Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00733902
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2008-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tanezumab in Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549319', 'term': 'tanezumab'}]}}, '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': 'Cases of osteonecrosis (ON) reported in this and other studies of this program, conducted up to 2010 were adjudicated post-hoc by an expert committee (2010-2012). Few of these events (2 of 87 reported ON cases), were confirmed as ON by the committee. Source: https://doi.org/10.1002/art.39492.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.', 'otherNumAtRisk': 172, 'otherNumAffected': 50, 'seriousNumAtRisk': 172, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.', 'otherNumAtRisk': 172, 'otherNumAffected': 71, 'seriousNumAtRisk': 172, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.', 'otherNumAtRisk': 172, 'otherNumAffected': 64, 'seriousNumAtRisk': 172, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.', 'otherNumAtRisk': 174, 'otherNumAffected': 87, 'seriousNumAtRisk': 174, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Conjunctival oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Traumatic brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 172, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 172, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], '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': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.05', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '7.19', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '6.99', 'spread': '1.43', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.51', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-3.27', 'spread': '2.78', 'groupId': 'OG001'}, {'value': '-3.39', 'spread': '2.65', 'groupId': 'OG002'}, {'value': '-3.67', 'spread': '2.83', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.73', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'Analysis of Covariance (ANCOVA) was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value 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': '-1.20', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '-0.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), 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 (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'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': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.64', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '6.91', 'spread': '1.49', 'groupId': 'OG002'}, {'value': '6.69', 'spread': '1.62', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.06', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '-2.93', 'spread': '2.67', 'groupId': 'OG001'}, {'value': '-3.14', 'spread': '2.59', 'groupId': 'OG002'}, {'value': '-3.34', 'spread': '2.70', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value 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': '-0.98', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '-0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value 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': '-1.24', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '-0.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set. 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': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.40', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '3.45', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '3.45', 'spread': '0.59', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '-0.91', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '-1.05', 'spread': '1.06', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value 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': '-0.56', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value 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': '-0.51', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.75', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-3.08', 'spread': '2.55', 'groupId': 'OG001'}, {'value': '-2.52', 'spread': '2.39', 'groupId': 'OG002'}, {'value': '-2.68', 'spread': '2.56', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '2.63', 'groupId': 'OG001'}, {'value': '-3.44', 'spread': '2.40', 'groupId': 'OG002'}, {'value': '-3.72', 'spread': '2.58', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.53', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-3.40', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '-3.32', 'spread': '2.38', 'groupId': 'OG002'}, {'value': '-3.84', 'spread': '2.56', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.55', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-3.70', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '-3.51', 'spread': '2.70', 'groupId': 'OG002'}, {'value': '-3.80', 'spread': '2.69', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-2.39', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-3.10', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '-2.99', 'spread': '2.64', 'groupId': 'OG002'}, {'value': '-3.55', 'spread': '2.91', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.326', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.275', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.918', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.93', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '-0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.68', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value 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': '-1.03', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '-0.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '-0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '-0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value 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': 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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 Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or 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assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set. 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) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.94', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '6.98', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '7.05', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '6.89', 'spread': '2.04', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.09', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '2.79', 'groupId': 'OG001'}, {'value': '-2.50', 'spread': '2.60', 'groupId': 'OG002'}, {'value': '-2.70', 'spread': '2.82', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.12', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '2.79', 'groupId': 'OG001'}, {'value': '-3.28', 'spread': '2.62', 'groupId': 'OG002'}, {'value': '-3.54', 'spread': '2.75', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.98', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '-3.06', 'spread': '2.55', 'groupId': 'OG002'}, {'value': '-3.70', 'spread': '2.75', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.10', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-3.44', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '-3.38', 'spread': '2.82', 'groupId': 'OG002'}, {'value': '-3.75', 'spread': '2.92', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.06', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '-3.20', 'spread': '2.72', 'groupId': 