}]}, {'title': '>=90% reduction', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '14.2', 'groupId': 'OG001'}, {'value': '14.9', 'groupId': 'OG002'}, {'value': '10.6', 'groupId': 'OG003'}]}]}, {'title': '=100% reduction', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}, {'value': '4.3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; \\>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '-1.70', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '-2.02', 'spread': '2.29', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.43', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-2.34', 'spread': '2.44', 'groupId': 'OG001'}, {'value': '-2.46', 'spread': '2.54', 'groupId': 'OG002'}, {'value': '-2.11', 'spread': '2.37', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.39', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '2.47', 'groupId': 'OG001'}, {'value': '-2.37', 'spread': '2.59', 'groupId': 'OG002'}, {'value': '-2.01', 'spread': '2.37', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.52', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-2.39', 'spread': '2.57', 'groupId': 'OG001'}, {'value': '-2.36', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '-2.02', 'spread': '2.54', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '2.68', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '2.80', 'groupId': 'OG002'}, {'value': '-1.82', 'spread': '2.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'Participants assessed their average daily pain score in the index hip/knee using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. A weekly mean was calculated using the daily index hip/knee pain scores within each specified study week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.19', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '7.07', 'spread': '1.67', 'groupId': 'OG001'}, {'value': '7.11', 'spread': '1.85', 'groupId': 'OG002'}, {'value': '6.96', 'spread': '1.99', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.54', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '-2.52', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '-2.39', 'spread': '2.77', 'groupId': 'OG002'}, {'value': '-2.45', 'spread': '2.51', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.69', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '2.63', 'groupId': 'OG001'}, {'value': '-3.10', 'spread': '2.96', 'groupId': 'OG002'}, {'value': '-2.51', 'spread': '2.47', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-3.31', 'spread': '2.79', 'groupId': 'OG001'}, {'value': '-2.90', 'spread': '3.09', 'groupId': 'OG002'}, {'value': '-2.32', 'spread': '2.41', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.72', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '-3.21', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '-3.06', 'spread': '3.24', 'groupId': 'OG002'}, {'value': '-2.41', 'spread': '2.67', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-3.17', 'spread': '2.89', 'groupId': 'OG001'}, {'value': '-2.95', 'spread': '3.27', 'groupId': 'OG002'}, {'value': '-2.24', 'spread': '2.70', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.21', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '7.06', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '7.19', 'spread': '1.39', 'groupId': 'OG002'}, {'value': '7.07', 'spread': '1.47', 'groupId': 'OG003'}]}]}, {'title': 'Change at week 2', 'categories': [{'measurements': [{'value': '-1.75', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '-2.50', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '-2.38', 'spread': '2.48', 'groupId': 'OG002'}, {'value': '-2.63', 'spread': '2.31', 'groupId': 'OG003'}]}]}, {'title': 'Change at week 4', 'categories': [{'measurements': [{'value': '-1.92', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '-3.11', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '-2.68', 'spread': '2.27', 'groupId': 'OG003'}]}]}, {'title': 'Change at week 8', 'categories': [{'measurements': [{'value': '-1.91', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-3.26', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '-2.94', 'spread': '2.79', 'groupId': 'OG002'}, {'value': '-2.52', 'spread': '2.24', 'groupId': 'OG003'}]}]}, {'title': 'Change at week 12', 'categories': [{'measurements': [{'value': '-1.85', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '-3.22', 'spread': '2.67', 'groupId': 'OG001'}, {'value': '-3.08', 'spread': '2.98', 'groupId': 'OG002'}, {'value': '-2.56', 'spread': '2.48', 'groupId': 'OG003'}]}]}, {'title': 'Change at week 16', 'categories': [{'measurements': [{'value': '-1.88', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-3.17', 'spread': '2.68', 'groupId': 'OG001'}, {'value': '-2.94', 'spread': '3.01', 'groupId': 'OG002'}, {'value': '-2.37', 'spread': '2.53', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \\[no pain\\] to 10 \\[worst possible pain\\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \\[minimum difficulty\\] to 10 \\[maximum difficulty\\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \\[no stiffness\\] to 10 \\[worst stiffness\\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.36', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '1.61', 'groupId': 'OG001'}, {'value': '7.23', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '7.22', 'spread': '1.61', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-2.64', 'spread': '2.60', 'groupId': 'OG001'}, {'value': '-2.44', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '-3.03', 