Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-29 @ 8:35 PM
Study NCT ID:
NCT01087203
Status:
TERMINATED
Last Update Posted:
2021-02-24
First Post:
2010-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'This study was terminated following a United States (US) Food and Drug Administration (FDA) partial clinical hold.'}}, '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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.', 'otherNumAtRisk': 35, 'otherNumAffected': 19, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.', 'otherNumAtRisk': 38, 'otherNumAffected': 24, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gravitational oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post procedural cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Electrocardiogram ST segment elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Areflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyporeflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.91', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '6.59', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-1.04', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '-2.10', 'spread': '3.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-2.28', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': 'Analysis of Covariance (ANCOVA) model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'Participants assessed their DPN pain during the past 24 hours using 11-point Numeric Rating Scale (NRS) with score range of 0 (no pain) to 10 ( worst possible pain). Baseline score was calculated as the mean of the average pain scores over the 3 days in the initial pain assessment period. The Week 16 value was the average DPN Pain score calculated for the 7 days prior to and including Day 113 (Week 16).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication. Last Observation Carried Forward (LOCF) method of imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.91', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '6.59', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1', 'categories': [{'measurements': [{'value': '-0.76', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '1.92', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '-1.78', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '1.68', 'groupId': 'OG000'}, {'value': '-2.04', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-0.98', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '-2.16', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-1.00', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '-2.14', 'spread': '3.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.332', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': 'Week 1: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.297', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'groupDescription': 'Week 2: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-1.81', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': 'Week 4: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-2.17', 'ciUpperLimit': '-0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': 'Week 6: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.32', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '-0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': 'Week 8: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '-0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'groupDescription': 'Week 12: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 4, 6, 8, 12', 'description': 'Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Greater than (>) 0%', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Greater than equal to (>=) 10%', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '>= 20%', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': '>= 30%', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': '>= 40%', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '>= 50%', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '>= 60%', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '>= 70%', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '>= 80%', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '>= 90%', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '= 100%', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Week 1: >= 30% Reduction', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: >= 50% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: >= 70% Reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: >= 90% Reduction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: >= 30% Reduction', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: >= 50% Reduction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: >= 70% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: >= 90% Reduction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: >= 30% Reduction', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: >= 50% Reduction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: >= 70% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: >= 90% Reduction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: >= 30% Reduction', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: >= 50% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: >= 70% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: >= 90% Reduction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: >= 30% Reduction', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: >= 50% Reduction', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: >= 70% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: >= 90% Reduction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: >= 30% Reduction', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: >= 50% Reduction', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: >= 70% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: >= 90% Reduction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: >= 30% Reduction', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: >= 50% Reduction', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: >= 70% Reduction', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: >= 90% Reduction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Worst Pain: Baseline', 'categories': [{'measurements': [{'value': '7.33', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '6.92', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain: Change at Week 8', 'categories': [{'measurements': [{'value': '-1.13', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-2.38', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Worst Pain: Change at Week 16', 'categories': [{'measurements': [{'value': '-1.10', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '3.06', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain: Baseline', 'categories': [{'measurements': [{'value': '6.17', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '5.62', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain: Change at Week 8', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Average Pain: Change at Week 16', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '2.