'OG002'}, {'value': '-3.50', 'spread': '2.92', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-2.02', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '-2.86', 'spread': '2.87', 'groupId': 'OG001'}, {'value': '-2.68', 'spread': '2.70', 'groupId': 'OG002'}, {'value': '-3.44', 'spread': '3.03', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.94', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '6.98', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '7.05', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '6.89', 'spread': '2.04', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.09', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '2.79', 'groupId': 'OG001'}, {'value': '-2.50', 'spread': '2.60', 'groupId': 'OG002'}, {'value': '-2.70', 'spread': '2.82', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.31', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-3.44', 'spread': '2.71', 'groupId': 'OG001'}, {'value': '-3.32', 'spread': '2.61', 'groupId': 'OG002'}, {'value': '-3.66', 'spread': '2.79', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.11', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '-2.96', 'spread': '2.80', 'groupId': 'OG001'}, {'value': '-3.22', 'spread': '2.47', 'groupId': 'OG002'}, {'value': '-3.83', 'spread': '2.72', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.42', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-3.59', 'spread': '2.82', 'groupId': 'OG001'}, {'value': '-3.62', 'spread': '2.72', 'groupId': 'OG002'}, {'value': '-4.04', 'spread': '2.79', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.40', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '2.86', 'groupId': 'OG001'}, {'value': '-3.36', 'spread': '2.67', 'groupId': 'OG002'}, {'value': '-3.99', 'spread': '2.75', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-2.45', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '-3.07', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-3.07', 'spread': '2.71', 'groupId': 'OG002'}, {'value': '-3.94', 'spread': '2.88', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-1.04', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '-1.04', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '-1.16', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '-1.16', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '-0.94', 'spread': '0.89', 'groupId': 'OG002'}, {'value': '-1.17', 'spread': '1.03', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-0.53', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.70', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '-0.93', 'spread': '1.11', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.486', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.24', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.63', 'ciUpperLimit': '-0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.46', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '-0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.57', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.35', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.36', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.67', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.63', 'ciUpperLimit': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.38', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '-0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.61', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.125', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.38', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.40', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '3.47', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '3.45', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '3.45', 'spread': '0.59', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '-0.82', 'spread': '0.99', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '-1.05', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '-1.18', 'spread': '1.00', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-0.86', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.90', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '-1.21', 'spread': '0.98', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '0.97', 'groupId': 'OG001'}, {'value': '-0.99', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '-1.28', 'spread': '1.03', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '-0.97', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '-1.19', 'spread': '1.05', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.82', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '-0.82', 'spread': '1.00', 'groupId': 'OG002'}, {'value': '-1.13', 'spread': '1.12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.486', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.24', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '-0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 2: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.46', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '-0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.44', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '-0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.57', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 4: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.35', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.40', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '-0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.71', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 8: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.59', 'ciUpperLimit': '-0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.55', 'ciUpperLimit': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.65', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '-0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'Change at Week 12: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.36', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.58', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 16: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value 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': '-0.50', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'groupDescription': 'Change at Week 24: ANCOVA was performed with treatment as main effects, baseline value as a covariate, and study site as a random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}, {'value': '60.9', 'groupId': 'OG002'}, {'value': '68.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '70.8', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '77.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '72.1', 'groupId': 'OG001'}, {'value': '73.7', 'groupId': 'OG002'}, {'value': '78.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000'}, {'value': '74.7', 'groupId': 'OG001'}, {'value': '74.4', 'groupId': 'OG002'}, {'value': '77.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}, {'value': '69.9', 'groupId': 'OG002'}, {'value': '70.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}, {'value': '62.3', 'groupId': 'OG001'}, {'value': '64.1', 'groupId': 'OG002'}, {'value': '69.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', 'description': 'OMERACT-OARSI response: greater than or equal to (\\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \\>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \\>=20% improvement from baseline and absolute change from baseline of \\>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}, {'value': '60.9', 'groupId': 'OG002'}, {'value': '68.