'spread': '2.68', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.18', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-3.38', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '-3.26', 'spread': '2.84', 'groupId': 'OG002'}, {'value': '-3.05', 'spread': '2.55', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.23', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '-3.29', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '-3.00', 'spread': '2.84', 'groupId': 'OG002'}, {'value': '-2.82', 'spread': '2.71', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.21', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-3.34', 'spread': '2.90', 'groupId': 'OG001'}, {'value': '-3.20', 'spread': '3.05', 'groupId': 'OG002'}, {'value': '-2.80', 'spread': '2.74', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.19', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '-3.22', 'spread': '2.90', 'groupId': 'OG001'}, {'value': '-2.95', 'spread': '3.10', 'groupId': 'OG002'}, {'value': '-2.64', 'spread': '2.81', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '207', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.33', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '8.05', 'spread': '1.50', 'groupId': 'OG001'}, {'value': '8.22', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '8.24', 'spread': '1.45', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.97', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '-2.84', 'spread': '2.64', 'groupId': 'OG001'}, {'value': '-2.64', 'spread': '2.72', 'groupId': 'OG002'}, {'value': '-2.93', 'spread': '2.60', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.19', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-3.54', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-3.35', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '-3.07', 'spread': '2.53', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.12', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-3.44', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '-3.30', 'spread': '2.99', 'groupId': 'OG002'}, {'value': '-2.88', 'spread': '2.52', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.05', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '3.03', 'groupId': 'OG001'}, {'value': '-3.38', 'spread': '3.15', 'groupId': 'OG002'}, {'value': '-2.84', 'spread': '2.67', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.06', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '-3.11', 'spread': '3.17', 'groupId': 'OG002'}, {'value': '-2.61', 'spread': '2.87', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Change at Week 12: General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.11', 'spread': '11.12', 'groupId': 'OG000'}, {'value': '3.51', 'spread': '13.04', 'groupId': 'OG001'}, {'value': '4.02', 'spread': '13.89', 'groupId': 'OG002'}, {'value': '3.05', 'spread': '13.72', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '12.38', 'groupId': 'OG001'}, {'value': '3.41', 'spread': '13.01', 'groupId': 'OG002'}, {'value': '3.12', 'spread': '11.52', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.45', 'spread': '20.05', 'groupId': 'OG000'}, {'value': '18.57', 'spread': '23.26', 'groupId': 'OG001'}, {'value': '18.40', 'spread': '26.35', 'groupId': 'OG002'}, {'value': '11.78', 'spread': '21.57', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.80', 'spread': '17.69', 'groupId': 'OG000'}, {'value': '17.26', 'spread': '21.04', 'groupId': 'OG001'}, {'value': '15.93', 'spread': '24.85', 'groupId': 'OG002'}, {'value': '11.22', 'spread': '20.80', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Role Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.62', 'spread': '23.47', 'groupId': 'OG000'}, {'value': '19.43', 'spread': '25.69', 'groupId': 'OG001'}, {'value': '16.66', 'spread': '24.67', 'groupId': 'OG002'}, {'value': '13.22', 'spread': '23.75', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Role Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.85', 'spread': '22.75', 'groupId': 'OG000'}, {'value': '17.95', 'spread': '26.59', 'groupId': 'OG001'}, {'value': '15.22', 'spread': '24.95', 'groupId': 'OG002'}, {'value': '11.48', 'spread': '24.21', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.13', 'spread': '21.91', 'groupId': 'OG000'}, {'value': '21.89', 'spread': '23.40', 'groupId': 'OG001'}, {'value': '20.40', 'spread': '24.28', 'groupId': 'OG002'}, {'value': '15.06', 'spread': '20.71', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Bodily Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.33', 'spread': '20.62', 'groupId': 'OG000'}, {'value': '19.73', 'spread': '24.00', 'groupId': 'OG001'}, {'value': '17.54', 'spread': '24.42', 'groupId': 'OG002'}, {'value': '13.95', 'spread': '19.22', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12:Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.85', 'spread': '14.45', 'groupId': 'OG000'}, {'value': '9.05', 'spread': '15.00', 'groupId': 'OG001'}, {'value': '6.52', 'spread': '17.53', 'groupId': 'OG002'}, {'value': '4.37', 'spread': '18.21', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16:Vitality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.75', 'spread': '13.97', 'groupId': 'OG000'}, {'value': '9.55', 'spread': '15.76', 'groupId': 'OG001'}, {'value': '6.97', 'spread': '17.53', 'groupId': 'OG002'}, {'value': '6.79', 'spread': '17.00', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.13', 'spread': '17.16', 'groupId': 