Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-04-18 @ 12:47 AM
Study NCT ID:
NCT00999518
Status:
TERMINATED
Last Update Posted:
2021-08-03
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'India', 'South Africa']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018856', 'term': 'Cystitis, Interstitial'}], 'ancestors': [{'id': 'D003556', 'term': 'Cystitis'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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}, 'limitationsAndCaveats': {'description': 'The study was terminated due to lack of efficacy of all doses of tanezumab demonstrated during pre-planned interim analysis.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Any clinical significant changes in physical examination and vital sign findings were reported as AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.', 'otherNumAtRisk': 42, 'otherNumAffected': 21, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.', 'otherNumAtRisk': 41, 'otherNumAffected': 25, 'seriousNumAtRisk': 41, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.', 'otherNumAtRisk': 37, 'otherNumAffected': 15, 'seriousNumAtRisk': 37, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.', 'otherNumAtRisk': 40, 'otherNumAffected': 27, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.', 'otherNumAtRisk': 40, 'otherNumAffected': 22, 'seriousNumAtRisk': 40, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Allodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased vibratory sense', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis interstitial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Unintended pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mean Average Daily Pain Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.38', 'spread': '1.259', 'groupId': 'OG000'}, {'value': '5.72', 'spread': '1.337', 'groupId': 'OG001'}, {'value': '6.01', 'spread': '1.381', 'groupId': 'OG002'}, {'value': '5.76', 'spread': '1.669', 'groupId': 'OG003'}, {'value': '6.08', 'spread': '1.288', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.21', 'spread': '1.682', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '1.760', 'groupId': 'OG001'}, {'value': '-1.49', 'spread': '2.502', 'groupId': 'OG002'}, {'value': '-1.60', 'spread': '2.175', 'groupId': 'OG003'}, {'value': '-1.57', 'spread': '1.610', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.35', 'groupDescription': 'The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% confidence interval (CI).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.68', 'groupDescription': 'The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.83', 'groupDescription': 'The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '0.47', 'groupDescription': 'The 3 parameter E max dose-response model, including baseline as a covariate, was fitted to estimate mean difference (tanezumab minus placebo) and associated 95% CI.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'spread': '1.100', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '0.997', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '1.715', 'groupId': 'OG002'}, {'value': '-0.39', 'spread': '0.821', 'groupId': 'OG003'}, {'value': '-0.43', 'spread': '1.055', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '1.296', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '1.151', 'groupId': 'OG001'}, {'value': '-1.07', 'spread': '2.039', 'groupId': 'OG002'}, {'value': '-0.73', 'spread': '1.450', 'groupId': 'OG003'}, {'value': '-0.99', 'spread': '1.273', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.14', 'spread': '1.521', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '1.642', 'groupId': 'OG001'}, {'value': '-1.09', 'spread': '2.135', 'groupId': 'OG002'}, {'value': '-1.10', 'spread': '1.590', 'groupId': 'OG003'}, {'value': '-1.17', 'spread': '1.283', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'spread': '1.559', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '1.797', 'groupId': 'OG001'}, {'value': '-1.50', 'spread': '2.153', 'groupId': 'OG002'}, {'value': '-1.41', 'spread': '1.789', 'groupId': 'OG003'}, {'value': '-1.41', 'spread': '1.640', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '1.576', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '1.686', 'groupId': 'OG001'}, {'value': '-1.51', 'spread': '2.121', 'groupId': 'OG002'}, {'value': '-1.52', 'spread': '2.063', 'groupId': 'OG003'}, {'value': '-1.56', 'spread': '1.456', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.97', 'spread': '1.650', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '1.815', 'groupId': 'OG001'}, {'value': '-1.69', 'spread': '2.084', 'groupId': 'OG002'}, {'value': '-1.42', 'spread': '2.074', 'groupId': 'OG003'}, {'value': '-1.47', 'spread': '1.537', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '1.814', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '1.894', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '2.308', 'groupId': 'OG002'}, {'value': '-1.61', 'spread': '2.131', 'groupId': 'OG003'}, {'value': '-1.66', 'spread': '1.770', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '1.774', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '1.844', 'groupId': 'OG001'}, {'value': '-1.68', 'spread': '2.439', 'groupId': 'OG002'}, {'value': '-1.74', 'spread': '2.219', 'groupId': 'OG003'}, {'value': '-1.74', 'spread': '1.485', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.42', 'spread': '1.881', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '1.930', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '2.628', 'groupId': 'OG002'}, {'value': '-1.61', 'spread': '1.822', 'groupId': 'OG003'}, {'value': '-1.98', 'spread': '1.779', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.53', 'spread': '1.770', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '1.961', 'groupId': 'OG001'}, {'value': '-2.10', 'spread': '2.504', 'groupId': 'OG002'}, {'value': '-1.85', 'spread': '2.502', 'groupId': 'OG003'}, {'value': '-1.95', 'spread': '1.884', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '1.598', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '1.768', 'groupId': 'OG001'}, {'value': '-1.93', 'spread': '2.177', 'groupId': 'OG002'}, {'value': '-1.84', 'spread': '2.517', 'groupId': 'OG003'}, {'value': '-1.94', 'spread': '1.630', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.58', 'spread': '1.751', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '1.944', 'groupId': 'OG001'}, {'value': '-2.05', 'spread': '2.129', 'groupId': 'OG002'}, {'value': '-1.83', 'spread': '2.374', 'groupId': 'OG003'}, {'value': '-2.16', 'spread': '1.678', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '1.882', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '2.195', 'groupId': 'OG001'}, {'value': '-1.86', 'spread': '1.988', 'groupId': 'OG002'}, {'value': '-1.68', 'spread': '2.355', 'groupId': 'OG003'}, {'value': '-1.85', 'spread': '1.760', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '1.785', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '1.710', 'groupId': 'OG001'}, {'value': '-2.00', 'spread': '1.959', 'groupId': 'OG002'}, {'value': '-1.68', 'spread': '2.399', 'groupId': 'OG003'}, {'value': '-2.03', 'spread': '1.740', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '1.728', 'groupId': 'OG000'}, {'value': '-1.87', 'spread': '1.915', 'groupId': 'OG001'}, {'value': '-2.39', 'spread': '2.546', 'groupId': 'OG002'}, {'value': '-1.76', 'spread': '2.382', 'groupId': 'OG003'}, {'value': '-2.29', 'spread': '1.630', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.64', 'spread': '2.182', 'groupId': 'OG000'}, {'value': '-1.85', 'spread': '1.882', 'groupId': 'OG001'}, {'value': '-2.36', 'spread': '2.376', 'groupId': 'OG002'}, {'value': '-1.95', 'spread': '2.282', 'groupId': 'OG003'}, {'value': '-1.97', 'spread': '1.921', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.47', 'spread': '2.248', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '1.894', 'groupId': 'OG001'}, {'value': '-2.85', 'spread': '2.521', 'groupId': 'OG002'}, {'value': '-1.95', 'spread': '2.338', 'groupId': 'OG003'}, {'value': '-1.98', 'spread': '1.855', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.74', 'spread': '2.096', 'groupId': 'OG000'}, {'value': '-2.65', 'spread': '1.508', 'groupId': 'OG001'}, {'value': '-2.93', 'spread': '2.555', 'groupId': 'OG002'}, {'value': '-1.86', 'spread': '2.498', 'groupId': 'OG003'}, {'value': '-1.77', 'spread': '1.756', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.71', 'spread': '2.207', 'groupId': 'OG000'}, {'value': '-2.51', 'spread': '1.487', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '2.226', 'groupId': 'OG002'}, {'value': '-1.73', 'spread': '2.575', 'groupId': 'OG003'}, {'value': '-1.96', 'spread': '1.896', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.98', 'spread': '2.264', 'groupId': 'OG000'}, {'value': '-2.76', 'spread': '1.515', 'groupId': 'OG001'}, {'value': '-1.76', 'spread': '2.227', 'groupId': 'OG002'}, {'value': '-1.99', 'spread': '2.542', 'groupId': 'OG003'}, {'value': '-1.81', 'spread': '2.069', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.85', 'spread': '2.380', 'groupId': 'OG000'}, {'value': '-2.56', 'spread': '1.833', 'groupId': 'OG001'}, {'value': '-1.75', 'spread': '2.626', 'groupId': 'OG002'}, {'value': '-1.49', 'spread': '1.795', 'groupId': 'OG003'}, {'value': '-1.97', 'spread': '1.941', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.36', 'spread': '2.701', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '2.012', 'groupId': 'OG001'}, {'value': '-1.59', 'spread': '2.168', 'groupId': 'OG002'}, {'value': '-1.20', 'spread': '1.647', 'groupId': 'OG003'}, {'value': '-1.59', 'spread': '2.473', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '2.278', 'groupId': 'OG000'}, {'value': '-2.11', 'spread': '2.083', 'groupId': 'OG001'}, {'value': '-1.84', 'spread': '2.290', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '1.625', 'groupId': 'OG003'}, {'value': '-1.58', 'spread': '1.952', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Week 8: At least 30% Reduction', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}, {'value': '35.1', 'groupId': 'OG002'}, {'value': '35.0', 'groupId': 'OG003'}, {'value': '35.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: At least 50% Reduction', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '17.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: At least 30% Reduction', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}, {'value': '35.1', 'groupId': 'OG002'}, {'value': '27.5', 'groupId': 'OG003'}, {'value': '27.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: At least 50% Reduction', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}, {'value': '15.0', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.660', 'ciLowerLimit': '0.259', 'ciUpperLimit': '1.683', 'groupDescription': 'Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.975', 'ciLowerLimit': '0.387', 'ciUpperLimit': '2.457', 'groupDescription': 'Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.969', 'ciLowerLimit': '0.392', 'ciUpperLimit': '2.398', 'groupDescription': 'Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.969', 'ciLowerLimit': '0.392', 'ciUpperLimit': '2.398', 'groupDescription': 'Week 8, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.629', 'ciLowerLimit': '0.202', 'ciUpperLimit': '1.960', 'groupDescription': 'Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.179', 'ciLowerLimit': '0.411', 'ciUpperLimit': '3.376', 'groupDescription': 'Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.222', 'ciLowerLimit': '0.438', 'ciUpperLimit': '3.414', 'groupDescription': 'Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.778', 'ciLowerLimit': '0.259', 'ciUpperLimit': '2.335', 'groupDescription': 'Week 8, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.929', 'ciLowerLimit': '0.370', 'ciUpperLimit': '2.327', 'groupDescription': 'Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.083', 'ciLowerLimit': '0.427', 'ciUpperLimit': '2.749', 'groupDescription': 'Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.759', 'ciLowerLimit': '0.295', 'ciUpperLimit': '1.952', 'groupDescription': 'Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.759', 'ciLowerLimit': '0.295', 'ciUpperLimit': '1.952', 'groupDescription': 'Week 16, at least 30% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.875', 'ciLowerLimit': '0.285', 'ciUpperLimit': '2.682', 'groupDescription': 'Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.366', 'ciLowerLimit': '0.466', 'ciUpperLimit': '4.006', 'groupDescription': 'Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.750', 'ciLowerLimit': '0.235', 'ciUpperLimit': '2.394', 'groupDescription': 'Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.063', 'ciLowerLimit': '0.356', 'ciUpperLimit': '3.168', 'groupDescription': 'Week 16, at least 50% Reduction: Logistic regression analysis with treatment as independent variable was used for the analysis.