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}, {'value': '76.3', 'groupId': 'OG002'}, {'value': '80.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '73.4', 'groupId': 'OG001'}, {'value': '77.6', 'groupId': 'OG002'}, {'value': '83.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '64.9', 'groupId': 'OG000'}, {'value': '80.5', 'groupId': 'OG001'}, {'value': '81.4', 'groupId': 'OG002'}, {'value': '85.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000'}, {'value': '72.7', 'groupId': 'OG001'}, {'value': '75.6', 'groupId': 'OG002'}, {'value': '82.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000'}, {'value': '70.8', 'groupId': 'OG001'}, {'value': '75.0', 'groupId': 'OG002'}, {'value': '82.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', 'description': 'OMERACT-OARSI response: \\>= 50% improvement from baseline and absolute change from baseline of \\>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \\>=20% improvement from baseline and absolute change from baseline of \\>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2: >=30% reduction', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}, {'value': '60.4', 'groupId': 'OG001'}, {'value': '50.6', 'groupId': 'OG002'}, {'value': '55.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: >=50% reduction', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '32.1', 'groupId': 'OG002'}, {'value': '41.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=30% reduction', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '66.2', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '72.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=50% reduction', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '56.5', 'groupId': 'OG001'}, {'value': '50.6', 'groupId': 'OG002'}, {'value': '57.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=30% reduction', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '65.6', 'groupId': 'OG001'}, {'value': '67.9', 'groupId': 'OG002'}, {'value': '74.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=50% reduction', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '48.7', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '63.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=30% reduction', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}, {'value': '67.5', 'groupId': 'OG001'}, {'value': '66.0', 'groupId': 'OG002'}, {'value': '73.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=50% reduction', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}, {'value': '57.1', 'groupId': 'OG001'}, {'value': '56.4', 'groupId': 'OG002'}, {'value': '57.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 16: >=30% reduction', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}, {'value': '65.4', 'groupId': 'OG002'}, {'value': '68.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 16: >=50% reduction', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '61.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: >=30% reduction', 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}, {'value': '59.7', 'groupId': 'OG001'}, {'value': '59.6', 'groupId': 'OG002'}, {'value': '66.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: >=50% reduction', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '47.4', 'groupId': 'OG001'}, {'value': '44.9', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2: >=30% reduction', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}, {'value': '60.4', 'groupId': 'OG001'}, {'value': '50.6', 'groupId': 'OG002'}, {'value': '55.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 2: >=50% reduction', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '32.1', 'groupId': 'OG002'}, {'value': '41.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=30% reduction', 'categories': [{'measurements': [{'value': '60.4', 'groupId': 'OG000'}, {'value': '69.5', 'groupId': 'OG001'}, {'value': '67.3', 'groupId': 'OG002'}, {'value': '74.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 4: >=50% reduction', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}, {'value': '57.8', 'groupId': 'OG001'}, {'value': '50.6', 'groupId': 'OG002'}, {'value': '59.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=30% reduction', 'categories': [{'measurements': [{'value': '53.9', 'groupId': 'OG000'}, {'value': '66.9', 'groupId': 'OG001'}, {'value': '71.2', 'groupId': 'OG002'}, {'value': '77.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 8: >=50% reduction', 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000'}, {'value': '49.4', 'groupId': 'OG001'}, {'value': '51.3', 'groupId': 'OG002'}, {'value': '65.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=30% reduction', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000'}, {'value': '73.4', 'groupId': 'OG001'}, {'value': '72.4', 'groupId': 'OG002'}, {'value': '79.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 12: >=50% reduction', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '60.4', 'groupId': 'OG001'}, {'value': '58.3', 'groupId': 'OG002'}, {'value': '61.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 16: >=30% reduction', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}, {'value': '68.8', 'groupId': 'OG001'}, {'value': '70.5', 'groupId': 'OG002'}, {'value': '78.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 16: >=50% reduction', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}, {'value': '53.2', 'groupId': 'OG001'}, {'value': '51.3', 'groupId': 'OG002'}, {'value': '68.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: >=30% reduction', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '66.2', 'groupId': 'OG001'}, {'value': '68.6', 'groupId': 'OG002'}, {'value': '78.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 24: >=50% reduction', 'categories': [{'measurements': [{'value': '44.8', 'groupId': 'OG000'}, {'value': '51.9', 'groupId': 'OG001'}, {'value': '49.4', 'groupId': 'OG002'}, {'value': '64.9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '14.7', 'groupId': 'OG002'}, {'value': '21.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '31.8', 'groupId': 'OG001'}, {'value': '24.4', 'groupId': 'OG002'}, {'value': '37.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}, {'value': '19.9', 'groupId': 'OG002'}, {'value': '33.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}, {'value': '24.4', 'groupId': 'OG002'}, {'value': '39.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}, {'value': '23.7', 'groupId': 'OG002'}, {'value': '30.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}, {'value': '18.6', 'groupId': 'OG002'}, {'value': '32.5', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}, {'value': '14.7', 'groupId': 'OG002'}, {'value': '21.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}, {'value': '24.4', 'groupId': 'OG002'}, {'value': '38.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}, {'value': '21.2', 'groupId': 'OG002'}, {'value': '35.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '42.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '25.3', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}, {'value': '35.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '21.4', 'groupId': 'OG001'}, {'value': '21.8', 'groupId': 'OG002'}, {'value': '39.