'OG000'}, {'value': '10.12', 'spread': '22.75', 'groupId': 'OG001'}, {'value': '8.07', 'spread': '22.66', 'groupId': 'OG002'}, {'value': '7.24', 'spread': '23.78', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Social Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.44', 'spread': '17.23', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '20.31', 'groupId': 'OG001'}, {'value': '7.30', 'spread': '20.23', 'groupId': 'OG002'}, {'value': '7.72', 'spread': '22.69', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Role Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.47', 'spread': '19.48', 'groupId': 'OG000'}, {'value': '8.02', 'spread': '23.00', 'groupId': 'OG001'}, {'value': '8.41', 'spread': '23.96', 'groupId': 'OG002'}, {'value': '1.75', 'spread': '28.39', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Role Emotional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.79', 'spread': '18.43', 'groupId': 'OG000'}, {'value': '8.49', 'spread': '22.13', 'groupId': 'OG001'}, {'value': '7.93', 'spread': '23.02', 'groupId': 'OG002'}, {'value': '3.71', 'spread': '25.24', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.42', 'spread': '12.91', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '13.29', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '15.44', 'groupId': 'OG002'}, {'value': '3.09', 'spread': '15.88', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Mental Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.59', 'spread': '11.64', 'groupId': 'OG000'}, {'value': '3.74', 'spread': '12.35', 'groupId': 'OG001'}, {'value': '3.52', 'spread': '15.81', 'groupId': 'OG002'}, {'value': '2.89', 'spread': '13.60', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, and 16', 'description': 'The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum), where higher score indicated a better health related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Change at Week 12: MCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.85', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '0.01', 'spread': '1.06', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: MCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.90', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: PCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '0.58', 'spread': '0.81', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: PCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.66', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '0.52', 'spread': '0.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 12, and 16', 'description': 'The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values. Here, 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not estimable due to less than 50% of population with event to meet the threshold for Kaplan-Meier analysis.', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '106.0'}, {'value': 'NA', 'comment': 'Median was not estimable due to less than 50% of population with event to meet the threshold for Kaplan-Meier analysis.', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '85.0'}, {'value': 'NA', 'comment': 'Median was not estimable due to less than 50% of population with event to meet the threshold for Kaplan-Meier analysis.', 'groupId': 'OG002', 'lowerLimit': '8.0', 'upperLimit': '92.0'}, {'value': 'NA', 'comment': 'Median was not estimable due to less than 50% of population with event to meet the threshold for Kaplan-Meier analysis.', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '78.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 16', 'description': 'Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.78', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '80.12', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '84.62', 'spread': '1.37', 'groupId': 'OG002'}, {'value': '72.87', 'spread': '1.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to Week 16', 'description': 'Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}, {'value': '63.3', 'groupId': 'OG001'}, {'value': '68.9', 'groupId': 'OG002'}, {'value': '46.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52.5', 'groupId': 'OG000'}, {'value': '47.1', 'groupId': 'OG001'}, {'value': '45.6', 'groupId': 'OG002'}, {'value': '36.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '38.9', 'groupId': 'OG001'}, {'value': '37.9', 'groupId': 'OG002'}, {'value': '35.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}, {'value': '33.2', 'groupId': 'OG001'}, {'value': '33.5', 'groupId': 'OG002'}, {'value': '33.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000'}, {'value': '33.2', 'groupId': 'OG001'}, {'value': '33.5', 'groupId': 'OG002'}, {'value': '30.