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8, 16', 'description': 'Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Missing values were imputed using baseline observation carried forward (BOCF) method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.84', 'spread': '1.341', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '1.489', 'groupId': 'OG001'}, {'value': '7.32', 'spread': '1.263', 'groupId': 'OG002'}, {'value': '7.15', 'spread': '1.342', 'groupId': 'OG003'}, {'value': '7.41', 'spread': '1.334', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.37', 'spread': '1.097', 'groupId': 'OG000'}, {'value': '-0.45', 'spread': '1.038', 'groupId': 'OG001'}, {'value': '-0.76', 'spread': '1.797', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '0.966', 'groupId': 'OG003'}, {'value': '-0.49', 'spread': '0.954', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'spread': '1.363', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '1.212', 'groupId': 'OG001'}, {'value': '-0.98', 'spread': '2.078', 'groupId': 'OG002'}, {'value': '-0.72', 'spread': '1.582', 'groupId': 'OG003'}, {'value': '-0.98', 'spread': '1.230', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.96', 'spread': '1.590', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '1.785', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '1.970', 'groupId': 'OG002'}, {'value': '-1.07', 'spread': '1.788', 'groupId': 'OG003'}, {'value': '-1.11', 'spread': '1.290', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '1.660', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '1.967', 'groupId': 'OG001'}, {'value': '-1.36', 'spread': '2.083', 'groupId': 'OG002'}, {'value': '-1.52', 'spread': '2.074', 'groupId': 'OG003'}, {'value': '-1.42', 'spread': '1.853', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.859', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '1.712', 'groupId': 'OG001'}, {'value': '-1.31', 'spread': '2.215', 'groupId': 'OG002'}, {'value': '-1.71', 'spread': '2.306', 'groupId': 'OG003'}, {'value': '-1.69', 'spread': '1.505', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '1.784', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '1.953', 'groupId': 'OG001'}, {'value': '-1.53', 'spread': '2.321', 'groupId': 'OG002'}, {'value': '-1.48', 'spread': '2.248', 'groupId': 'OG003'}, {'value': '-1.53', 'spread': '1.715', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'spread': '1.963', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '2.163', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '2.297', 'groupId': 'OG002'}, {'value': '-1.77', 'spread': '2.324', 'groupId': 'OG003'}, {'value': '-1.73', 'spread': '1.958', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '1.927', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '1.831', 'groupId': 'OG001'}, {'value': '-1.30', 'spread': '2.462', 'groupId': 'OG002'}, {'value': '-1.68', 'spread': '2.415', 'groupId': 'OG003'}, {'value': '-1.78', 'spread': '1.751', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '1.940', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '2.227', 'groupId': 'OG001'}, {'value': '-1.51', 'spread': '2.401', 'groupId': 'OG002'}, {'value': '-1.74', 'spread': '2.501', 'groupId': 'OG003'}, {'value': '-1.92', 'spread': '1.679', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '2.050', 'groupId': 'OG000'}, {'value': '-1.02', 'spread': '2.078', 'groupId': 'OG001'}, {'value': '-1.95', 'spread': '2.449', 'groupId': 'OG002'}, {'value': '-1.77', 'spread': '2.181', 'groupId': 'OG003'}, {'value': '-2.13', 'spread': '2.000', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.41', 'spread': '1.999', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '2.185', 'groupId': 'OG001'}, {'value': '-1.92', 'spread': '2.334', 'groupId': 'OG002'}, {'value': '-2.00', 'spread': '2.677', 'groupId': 'OG003'}, {'value': '-2.19', 'spread': '2.209', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '1.836', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '2.075', 'groupId': 'OG001'}, {'value': '-1.73', 'spread': '2.175', 'groupId': 'OG002'}, {'value': '-1.84', 'spread': '2.787', 'groupId': 'OG003'}, {'value': '-2.06', 'spread': '2.056', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.49', 'spread': '1.937', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '2.109', 'groupId': 'OG001'}, {'value': '-1.82', 'spread': '2.250', 'groupId': 'OG002'}, {'value': '-1.86', 'spread': '2.617', 'groupId': 'OG003'}, {'value': '-2.35', 'spread': '2.098', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.49', 'spread': '1.982', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '2.319', 'groupId': 'OG001'}, {'value': '-1.54', 'spread': '1.903', 'groupId': 'OG002'}, {'value': '-1.69', 'spread': '2.611', 'groupId': 'OG003'}, {'value': '-2.00', 'spread': '2.116', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.858', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '2.138', 'groupId': 'OG001'}, {'value': '-1.64', 'spread': '1.881', 'groupId': 'OG002'}, {'value': '-1.80', 'spread': '2.608', 'groupId': 'OG003'}, {'value': '-2.12', 'spread': '2.212', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.66', 'spread': '1.878', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '2.317', 'groupId': 'OG001'}, {'value': '-2.21', 'spread': '2.405', 'groupId': 'OG002'}, {'value': '-1.89', 'spread': '2.547', 'groupId': 'OG003'}, {'value': '-2.39', 'spread': '2.107', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '2.138', 'groupId': 'OG000'}, {'value': '-1.27', 'spread': '2.339', 'groupId': 'OG001'}, {'value': '-1.83', 'spread': '2.228', 'groupId': 'OG002'}, {'value': '-1.93', 'spread': '2.568', 'groupId': 'OG003'}, {'value': '-2.08', 'spread': '2.273', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '2.066', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '2.275', 'groupId': 'OG001'}, {'value': '-2.53', 'spread': '2.530', 'groupId': 'OG002'}, {'value': '-2.06', 'spread': '2.761', 'groupId': 'OG003'}, {'value': '-1.99', 'spread': '2.105', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.54', 'spread': '2.388', 'groupId': 'OG000'}, {'value': '-1.92', 'spread': '2.827', 'groupId': 'OG001'}, {'value': '-2.68', 'spread': '2.717', 'groupId': 'OG002'}, {'value': '-1.92', 'spread': '2.916', 'groupId': 'OG003'}, {'value': '-1.66', 'spread': '2.184', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.42', 'spread': '2.318', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '2.517', 'groupId': 'OG001'}, {'value': '-1.79', 'spread': '2.393', 'groupId': 'OG002'}, {'value': '-1.85', 'spread': '2.990', 'groupId': 'OG003'}, {'value': '-1.85', 'spread': '2.068', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.73', 'spread': '2.356', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '2.344', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '1.695', 'groupId': 'OG002'}, {'value': '-2.24', 'spread': '2.975', 'groupId': 'OG003'}, {'value': '-1.64', 'spread': '2.246', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.69', 'spread': '2.674', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '2.607', 'groupId': 'OG001'}, {'value': '-1.46', 'spread': '2.425', 'groupId': 'OG002'}, {'value': '-1.62', 'spread': '2.268', 'groupId': 'OG003'}, {'value': '-1.82', 'spread': '2.103', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.32', 'spread': '2.749', 'groupId': 'OG000'}, {'value': '-1.01', 'spread': '2.686', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '1.887', 'groupId': 'OG002'}, {'value': '-1.20', 'spread': '1.821', 'groupId': 'OG003'}, {'value': '-1.28', 'spread': '2.562', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.91', 'spread': '2.701', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '2.695', 'groupId': 'OG001'}, {'value': '-1.90', 'spread': '2.225', 'groupId': 'OG002'}, {'value': '-0.93', 'spread': '1.738', 'groupId': 'OG003'}, {'value': '-1.48', 'spread': '2.041', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Patient Global Assessment of Health Status Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.82', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '0.61', 'groupId': 'OG003'}, {'value': '3.1', 'spread': '0.76', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '0.77', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '0.66', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.94', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '0.93', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '0.83', 'groupId': 'OG003'}, {'value': '2.9', 'spread': '0.90', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.82', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '0.88', 'groupId': 'OG003'}, {'value': '2.8', 'spread': '0.80', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.94', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '0.79', 'groupId': 'OG003'}, {'value': '3.4', 'spread': '0.86', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': 'Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Global Response Assessment Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Week 8: Markedly Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Moderately Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Slightly Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Slightly Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Moderately Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Markedly Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Markedly Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Moderately Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Slightly Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Slightly Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Moderately Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Markedly Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Markedly Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Moderately Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Slightly Worse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: No Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Slightly Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Moderately Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Markedly Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.5731', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.263', 'ciLowerLimit': '0.560', 'ciUpperLimit': '2.848', 'groupDescription': 'Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2592', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.656', 'ciLowerLimit': '0.689', 'ciUpperLimit': '3.980', 'groupDescription': 'Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '1.045', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9181', 'ciLowerLimit': '0.452', 'ciUpperLimit': '2.417', 'groupDescription': 'Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5289', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.306', 'ciLowerLimit': '0.569', 'ciUpperLimit': '2.997', 'groupDescription': 'Week 8: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7930', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.893', 'ciLowerLimit': '0.385', 'ciUpperLimit': '2.074', 'groupDescription': "Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7386', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.167', 'ciLowerLimit': '0.471', 'ciUpperLimit': '2.892', 'groupDescription': "Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9354', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.036', 'ciLowerLimit': '0.437', 'ciUpperLimit': '2.460', 'groupDescription': "Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6207', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.805', 'ciLowerLimit': '0.341', 'ciUpperLimit': '1.899', 'groupDescription': "Week 16: Proportional odds logistic regression analysis with treatment as independent variable was used for the analysis. For Week 16, data scores were combined into 3 categories: Improved ('slightly improved', 'moderately improved', 'markedly improved'), No Change ('no change') and Worse ('markedly worse', 'moderately worse', 'slightly worse') for comparison.", 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set. Missing values were imputed using last observation carried forward (LOCF) method. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.98', 'spread': '5.207', 'groupId': 'OG000'}, {'value': '13.04', 'spread': '5.500', 'groupId': 'OG001'}, {'value': '14.12', 'spread': '6.728', 'groupId': 'OG002'}, {'value': '13.27', 'spread': '5.403', 'groupId': 'OG003'}, {'value': '13.13', 'spread': '5.681', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.03', 'spread': '4.867', 'groupId': 'OG000'}, {'value': '11.81', 'spread': '6.843', 'groupId': 'OG001'}, {'value': '11.41', 'spread': '5.735', 'groupId': 'OG002'}, {'value': '10.62', 'spread': '6.635', 'groupId': 'OG003'}, {'value': '13.14', 'spread': '7.930', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.61', 'spread': '5.662', 'groupId': 'OG000'}, {'value': '12.18', 'spread': '6.675', 'groupId': 'OG001'}, {'value': '10.39', 'spread': '4.842', 'groupId': 'OG002'}, {'value': '11.52', 'spread': '7.009', 'groupId': 'OG003'}, {'value': '11.13', 'spread': '7.754', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.19', 'spread': '5.265', 'groupId': 'OG000'}, {'value': '12.88', 'spread': '7.234', 'groupId': 'OG001'}, {'value': '10.58', 'spread': '4.933', 'groupId': 'OG002'}, {'value': '10.21', 'spread': '6.185', 'groupId': 'OG003'}, {'value': '10.15', 'spread': '5.695', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9.24', 'spread': '4.940', 'groupId': 'OG000'}, {'value': '11.27', 'spread': '4.892', 'groupId': 'OG001'}, {'value': '10.93', 'spread': '3.810', 'groupId': 'OG002'}, {'value': '8.90', 'spread': '6.212', 'groupId': 'OG003'}, {'value': '9.99', 'spread': '5.355', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.82', 'spread': '6.034', 'groupId': 'OG000'}, {'value': '12.11', 'spread': '5.985', 'groupId': 'OG001'}, {'value': '9.61', 'spread': '4.987', 'groupId': 'OG002'}, {'value': '10.17', 'spread': '7.354', 'groupId': 'OG003'}, {'value': '12.26', 'spread': '7.272', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.10', 'spread': '6.190', 'groupId': 'OG000'}, {'value': '10.67', 'spread': '5.871', 'groupId': 'OG001'}, {'value': '10.67', 'spread': '5.571', 'groupId': 'OG002'}, {'value': '11.36', 'spread': '5.575', 'groupId': 'OG003'}, {'value': '11.04', 'spread': '6.417', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': 'The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.', 'unitOfMeasure': 'micturitions per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Nocturnal Micturitions Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.63', 'spread': '1.641', 'groupId': 'OG000'}, {'value': '3.34', 'spread': '2.379', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '1.850', 'groupId': 'OG002'}, {'value': '3.39', 'spread': '2.667', 'groupId': 'OG003'}, {'value': '2.95', 'spread': '1.761', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.25', 'spread': '1.634', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '2.904', 'groupId': 'OG001'}, {'value': '2.85', 'spread': '1.720', 'groupId': 'OG002'}, {'value': '2.44', 'spread': '2.671', 'groupId': 'OG003'}, {'value': '2.72', 'spread': '2.601', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.58', 'spread': '1.982', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '2.094', 'groupId': 'OG001'}, {'value': '2.44', 'spread': '1.851', 'groupId': 'OG002'}, {'value': '3.12', 'spread': '3.316', 'groupId': 'OG003'}, {'value': '2.73', 'spread': '2.258', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.97', 'spread': '1.326', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '2.023', 'groupId': 'OG001'}, {'value': '2.62', 'spread': '1.371', 'groupId': 'OG002'}, {'value': '2.02', 'spread': '2.106', 'groupId': 'OG003'}, {'value': '2.71', 'spread': '2.023', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.45', 'spread': '3.141', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '2.982', 'groupId': 'OG001'}, {'value': '2.77', 'spread': '1.456', 'groupId': 'OG002'}, {'value': '2.17', 'spread': '1.789', 'groupId': 'OG003'}, {'value': '2.31', 'spread': '1.949', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.95', 'spread': '3.031', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '4.302', 'groupId': 'OG001'}, {'value': '2.29', 'spread': '1.279', 'groupId': 'OG002'}, {'value': '2.96', 'spread': '2.937', 'groupId': 'OG003'}, {'value': '3.89', 'spread': '3.129', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '1.693', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '2.132', 'groupId': 'OG001'}, {'value': '2.68', 'spread': '1.426', 'groupId': 'OG002'}, {'value': '3.39', 'spread': '3.731', 'groupId': 