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Greater than (>) 0%', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000'}, {'value': '79.2', 'groupId': 'OG001'}, {'value': '79.5', 'groupId': 'OG002'}, {'value': '76.0', 'groupId': 'OG003'}]}]}, {'title': '>=10%', 'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000'}, {'value': '75.3', 'groupId': 'OG001'}, {'value': '78.2', 'groupId': 'OG002'}, {'value': '74.7', 'groupId': 'OG003'}]}]}, {'title': '>=20%', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}, {'value': '70.8', 'groupId': 'OG001'}, {'value': '69.9', 'groupId': 'OG002'}, {'value': '70.1', 'groupId': 'OG003'}]}]}, {'title': '>=30%', 'categories': [{'measurements': [{'value': '51.3', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}, {'value': '65.4', 'groupId': 'OG002'}, {'value': '68.2', 'groupId': 'OG003'}]}]}, {'title': '>=40%', 'categories': [{'measurements': [{'value': '48.7', 'groupId': 'OG000'}, {'value': '58.4', 'groupId': 'OG001'}, {'value': '57.7', 'groupId': 'OG002'}, {'value': '67.5', 'groupId': 'OG003'}]}]}, {'title': '>=50%', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000'}, {'value': '50.6', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '61.7', 'groupId': 'OG003'}]}]}, {'title': '>=60%', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}, {'value': '55.8', 'groupId': 'OG003'}]}]}, {'title': '>=70%', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}, {'value': '39.1', 'groupId': 'OG002'}, {'value': '44.2', 'groupId': 'OG003'}]}]}, {'title': '>=80%', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '27.6', 'groupId': 'OG002'}, {'value': '31.8', 'groupId': 'OG003'}]}]}, {'title': '>=90%', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}, {'value': '12.8', 'groupId': 'OG002'}, {'value': '24.0', 'groupId': 'OG003'}]}]}, {'title': '=100%', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '7.1', '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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Cumulative Reduction From Baseline to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': '>0%', 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000'}, {'value': '87.7', 'groupId': 'OG001'}, {'value': '92.9', 'groupId': 'OG002'}, {'value': '92.9', 'groupId': 'OG003'}]}]}, {'title': '>=10%', 'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000'}, {'value': '83.1', 'groupId': 'OG001'}, {'value': '87.2', 'groupId': 'OG002'}, {'value': '90.9', 'groupId': 'OG003'}]}]}, {'title': '>=20%', 'categories': [{'measurements': [{'value': '66.2', 'groupId': 'OG000'}, {'value': '76.6', 'groupId': 'OG001'}, {'value': '75.6', 'groupId': 'OG002'}, {'value': '83.1', 'groupId': 'OG003'}]}]}, {'title': '>=30%', 'categories': [{'measurements': [{'value': '61.7', 'groupId': 'OG000'}, {'value': '68.8', 'groupId': 'OG001'}, {'value': '70.5', 'groupId': 'OG002'}, {'value': '78.6', 'groupId': 'OG003'}]}]}, {'title': '>=40%', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '62.3', 'groupId': 'OG001'}, {'value': '60.3', 'groupId': 'OG002'}, {'value': '75.3', 'groupId': 'OG003'}]}]}, {'title': '>=50%', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}, {'value': '53.2', 'groupId': 'OG001'}, {'value': '51.3', 'groupId': 'OG002'}, {'value': '68.2', 'groupId': 'OG003'}]}]}, {'title': '>=60%', 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000'}, {'value': '40.9', 'groupId': 'OG001'}, {'value': '46.2', 'groupId': 'OG002'}, {'value': '62.3', 'groupId': 'OG003'}]}]}, {'title': '>=70%', 'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000'}, {'value': '33.8', 'groupId': 'OG001'}, {'value': '39.7', 'groupId': 'OG002'}, {'value': '47.4', 'groupId': 'OG003'}]}]}, {'title': '>=80%', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}, {'value': '28.2', 'groupId': 'OG002'}, {'value': '34.4', 'groupId': 'OG003'}]}]}, {'title': '>=90%', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}, {'value': '13.5', 'groupId': 'OG002'}, {'value': '25.3', 'groupId': 'OG003'}]}]}, {'title': '=100%', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}, {'value': '5.8', 'groupId': 'OG002'}, {'value': '8.4', '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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.38', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '6.70', 'spread': '1.83', 'groupId': 'OG001'}, {'value': '6.74', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '6.55', 'spread': '1.91', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 1', 'categories': [{'measurements': [{'value': '-1.21', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '2.04', 'groupId': 'OG001'}, {'value': '-1.83', 'spread': '1.84', 'groupId': 'OG002'}, {'value': '-2.09', 'spread': '2.03', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.68', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '-1.83', 'spread': '2.02', 'groupId': 'OG002'}, {'value': '-2.15', 'spread': '2.31', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 3', 'categories': [{'measurements': [{'value': '-1.73', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '2.52', 'groupId': 'OG001'}, {'value': '-1.90', 'spread': '2.06', 'groupId': 'OG002'}, {'value': '-2.17', 'spread': '2.47', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.81', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-2.73', 'spread': '2.49', 'groupId': 'OG001'}, {'value': '-2.47', 'spread': '2.14', 'groupId': 'OG002'}, {'value': '-2.99', 'spread': '2.52', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-1.83', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '2.66', 'groupId': 'OG001'}, {'value': '-2.50', 'spread': '2.20', 'groupId': 'OG002'}, {'value': '-3.07', 'spread': '2.59', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-2.45', 'spread': '2.61', 'groupId': 'OG001'}, {'value': '-2.47', 'spread': '2.18', 'groupId': 'OG002'}, {'value': '-3.10', 'spread': '2.63', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-1.84', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-2.80', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-2.65', 'spread': '2.40', 'groupId': 'OG002'}, {'value': '-3.33', 'spread': '2.82', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.82', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '2.76', 'groupId': 'OG001'}, {'value': '-2.78', 'spread': '2.52', 'groupId': 'OG002'}, {'value': '-3.27', 'spread': '2.72', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-1.73', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '-2.28', 'spread': '2.69', 'groupId': 'OG001'}, {'value': '-2.58', 'spread': '2.47', 'groupId': 'OG002'}, {'value': '-3.15', 'spread': '2.76', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 20', 'categories': [{'measurements': [{'value': '-1.80', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-2.80', 'spread': '2.88', 'groupId': 'OG001'}, {'value': '-2.81', 'spread': '2.54', 'groupId': 'OG002'}, {'value': '-3.27', 'spread': '2.83', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-1.63', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-2.44', 'spread': '2.78', 'groupId': 'OG001'}, {'value': '-2.29', 'spread': '2.48', 'groupId': 'OG002'}, {'value': '-2.98', 'spread': '2.93', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24', 'description': 'Participants assessed daily average knee pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Baseline score was calculated as the mean of the scores over the 3 days and a weekly mean was calculated using the daily pain scores within each study week. The change from Baseline was calculated using difference between each post-baseline weekly mean and the Baseline mean score.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set. 