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Duration of Rescue Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Amount of Rescue Medication Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3967.98', 'spread': '5614.49', 'groupId': 'OG000'}, {'value': '3661.84', 'spread': '5025.34', 'groupId': 'OG001'}, {'value': '3325.24', 'spread': '4143.00', 'groupId': 'OG002'}, {'value': '2069.71', 'spread': '3851.87', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3392.16', 'spread': '5588.13', 'groupId': 'OG000'}, {'value': '2442.31', 'spread': '4423.97', 'groupId': 'OG001'}, {'value': '2648.06', 'spread': '4653.47', 'groupId': 'OG002'}, {'value': '1713.94', 'spread': '3652.96', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3329.27', 'spread': '5733.90', 'groupId': 'OG000'}, {'value': '2024.04', 'spread': '4124.50', 'groupId': 'OG001'}, {'value': '2274.27', 'spread': '4692.11', 'groupId': 'OG002'}, {'value': '1956.94', 'spread': '4967.74', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3055.83', 'spread': '5712.68', 'groupId': 'OG000'}, {'value': '2012.02', 'spread': '4261.23', 'groupId': 'OG001'}, {'value': '1963.59', 'spread': '4531.99', 'groupId': 'OG002'}, {'value': '1851.67', 'spread': '3918.89', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3155.34', 'spread': '5899.37', 'groupId': 'OG000'}, {'value': '1968.75', 'spread': '4265.10', 'groupId': 'OG001'}, {'value': '2014.56', 'spread': '4631.26', 'groupId': 'OG002'}, {'value': '1827.75', 'spread': '4138.99', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). LOCF method was used to impute missing values. Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '204', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}, {'value': '164', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': 'Laboratory values: hematology (hemoglobin; hematocrit; red blood cell count \\[less than {\\<}0.8\\* lower limit of normal \\[LLN\\], platelets \\<0.5\\* LLN,\\>1.75\\* upper limit of normal (ULN), white blood cell count\\<0.6\\* LLN, \\>1.5\\* ULN, liver function (total bilirubin\\>1.5\\* ULN, aspartate aminotransferase; alanine aminotransferase; gamma-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase\\>3.0\\* ULN, total protein; albumin\\<0.8\\* LLN; \\>1.2\\* ULN), renal function (blood urea nitrogen; creatinine\\>1.3\\* ULN, uric acid\\>1.2\\* ULN), lipids (cholesterol, triglycerides \\>1.3\\*ULN), electrolytes (sodium\\<0.95\\* LLN, \\>1.05\\* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate\\<0.9\\* LLN, \\>1.1\\* ULN), chemistry (glucose \\<0.6\\*LLN, \\>1.5\\*ULN; creatine kinase \\>2.0\\*ULN), urinalysis (specific gravity \\<1.003, \\>1.030; pH\\<4.5, \\>8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase\\>=1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'QRS complex abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T wave abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'T wave inversion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bradycardia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ventricular extrasystoles', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': "All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula \\[QTcF\\], QT interval corrected for heart rate using Bazett's formula \\[QTcB\\], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as treatment related adverse events were presented. Relatedness to treatment was assessed by investigator.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '3.29', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '3.04', 'groupId': 'OG001'}, {'value': '0.92', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '1.14', 'spread': '3.18', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '198', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '1.65', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '1.85', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '1.60', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '194', 'groupId': 'OG002'}, {'value': '188', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '2.13', 'groupId': 'OG002'}, {'value': '-0.18', 'spread': '1.54', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '173', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.66', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '1.65', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '1.78', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-0.32', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '1.78', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '145', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.52', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '1.54', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '1.80', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, 16, and 24', 'description': 'NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 122 (maximum impairment), higher scores indicated increased impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibody (ADA) Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG001', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: Tanezumab 5 mg + Placebo and Tanezumab 10 mg + Placebo. Results with titer value \\>= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here, 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure. This outcome measure was planned not to be analyzed for reporting arms: Placebo and Naproxen + Placebo."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Physical Examinations Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'title': 'Abdomen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '210', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'Ears', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Extremities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Eyes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}, {'title': 'General', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Head', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Heart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Lungs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Musculoskeletal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '88', 'groupId': 'OG003'}]}]}, {'title': 'Neck', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Thyroid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1)', 