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8, 16', 'description': 'BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consists of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses are provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consists of 7 item subsets (A to G) which measure the level of interference of pain on daily functions. Responses are given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument is scored by item and by dimension, with lower scores indicating less pain or pain interference.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. Here, Overall Number of Participants Analyzed signifies participants evaluable for this measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8, 16', 'description': 'Participant rated questionnaire to evaluate different symptoms of neuropathic pain (burning \\[superficial\\] spontaneous pain, pressing \\[deep\\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \\[P/D\\]) during past 24-hour period and included 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number of Participants Analyzed'= participants evaluable for this measure. 'Number Analyzed' = participants who were evaluable for this measure at given time point for each arm, respectively. LOCF method of imputation was used."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Pain Interference Index (PII);Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.23', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '2.41', 'groupId': 'OG001'}]}]}, {'title': 'PII: Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.12', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '3.15', 'groupId': 'OG001'}]}]}, {'title': 'PII: Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.64', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-1.24', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'PI General Activity: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.30', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'PI General Activity: Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.26', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '3.86', 'groupId': 'OG001'}]}]}, {'title': 'PI General Activity: Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '3.51', 'groupId': 'OG001'}]}]}, {'title': 'PI Walking Ability: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.43', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '5.54', 'spread': '2.80', 'groupId': 'OG001'}]}]}, {'title': 'PI Walking Ability: Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '-2.25', 'spread': '3.21', 'groupId': 'OG001'}]}]}, {'title': 'PI Walking Ability: Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '1.41', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'PI Sleep: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.70', 'spread': '2.78', 'groupId': 'OG000'}, {'value': '5.95', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'PI Sleep: Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '-2.34', 'spread': '3.60', 'groupId': 'OG001'}]}]}, {'title': 'PI Sleep: Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'PI Normal Work: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.33', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '4.78', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'PI Normal Work: Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.04', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '3.86', 'groupId': 'OG001'}]}]}, {'title': 'PI Normal Work: Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '3.51', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8, 16', 'description': 'BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses were provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consisted of 7 item subsets (A to G) as being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument was scored by item and by dimension, with lower scores indicated less pain or pain interference.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number of Participants Analyzed= participants evaluable for this measure. 'Number Analyzed' =participants who were evaluable for this measure at given time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.17', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '2.89', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-0.47', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 12, 16', 'description': 'The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number Analyzed' signifies those participants who were evaluable for this measure. LOCF method of imputation was used."}, {'type': 'SECONDARY', 'title': "Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy", 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 8, 12, 16', 'description': 'The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.22', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'EQ-5D: 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 or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Scoring formula developed by Euro Quality of life 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 indicated a better health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation Due to Lack of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '22'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 16', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Used Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Days Per Week of Rescue Medication Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.', 'unitOfMeasure': 'Days per week', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. Here, 'Overall Number of Participants Analyzed'=participants evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Amount of Rescue Medication Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2666.67', 'spread': '4090.46', 'groupId': 'OG000'}, {'value': '2759.26', 'spread': '3716.83', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2020.83', 'spread': '2939.53', 'groupId': 'OG000'}, {'value': '2178.57', 'spread': '3174.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1354.17', 'spread': '1997.17', 'groupId': 'OG000'}, {'value': '1464.29', 'spread': '2567.35', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1395.83', 'spread': '1978.03', 'groupId': 'OG000'}, {'value': '1250.00', 'spread': '2420.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1354.17', 'spread': '1997.17', 'groupId': 'OG000'}, {'value': '1160.71', 'spread': '2419.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1416.67', 'spread': '2009.04', 'groupId': 'OG000'}, {'value': '1160.71', 'spread': '2419.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1416.67', 'spread': '2009.04', 'groupId': 'OG000'}, {'value': '1160.71', 'spread': '2419.