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 Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.88', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '7.05', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '6.86', 'spread': '1.52', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-2.34', 'spread': '2.31', 'groupId': 'OG000'}, {'value': '-2.95', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '-2.46', 'spread': '2.29', 'groupId': 'OG002'}, {'value': '-2.67', 'spread': '2.49', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-2.32', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-3.42', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '-3.29', 'spread': '2.35', 'groupId': 'OG002'}, {'value': '-3.55', 'spread': '2.50', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.17', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-3.09', 'spread': '2.53', 'groupId': 'OG001'}, {'value': '-3.13', 'spread': '2.31', 'groupId': 'OG002'}, {'value': '-3.68', 'spread': '2.52', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-2.26', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '-3.51', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '-3.38', 'spread': '2.62', 'groupId': 'OG002'}, {'value': '-3.70', 'spread': '2.64', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-2.21', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-3.05', 'spread': '2.67', 'groupId': 'OG001'}, {'value': '-3.25', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '-3.51', 'spread': '2.71', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-2.91', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '-2.81', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '-3.43', 'spread': '2.82', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline: Q1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.90', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '7.18', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '7.28', 'spread': '1.59', 'groupId': 'OG002'}, {'value': '6.96', 'spread': '1.71', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.10', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '8.21', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '8.21', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '8.18', 'spread': '1.44', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2: Q1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '2.87', 'groupId': 'OG001'}, {'value': '-2.58', 'spread': '2.56', 'groupId': 'OG002'}, {'value': '-2.95', 'spread': '2.73', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 2: Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.49', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-3.08', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '-2.59', 'spread': '2.48', 'groupId': 'OG002'}, {'value': '-2.99', 'spread': '2.66', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Q1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.55', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-3.78', 'spread': '2.90', 'groupId': 'OG001'}, {'value': '-3.49', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '-3.89', 'spread': '2.66', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4: Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.54', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-3.67', 'spread': '2.96', 'groupId': 'OG001'}, {'value': '-3.43', 'spread': '2.60', 'groupId': 'OG002'}, {'value': '-3.94', 'spread': '2.80', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8: Q1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.41', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-3.40', 'spread': '2.95', 'groupId': 'OG001'}, {'value': '-3.30', 'spread': '2.45', 'groupId': 'OG002'}, {'value': '-3.86', 'spread': '2.73', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8: Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.34', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '-3.28', 'spread': '2.91', 'groupId': 'OG001'}, {'value': '-3.26', 'spread': '2.52', 'groupId': 'OG002'}, {'value': '-3.95', 'spread': '2.87', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Q1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.38', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '-3.73', 'spread': '2.98', 'groupId': 'OG001'}, {'value': '-3.51', 'spread': '2.82', 'groupId': 'OG002'}, {'value': '-3.75', 'spread': '2.80', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.42', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '-3.77', 'spread': '3.08', 'groupId': 'OG001'}, {'value': '-3.48', 'spread': '3.00', 'groupId': 'OG002'}, {'value': '-3.95', 'spread': '3.04', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Q1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '2.73', 'groupId': 'OG000'}, {'value': '-3.26', 'spread': '3.00', 'groupId': 'OG001'}, {'value': '-3.42', 'spread': '2.84', 'groupId': 'OG002'}, {'value': '-3.64', 'spread': '2.99', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 16: Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.28', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '-3.23', 'spread': '3.00', 'groupId': 'OG001'}, {'value': '-3.37', 'spread': '2.86', 'groupId': 'OG002'}, {'value': '-3.79', 'spread': '3.02', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Q1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.27', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '-3.10', 'spread': '3.08', 'groupId': 'OG001'}, {'value': '-3.03', 'spread': '2.80', 'groupId': 'OG002'}, {'value': '-3.56', 'spread': '3.13', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '155', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '-3.10', 'spread': '3.09', 'groupId': 'OG001'}, {'value': '-2.97', 'spread': '2.89', 'groupId': 'OG002'}, {'value': '-3.75', 'spread': '3.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered, Question (Q)1: "How much pain have you had when walking on a flat surface?" and Q2: "How much pain have you had when going up or down the stairs?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies participants evaluated at specific time points for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline: General health', 'categories': [{'measurements': [{'value': '67.16', 'spread': '18.72', 'groupId': 'OG000'}, {'value': '65.39', 'spread': '17.74', 'groupId': 'OG001'}, {'value': '65.99', 'spread': '17.82', 'groupId': 'OG002'}, {'value': '69.38', 'spread': '17.47', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Physical Function', 'categories': [{'measurements': [{'value': '32.64', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '30.52', 'spread': '20.07', 'groupId': 'OG001'}, {'value': '30.46', 'spread': '19.11', 'groupId': 'OG002'}, {'value': '33.42', 'spread': '20.90', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Role Physical', 'categories': [{'measurements': [{'value': '45.74', 'spread': '25.76', 'groupId': 'OG000'}, {'value': '42.25', 'spread': '24.41', 'groupId': 'OG001'}, {'value': '43.51', 'spread': '24.39', 'groupId': 'OG002'}, {'value': '45.33', 'spread': '27.98', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Bodily Pain', 'categories': [{'measurements': [{'value': '34.48', 'spread': '15.60', 'groupId': 'OG000'}, {'value': '33.84', 'spread': '17.50', 'groupId': 'OG001'}, {'value': '33.50', 'spread': '16.28', 'groupId': 'OG002'}, {'value': '34.20', 'spread': '16.06', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Vitality', 'categories': [{'measurements': [{'value': '51.42', 'spread': '19.22', 'groupId': 'OG000'}, {'value': '54.26', 'spread': '18.62', 'groupId': 'OG001'}, {'value': '55.25', 'spread': '18.27', 'groupId': 'OG002'}, {'value': '53.45', 'spread': '21.43', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Social Function', 'categories': [{'measurements': [{'value': '69.48', 'spread': '25.53', 'groupId': 