'description': "Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Criteria for abnormal physical findings were based on investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo). Here, 'number analyzed' signifies those participants who were evaluable for each specified category for each group, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Associated With Vital Sign Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '211', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'OG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'OG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': "Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant vital signs (based on the investigator's judgment) considered as adverse events were reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of randomized IV study drug (either tanezumab or IV placebo).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'FG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'FG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'FG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '213'}, {'groupId': 'FG003', 'numSubjects': '212'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '209'}, {'groupId': 'FG001', 'numSubjects': '211'}, {'groupId': 'FG002', 'numSubjects': '209'}, {'groupId': 'FG003', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '185'}, {'groupId': 'FG002', 'numSubjects': '187'}, {'groupId': 'FG003', 'numSubjects': '191'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized, but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Entered extension study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '113'}, {'groupId': 'FG003', 'numSubjects': '125'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}, {'value': '840', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matched to tanezumab (PF-04383119) intravenous (IV) infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily at Baseline (Day 1), and at Weeks 4, 8 and 12.'}, {'id': 'BG001', 'title': 'Tanezumab 5 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 5 milligram (mg) IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'BG002', 'title': 'Tanezumab 10 mg + Placebo', 'description': 'Participants received tanezumab (PF-04383119) 10 mg IV infusion over 5 minutes at Baseline (Day 1) and Week 8 along with placebo matched to naproxen tablet orally twice daily from Baseline up to Week 12.'}, {'id': 'BG003', 'title': 'Naproxen + Placebo', 'description': 'Participants received naproxen 500 mg tablet orally twice daily at Baseline (Day 1), Weeks 4, 8 and 12 along with placebo matched to tanezumab (PF-04383119) IV infusion at Baseline (Day 1) and Week 8.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 to 44 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': '45 to 64 years', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}, {'value': '526', 'groupId': 'BG004'}]}, {'title': 'Greater than or equal to (>=) 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '267', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}, {'value': '534', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '306', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of randomized IV study medication (either tanezumab or placebo IV).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 849}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2011-05-02', 'completionDateStruct': {'date': '2010-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-20', 'studyFirstSubmitDate': '2009-03-13', 'dispFirstSubmitQcDate': '2011-05-02', 'resultsFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2009-03-16', 'dispFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-20', 'studyFirstPostDateStruct': {'date': '2009-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 16', 'description': "WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function."}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 16', 'description': 'PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, and 12', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, and 12', 'description': "WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function."}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': "WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function."}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, and 12', 'description': 'Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.'}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'Patient global assessment of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition.'}, {'measure': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (\\>=) 50 percent and \\>=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was \\>=20 percent and \\>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \\[no pain\\] to 10 \\[worst possible pain\\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \\[minimum difficulty\\] to 10 \\[maximum difficulty\\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \\[very good\\] to 5 \\[very poor\\], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'Participants were considered as OMERACT-OARSI responder: if the improvement from baseline to week of interest was \\>=50 percent and \\>=2 units in WOMAC pain subscale or WOMAC physical function subscale score; if improvement from baseline to week of interest was \\>=20 percent and \\>=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 \\[no pain\\] to 10 \\[worst possible pain\\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \\[minimum difficulty\\] to 10 \\[maximum difficulty\\], higher score = worse physical function) and PGA of osteoarthritis (score: 1 \\[very good\\] to 5 \\[very poor\\], higher score = worse condition). Percentage of participants who were considered as OMERACT-OARSI responder were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale at specified weeks were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.'