'OG003'}, {'value': '2.56', 'spread': '1.891', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': "The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.", 'unitOfMeasure': 'micturitions per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Micturition-related Urgency Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.88', 'spread': '6.721', 'groupId': 'OG000'}, {'value': '7.04', 'spread': '6.040', 'groupId': 'OG001'}, {'value': '9.24', 'spread': '7.665', 'groupId': 'OG002'}, {'value': '8.38', 'spread': '5.774', 'groupId': 'OG003'}, {'value': '7.20', 'spread': '6.842', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.64', 'spread': '5.680', 'groupId': 'OG000'}, {'value': '6.90', 'spread': '7.560', 'groupId': 'OG001'}, {'value': '8.27', 'spread': '10.391', 'groupId': 'OG002'}, {'value': '5.97', 'spread': '4.849', 'groupId': 'OG003'}, {'value': '6.91', 'spread': '8.820', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6.06', 'spread': '7.493', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '7.674', 'groupId': 'OG001'}, {'value': '5.86', 'spread': '5.213', 'groupId': 'OG002'}, {'value': '6.51', 'spread': '7.504', 'groupId': 'OG003'}, {'value': '6.23', 'spread': '8.625', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': '6.575', 'groupId': 'OG000'}, {'value': '5.73', 'spread': '5.419', 'groupId': 'OG001'}, {'value': '5.89', 'spread': '5.035', 'groupId': 'OG002'}, {'value': '5.09', 'spread': '4.852', 'groupId': 'OG003'}, {'value': '5.31', 'spread': '6.597', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.78', 'spread': '6.254', 'groupId': 'OG000'}, {'value': '5.06', 'spread': '4.473', 'groupId': 'OG001'}, {'value': '6.52', 'spread': '6.374', 'groupId': 'OG002'}, {'value': '4.34', 'spread': '4.940', 'groupId': 'OG003'}, {'value': '6.01', 'spread': '6.511', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.81', 'spread': '5.482', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '5.341', 'groupId': 'OG001'}, {'value': '5.37', 'spread': '5.840', 'groupId': 'OG002'}, {'value': '5.09', 'spread': '5.565', 'groupId': 'OG003'}, {'value': '7.40', 'spread': '8.167', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.53', 'spread': '6.286', 'groupId': 'OG000'}, {'value': '3.65', 'spread': '5.695', 'groupId': 'OG001'}, {'value': '6.80', 'spread': '6.568', 'groupId': 'OG002'}, {'value': '6.62', 'spread': '8.546', 'groupId': 'OG003'}, {'value': '6.43', 'spread': '7.734', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': 'The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.', 'unitOfMeasure': 'urgency episodes per 24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': "Participant's Urge to Urinate", 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.63', 'spread': '4.313', 'groupId': 'OG000'}, {'value': '17.04', 'spread': '5.015', 'groupId': 'OG001'}, {'value': '18.95', 'spread': '4.750', 'groupId': 'OG002'}, {'value': '17.73', 'spread': '3.794', 'groupId': 'OG003'}, {'value': '17.11', 'spread': '5.011', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.75', 'spread': '5.871', 'groupId': 'OG000'}, {'value': '16.27', 'spread': '5.990', 'groupId': 'OG001'}, {'value': '14.87', 'spread': '5.750', 'groupId': 'OG002'}, {'value': '15.71', 'spread': '4.699', 'groupId': 'OG003'}, {'value': '14.83', 'spread': '6.234', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.81', 'spread': '4.951', 'groupId': 'OG000'}, {'value': '15.80', 'spread': '6.338', 'groupId': 'OG001'}, {'value': '14.71', 'spread': '6.297', 'groupId': 'OG002'}, {'value': '14.38', 'spread': '4.804', 'groupId': 'OG003'}, {'value': '13.81', 'spread': '6.830', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.21', 'spread': '6.010', 'groupId': 'OG000'}, {'value': '15.64', 'spread': '6.904', 'groupId': 'OG001'}, {'value': '13.75', 'spread': '6.376', 'groupId': 'OG002'}, {'value': '14.43', 'spread': '5.635', 'groupId': 'OG003'}, {'value': '14.02', 'spread': '7.761', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.59', 'spread': '5.589', 'groupId': 'OG000'}, {'value': '14.28', 'spread': '6.083', 'groupId': 'OG001'}, {'value': '13.49', 'spread': '6.223', 'groupId': 'OG002'}, {'value': '14.05', 'spread': '5.812', 'groupId': 'OG003'}, {'value': '13.85', 'spread': '8.156', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.05', 'spread': '5.729', 'groupId': 'OG000'}, {'value': '12.75', 'spread': '7.124', 'groupId': 'OG001'}, {'value': '11.95', 'spread': '7.226', 'groupId': 'OG002'}, {'value': '13.97', 'spread': '5.887', 'groupId': 'OG003'}, {'value': '15.62', 'spread': '9.020', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12.39', 'spread': '7.258', 'groupId': 'OG000'}, {'value': '13.25', 'spread': '6.489', 'groupId': 'OG001'}, {'value': '11.13', 'spread': '7.442', 'groupId': 'OG002'}, {'value': '14.28', 'spread': '4.870', 'groupId': 'OG003'}, {'value': '15.87', 'spread': '8.800', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': "Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Mean Voided Volume Per Micturition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '142.12', 'spread': '68.374', 'groupId': 'OG000'}, {'value': '129.58', 'spread': '57.649', 'groupId': 'OG001'}, {'value': '122.78', 'spread': '65.259', 'groupId': 'OG002'}, {'value': '146.71', 'spread': '71.013', 'groupId': 'OG003'}, {'value': '139.92', 'spread': '71.064', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '130.75', 'spread': '57.303', 'groupId': 'OG000'}, {'value': '144.48', 'spread': '110.219', 'groupId': 'OG001'}, {'value': '117.45', 'spread': '59.046', 'groupId': 'OG002'}, {'value': '175.99', 'spread': '97.418', 'groupId': 'OG003'}, {'value': '140.84', 'spread': '91.375', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '132.33', 'spread': '57.848', 'groupId': 'OG000'}, {'value': '148.56', 'spread': '109.210', 'groupId': 'OG001'}, {'value': '165.02', 'spread': '114.862', 'groupId': 'OG002'}, {'value': '152.77', 'spread': '86.116', 'groupId': 'OG003'}, {'value': '155.09', 'spread': '106.398', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '136.60', 'spread': '64.056', 'groupId': 'OG000'}, {'value': '164.68', 'spread': '180.771', 'groupId': 'OG001'}, {'value': '136.06', 'spread': '88.539', 'groupId': 'OG002'}, {'value': '180.01', 'spread': '85.147', 'groupId': 'OG003'}, {'value': '158.35', 'spread': '119.294', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '141.39', 'spread': '67.788', 'groupId': 'OG000'}, {'value': '117.78', 'spread': '75.291', 'groupId': 'OG001'}, {'value': '112.86', 'spread': '66.617', 'groupId': 'OG002'}, {'value': '180.71', 'spread': '88.065', 'groupId': 'OG003'}, {'value': '163.20', 'spread': '128.409', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '131.52', 'spread': '61.604', 'groupId': 'OG000'}, {'value': '118.44', 'spread': '68.203', 'groupId': 'OG001'}, {'value': '139.61', 'spread': '64.196', 'groupId': 'OG002'}, {'value': '189.66', 'spread': '86.580', 'groupId': 'OG003'}, {'value': '135.80', 'spread': '95.869', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '138.77', 'spread': '87.222', 'groupId': 'OG000'}, {'value': '124.48', 'spread': '76.990', 'groupId': 'OG001'}, {'value': '152.99', 'spread': '102.429', 'groupId': 'OG002'}, {'value': '182.66', 'spread': '95.542', 'groupId': 'OG003'}, {'value': '174.96', 'spread': '118.350', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': 'Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': "O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '3.15', 'groupId': 'OG001'}, {'value': '15.2', 'spread': '3.25', 'groupId': 'OG002'}, {'value': '14.4', 'spread': '2.78', 'groupId': 'OG003'}, {'value': '14.5', 'spread': '2.72', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '3.72', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '4.62', 'groupId': 'OG002'}, {'value': '12.9', 'spread': '3.66', 'groupId': 'OG003'}, {'value': '13.0', 'spread': '3.82', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '4.44', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '5.06', 'groupId': 'OG002'}, {'value': '12.2', 'spread': '4.23', 'groupId': 'OG003'}, {'value': '12.2', 'spread': '4.70', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '4.22', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '3.77', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '4.47', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '4.89', 'groupId': 'OG003'}, {'value': '12.3', 'spread': '4.92', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '4.79', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '5.06', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '4.67', 'groupId': 'OG002'}, {'value': '12.2', 'spread': '4.33', 'groupId': 'OG003'}, {'value': '11.5', 'spread': '5.61', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': 'The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory-Short Form (BPI-sf) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline: PSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.14', 'spread': '1.387', 'groupId': 'OG000'}, {'value': '5.28', 'spread': '1.788', 'groupId': 'OG001'}, {'value': '5.74', 'spread': '1.817', 'groupId': 'OG002'}, {'value': '5.49', 'spread': '1.904', 'groupId': 'OG003'}, {'value': '5.82', 'spread': '1.491', 'groupId': 'OG004'}]}]}, {'title': 'Baseline: PII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.80', 'spread': '1.963', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '2.082', 'groupId': 'OG001'}, {'value': '5.49', 'spread': '2.251', 'groupId': 'OG002'}, {'value': '4.97', 'spread': '1.932', 'groupId': 'OG003'}, {'value': '5.74', 'spread': '1.808', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: PSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.12', 'spread': '2.072', 'groupId': 'OG000'}, {'value': '4.28', 'spread': '2.090', 'groupId': 'OG001'}, {'value': '4.84', 'spread': '2.318', 'groupId': 'OG002'}, {'value': '4.30', 'spread': '2.293', 'groupId': 'OG003'}, {'value': '4.60', 'spread': '1.984', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: PII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.76', 'spread': '2.432', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '2.607', 'groupId': 'OG001'}, {'value': '4.46', 'spread': '2.980', 'groupId': 'OG002'}, {'value': '3.93', 'spread': '2.513', 'groupId': 'OG003'}, {'value': '4.61', 'spread': '2.598', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: PSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.86', 'spread': '2.023', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '2.238', 'groupId': 'OG001'}, {'value': '4.21', 'spread': '2.136', 'groupId': 'OG002'}, {'value': '4.23', 'spread': '2.417', 'groupId': 'OG003'}, {'value': '4.51', 'spread': '1.912', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: PII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.59', 'spread': '2.511', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '2.552', 'groupId': 'OG001'}, {'value': '4.52', 'spread': '2.715', 'groupId': 'OG002'}, {'value': '3.87', 'spread': '2.600', 'groupId': 'OG003'}, {'value': '4.31', 'spread': '2.467', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: PSI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.96', 'spread': '2.159', 'groupId': 'OG000'}, {'value': '3.16', 'spread': '1.871', 'groupId': 'OG001'}, {'value': '3.99', 'spread': '2.376', 'groupId': 'OG002'}, {'value': '4.57', 'spread': '2.001', 'groupId': 'OG003'}, {'value': '5.16', 'spread': '1.879', 'groupId': 'OG004'}]}]}, {'title': 'Week 24, PII', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.16', 'spread': '2.153', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '2.739', 'groupId': 'OG001'}, {'value': '4.48', 'spread': '3.149', 'groupId': 'OG002'}, {'value': '4.54', 'spread': '2.246', 'groupId': 'OG003'}, {'value': '4.39', 'spread': '2.699', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8, 16, 24', 'description': 'BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Patient Global Satisfaction Assessment Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Week 8: Extremely Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Satisfy/Dissatisfy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Extremely Dissatisf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Extremely Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week16: Satisfy/Dissatisfy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Extremely Dissatisf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Extremely Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Satisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Satisfy/Dissatisfy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Dissatisfied', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Extremely Dissatisf', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant\'s response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Patient Global Preference Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Week 8: Lifestyle Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Physical Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Toileting Programs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Drug Given Into Bladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Drug Taken by Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: No Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Def Pref Current Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Week 8:Slight Pref Current', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: No Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Week8:Slight Pref Prior T/T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Def Pref Prior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 16:Lifestyle Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Physical Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Toileting Programs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 16:Drug Given Into Bladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Drug Taken by Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: No Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Def Pref Current Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 16:Slight Pref Current', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: No Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Week16:Slight Pref Prior T/T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 16:Def Pref Prior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24:Lifestyle Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Physical Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Toileting Programs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24:Drug Given Into Bladder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Drug Taken by Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: No Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Def Pref Current Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 