'OG000'}, {'value': '68.91', 'spread': '27.28', 'groupId': 'OG001'}, {'value': '70.03', 'spread': '25.59', 'groupId': 'OG002'}, {'value': '72.65', 'spread': '24.58', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Role Emotional', 'categories': [{'measurements': [{'value': '73.43', 'spread': '27.13', 'groupId': 'OG000'}, {'value': '67.48', 'spread': '29.88', 'groupId': 'OG001'}, {'value': '71.85', 'spread': '28.29', 'groupId': 'OG002'}, {'value': '71.37', 'spread': '30.19', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Mental Health', 'categories': [{'measurements': [{'value': '74.35', 'spread': '16.18', 'groupId': 'OG000'}, {'value': '75.49', 'spread': '18.23', 'groupId': 'OG001'}, {'value': '76.44', 'spread': '16.86', 'groupId': 'OG002'}, {'value': '76.36', 'spread': '17.42', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: General health', 'categories': [{'measurements': [{'value': '3.28', 'spread': '12.12', 'groupId': 'OG000'}, {'value': '3.62', 'spread': '11.81', 'groupId': 'OG001'}, {'value': '5.81', 'spread': '14.17', 'groupId': 'OG002'}, {'value': '5.11', 'spread': '13.44', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Physical Function', 'categories': [{'measurements': [{'value': '8.26', 'spread': '18.75', 'groupId': 'OG000'}, {'value': '19.99', 'spread': '22.43', 'groupId': 'OG001'}, {'value': '18.12', 'spread': '22.72', 'groupId': 'OG002'}, {'value': '19.34', 'spread': '22.36', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Role Physical', 'categories': [{'measurements': [{'value': '8.97', 'spread': '24.21', 'groupId': 'OG000'}, {'value': '19.85', 'spread': '27.50', 'groupId': 'OG001'}, {'value': '19.51', 'spread': '25.54', 'groupId': 'OG002'}, {'value': '18.06', 'spread': '25.56', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Bodily Pain', 'categories': [{'measurements': [{'value': '11.83', 'spread': '19.60', 'groupId': 'OG000'}, {'value': '22.46', 'spread': '25.53', 'groupId': 'OG001'}, {'value': '21.19', 'spread': '23.77', 'groupId': 'OG002'}, {'value': '24.36', 'spread': '24.62', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Vitality', 'categories': [{'measurements': [{'value': '4.34', 'spread': '14.62', 'groupId': 'OG000'}, {'value': '6.94', 'spread': '16.16', 'groupId': 'OG001'}, {'value': '6.69', 'spread': '18.58', 'groupId': 'OG002'}, {'value': '9.28', 'spread': '17.04', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Social Function', 'categories': [{'measurements': [{'value': '6.25', 'spread': '22.20', 'groupId': 'OG000'}, {'value': '10.96', 'spread': '25.70', 'groupId': 'OG001'}, {'value': '11.46', 'spread': '21.15', 'groupId': 'OG002'}, {'value': '7.47', 'spread': '22.44', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Role Emotional', 'categories': [{'measurements': [{'value': '5.30', 'spread': '21.28', 'groupId': 'OG000'}, {'value': '10.71', 'spread': '26.47', 'groupId': 'OG001'}, {'value': '8.81', 'spread': '23.95', 'groupId': 'OG002'}, {'value': '10.50', 'spread': '28.26', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Mental Health', 'categories': [{'measurements': [{'value': '3.80', 'spread': '13.59', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '14.08', 'groupId': 'OG001'}, {'value': '4.17', 'spread': '15.91', 'groupId': 'OG002'}, {'value': '3.77', 'spread': '14.02', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: General health', 'categories': [{'measurements': [{'value': '3.38', 'spread': '11.81', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '11.87', 'groupId': 'OG001'}, {'value': '3.31', 'spread': '13.10', 'groupId': 'OG002'}, {'value': '2.94', 'spread': '10.20', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Physical Function', 'categories': [{'measurements': [{'value': '8.75', 'spread': '19.53', 'groupId': 'OG000'}, {'value': '15.25', 'spread': '20.98', 'groupId': 'OG001'}, {'value': '13.54', 'spread': '23.00', 'groupId': 'OG002'}, {'value': '17.97', 'spread': '23.32', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Role Physical', 'categories': [{'measurements': [{'value': '7.75', 'spread': '22.97', 'groupId': 'OG000'}, {'value': '14.12', 'spread': '26.73', 'groupId': 'OG001'}, {'value': '12.82', 'spread': '23.51', 'groupId': 'OG002'}, {'value': '17.21', 'spread': '25.35', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Bodily Pain', 'categories': [{'measurements': [{'value': '11.68', 'spread': '21.15', 'groupId': 'OG000'}, {'value': '15.34', 'spread': '24.39', 'groupId': 'OG001'}, {'value': '14.23', 'spread': '22.96', 'groupId': 'OG002'}, {'value': '19.02', 'spread': '24.36', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Vitality', 'categories': [{'measurements': [{'value': '3.21', 'spread': '14.40', 'groupId': 'OG000'}, {'value': '4.79', 'spread': '15.75', 'groupId': 'OG001'}, {'value': '3.17', 'spread': '14.80', 'groupId': 'OG002'}, {'value': '5.68', 'spread': '14.56', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Social Function', 'categories': [{'measurements': [{'value': '4.95', 'spread': '22.62', 'groupId': 'OG000'}, {'value': '6.98', 'spread': '25.53', 'groupId': 'OG001'}, {'value': '7.69', 'spread': '21.65', 'groupId': 'OG002'}, {'value': '7.87', 'spread': '18.02', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Role Emotional', 'categories': [{'measurements': [{'value': '4.44', 'spread': '20.08', 'groupId': 'OG000'}, {'value': '7.58', 'spread': '23.56', 'groupId': 'OG001'}, {'value': '6.41', 'spread': '22.18', 'groupId': 'OG002'}, {'value': '10.44', 'spread': '25.25', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Mental Health', 'categories': [{'measurements': [{'value': '2.21', 'spread': '12.30', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '14.39', 'groupId': 'OG001'}, {'value': '2.31', 'spread': '13.24', 'groupId': 'OG002'}, {'value': '2.11', 'spread': '13.88', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Baseline: Mental Component Aggregate', 'categories': [{'measurements': [{'value': '0.23', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '0.30', 'spread': '1.11', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Physical Component Aggregate', 'categories': [{'measurements': [{'value': '-1.79', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '-1.86', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-1.89', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-1.76', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Mental Component Aggregate', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '0.14', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '0.11', 'spread': '0.90', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 12: Physical Component Aggregate', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '0.83', 'spread': '0.85', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Mental Component Aggregate', 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.80', 'groupId': 'OG002'}, {'value': '0.09', 'spread': '0.83', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 24: Physical Component Aggregate', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.89', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '0.72', 'spread': '0.90', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24', 'description': "SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition. For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States \\[US\\] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score \\[better functioning\\])/lower (in case of negative z-score \\[worse functioning\\]) participant's value was relative to the mean of the reference population.", 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. BOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '172', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and full range cannot be estimated due to less number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and full range cannot be estimated due to less number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and full range cannot be estimated due to less number of participants with events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and full range cannot be estimated due to less number of participants with events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], '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': 'Intent-to-treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Rescue Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '154', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}, {'value': '63.0', 'groupId': 'OG001'}, {'value': '65.4', 'groupId': 'OG002'}, {'value': '66.