}, {'measure': 'Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Improvement signifies a decrease of at least 2 points on the 5-point scale relative to baseline value. Percentage of participants with improvement of at least 2 points in PGA of osteoarthritis were reported.'}, {'measure': 'Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline up to Week 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0 percent \\[%\\]; \\>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.'}, {'measure': 'Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline up to Week 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than 0%; \\>= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.'}, {'measure': 'Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'Participants assessed their average daily pain score in the index hip/knee using a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. A weekly mean was calculated using the daily index hip/knee pain scores within each specified study week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip).The WOMAC stiffness subscale was a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in the index joint (knee or hip) during the past 48 hours. It was calculated as mean of the scores from 2 individual questions scored on NRS of 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness. Total score range for WOMAC stiffness subscale score was 0 (no stiffness) to 10 (worst stiffness), where higher scores indicated higher stiffness.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 \\[no pain\\] to 10 \\[worst possible pain\\], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 \\[minimum difficulty\\] to 10 \\[maximum difficulty\\], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 \\[no stiffness\\] to 10 \\[worst stiffness\\], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no difficulty) to 10 (maximum difficulty), where higher scores indicated worse response.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, and 16', 'description': 'WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.'}, {'measure': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 12, and 16', 'description': 'The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum), where higher score indicated a better health related quality of life.'}, {'measure': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Weeks 12, and 16', 'description': 'The SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each of the 8 domains were scaled from 0 (minimum) to 100 (maximum). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.'}, {'measure': 'Time to Discontinuation Due to Lack of Efficacy', 'timeFrame': 'Baseline up to Week 16', 'description': 'Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Who Used Rescue Medication', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.'}, {'measure': 'Duration of Rescue Medication Use', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.'}, {'measure': 'Amount of Rescue Medication Taken', 'timeFrame': 'Weeks 2, 4, 8, 12, and 16', 'description': 'In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': 'Laboratory values: hematology (hemoglobin; hematocrit; red blood cell count \\[less than {\\<}0.8\\* lower limit of normal \\[LLN\\], platelets \\<0.5\\* LLN,\\>1.75\\* upper limit of normal (ULN), white blood cell count\\<0.6\\* LLN, \\>1.5\\* ULN, liver function (total bilirubin\\>1.5\\* ULN, aspartate aminotransferase; alanine aminotransferase; gamma-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase\\>3.0\\* ULN, total protein; albumin\\<0.8\\* LLN; \\>1.2\\* ULN), renal function (blood urea nitrogen; creatinine\\>1.3\\* ULN, uric acid\\>1.2\\* ULN), lipids (cholesterol, triglycerides \\>1.3\\*ULN), electrolytes (sodium\\<0.95\\* LLN, \\>1.05\\* ULN; potassium; chloride; calcium; magnesium; phosphate; bicarbonate\\<0.9\\* LLN, \\>1.1\\* ULN), chemistry (glucose \\<0.6\\*LLN, \\>1.5\\*ULN; creatine kinase \\>2.0\\*ULN), urinalysis (specific gravity \\<1.003, \\>1.030; pH\\<4.5, \\>8, glucose; protein; blood; ketones; urobilinogen; bilirubin; nitrite, esterase\\>=1).'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram (ECG) Findings', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': "All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula \\[QTcF\\], QT interval corrected for heart rate using Bazett's formula \\[QTcB\\], RR intervals and heart rate) were analyzed. Participants with abnormal ECG findings reported as treatment related adverse events were presented. Relatedness to treatment was assessed by investigator."}, {'measure': 'Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, 16, and 24', 'description': 'NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 122 (maximum impairment), higher scores indicated increased impairment.'