24:Slight Pref Current', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: No Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Slight Pref Prior T/T', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24:Def Pref Prior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Willingness to Re-use Medicine Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Week 8: Definitely Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Might Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Not Sure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Might not Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: Definitely not Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Definitely Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Might Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Not Sure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Might not Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: Definitely not Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Definitely Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Might Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Not Sure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Might not Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: Definitely not Want', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life (EQ-5D) - Health State Profile Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.209', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.182', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '0.233', 'groupId': 'OG002'}, {'value': '0.70', 'spread': '0.167', 'groupId': 'OG003'}, {'value': '0.61', 'spread': '0.224', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.235', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.191', 'groupId': 'OG001'}, {'value': '0.69', 'spread': '0.214', 'groupId': 'OG002'}, {'value': '0.70', 'spread': '0.185', 'groupId': 'OG003'}, {'value': '0.68', 'spread': '0.233', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '29', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.221', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.187', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.162', 'groupId': 'OG002'}, {'value': '0.77', 'spread': '0.124', 'groupId': 'OG003'}, {'value': '0.73', 'spread': '0.215', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.174', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.187', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.232', 'groupId': 'OG002'}, {'value': '0.67', 'spread': '0.202', 'groupId': 'OG003'}, {'value': '0.66', 'spread': '0.252', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8, 16, 24', 'description': 'EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11.49', 'spread': '4.774', 'groupId': 'OG000'}, {'value': '10.56', 'spread': '4.147', 'groupId': 'OG001'}, {'value': '10.39', 'spread': '5.531', 'groupId': 'OG002'}, {'value': '11.44', 'spread': '3.938', 'groupId': 'OG003'}, {'value': '10.42', 'spread': '5.172', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.41', 'spread': '5.784', 'groupId': 'OG000'}, {'value': '12.79', 'spread': '5.173', 'groupId': 'OG001'}, {'value': '13.77', 'spread': '6.953', 'groupId': 'OG002'}, {'value': '15.34', 'spread': '5.895', 'groupId': 'OG003'}, {'value': '13.24', 'spread': '6.093', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.47', 'spread': '5.256', 'groupId': 'OG000'}, {'value': '12.02', 'spread': '5.594', 'groupId': 'OG001'}, {'value': '15.26', 'spread': '7.272', 'groupId': 'OG002'}, {'value': '14.42', 'spread': '6.635', 'groupId': 'OG003'}, {'value': '14.10', 'spread': '6.606', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.49', 'spread': '6.180', 'groupId': 'OG000'}, {'value': '11.19', 'spread': '4.486', 'groupId': 'OG001'}, {'value': '15.21', 'spread': '6.671', 'groupId': 'OG002'}, {'value': '17.23', 'spread': '5.868', 'groupId': 'OG003'}, {'value': '13.94', 'spread': '7.153', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '14.27', 'spread': '7.808', 'groupId': 'OG000'}, {'value': '14.45', 'spread': '5.663', 'groupId': 'OG001'}, {'value': '16.77', 'spread': '8.044', 'groupId': 'OG002'}, {'value': '14.27', 'spread': '5.813', 'groupId': 'OG003'}, {'value': '15.05', 'spread': '6.852', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': "PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Received Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}, {'value': '65.9', 'groupId': 'OG001'}, {'value': '56.8', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '57.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '53.7', 'groupId': 'OG001'}, {'value': '48.6', 'groupId': 'OG002'}, {'value': '50.0', 'groupId': 'OG003'}, {'value': '42.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '53.7', 'groupId': 'OG001'}, {'value': '54.1', 'groupId': 'OG002'}, {'value': '57.5', 'groupId': 'OG003'}, {'value': '42.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '51.2', 'groupId': 'OG001'}, {'value': '48.6', 'groupId': 'OG002'}, {'value': '47.5', 'groupId': 'OG003'}, {'value': '40.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '53.7', 'groupId': 'OG001'}, {'value': '43.2', 'groupId': 'OG002'}, {'value': '45.0', 'groupId': 'OG003'}, {'value': '45.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 5', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}, {'value': '40.5', 'groupId': 'OG002'}, {'value': '40.0', 'groupId': 'OG003'}, {'value': '45.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}, {'value': '42.5', 'groupId': 'OG003'}, {'value': '32.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 7', 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}, {'value': '35.0', 'groupId': 'OG003'}, {'value': '37.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '35.1', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}, {'value': '35.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 9', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}, {'value': '31.7', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}, {'value': '30.0', 'groupId': 'OG003'}, {'value': '30.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 10', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '34.1', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}, {'value': '22.5', 'groupId': 'OG003'}, {'value': '30.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 11', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}, {'value': '29.7', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '32.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}, {'value': '24.4', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}, {'value': '27.5', 'groupId': 'OG003'}, {'value': '30.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 13', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}, {'value': '24.4', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}, {'value': '22.5', 'groupId': 'OG003'}, {'value': '27.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 14', 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}, {'value': '24.4', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '32.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 15', 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '27.0', 'groupId': 'OG002'}, {'value': '22.5', 'groupId': 'OG003'}, {'value': '20.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '18.9', 'groupId': 'OG002'}, {'value': '25.0', 'groupId': 'OG003'}, {'value': '17.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 17', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '18.9', 'groupId': 'OG002'}, {'value': '22.5', 'groupId': 'OG003'}, {'value': '22.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 18', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '17.1', 'groupId': 'OG001'}, {'value': '16.2', 'groupId': 'OG002'}, {'value': '17.5', 'groupId': 'OG003'}, {'value': '15.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 19', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}, {'value': '19.5', 'groupId': 'OG001'}, {'value': '13.5', 'groupId': 'OG002'}, {'value': '17.5', 'groupId': 'OG003'}, {'value': '17.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '21.6', 'groupId': 'OG002'}, {'value': '17.5', 'groupId': 'OG003'}, {'value': '15.0', 'groupId': 'OG004'}]}]}, {'title': 'Week 21', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '18.9', 'groupId': 'OG002'}, {'value': '20.0', 'groupId': 'OG003'}, {'value': '7.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 22', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}, {'value': '10.8', 'groupId': 'OG002'}, {'value': '10.8', 'groupId': 'OG003'}, {'value': '7.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 23', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}, {'value': '10.8', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '7.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '7.3', 'groupId': 'OG001'}, {'value': '5.4', 'groupId': 'OG002'}, {'value': '10.0', 'groupId': 'OG003'}, {'value': '7.5', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who had received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Days of Rescue Medication Usage Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.39', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '2.27', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '2.36', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '2.08', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '2.01', 'groupId': 'OG003'}, {'value': '4.8', 'spread': '1.68', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.42', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '2.38', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '2.31', 'groupId': 'OG004'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '2.27', 'groupId': 'OG003'}, {'value': '4.3', 'spread': '2.27', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '2.35', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '2.40', 'groupId': 'OG003'}, {'value': '3.9', 'spread': '2.63', 'groupId': 'OG004'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '2.66', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '2.57', 'groupId': 'OG003'}, {'value': '4.2', 'spread': '2.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '2.22', 'groupId': 'OG002'}, {'value': '2.22', 'spread': '2.33', 'groupId': 'OG003'}, {'value': '4.5', 'spread': '2.60', 'groupId': 'OG004'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '2.37', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '2.38', 'groupId': 'OG003'}, {'value': '4.5', 'spread': '2.36', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '2.58', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '2.61', 'groupId': 'OG003'}, {'value': '4.3', 'spread': '2.05', 'groupId': 'OG004'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '2.37', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '2.37', 'groupId': 'OG004'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '2.46', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '2.86', 'groupId': 'OG003'}, {'value': '4.3', 'spread': '2.46', 'groupId': 'OG004'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '2.64', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '2.60', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '3.8', 'spread': '2.41', 'groupId': 'OG004'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '2.28', 'groupId': 'OG003'}, {'value': '4.5', 'spread': '2.21', 'groupId': 'OG004'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '2.07', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '2.58', 'groupId': 'OG003'}, {'value': '4.1', 'spread': '2.36', 'groupId': 'OG004'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '2.59', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '2.40', 'groupId': 'OG003'}, {'value': '5.0', 'spread': '2.00', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.95', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '2.81', 'groupId': 'OG003'}, {'value': '4.6', 'spread': '1.27', 'groupId': 'OG004'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '2.46', 'groupId': 'OG003'}, {'value': '3.7', 'spread': '2.18', 'groupId': 'OG004'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '2.67', 'groupId': 'OG003'}, {'value': '4.7', 'spread': '2.42', 'groupId': 'OG004'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '2.51', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '3.6', 'spread': '2.57', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '2.39', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '1.98', 'groupId': 'OG003'}, {'value': '4.0', 'spread': '2.37', 'groupId': 'OG004'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '2.4', 'spread': '2.13', 'groupId': 'OG003'}, {'value': '5.7', 'spread': '1.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '2.14', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '2.14', 'groupId': 'OG003'}, {'value': '4.7', 'spread': '3.21', 'groupId': 'OG004'}]}]}, {'title': 'Week 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.30', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '2.06', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '2.22', 'groupId': 'OG003'}, {'value': '4.7', 'spread': '3.21', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '2.87', 'groupId': 'OG003'}, {'value': '5.7', 'spread': '2.31', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.', 'unitOfMeasure': 'days per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Rescue Medication Doses Used Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.09', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '3.56', 'spread': '2.39', 'groupId': 'OG001'}, {'value': '3.81', 'spread': '2.27', 'groupId': 'OG002'}, {'value': '4.10', 'spread': '2.36', 'groupId': 'OG003'}, {'value': '4.61', 'spread': '2.08', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '4.05', 'spread': '2.21', 'groupId': 'OG001'}, {'value': '3.78', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '4.55', 'spread': '2.01', 'groupId': 'OG003'}, {'value': '4.76', 'spread': '1.68', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '3.55', 'spread': '2.42', 'groupId': 'OG002'}, {'value': '3.70', 'spread': '2.38', 'groupId': 'OG003'}, {'value': '4.24', 'spread': '2.31', 'groupId': 'OG004'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.53', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '3.48', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '3.89', 'spread': '2.49', 'groupId': 'OG002'}, {'value': '3.58', 'spread': '2.27', 'groupId': 'OG003'}, {'value': '4.31', 'spread': '2.27', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.29', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '2.42', 'groupId': 'OG001'}, {'value': '3.06', 'spread': '2.35', 'groupId': 'OG002'}, {'value': '3.67', 'spread': '2.40', 'groupId': 'OG003'}, {'value': '3.89', 'spread': '2.63', 'groupId': 'OG004'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.64', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '4.56', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '3.93', 'spread': '2.66', 'groupId': 'OG002'}, {'value': '3.25', 'spread': '2.57', 'groupId': 'OG003'}, {'value': '4.22', 'spread': '2.