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '55.2', 'groupId': 'OG000'}, {'value': '40.3', 'groupId': 'OG001'}, {'value': '36.5', 'groupId': 'OG002'}, {'value': '40.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}, {'value': '39.1', 'groupId': 'OG002'}, {'value': '39.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}, {'value': '34.0', 'groupId': 'OG002'}, {'value': '32.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '40.9', 'groupId': 'OG001'}, {'value': '32.7', 'groupId': 'OG002'}, {'value': '31.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '35.7', 'groupId': 'OG001'}, {'value': '28.8', 'groupId': 'OG002'}, {'value': '26.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', '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.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo), except for those who were potentially unblinded and from site 1006. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Duration of Rescue Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', '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.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set. 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': 'Amount of Rescue Medication Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '3493.51', 'spread': '4969.51', 'groupId': 'OG000'}, {'value': '2818.18', 'spread': '4063.15', 'groupId': 'OG001'}, {'value': '3419.87', 'spread': '4759.20', 'groupId': 'OG002'}, {'value': '2993.46', 'spread': '4226.71', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2691.56', 'spread': '4484.61', 'groupId': 'OG000'}, {'value': '1925.32', 'spread': '3943.13', 'groupId': 'OG001'}, {'value': '1891.03', 'spread': '4038.24', 'groupId': 'OG002'}, {'value': '2065.36', 'spread': '4510.11', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2383.12', 'spread': '4292.72', 'groupId': 'OG000'}, {'value': '2133.12', 'spread': '4199.69', 'groupId': 'OG001'}, {'value': '1753.21', 'spread': '4109.59', 'groupId': 'OG002'}, {'value': '1934.64', 'spread': '4568.45', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1941.56', 'spread': '4184.45', 'groupId': 'OG000'}, {'value': '1788.96', 'spread': '4455.58', 'groupId': 'OG001'}, {'value': '1567.31', 'spread': '4359.67', 'groupId': 'OG002'}, {'value': '1977.12', 'spread': '6122.20', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '2058.44', 'spread': '4440.22', 'groupId': 'OG000'}, {'value': '2207.79', 'spread': '4696.58', 'groupId': 'OG001'}, {'value': '1820.51', 'spread': '4615.52', 'groupId': 'OG002'}, {'value': '1663.40', 'spread': '4367.50', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '1704.55', 'spread': '4183.54', 'groupId': 'OG000'}, {'value': '1879.87', 'spread': '4351.79', 'groupId': 'OG001'}, {'value': '1836.54', 'spread': '4768.57', 'groupId': 'OG002'}, {'value': '1588.24', 'spread': '4443.03', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', '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.', 'unitOfMeasure': 'mg/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set. LOCF method was used to impute missing values. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'FG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'FG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'FG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '174'}, {'groupId': 'FG003', 'numSubjects': '175'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '172'}, {'groupId': 'FG002', 'numSubjects': '172'}, {'groupId': 'FG003', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '161'}, {'groupId': 'FG003', 'numSubjects': '164'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'Entered extension study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '124'}, {'groupId': 'FG002', 'numSubjects': '111'}, {'groupId': 'FG003', 'numSubjects': '109'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants who discontinued due to lack of efficacy or completed the treatment in this study were eligible to enroll in safety extension study A4091016 (NCT00809783).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}, {'value': '690', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'BG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 milligram (mg) intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'BG002', 'title': 'Tanezumab 5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 5 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'BG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg intravenous infusion over 5 minutes at Day 1, Week 8 and Week 16.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '10.5', 'groupId': 'BG003'}, {'value': '61.6', 'spread': '10.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '420', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '270', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of intravenous study medication (either tanezumab or matching placebo).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 697}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2010-12-21', 'completionDateStruct': {'date': '2010-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2008-08-11', 'dispFirstSubmitQcDate': '2011-01-04', 'resultsFirstSubmitDate': '2021-02-24', 'studyFirstSubmitQcDate': '2008-08-12', 'dispFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-24', 'studyFirstPostDateStruct': {'date': '2008-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-08-24', '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 (Day 1), 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 (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate 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 OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living."}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 16', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 24', 'description': "WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living"}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': "WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living"}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee.'}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.'}, {'measure': 'Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.'}, {'measure': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', 'description': 'OMERACT-OARSI response: greater than or equal to (\\>=) 50 percent (%) improvement from baseline and absolute change from baseline of \\>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \\>=20% improvement from baseline and absolute change from baseline of \\>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).'