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.', 'unitOfMeasure': 'mg/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 112 days after last dose of study treatment (up to 169 days)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 24', 'description': 'Criteria:Hemoglobin(Hgb),hematocrit,red blood cell(RBC)count:less than(\\<)0.8\\*lower limit of normal(LLN), mean cell Hgb,mean corpuscular volume,mean corpuscular Hgb concentration,mean platelet volume:\\<0.9\\*LLNor\\>1.1\\*upper limit of normal(ULN),platelet:\\<0.5\\*LLN \\>1.75\\* ULN, lymphocyte,neutrophil:\\<0.8\\*LLN or\\>1.2\\*ULN,basophil, eosinophil,monocyte:\\>1.2\\*ULN;bilirubin(total, direct,)\\>1.5\\*ULN, aspartate and alanine aminotransferase,alkaline phosphatase:\\> 3.0\\*ULN;gamma GT\\>3.0;cholestrol,triglycerides:\\>1.3\\*ULN; total protein, albumin:\\<0.8\\*LLN or\\>1.2\\*ULN ;blood urea nitrogen,creatinine:\\>1.3\\*ULN,uric acid\\>1.2\\*ULN;sodium \\<0.95\\*LLNor\\>1.05\\*ULN,potassium,chloride,calcium,bicarbonate, magnesium:\\<0.9\\*LLN or \\>1.1\\*ULN;phosphate\\<0.8\\*LLN or\\>1.2\\*ULN;glucose \\<0.6\\*LLNor\\>1.5\\*ULN,glycosylated Hgb\\>1.3\\*ULN,creatine kinase \\>2.0\\*ULN;urine(specific gravity\\<1.003or\\>1.030;pH \\<4.8or\\>8;glucose,ketone,proteins,blood/Hgb,bilirubin,nitrite\\>=1;WBC, RBC≥20/HPF;hyaline cast≥1;epithelial cell\\>=6;bacteria \\>1);serum pregnancy \\>=1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number of Participants Analyzed'= total number of participants with at least one observation of the given laboratory test while on study treatment or during lag time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 24', 'description': "Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 24', 'description': 'Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 24', 'description': 'Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti Drug Antibody (ADA) for Tanezumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], '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).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for Tanezumab 20 mg group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.42', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '15.86', 'spread': '10.77', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.90', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '4.93', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '7.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.63', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '5.40', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.27', 'spread': '3.87', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '6.13', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.58', 'spread': '3.83', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '6.31', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '6.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, 16 and 24', 'description': 'Neurologic examination assessed 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 in order to complete the NIS. The NIS consists of 74 items (37 items assessed on the right side and 37 items assessed on the left side). Each item was rated on a scale of either 0 to 4 or 0 to 2 points, which were summed to calculate a total score. The NIS total score ranges from 0 to 244, where higher scores represent greater impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively. LOCF method of imputation was used."}, {'type': 'SECONDARY', 'title': 'Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.97', 'spread': '4.04', 'groupId': 'OG000'}, {'value': '7.57', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '2.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': "The NSC (Neuropathy symptoms and change) is a standardized instrument and has been used to evaluate participants for number of symptoms of peripheral neuropathy. The NSC score included 38 (muscle weakness, Q1-19; sensation, Q20-29; and autonomic symptoms, Q30-38) symptom questions where the participants indicated experiencing the number of symptoms (to any severity). The score ranged from 0 to 38, with higher scores indicated more symptoms. The change score is the participant's comparison of the symptoms at last evaluation to the symptoms at onset. A change from baseline \\> 0 indicated increased neuropathy.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively. LOCF method of imputation was used."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quantitative Sensory Testing (QST) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Baseline: VDT Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.64', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: CDT Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '1.18', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: HPDT 0.5 Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: HPDT 5.0 Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '2.00', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: HPDT 5.0-0.5 Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '1.38', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: VDT Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.31', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: CDT Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: HPDT 0.5 Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: HPDT 5.0 Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: HPDT 5.0-0.5 Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: VDT Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: CDT Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: HPDT 0.5 Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: HPDT 5.0 Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '1.20', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16:HPDT 5.0-0.5 Left Foot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.48', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: VDT Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: CDT Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: HPDT 0.5 Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: HPDT 5.0 Left', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16:HPDT 5.0-0.5 Left Thigh', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '1.38', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16', 'description': "QST was performed on dorsum of foot and anterior thigh (at midpoint of a line from inguinal crease to midpoint of patella) to assess and quantify sensory function in lower extremity. Parameters were selected to assess small fiber function such as cooling detection threshold (mainly small diameter myelinated fibers, A delta), heat pain detection threshold (A delta and C fiber functions), and large fiber function via vibration detection threshold. normal deviate scores derived from a normal distribution of a reference population. A standard deviate score of 0 corresponds to 50th percentile of control population. Standard deviate score 1.96 corresponds to 95th percentile of normal distribution and -1.96 corresponds to 5th percentile of normal distribution. A normal deviate score indicated how many standard deviations higher (in case of positive normal deviate score) or lower (in case of negative normal deviate score) participant's value was relative to mean of reference population.", 'unitOfMeasure': 'Normal deviate score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Change at Week 16: Distal Calves', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16: Distal Thighs', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16', 'description': 'IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. IENF density was assessed from skin biopsies taken from the distal calves and distal thigh.', 'unitOfMeasure': 'Fibers/mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.'