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.67', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '3.79', 'spread': '2.22', 'groupId': 'OG002'}, {'value': '3.06', 'spread': '2.33', 'groupId': 'OG003'}, {'value': '4.54', 'spread': '2.60', 'groupId': 'OG004'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.69', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '3.93', 'spread': '2.37', 'groupId': 'OG002'}, {'value': '3.50', 'spread': '2.38', 'groupId': 'OG003'}, {'value': '4.47', 'spread': '2.36', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '4.57', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '3.85', 'spread': '2.58', 'groupId': 'OG002'}, {'value': '3.58', 'spread': '2.61', 'groupId': 'OG003'}, {'value': '4.29', 'spread': '2.05', 'groupId': 'OG004'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.23', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '4.07', 'spread': '2.37', 'groupId': 'OG002'}, {'value': '4.08', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '3.83', 'spread': '2.37', 'groupId': 'OG004'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.13', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '3.71', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '4.36', 'spread': '2.46', 'groupId': 'OG002'}, {'value': '4.22', 'spread': '2.86', 'groupId': 'OG003'}, {'value': '4.33', 'spread': '2.46', 'groupId': 'OG004'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.23', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '2.41', 'groupId': 'OG001'}, {'value': '4.18', 'spread': '2.32', 'groupId': 'OG002'}, {'value': '3.90', 'spread': '2.64', 'groupId': 'OG003'}, {'value': '4.08', 'spread': '2.60', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.64', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '1.90', 'groupId': 'OG001'}, {'value': '5.00', 'spread': '2.50', 'groupId': 'OG002'}, {'value': '4.09', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '3.83', 'spread': '2.41', 'groupId': 'OG004'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.15', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '4.67', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '4.78', 'spread': '2.28', 'groupId': 'OG003'}, {'value': '4.45', 'spread': '2.21', 'groupId': 'OG004'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.69', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '3.80', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '4.63', 'spread': '2.07', 'groupId': 'OG002'}, {'value': '4.30', 'spread': '2.58', 'groupId': 'OG003'}, {'value': '4.08', 'spread': '2.36', 'groupId': 'OG004'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.17', 'spread': '2.17', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '3.60', 'spread': '2.59', 'groupId': 'OG002'}, {'value': '3.33', 'spread': '2.40', 'groupId': 'OG003'}, {'value': '5.00', 'spread': '2.00', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.50', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '4.14', 'spread': '1.95', 'groupId': 'OG002'}, {'value': '3.90', 'spread': '2.81', 'groupId': 'OG003'}, {'value': '4.57', 'spread': '1.27', 'groupId': 'OG004'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.67', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '2.29', 'groupId': 'OG001'}, {'value': '4.43', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '3.44', 'spread': '2.46', 'groupId': 'OG003'}, {'value': '3.67', 'spread': '2.18', 'groupId': 'OG004'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.63', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '4.50', 'spread': '1.64', 'groupId': 'OG002'}, {'value': '3.14', 'spread': '2.67', 'groupId': 'OG003'}, {'value': '4.67', 'spread': '2.42', 'groupId': 'OG004'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.89', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '4.60', 'spread': '2.51', 'groupId': 'OG002'}, {'value': '3.71', 'spread': '2.43', 'groupId': 'OG003'}, {'value': '3.57', 'spread': '2.57', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.83', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '4.00', 'spread': '2.39', 'groupId': 'OG002'}, {'value': '3.29', 'spread': '1.98', 'groupId': 'OG003'}, {'value': '4.00', 'spread': '2.37', 'groupId': 'OG004'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.83', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '3.40', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '2.29', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '2.38', 'spread': '2.13', 'groupId': 'OG003'}, {'value': '5.67', 'spread': '1.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.38', 'spread': '1.69', 'groupId': 'OG000'}, {'value': '3.17', 'spread': '2.14', 'groupId': 'OG001'}, {'value': '4.25', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '3.17', 'spread': '2.14', 'groupId': 'OG003'}, {'value': '4.67', 'spread': '3.21', 'groupId': 'OG004'}]}]}, {'title': 'Week 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '2.30', 'groupId': 'OG001'}, {'value': '4.25', 'spread': '2.06', 'groupId': 'OG002'}, {'value': '2.75', 'spread': '2.22', 'groupId': 'OG003'}, {'value': '4.67', 'spread': '3.21', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '2.00', 'groupId': 'OG001'}, {'value': '7.00', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '3.25', 'spread': '2.87', 'groupId': 'OG003'}, {'value': '5.67', 'spread': '2.31', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.', 'unitOfMeasure': 'doses per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Amount of Rescue Medication Taken Per Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5827.3', 'spread': '4485.87', 'groupId': 'OG000'}, {'value': '4781.5', 'spread': '4596.49', 'groupId': 'OG001'}, {'value': '5428.6', 'spread': '4688.51', 'groupId': 'OG002'}, {'value': '5875.0', 'spread': '4795.49', 'groupId': 'OG003'}, {'value': '5695.7', 'spread': '4255.32', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5527.8', 'spread': '3908.78', 'groupId': 'OG000'}, {'value': '5090.9', 'spread': '4055.09', 'groupId': 'OG001'}, {'value': '5444.4', 'spread': '6125.86', 'groupId': 'OG002'}, {'value': '6375.0', 'spread': '4737.52', 'groupId': 'OG003'}, {'value': '6058.8', 'spread': '3273.39', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4333.3', 'spread': '4749.56', 'groupId': 'OG000'}, {'value': '4590.9', 'spread': '4052.15', 'groupId': 'OG001'}, {'value': '5300.0', 'spread': '5795.64', 'groupId': 'OG002'}, {'value': '5369.6', 'spread': '5341.13', 'groupId': 'OG003'}, {'value': '5647.1', 'spread': '4018.57', 'groupId': 'OG004'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4573.3', 'spread': '4831.66', 'groupId': 'OG000'}, {'value': '4190.5', 'spread': '3838.87', 'groupId': 'OG001'}, {'value': '5861.1', 'spread': '5232.27', 'groupId': 'OG002'}, {'value': '5368.4', 'spread': '4669.17', 'groupId': 'OG003'}, {'value': '6218.8', 'spread': '4837.25', 'groupId': 'OG004'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4371.4', 'spread': '4431.60', 'groupId': 'OG000'}, {'value': '4013.6', 'spread': '4024.84', 'groupId': 'OG001'}, {'value': '4312.5', 'spread': '4003.64', 'groupId': 'OG002'}, {'value': '5500.0', 'spread': '5787.92', 'groupId': 'OG003'}, {'value': '5194.4', 'spread': '4765.50', 'groupId': 'OG004'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4342.9', 'spread': '4300.22', 'groupId': 'OG000'}, {'value': '5625.0', 'spread': '4368.45', 'groupId': 'OG001'}, {'value': '5866.7', 'spread': '5569.26', 'groupId': 'OG002'}, {'value': '4843.8', 'spread': '5545.93', 'groupId': 'OG003'}, {'value': '5694.4', 'spread': '4902.40', 'groupId': 'OG004'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4873.3', 'spread': '4005.08', 'groupId': 'OG000'}, {'value': '3320.0', 'spread': '2758.83', 'groupId': 'OG001'}, {'value': '5178.6', 'spread': '4846.12', 'groupId': 'OG002'}, {'value': '4735.3', 'spread': '6200.09', 'groupId': 'OG003'}, {'value': '6500.0', 'spread': '4267.12', 'groupId': 'OG004'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5181.3', 'spread': '4803.36', 'groupId': 'OG000'}, {'value': '6181.8', 'spread': '3363.57', 'groupId': 'OG001'}, {'value': '5392.9', 'spread': '4637.55', 'groupId': 'OG002'}, {'value': '4928.6', 'spread': '5473.21', 'groupId': 'OG003'}, {'value': '6500.0', 'spread': '4263.63', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4740.0', 'spread': '2844.74', 'groupId': 'OG000'}, {'value': '6071.4', 'spread': '4367.08', 'groupId': 'OG001'}, {'value': '6307.7', 'spread': '6223.40', 'groupId': 'OG002'}, {'value': '5875.0', 'spread': '6045.75', 'groupId': 'OG003'}, {'value': '6428.6', 'spread': '4807.27', 'groupId': 'OG004'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5238.5', 'spread': '2722.91', 'groupId': 'OG000'}, {'value': '6884.6', 'spread': '5838.64', 'groupId': 'OG001'}, {'value': '6464.3', 'spread': '6203.18', 'groupId': 'OG002'}, {'value': '6166.7', 'spread': '6087.74', 'groupId': 'OG003'}, {'value': '5958.3', 'spread': '5565.55', 'groupId': 'OG004'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4266.7', 'spread': '3272.54', 'groupId': 'OG000'}, {'value': '4785.7', 'spread': '4259.44', 'groupId': 'OG001'}, {'value': '7181.8', 'spread': '5934.11', 'groupId': 'OG002'}, {'value': '6333.3', 'spread': '6359.05', 'groupId': 'OG003'}, {'value': '6916.7', 'spread': '5418.12', 'groupId': 'OG004'}]}]}, {'title': 'Week 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5538.5', 'spread': '3078.57', 'groupId': 'OG000'}, {'value': '5681.8', 'spread': '5316.36', 'groupId': 'OG001'}, {'value': '5500.0', 'spread': '4398.86', 'groupId': 'OG002'}, {'value': '5750.0', 'spread': '5422.43', 'groupId': 'OG003'}, {'value': '6807.7', 'spread': '7084.43', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4954.5', 'spread': '3791.14', 'groupId': 'OG000'}, {'value': '6250.0', 'spread': '5731.25', 'groupId': 'OG001'}, {'value': '6333.3', 'spread': '3848.70', 'groupId': 'OG002'}, {'value': '7500.0', 'spread': '7861.30', 'groupId': 'OG003'}, {'value': '5583.3', 'spread': '5142.66', 'groupId': 'OG004'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6500.0', 'spread': '8638.58', 'groupId': 'OG000'}, {'value': '5800.0', 'spread': '4211.10', 'groupId': 'OG001'}, {'value': '6777.8', 'spread': '5810.07', 'groupId': 'OG002'}, {'value': '6888.9', 'spread': '6406.92', 'groupId': 'OG003'}, {'value': '6772.7', 'spread': '4808.14', 'groupId': 'OG004'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6269.2', 'spread': '5666.48', 'groupId': 'OG000'}, {'value': '5250.0', 'spread': '4184.96', 'groupId': 'OG001'}, {'value': '5562.5', 'spread': '3310.56', 'groupId': 'OG002'}, {'value': '6250.0', 'spread': '6161.03', 'groupId': 'OG003'}, {'value': '6807.7', 'spread': '5717.44', 'groupId': 'OG004'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5083.3', 'spread': '4655.56', 'groupId': 'OG000'}, {'value': '8214.3', 'spread': '8489.49', 'groupId': 'OG001'}, {'value': '4700.0', 'spread': '4601.93', 'groupId': 'OG002'}, {'value': '7333.3', 'spread': '8437.27', 'groupId': 'OG003'}, {'value': '6500.0', 'spread': '3909.69', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5375.0', 'spread': '4332.19', 'groupId': 'OG000'}, {'value': '6083.3', 'spread': '3292.67', 'groupId': 'OG001'}, {'value': '5500.0', 'spread': '3807.89', 'groupId': 'OG002'}, {'value': '6900.0', 'spread': '6814.20', 'groupId': 'OG003'}, {'value': '6142.9', 'spread': '2925.67', 'groupId': 'OG004'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6000.0', 'spread': '5454.36', 'groupId': 'OG000'}, {'value': '3571.4', 'spread': '3207.13', 'groupId': 'OG001'}, {'value': '6000.0', 'spread': '4133.20', 'groupId': 'OG002'}, {'value': '4722.2', 'spread': '3392.19', 'groupId': 'OG003'}, {'value': '6111.1', 'spread': '6303.66', 'groupId': 'OG004'}]}]}, {'title': 'Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6437.5', 'spread': '6038.20', 'groupId': 'OG000'}, {'value': '3285.7', 'spread': '2766.72', 'groupId': 'OG001'}, {'value': '6583.3', 'spread': '4128.16', 'groupId': 'OG002'}, {'value': '3714.3', 'spread': '3672.61', 'groupId': 'OG003'}, {'value': '5583.3', 'spread': '4079.42', 'groupId': 'OG004'}]}]}, {'title': 'Week 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6500.0', 'spread': '4242.64', 'groupId': 'OG000'}, {'value': '4250.0', 'spread': '4157.61', 'groupId': 'OG001'}, {'value': '6400.0', 'spread': '5042.32', 'groupId': 'OG002'}, {'value': '4214.3', 'spread': '3717.72', 'groupId': 'OG003'}, {'value': '4214.3', 'spread': '4270.61', 'groupId': 'OG004'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7333.3', 'spread': '4191.26', 'groupId': 'OG000'}, {'value': '3300.0', 'spread': '3290.14', 'groupId': 'OG001'}, {'value': '5375.0', 'spread': '4413.86', 'groupId': 'OG002'}, {'value': '3714.3', 'spread': '3186.65', 'groupId': 'OG003'}, {'value': '5000.0', 'spread': '5167.20', 'groupId': 'OG004'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6333.3', 'spread': '4792.36', 'groupId': 'OG000'}, {'value': '3600.0', 'spread': '3595.14', 'groupId': 'OG001'}, {'value': '2428.6', 'spread': '1592.39', 'groupId': 'OG002'}, {'value': '2750.0', 'spread': '2563.48', 'groupId': 'OG003'}, {'value': '7333.3', 'spread': '7333.3', 'groupId': 'OG004'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5625.0', 'spread': '3482.10', 'groupId': 'OG000'}, {'value': '2750.0', 'spread': '2715.70', 'groupId': 'OG001'}, {'value': '5375.0', 'spread': '4534.59', 'groupId': 'OG002'}, {'value': '5250.0', 'spread': '3489.27', 'groupId': 'OG003'}, {'value': '6000.0', 'spread': '4582.58', 'groupId': 'OG004'}]}]}, {'title': 'Week 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8375.0', 'spread': '5566.16', 'groupId': 'OG000'}, {'value': '3300.0', 'spread': '2841.65', 'groupId': 'OG001'}, {'value': '4500.0', 'spread': '2886.75', 'groupId': 'OG002'}, {'value': '3125.0', 'spread': '1931.11', 'groupId': 'OG003'}, {'value': '6666.7', 'spread': '5507.57', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7500.0', 'spread': '4560.70', 'groupId': 'OG000'}, {'value': '3166.7', 'spread': '2020.73', 'groupId': 'OG001'}, {'value': '6000.0', 'spread': '2121.32', 'groupId': 'OG002'}, {'value': '3625.0', 'spread': '2780.14', 'groupId': 'OG003'}, {'value': '8500.0', 'spread': '5766.28', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.', 'unitOfMeasure': 'mg/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Serum Total Nerve Growth Factor (NGF) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '41.756', 'spread': '11.5576', 'groupId': 'OG000'}, {'value': '39.929', 'spread': '10.7855', 'groupId': 'OG001'}, {'value': '37.209', 'spread': '8.4699', 'groupId': 'OG002'}, {'value': '38.381', 'spread': '11.0441', 