}, {'measure': 'Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', 'description': 'OMERACT-OARSI response: \\>= 50% improvement from baseline and absolute change from baseline of \\>=2 units at Week of interest in WOMAC pain or physical function subscale, or at least 2 of the following 3 being true: \\>=20% improvement from baseline and absolute change from baseline of \\>=1 unit at Week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis (score: 1-5, higher score=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0-10, higher score=higher pain/difficulty).'}, {'measure': 'Percentage of Participants With at Least 30% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.'}, {'measure': 'Percentage of Participants With at Least 30 Percent (%) and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.'}, {'measure': 'Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.'}, {'measure': 'Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today". Participants responded on a scale ranging from 1-5, where 1= very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.'}, {'measure': 'Percentage of Participants With Cumulative Reduction From Baseline 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.'}, {'measure': 'Percentage of Participants With Cumulative Reduction From Baseline 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 OA. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline up to Week 16 are reported.'}, {'measure': 'Change From Baseline in Average Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24', 'description': 'Participants assessed daily average knee pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Baseline score was calculated as the mean of the scores over the 3 days and a weekly mean was calculated using the daily pain scores within each study week. The change from Baseline was calculated using 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) Average Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher score indicates worse response.'}, {'measure': 'Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 2, 4, 8, 12, 16, 24', 'description': 'Participants answered, Question (Q)1: "How much pain have you had when walking on a flat surface?" and Q2: "How much pain have you had when going up or down the stairs?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain.'}, {'measure': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 12, 24', 'description': 'SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition.'}, {'measure': 'Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12, 24: Baseline Observation Carried Forward (BOCF)', 'timeFrame': 'Baseline, Week 12, 24', 'description': "SF-36v2: standardized survey evaluating 8 domains of functional health and wellbeing (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health). Total score for each domain were scaled 0 (poor health) to 100 (best health), higher scores indicating good health condition. For obtaining physical and mental component scores, z-score for each scale = (observed score - mean score for general 1990 United States \\[US\\] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score \\[better functioning\\])/lower (in case of negative z-score \\[worse functioning\\]) participant's value was relative to the mean of the reference population."}, {'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 Medications', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', '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.'}, {'measure': 'Duration of Rescue Medication Use', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', '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.'}, {'measure': 'Amount of Rescue Medication Taken', 'timeFrame': 'Week 2, 4, 8, 12, 16, 24', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['monoclonal antibody', 'RN624', 'PF-04383119', 'nerve growth factor', 'anti-nerve growth factor', 'OA', 'pain'], 'conditions': ['Arthritis', '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': '26554876', 'type': 'DERIVED', 'citation': 'Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091011&StudyName=Tanezumab%20in%20Osteoarthritis%20of%20the%20Knee%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.\n* Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.\n* Pain level and function levels as required by the protocol at Screening and Baseline.\n* Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.\n* Must agree to the contraceptive requirements of the protocol if applicable.\n* Must agree to the treatment plan, scheduled visits, and procedures of the protocol.\n\nExclusion Criteria:\n\n* Pregnancy or intent to become pregnant during the study\n* BMI greater than 39\n* other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results'}, 'identificationModule': {'nctId': 'NCT00733902', 'briefTitle': 'Tanezumab in Osteoarthritis of the Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE', 'orgStudyIdInfo': {'id': 'A4091011'}, 'secondaryIdInfos': [{'id': 'P3 OA KNEE', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tanezumab 10 mg', 'interventionNames': ['Biological: tanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tanezumab 5 mg', 'interventionNames': ['Biological: tanezumab']}, {'type': 'EXPERIMENTAL', 'label': 'Tanezumab 2.5 mg', 'interventionNames': ['Biological: tanezumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'tanezumab', 'type': 'BIOLOGICAL', 'description': 'IV tanezumab 10 mg at 1 dose every 8 weeks', 'armGroupLabels': ['Tanezumab 10 mg']}, {'name': 'tanezumab', 'type': 'BIOLOGICAL', 'description': 'IV tanezumab 5 mg at 1 dose every 8 weeks', 'armGroupLabels': ['Tanezumab 5 mg']}, {'name': 'tanezumab', 'type': 'BIOLOGICAL', 'description': 'IV tanezumab 2.5 mg at 1 dose every 8 weeks', 'armGroupLabels': ['Tanezumab 2.5 mg']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'IV placebo to match tanezumab at 1 dose every 8 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center, Inc.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Clinical Research Center of Connecticut', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Therapeutics Consortium', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'Javed Rheumatology Associates, Inc.', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research of West Florida, Inc.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa Bay Medical Research, Inc.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Rearch, LLC', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Arthritis Associates of South Florida, Clinical Research Center', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33484', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Delray Research 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Harbor', 'state': 'Florida', 'country': 'United States', 'facility': 'The Arthritis Center', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'zip': '33024', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'University Clinical Research Incorporated', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Clinical Research Centers', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'AVIVOCLIN Clinical Services', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33713', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Dale G. Bramlet, MD, P.L', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Palm Beach Research Center', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Laureate Clinical Reseach Group', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Jefrey D. 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