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibody (ADA) Level', 'timeFrame': 'Baseline, Weeks 8, 16, and 24', 'description': 'Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: Tanezumab 5 mg + Placebo and Tanezumab 10 mg + Placebo. Results with titer value \\>= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.'}, {'measure': 'Number of Participants With Abnormal Physical Examinations Findings', 'timeFrame': 'Baseline (Day 1)', 'description': "Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others. Criteria for abnormal physical findings were based on investigator's discretion."}, {'measure': 'Number of Participants With Adverse Events Associated With Vital Sign Measurements', 'timeFrame': 'Baseline (Day 1) up to Week 24', 'description': "Vital signs included the assessment of the following: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant vital signs (based on the investigator's judgment) considered as adverse events were reported."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '37460782', 'type': 'DERIVED', 'citation': 'Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.'}, {'pmid': '30936738', 'type': 'DERIVED', 'citation': 'Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019.'}, {'pmid': '25274899', 'type': 'DERIVED', 'citation': 'Ekman EF, Gimbel JS, Bello AE, Smith MD, Keller DS, Annis KM, Brown MT, West CR, Verburg KM. Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen. J Rheumatol. 2014 Nov;41(11):2249-59. doi: 10.3899/jrheum.131294. Epub 2014 Oct 1.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091018&StudyName=Tanezumab%20in%20osteoarthritis%20of%20the%20hip%20or%20knee%20%282%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2\n\nExclusion Criteria:\n\n* pregnancy or intent to become pregnant\n* BMI greater than 39\n* other severe pain, significant cardiac, neurological or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT00863304', 'briefTitle': 'Tanezumab in Osteoarthritis of the Hip or Knee (2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE', 'orgStudyIdInfo': {'id': 'A4091018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Biological: tanezumab 10 mg']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Biological: tanezumab 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: naproxen']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'tanezumab 10 mg', 'type': 'BIOLOGICAL', 'description': 'tanezumab 10 mg one dose at weeks 0 and 8', 'armGroupLabels': ['1']}, {'name': 'tanezumab 5 mg', 'type': 'BIOLOGICAL', 'description': 'tanezumab 5 mg one dose at weeks 0 and 8', 'armGroupLabels': ['2']}, {'name': 'naproxen', 'type': 'DRUG', 'description': 'naproxen 1000 mg daily for 16 weeks', 'armGroupLabels': ['3']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo to match tanezumab and naproxen dosing', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35242', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Greystone Medical Research, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Saadat Ansari, MD', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Clinical Research, Inc.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC', 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'HeartCare', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33166', 'city': 'Doral', 'state': 'Florida', 'country': 'United States', 'facility': 'In Vivo Clinical Research, Inc', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33306', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'S & W Clinical Research', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Centre for Rheumatology, Immunology and Arthritis', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Kendall South Medical Center, Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33054', 'city': 'Opa-locka', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunshine Research Center', 'geoPoint': {'lat': 25.90232, 'lon': -80.25033}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Rheumatology Associates of Central Florida, PA', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'HeartCare Research', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Medical Group PA', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Masters of Clinical Research, Inc.', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30513', 'city': 'Blue Ridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'River Birch Research Alliance, LLC', 'geoPoint': {'lat': 34.86397, 'lon': -84.32409}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Millennium Pain Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rehabilitation Institute of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'MediSphere Medical Research Center, LLC', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Pasadena Pharmacy', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Pain Treatment Center of the Bluegrass', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'L-Marc Research Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Bone and Joint Clinic of Baton Rouge', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Gulf Coast Research, LLC', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '20636', 'city': 'Hollywood', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid-Atlantic Medical Research Centers', 'geoPoint': {'lat': 39.07511, 'lon': -76.5858}}, {'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beacon Clinical Research, LLC', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Miray Medical Center', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United 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