'groupId': 'OG003'}, {'value': '38.150', 'spread': '7.6355', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39.260', 'spread': '13.2510', 'groupId': 'OG000'}, {'value': '552.485', 'spread': '221.4202', 'groupId': 'OG001'}, {'value': '730.917', 'spread': '253.8217', 'groupId': 'OG002'}, {'value': '1034.317', 'spread': '221.8687', 'groupId': 'OG003'}, {'value': '1113.780', 'spread': '307.0217', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.162', 'spread': '10.1141', 'groupId': 'OG000'}, {'value': '901.633', 'spread': '335.4488', 'groupId': 'OG001'}, {'value': '1242.388', 'spread': '425.2031', 'groupId': 'OG002'}, {'value': '1644.283', 'spread': '396.6413', 'groupId': 'OG003'}, {'value': '1812.559', 'spread': '530.0335', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '58.075', 'spread': '103.6542', 'groupId': 'OG000'}, {'value': '841.984', 'spread': '446.1437', 'groupId': 'OG001'}, {'value': '1545.148', 'spread': '770.2641', 'groupId': 'OG002'}, {'value': '2502.127', 'spread': '833.8403', 'groupId': 'OG003'}, {'value': '3369.039', 'spread': '1795.1505', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '48.207', 'spread': '28.6793', 'groupId': 'OG000'}, {'value': '590.896', 'spread': '638.2373', 'groupId': 'OG001'}, {'value': '1079.050', 'spread': '803.0958', 'groupId': 'OG002'}, {'value': '3171.980', 'spread': '1205.2251', 'groupId': 'OG003'}, {'value': '3497.462', 'spread': '2837.0678', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '40.626', 'spread': '8.9706', 'groupId': 'OG000'}, {'value': '131.474', 'spread': '123.8849', 'groupId': 'OG001'}, {'value': '321.928', 'spread': '331.1179', 'groupId': 'OG002'}, {'value': '2153.000', 'spread': '929.5347', 'groupId': 'OG003'}, {'value': '3137.829', 'spread': '3612.2725', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 8, 16, 24', 'description': 'Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Neurological Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Week 24 or early termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2, 8, 16, Week 24 or early termination', 'description': 'A neurological examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '3.10', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '2.87', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '0.84', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '1.32', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '2.88', 'groupId': 'OG003'}, {'value': '-0.0', 'spread': '0.16', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '5.28', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.41', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.66', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '6.33', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.23', 'groupId': 'OG004'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.74', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '5.15', 'groupId': 'OG003'}, {'value': '0.1', 'spread': '0.37', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': 'The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.56', 'spread': '0.323', 'groupId': 'OG000'}, {'value': '36.71', 'spread': '0.304', 'groupId': 'OG001'}, {'value': '36.56', 'spread': '0.363', 'groupId': 'OG002'}, {'value': '36.58', 'spread': '0.341', 'groupId': 'OG003'}, {'value': '36.67', 'spread': '0.328', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.56', 'spread': '0.359', 'groupId': 'OG000'}, {'value': '36.62', 'spread': '0.327', 'groupId': 'OG001'}, {'value': '36.64', 'spread': '0.321', 'groupId': 'OG002'}, {'value': '36.55', 'spread': '0.362', 'groupId': 'OG003'}, {'value': '36.57', 'spread': '0.246', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.46', 'spread': '0.306', 'groupId': 'OG000'}, {'value': '36.55', 'spread': '0.372', 'groupId': 'OG001'}, {'value': '36.65', 'spread': '0.304', 'groupId': 'OG002'}, {'value': '36.50', 'spread': '0.364', 'groupId': 'OG003'}, {'value': '36.58', 'spread': '0.322', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.57', 'spread': '0.338', 'groupId': 'OG000'}, {'value': '36.67', 'spread': '0.351', 'groupId': 'OG001'}, {'value': '36.52', 'spread': '0.349', 'groupId': 'OG002'}, {'value': '36.58', 'spread': '0.317', 'groupId': 'OG003'}, {'value': '36.48', 'spread': '0.351', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.56', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '36.57', 'spread': '0.401', 'groupId': 'OG001'}, {'value': '36.55', 'spread': '0.376', 'groupId': 'OG002'}, {'value': '36.63', 'spread': '0.360', 'groupId': 'OG003'}, {'value': '36.54', 'spread': '0.294', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (1 hour pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.56', 'spread': '0.321', 'groupId': 'OG000'}, {'value': '36.59', 'spread': '0.285', 'groupId': 'OG001'}, {'value': '36.66', 'spread': '0.342', 'groupId': 'OG002'}, {'value': '36.58', 'spread': '0.339', 'groupId': 'OG003'}, {'value': '36.60', 'spread': '0.350', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (1 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.57', 'spread': '0.307', 'groupId': 'OG000'}, {'value': '36.63', 'spread': '0.301', 'groupId': 'OG001'}, {'value': '36.60', 'spread': '0.350', 'groupId': 'OG002'}, {'value': '36.45', 'spread': '0.244', 'groupId': 'OG003'}, {'value': '36.66', 'spread': '0.305', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.53', 'spread': '0.353', 'groupId': 'OG000'}, {'value': '36.66', 'spread': '0.398', 'groupId': 'OG001'}, {'value': '36.64', 'spread': '0.341', 'groupId': 'OG002'}, {'value': '36.37', 'spread': '0.299', 'groupId': 'OG003'}, {'value': '36.71', 'spread': '0.251', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36.60', 'spread': '0.387', 'groupId': 'OG000'}, {'value': '36.63', 'spread': '0.411', 'groupId': 'OG001'}, {'value': '36.53', 'spread': '0.368', 'groupId': 'OG002'}, {'value': '36.53', 'spread': '0.325', 'groupId': 'OG003'}, {'value': '36.60', 'spread': '0.300', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24', 'unitOfMeasure': 'degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Screening: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '126.3', 'spread': '15.95', 'groupId': 'OG000'}, {'value': '118.5', 'spread': '14.15', 'groupId': 'OG001'}, {'value': '121.3', 'spread': '12.25', 'groupId': 'OG002'}, {'value': '123.5', 'spread': '12.40', 'groupId': 'OG003'}, {'value': '123.2', 'spread': '13.39', 'groupId': 'OG004'}]}]}, {'title': 'Screening: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.4', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '73.4', 'spread': '9.05', 'groupId': 'OG001'}, {'value': '76.4', 'spread': '9.46', 'groupId': 'OG002'}, {'value': '76.8', 'spread': '10.35', 'groupId': 'OG003'}, {'value': '75.0', 'spread': '9.34', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour pre-dose): SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '125.8', 'spread': '16.81', 'groupId': 'OG000'}, {'value': '118.0', 'spread': '13.88', 'groupId': 'OG001'}, {'value': '119.4', 'spread': '12.02', 'groupId': 'OG002'}, {'value': '121.1', 'spread': '14.86', 'groupId': 'OG003'}, {'value': '121.3', 'spread': '12.75', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour pre-dose): DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.9', 'spread': '10.13', 'groupId': 'OG000'}, {'value': '73.1', 'spread': '8.60', 'groupId': 'OG001'}, {'value': '75.9', 'spread': '10.61', 'groupId': 'OG002'}, {'value': '74.5', 'spread': '10.02', 'groupId': 'OG003'}, {'value': '75.5', 'spread': '9.47', 'groupId': 'OG004'}]}]}, {'title': 'Day 1(1 hour post-dose): SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '125.0', 'spread': '13.06', 'groupId': 'OG000'}, {'value': '118.5', 'spread': '12.41', 'groupId': 'OG001'}, {'value': '121.5', 'spread': '12.78', 'groupId': 'OG002'}, {'value': '123.4', 'spread': '15.02', 'groupId': 'OG003'}, {'value': '122.7', 'spread': '14.17', 'groupId': 'OG004'}]}]}, {'title': 'Day 1(1 hour post-dose): DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '8.77', 'groupId': 'OG001'}, {'value': '73.8', 'spread': '11.72', 'groupId': 'OG002'}, {'value': '74.8', 'spread': '9.05', 'groupId': 'OG003'}, {'value': '76.8', 'spread': '8.65', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '124.6', 'spread': '17.29', 'groupId': 'OG000'}, {'value': '117.4', 'spread': '14.44', 'groupId': 'OG001'}, {'value': '116.8', 'spread': '12.07', 'groupId': 'OG002'}, {'value': '117.9', 'spread': '13.35', 'groupId': 'OG003'}, {'value': '119.4', 'spread': '12.44', 'groupId': 'OG004'}]}]}, {'title': 'Week 1: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74.9', 'spread': '11.27', 'groupId': 'OG000'}, {'value': '72.6', 'spread': '9.42', 'groupId': 'OG001'}, {'value': '74.7', 'spread': '9.69', 'groupId': 'OG002'}, {'value': '71.6', 'spread': '9.88', 'groupId': 'OG003'}, {'value': '73.9', 'spread': '10.32', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '124.4', 'spread': '14.26', 'groupId': 'OG000'}, {'value': '113.3', 'spread': '11.82', 'groupId': 'OG001'}, {'value': '118.8', 'spread': '13.47', 'groupId': 'OG002'}, {'value': '122.0', 'spread': '16.45', 'groupId': 'OG003'}, {'value': '118.2', 'spread': '12.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74.8', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '8.46', 'groupId': 'OG001'}, {'value': '76.8', 'spread': '8.99', 'groupId': 'OG002'}, {'value': '74.5', 'spread': '9.44', 'groupId': 'OG003'}, {'value': '72.4', 'spread': '9.15', 'groupId': 'OG004'}]}]}, {'title': 'Week 8(1 hour pre-dose): SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '120.1', 'spread': '12.64', 'groupId': 'OG000'}, {'value': '115.1', 'spread': '13.42', 'groupId': 'OG001'}, {'value': '117.0', 'spread': '14.06', 'groupId': 'OG002'}, {'value': '122.4', 'spread': '17.13', 'groupId': 'OG003'}, {'value': '113.4', 'spread': '11.83', 'groupId': 'OG004'}]}]}, {'title': 'Week 8(1 hour pre-dose): DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '73.8', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '73.5', 'spread': '9.93', 'groupId': 'OG001'}, {'value': '72.0', 'spread': '7.08', 'groupId': 'OG002'}, {'value': '73.4', 'spread': '9.73', 'groupId': 'OG003'}, {'value': '71.5', 'spread': '7.98', 'groupId': 'OG004'}]}]}, {'title': 'Week 8(1 hour post-dose): SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '123.0', 'spread': '12.39', 'groupId': 'OG000'}, {'value': '111.8', 'spread': '11.12', 'groupId': 'OG001'}, {'value': '119.1', 'spread': '9.18', 'groupId': 'OG002'}, {'value': '120.7', 'spread': '17.35', 'groupId': 'OG003'}, {'value': '118.8', 'spread': '9.98', 'groupId': 'OG004'}]}]}, {'title': 'Week 8(1 hour post-dose): DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '7.71', 'groupId': 'OG000'}, {'value': '69.9', 'spread': '8.63', 'groupId': 'OG001'}, {'value': '75.2', 'spread': '6.07', 'groupId': 'OG002'}, {'value': '74.8', 'spread': '9.34', 'groupId': 'OG003'}, {'value': '73.8', 'spread': '6.15', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '125.4', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '117.4', 'spread': '13.72', 'groupId': 'OG001'}, {'value': '119.7', 'spread': '13.63', 'groupId': 'OG002'}, {'value': '121.8', 'spread': '14.89', 'groupId': 'OG003'}, {'value': '115.8', 'spread': '10.33', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.3', 'spread': '10.51', 'groupId': 'OG000'}, {'value': '71.2', 'spread': '8.24', 'groupId': 'OG001'}, {'value': '72.8', 'spread': '12.69', 'groupId': 'OG002'}, {'value': '75.7', 'spread': '12.15', 'groupId': 'OG003'}, {'value': '71.2', 'spread': '9.94', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '124.3', 'spread': '16.37', 'groupId': 'OG000'}, {'value': '118.3', 'spread': '12.06', 'groupId': 'OG001'}, {'value': '122.1', 'spread': '12.78', 'groupId': 'OG002'}, {'value': '122.4', 'spread': '17.38', 'groupId': 'OG003'}, {'value': '120.0', 'spread': '12.43', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: DBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '77.6', 'spread': '9.66', 'groupId': 'OG000'}, {'value': '71.9', 'spread': '10.13', 'groupId': 'OG001'}, {'value': '78.1', 'spread': '8.58', 'groupId': 'OG002'}, {'value': '73.8', 'spread': '10.05', 'groupId': 'OG003'}, {'value': '74.1', 'spread': '7.70', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24', 'description': 'Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.', 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74.7', 'spread': '10.37', 'groupId': 'OG000'}, {'value': '76.4', 'spread': '10.40', 'groupId': 'OG001'}, {'value': '75.0', 'spread': '12.72', 'groupId': 'OG002'}, {'value': '74.2', 'spread': '15.22', 'groupId': 'OG003'}, {'value': '75.5', 'spread': '11.81', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.4', 'spread': '10.45', 'groupId': 'OG000'}, {'value': '77.5', 'spread': '10.86', 'groupId': 'OG001'}, {'value': '75.5', 'spread': '12.06', 'groupId': 'OG002'}, {'value': '73.6', 'spread': '14.03', 'groupId': 'OG003'}, {'value': '76.5', 'spread': '11.17', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.1', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '75.3', 'spread': '9.18', 'groupId': 'OG001'}, {'value': '74.8', 'spread': '12.30', 'groupId': 'OG002'}, {'value': '71.9', 'spread': '12.76', 'groupId': 'OG003'}, {'value': '75.3', 'spread': '10.60', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '77.2', 'spread': '10.66', 'groupId': 'OG000'}, {'value': '79.4', 'spread': '11.07', 'groupId': 'OG001'}, {'value': '76.4', 'spread': '12.06', 'groupId': 'OG002'}, {'value': '72.4', 'spread': '14.00', 'groupId': 'OG003'}, {'value': '80.1', 'spread': '12.74', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '11.24', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '10.36', 'groupId': 'OG001'}, {'value': '75.8', 'spread': '10.92', 'groupId': 'OG002'}, {'value': '74.0', 'spread': '14.22', 'groupId': 'OG003'}, {'value': '77.8', 'spread': '11.37', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (1 hour pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '74.7', 'spread': '10.91', 'groupId': 'OG000'}, {'value': '77.4', 'spread': '14.51', 'groupId': 'OG001'}, {'value': '71.1', 'spread': '10.43', 'groupId': 'OG002'}, {'value': '71.4', 'spread': '15.02', 'groupId': 'OG003'}, {'value': '75.1', 'spread': '11.34', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (1 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '77.3', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '72.3', 'spread': '10.92', 'groupId': 'OG002'}, {'value': '69.2', 'spread': '15.58', 'groupId': 'OG003'}, {'value': '71.3', 'spread': '11.29', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.6', 'spread': '9.84', 'groupId': 'OG000'}, {'value': '75.0', 'spread': '11.54', 'groupId': 'OG001'}, {'value': '75.9', 'spread': '11.95', 'groupId': 'OG002'}, {'value': '70.9', 'spread': '15.77', 'groupId': 'OG003'}, {'value': '75.6', 'spread': '13.60', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '10.44', 'groupId': 'OG000'}, {'value': '79.9', 'spread': '11.68', 'groupId': 'OG001'}, {'value': '75.3', 'spread': '11.22', 'groupId': 'OG002'}, {'value': '72.7', 'spread': '13.81', 'groupId': 'OG003'}, {'value': '77.3', 'spread': '9.65', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '2.46', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '2.89', 'groupId': 'OG001'}, {'value': '16.3', 'spread': '1.74', 'groupId': 'OG002'}, {'value': '16.5', 'spread': '2.83', 'groupId': 'OG003'}, {'value': '16.1', 'spread': '1.75', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '2.35', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '2.14', 'groupId': 'OG002'}, {'value': '16.2', 'spread': '2.97', 'groupId': 'OG003'}, {'value': '15.9', 'spread': '1.83', 'groupId': 'OG004'}]}]}, {'title': 'Day 1 (1 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '2.42', 'groupId': 'OG002'}, {'value': '16.2', 'spread': '3.04', 'groupId': 'OG003'}, {'value': '15.8', 'spread': '1.98', 'groupId': 'OG004'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '2.33', 'groupId': 'OG001'}, {'value': '16.1', 'spread': '2.08', 'groupId': 'OG002'}, {'value': '16.2', 'spread': '2.99', 'groupId': 'OG003'}, {'value': '15.7', 'spread': '2.09', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '2.29', 'groupId': 'OG002'}, {'value': '16.8', 'spread': '2.77', 'groupId': 'OG003'}, {'value': '16.2', 'spread': '1.94', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (1 hour pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '15.8', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '16.3', 'spread': '2.25', 'groupId': 'OG002'}, {'value': '15.9', 'spread': '3.02', 'groupId': 'OG003'}, {'value': '16.1', 'spread': '1.88', 'groupId': 'OG004'}]}]}, {'title': 'Week 8 (1 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '2.18', 'groupId': 'OG001'}, {'value': '16.6', 'spread': '1.87', 'groupId': 'OG002'}, {'value': '16.4', 'spread': '3.00', 'groupId': 'OG003'}, {'value': '16.0', 'spread': '1.54', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '2.24', 'groupId': 'OG002'}, {'value': '16.2', 'spread': '2.56', 'groupId': 'OG003'}, {'value': '16.0', 'spread': '1.67', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16.1', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '2.40', 'groupId': 'OG002'}, {'value': '16.0', 'spread': '2.64', 'groupId': 'OG003'}, {'value': '15.8', 'spread': '2.08', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24', 'unitOfMeasure': 'respirations per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Screening: RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '868.9', 'spread': '152.10', 'groupId': 'OG000'}, {'value': '863.3', 'spread': '138.89', 'groupId': 'OG001'}, {'value': '849.6', 'spread': '136.23', 'groupId': 'OG002'}, {'value': '878.5', 'spread': '189.33', 'groupId': 'OG003'}, {'value': '863.2', 'spread': '143.31', 'groupId': 'OG004'}]}]}, {'title': 'Screening: PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '155.1', 'spread': '22.47', 'groupId': 'OG000'}, {'value': '154.3', 'spread': '19.60', 'groupId': 'OG001'}, {'value': '156.4', 'spread': '20.83', 'groupId': 'OG002'}, {'value': '154.8', 'spread': '24.53', 'groupId': 'OG003'}, {'value': '158.6', 'spread': '28.85', 'groupId': 'OG004'}]}]}, {'title': 'Screening: QRS Complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '90.2', 'spread': '7.23', 'groupId': 'OG000'}, {'value': '89.0', 'spread': '11.62', 'groupId': 'OG001'}, {'value': '88.6', 'spread': '8.33', 'groupId': 'OG002'}, {'value': '87.5', 'spread': '9.17', 'groupId': 'OG003'}, {'value': '90.6', 'spread': '6.82', 'groupId': 'OG004'}]}]}, {'title': 'Screening: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '389.1', 'spread': '26.58', 'groupId': 'OG000'}, {'value': '386.0', 'spread': '28.24', 'groupId': 'OG001'}, {'value': '389.1', 'spread': '27.69', 'groupId': 'OG002'}, {'value': '390.5', 'spread': '37.31', 'groupId': 'OG003'}, {'value': '384.0', 'spread': '29.36', 'groupId': 'OG004'}]}]}, {'title': 'Screening: QTcB Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '420.2', 'spread': '24.73', 'groupId': 'OG000'}, {'value': '418.0', 'spread': '20.17', 'groupId': 'OG001'}, {'value': '424.2', 'spread': '22.27', 'groupId': 'OG002'}, {'value': '416.8', 'spread': '22.81', 'groupId': 'OG003'}, {'value': '415.3', 'spread': '19.71', 'groupId': 'OG004'}]}]}, {'title': 'Screening: QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '409.3', 'spread': '19.44', 'groupId': 'OG000'}, {'value': '406.8', 'spread': '18.29', 'groupId': 'OG001'}, {'value': '411.9', 'spread': '19.10', 'groupId': 'OG002'}, {'value': '407.3', 'spread': '21.13', 'groupId': 'OG003'}, {'value': '404.3', 'spread': '17.83', 'groupId': 'OG004'}]}]}, {'title': 'Day 1: RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '852.3', 'spread': '149.92', 'groupId': 'OG000'}, {'value': '848.7', 'spread': '137.85', 'groupId': 'OG001'}, {'value': '849.4', 'spread': '126.73', 'groupId': 'OG002'}, {'value': '883.4', 'spread': '183.93', 'groupId': 'OG003'}, {'value': '836.4', 'spread': '117.33', 'groupId': 'OG004'}]}]}, {'title': 'Day 1: PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '153.9', 'spread': '20.71', 'groupId': 'OG000'}, {'value': '156.1', 'spread': '17.76', 'groupId': 'OG001'}, {'value': '153.6', 'spread': '22.14', 'groupId': 'OG002'}, {'value': '153.2', 'spread': '23.98', 'groupId': 'OG003'}, {'value': '158.2', 'spread': '34.39', 'groupId': 'OG004'}]}]}, {'title': 'Day 1: QRS Complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '87.6', 'spread': '8.43', 'groupId': 'OG000'}, {'value': '90.2', 'spread': '9.91', 'groupId': 'OG001'}, {'value': '87.3', 'spread': '8.34', 'groupId': 'OG002'}, {'value': '87.4', 'spread': '10.46', 'groupId': 'OG003'}, {'value': '89.1', 'spread': '8.13', 'groupId': 'OG004'}]}]}, {'title': 'Day 1: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '391.4', 'spread': '31.92', 'groupId': 'OG000'}, {'value': '382.1', 'spread': '33.15', 'groupId': 'OG001'}, {'value': '386.2', 'spread': '27.28', 'groupId': 'OG002'}, {'value': '392.5', 'spread': '33.74', 'groupId': 'OG003'}, {'value': '382.8', 'spread': '23.82', 'groupId': 'OG004'}]}]}, {'title': 'Day 1: QTcB Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '425.6', 'spread': '21.20', 'groupId': 'OG000'}, {'value': '416.9', 'spread': '18.02', 'groupId': 'OG001'}, {'value': '420.8', 'spread': '20.52', 'groupId': 'OG002'}, {'value': '418.9', 'spread': '18.21', 'groupId': 'OG003'}, {'value': '418.4', 'spread': '17.21', 'groupId': 'OG004'}]}]}, {'title': 'Day 1: QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '413.6', 'spread': '19.16', 'groupId': 'OG000'}, {'value': '404.8', 'spread': '19.19', 'groupId': 'OG001'}, {'value': '408.7', 'spread': '18.27', 'groupId': 'OG002'}, {'value': '409.5', 'spread': '15.95', 'groupId': 'OG003'}, {'value': '406.0', 'spread': '15.28', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '835.3', 'spread': '140.48', 'groupId': 'OG000'}, {'value': '825.1', 'spread': '117.52', 'groupId': 'OG001'}, {'value': '857.5', 'spread': '123.18', 'groupId': 'OG002'}, {'value': '867.4', 'spread': '191.34', 'groupId': 'OG003'}, {'value': '833.4', 'spread': '134.21', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '151.1', 'spread': '21.46', 'groupId': 'OG000'}, {'value': '158.4', 'spread': '20.83', 'groupId': 'OG001'}, {'value': '158.9', 'spread': '21.31', 'groupId': 'OG002'}, {'value': '152.7', 'spread': '24.00', 'groupId': 'OG003'}, {'value': '160.8', 'spread': '28.15', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: QRS Complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '88.5', 'spread': '8.81', 'groupId': 'OG000'}, {'value': '89.6', 'spread': '12.50', 'groupId': 'OG001'}, {'value': '89.6', 'spread': '9.51', 'groupId': 'OG002'}, {'value': '88.5', 'spread': '8.50', 'groupId': 'OG003'}, {'value': '90.0', 'spread': '7.07', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '382.6', 'spread': '27.92', 'groupId': 'OG000'}, {'value': '382.6', 'spread': '30.00', 'groupId': 'OG001'}, {'value': '389.5', 'spread': '29.46', 'groupId': 'OG002'}, {'value': '386.4', 'spread': '36.77', 'groupId': 'OG003'}, {'value': '382.0', 'spread': '23.45', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: QTcB Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '422.6', 'spread': '23.99', 'groupId': 'OG000'}, {'value': '423.1', 'spread': '21.21', 'groupId': 'OG001'}, {'value': '422.1', 'spread': '17.73', 'groupId': 'OG002'}, {'value': '418.1', 'spread': '20.29', 'groupId': 'OG003'}, {'value': '420.9', 'spread': '20.48', 'groupId': 'OG004'}]}]}, {'title': 'Week 2: QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '408.6', 'spread': '19.88', 'groupId': 'OG000'}, {'value': '408.9', 'spread': '20.89', 'groupId': 'OG001'}, {'value': '410.6', 'spread': '17.61', 'groupId': 'OG002'}, {'value': '406.7', 'spread': '18.85', 'groupId': 'OG003'}, {'value': '407.3', 'spread': '15.44', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '849.6', 'spread': '134.00', 'groupId': 'OG000'}, {'value': '842.7', 'spread': '121.90', 'groupId': 'OG001'}, {'value': '855.0', 'spread': '126.13', 'groupId': 'OG002'}, {'value': '919.6', 'spread': '199.85', 'groupId': 'OG003'}, {'value': '882.8', 'spread': '152.53', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '153.4', 'spread': '20.12', 'groupId': 'OG000'}, {'value': '158.6', 'spread': '19.44', 'groupId': 'OG001'}, {'value': '157.0', 'spread': '22.20', 'groupId': 'OG002'}, {'value': '154.3', 'spread': '25.04', 'groupId': 'OG003'}, {'value': '156.8', 'spread': '29.74', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: QRS Complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '87.4', 'spread': '9.88', 'groupId': 'OG000'}, {'value': '88.1', 'spread': '11.59', 'groupId': 'OG001'}, {'value': '89.4', 'spread': '9.69', 'groupId': 'OG002'}, {'value': '88.7', 'spread': '10.52', 'groupId': 'OG003'}, {'value': '90.5', 'spread': '7.80', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '385.8', 'spread': '29.34', 'groupId': 'OG000'}, {'value': '379.8', 'spread': '30.21', 'groupId': 'OG001'}, {'value': '387.3', 'spread': '21.80', 'groupId': 'OG002'}, {'value': '401.5', 'spread': '40.44', 'groupId': 'OG003'}, {'value': '392.0', 'spread': '28.49', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: QTcB Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '419.8', 'spread': '21.38', 'groupId': 'OG000'}, {'value': '414.7', 'spread': '16.98', 'groupId': 'OG001'}, {'value': '421.1', 'spread': '24.04', 'groupId': 'OG002'}, {'value': '419.3', 'spread': '16.86', 'groupId': 'OG003'}, {'value': '419.8', 'spread': '20.18', 'groupId': 'OG004'}]}]}, {'title': 'Week 8: QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '407.8', 'spread': '19.36', 'groupId': 'OG000'}, {'value': '402.5', 'spread': '18.11', 'groupId': 'OG001'}, {'value': '409.2', 'spread': '18.95', 'groupId': 'OG002'}, {'value': '412.8', 'spread': '18.30', 'groupId': 'OG003'}, {'value': '410.0', 'spread': '16.65', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '825.7', 'spread': '109.43', 'groupId': 'OG000'}, {'value': '847.5', 'spread': '138.15', 'groupId': 'OG001'}, {'value': '799.6', 'spread': '87.02', 'groupId': 'OG002'}, {'value': '925.9', 'spread': '224.34', 'groupId': 'OG003'}, {'value': '865.4', 'spread': '188.59', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '152.1', 'spread': '24.39', 'groupId': 'OG000'}, {'value': '157.1', 'spread': '17.66', 'groupId': 'OG001'}, {'value': '155.2', 'spread': '18.75', 'groupId': 'OG002'}, {'value': '156.6', 'spread': '26.49', 'groupId': 'OG003'}, {'value': '150.5', 'spread': '21.33', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: QRS Complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '90.1', 'spread': '7.69', 'groupId': 'OG000'}, {'value': '89.3', 'spread': '8.68', 'groupId': 'OG001'}, {'value': '90.8', 'spread': '8.85', 'groupId': 'OG002'}, {'value': '89.2', 'spread': '8.79', 'groupId': 'OG003'}, {'value': '90.4', 'spread': '6.33', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '386.6', 'spread': '25.90', 'groupId': 'OG000'}, {'value': '380.7', 'spread': '35.74', 'groupId': 'OG001'}, {'value': '381.3', 'spread': '23.89', 'groupId': 'OG002'}, {'value': '403.9', 'spread': '37.73', 'groupId': 'OG003'}, {'value': '385.8', 'spread': '30.81', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: QTcB Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '426.8', 'spread': '20.63', 'groupId': 'OG000'}, {'value': '418.0', 'spread': '14.16', 'groupId': 'OG001'}, {'value': '427.6', 'spread': '25.18', 'groupId': 'OG002'}, {'value': '421.6', 'spread': '21.94', 'groupId': 'OG003'}, {'value': '418.7', 'spread': '24.51', 'groupId': 'OG004'}]}]}, {'title': 'Week 16: QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '412.8', 'spread': '18.96', 'groupId': 'OG000'}, {'value': '404.8', 'spread': '17.65', 'groupId': 'OG001'}, {'value': '411.4', 'spread': '22.01', 'groupId': 'OG002'}, {'value': '414.9', 'spread': '17.40', 'groupId': 'OG003'}, {'value': '406.9', 'spread': '17.80', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: RR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '849.1', 'spread': '116.70', 'groupId': 'OG000'}, {'value': '850.6', 'spread': '136.92', 'groupId': 'OG001'}, {'value': '821.8', 'spread': '122.24', 'groupId': 'OG002'}, {'value': '894.9', 'spread': '164.80', 'groupId': 'OG003'}, {'value': '851.2', 'spread': '106.90', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '155.4', 'spread': '20.29', 'groupId': 'OG000'}, {'value': '157.0', 'spread': '17.56', 'groupId': 'OG001'}, {'value': '157.7', 'spread': '21.18', 'groupId': 'OG002'}, {'value': '158.9', 'spread': '23.25', 'groupId': 'OG003'}, {'value': '159.1', 'spread': '27.92', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: QRS Complex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '89.2', 'spread': '7.68', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '11.48', 'groupId': 'OG001'}, {'value': '89.4', 'spread': '8.10', 'groupId': 'OG002'}, {'value': '88.9', 'spread': '8.56', 'groupId': 'OG003'}, {'value': '89.4', 'spread': '7.77', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '384.7', 'spread': '28.57', 'groupId': 'OG000'}, {'value': '386.4', 'spread': '34.67', 'groupId': 'OG001'}, {'value': '388.3', 'spread': '27.18', 'groupId': 'OG002'}, {'value': '395.0', 'spread': '33.83', 'groupId': 'OG003'}, {'value': '383.5', 'spread': '24.31', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: QTcB Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '418.7', 'spread': '19.71', 'groupId': 'OG000'}, {'value': '418.7', 'spread': '19.47', 'groupId': 'OG001'}, {'value': '427.7', 'spread': '21.73', 'groupId': 'OG002'}, {'value': '419.5', 'spread': '23.12', 'groupId': 'OG003'}, {'value': '418.4', 'spread': '19.80', 'groupId': 'OG004'}]}]}, {'title': 'Week 24: QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '406.8', 'spread': '19.45', 'groupId': 'OG000'}, {'value': '407.3', 'spread': '21.52', 'groupId': 'OG001'}, {'value': '413.9', 'spread': '20.07', 'groupId': 'OG002'}, {'value': '410.8', 'spread': '20.48', 'groupId': 'OG003'}, {'value': '406.3', 'spread': '18.21', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1, Week 2, 8, 16, 24', 'description': "Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB).", 'unitOfMeasure': 'millisecond (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Electrocardiogram Parameter: Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '71.1', 'spread': '12.18', 'groupId': 'OG000'}, {'value': '71.2', 'spread': '10.77', 'groupId': 'OG001'}, {'value': '72.4', 'spread': '11.49', 'groupId': 'OG002'}, {'value': '71.3', 'spread': '14.47', 'groupId': 'OG003'}, {'value': '71.4', 'spread': '12.42', 'groupId': 'OG004'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '72.4', 'spread': '12.41', 'groupId': 'OG000'}, {'value': '72.5', 'spread': '11.34', 'groupId': 'OG001'}, {'value': '72.3', 'spread': '11.58', 'groupId': 'OG002'}, {'value': '70.7', 'spread': '14.36', 'groupId': 'OG003'}, {'value': '73.2', 'spread': '11.06', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '12.46', 'groupId': 'OG000'}, {'value': '74.1', 'spread': '10.38', 'groupId': 'OG001'}, {'value': '71.5', 'spread': '10.94', 'groupId': 'OG002'}, {'value': '72.0', 'spread': '13.98', 'groupId': 'OG003'}, {'value': '73.8', 'spread': '11.68', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '72.3', 'spread': '11.47', 'groupId': 'OG000'}, {'value': '72.8', 'spread': '11.66', 'groupId': 'OG001'}, {'value': '71.7', 'spread': '10.93', 'groupId': 'OG002'}, {'value': '68.4', 'spread': '15.47', 'groupId': 'OG003'}, {'value': '69.9', 'spread': '12.56', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '73.8', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '12.76', 'groupId': 'OG001'}, {'value': '75.9', 'spread': '8.69', 'groupId': 'OG002'}, {'value': '68.3', 'spread': '15.39', 'groupId': 'OG003'}, {'value': '72.2', 'spread': '14.41', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '71.9', 'spread': '9.81', 'groupId': 'OG000'}, {'value': '72.4', 'spread': '11.98', 'groupId': 'OG001'}, {'value': '74.7', 'spread': '11.55', 'groupId': 'OG002'}, {'value': '69.3', 'spread': '13.12', 'groupId': 'OG003'}, {'value': '71.5', 'spread': '9.09', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1, Week 2, 8, 16, 24', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Post-void Residual (PVR) Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '31.44', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '33.29', 'groupId': 'OG001'}, {'value': '24.8', 'spread': '36.99', 'groupId': 'OG002'}, {'value': '25.2', 'spread': '27.10', 'groupId': 'OG003'}, {'value': '24.5', 'spread': '35.56', 'groupId': 'OG004'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.9', 'spread': '30.43', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '17.16', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '34.58', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '28.03', 'groupId': 'OG003'}, {'value': '25.8', 'spread': '39.61', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.2', 'spread': '24.37', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '21.47', 'groupId': 'OG001'}, {'value': '17.7', 'spread': '21.36', 'groupId': 'OG002'}, {'value': '21.4', 'spread': '32.82', 'groupId': 'OG003'}, {'value': '21.2', 'spread': '29.39', 'groupId': 'OG004'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '37.61', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '15.33', 'groupId': 'OG001'}, {'value': '27.3', 'spread': '47.43', 'groupId': 'OG002'}, {'value': '25.7', 'spread': '26.40', 'groupId': 'OG003'}, {'value': '23.9', 'spread': '31.41', 'groupId': 'OG004'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17.2', 'spread': '25.05', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '24.27', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '33.84', 'groupId': 'OG002'}, {'value': '16.8', 'spread': '25.50', 'groupId': 'OG003'}, {'value': '17.6', 'spread': '22.14', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Week 2, 8, 16, 24', 'description': 'PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Urinalysis Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Urine Specific Gravity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Urine pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Urine Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Urine Ketones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Urine Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Urine Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Urine Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Urine Nitrite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Urine Leukocyte Esterase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening up to Week 24', 'description': 'Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (\\<1.003 and \\>1.030), urine pH (\\<4.5 and \\>8), protein (\\>=1 value in qualitative test), glucose (\\>=1 value in qualitative test), ketones (\\>=1 value in qualitative test), blood (\\>=1 value in qualitative test), bilirubin (\\>=1 value in qualitative test), nitrites (\\>=1), and leukocyte esterase (\\>=1) are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening up to Week 24', 'description': 'Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 112 days after the last dose (up to Week 24)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who had received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Anti-Drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG001', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG002', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'OG003', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 8, 16, 24', 'description': 'Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'FG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'FG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'FG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'FG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '41'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Randomized but not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '200', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'BG001', 'title': 'Tanezumab 1 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 1 milligram (mg) subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'BG002', 'title': 'Tanezumab 2.5 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 2.5 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'BG003', 'title': 'Tanezumab 10 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 10 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'BG004', 'title': 'Tanezumab 20 mg', 'description': 'Tanezumab (RN624 or PF-04383119) 20 mg subcutaneous injection at Day 1 and Week 8. Participants were followed up to Week 24.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '13.1', 'groupId': 'BG002'}, {'value': '51.3', 'spread': '14.5', 'groupId': 'BG003'}, {'value': '45.3', 'spread': '14.2', 'groupId': 'BG004'}, {'value': '48.1', 'spread': '14.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '170', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) analysis set included all randomized participants who had received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'dispFirstSubmitDate': '2012-01-27', 'completionDateStruct': {'date': '2011-01-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-12', 'studyFirstSubmitDate': '2009-10-20', 'dispFirstSubmitQcDate': '2012-08-23', 'resultsFirstSubmitDate': '2021-07-12', 'studyFirstSubmitQcDate': '2009-10-20', 'dispFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-12', 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Neurological Examination Findings', 'timeFrame': 'Week 2, 8, 16, Week 24 or early termination', 'description': 'A neurological examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.'}, {'measure': 'Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24', 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': 'The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment.'}, {'measure': 'Body Temperature', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24'}, {'measure': 'Systolic and Diastolic Blood Pressure', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24', 'description': 'Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.'}, {'measure': 'Heart Rate', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24'}, {'measure': 'Respiratory Rate', 'timeFrame': 'Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24'}, {'measure': 'Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals', 'timeFrame': 'Screening, Day 1, Week 2, 8, 16, 24', 'description': "Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB)."}, {'measure': 'Electrocardiogram Parameter: Heart Rate', 'timeFrame': 'Screening, Day 1, Week 2, 8, 16, 24'}, {'measure': 'Post-void Residual (PVR) Volume', 'timeFrame': 'Screening, Week 2, 8, 16, 24', 'description': 'PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.'}, {'measure': 'Number of Participants With Urinalysis Abnormalities', 'timeFrame': 'Screening up to Week 24', 'description': 'Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (\\<1.003 and \\>1.030), urine pH (\\<4.5 and \\>8), protein (\\>=1 value in qualitative test), glucose (\\>=1 value in qualitative test), ketones (\\>=1 value in qualitative test), blood (\\>=1 value in qualitative test), bilirubin (\\>=1 value in qualitative test), nitrites (\\>=1), and leukocyte esterase (\\>=1) are reported.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Screening up to Week 24', 'description': 'Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 112 days after the last dose (up to Week 24)', 'description': 'An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.'}, {'measure': 'Number of Participants With Anti-Drug Antibody (ADA)', 'timeFrame': 'Baseline, Week 8, 16, 24', 'description': 'Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Mean Average Daily Pain Score at Week 8', 'timeFrame': 'Baseline, Week 8', 'description': 'Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.'}, {'measure': 'Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score', 'timeFrame': 'Week 8, 16', 'description': 'Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.'}, {'measure': 'Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.'}, {'measure': 'Patient Global Assessment of Health Status Scores', 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': 'Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.'}, {'measure': 'Number of Participants With Global Response Assessment Scores', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.'}, {'measure': 'Number of Micturitions Per 24 Hours', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': 'The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.'}, {'measure': 'Number of Nocturnal Micturitions Per 24 Hours', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': "The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected."}, {'measure': 'Number of Micturition-related Urgency Episodes Per 24 Hours', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': 'The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.'}, {'measure': "Participant's Urge to Urinate", 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': "Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point."}, {'measure': 'Mean Voided Volume Per Micturition', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24', 'description': 'Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.'}, {'measure': "O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score", 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': 'The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.'}, {'measure': 'Brief Pain Inventory-Short Form (BPI-sf) Score', 'timeFrame': 'Baseline, Week 8, 16, 24', 'description': 'BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.'}, {'measure': 'Number of Participants With Patient Global Satisfaction Assessment Scores', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant\'s response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.'}, {'measure': 'Number of Participants With Patient Global Preference Assessment Score', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.'}, {'measure': 'Number of Participants With Willingness to Re-use Medicine Assessment', 'timeFrame': 'Week 8, 16, 24', 'description': 'Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).'}, {'measure': 'Euro Quality of Life (EQ-5D) - Health State Profile Utility Score', 'timeFrame': 'Baseline, Week 8, 16, 24', 'description': 'EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.'}, {'measure': 'Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score', 'timeFrame': 'Baseline, Week 2, 8, 16, 24', 'description': "PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life."}, {'measure': 'Percentage of Participants Who Received Rescue Medication', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.'}, {'measure': 'Number of Days of Rescue Medication Usage Per Week', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.'}, {'measure': 'Number of Rescue Medication Doses Used Per Week', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.'}, {'measure': 'Amount of Rescue Medication Taken Per Week', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.'}, {'measure': 'Serum Total Nerve Growth Factor (NGF) Levels', 'timeFrame': 'Baseline, Week 1, 2, 8, 16, 24', 'description': 'Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety'], 'conditions': ['Cystitis, Interstitial']}, 'referencesModule': {'references': [{'pmid': '32734597', 'type': 'DERIVED', 'citation': 'Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091035&StudyName=A%20Study%20To%20Investigate%20Tanezumab%20In%20Patients%20With%20Interstitial%20Cystitis/%20Painful%20Bladder%20Syndrome', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels", 'detailedDescription': 'This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.\n* Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.\n\nExclusion Criteria:\n\n* Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.\n* Body mass index (BMI) of \\>39 kg/m2.\n* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.\n* Patients with peripheral neuropathy.\n* Patients with Type I or type II diabetes mellitus who have an HbA1c \\> 8.0%.'}, 'identificationModule': {'nctId': 'NCT00999518', 'briefTitle': 'A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).', 'orgStudyIdInfo': {'id': 'A4091035'}, 'secondaryIdInfos': 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