}, {'type': 'SECONDARY', 'title': 'Plasma Tanezumab Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.66', 'spread': '59.710', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1752', 'spread': '610.54', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1316', 'spread': '438.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '591.9', 'spread': '232.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '475.9', 'spread': '430.22', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '265.6', 'spread': '282.50', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.77', 'spread': '59.975', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline(Day 1), Week 2, 4, 8, 12, 16, 24', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively."}, {'type': 'SECONDARY', 'title': 'Serum Nerve Growth Factor (NGF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.10', 'spread': '11.04', 'groupId': 'OG000'}, {'value': '45.54', 'spread': '12.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.15', 'spread': '11.21', 'groupId': 'OG000'}, {'value': '4193.9', 'spread': '1304', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.12', 'spread': '10.65', 'groupId': 'OG000'}, {'value': '2811.3', 'spread': '1284', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.69', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '2689.0', 'spread': '316.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1, Week 8, 16, 24', 'description': 'Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (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 received at least 1 dose of study medication. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for each group respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Subcutaneous Doses of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'OG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'classes': [{'title': '1 dose', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': '2 doses', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Week 8', 'description': 'Number of participants are reported based on the maximum number of Subcutaneous doses of either tanezumab or placebo received.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'FG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'BG001', 'title': 'Tanezumab', 'description': 'Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '61.6', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '60.7', 'spread': '10.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent to treat (ITT) analysis set included all randomized participants who 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': 73}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'dispFirstSubmitDate': '2012-01-27', 'completionDateStruct': {'date': '2011-07-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2010-03-11', 'dispFirstSubmitQcDate': '2012-08-23', 'resultsFirstSubmitDate': '2021-01-13', 'studyFirstSubmitQcDate': '2010-03-12', 'dispFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-22', 'studyFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Subcutaneous Doses of Study Medication', 'timeFrame': 'Day 1 up to Week 8', 'description': 'Number of participants are reported based on the maximum number of Subcutaneous doses of either tanezumab or placebo received.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'Participants assessed their DPN pain during the past 24 hours using 11-point Numeric Rating Scale (NRS) with score range of 0 (no pain) to 10 ( worst possible pain). Baseline score was calculated as the mean of the average pain scores over the 3 days in the initial pain assessment period. The Week 16 value was the average DPN Pain score calculated for the 7 days prior to and including Day 113 (Week 16).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12', 'timeFrame': 'Baseline, Week 1, 2, 4, 6, 8, 12', 'description': 'Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.'}, {'measure': 'Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16', 'timeFrame': 'Week 16', 'description': 'Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain.'}, {'measure': 'Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.'}, {'measure': 'Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16', 'timeFrame': 'Baseline, Week 8, 16', 'description': 'BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consists of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses are provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consists of 7 item subsets (A to G) which measure the level of interference of pain on daily functions. Responses are given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument is scored by item and by dimension, with lower scores indicating less pain or pain interference.'}, {'measure': 'Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 8, 16', 'description': 'Participant rated questionnaire to evaluate different symptoms of neuropathic pain (burning \\[superficial\\] spontaneous pain, pressing \\[deep\\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \\[P/D\\]) during past 24-hour period and included 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.'}, {'measure': 'Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16', 'timeFrame': 'Baseline, Week 8, 16', 'description': 'BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses were provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consisted of 7 item subsets (A to G) as being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument was scored by item and by dimension, with lower scores indicated less pain or pain interference.'}, {'measure': "Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16", 'timeFrame': 'Baseline, Week 4, 8, 12, 16', 'description': 'The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).'}, {'measure': "Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy", 'timeFrame': 'Week 4, 8, 12, 16', 'description': 'The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).'}, {'measure': 'Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': 'EQ-5D: 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 or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Scoring formula developed by Euro Quality of life 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 indicated a better health state.'}, {'measure': 'Time to Discontinuation Due to Lack of Efficacy', 'timeFrame': 'Baseline up to Week 16'}, {'measure': 'Number of Participants Who Used Rescue Medication', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.'}, {'measure': 'Days Per Week of Rescue Medication Usage', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.'}, {'measure': 'Amount of Rescue Medication Taken', 'timeFrame': 'Week 1, 2, 4, 6, 8, 12, 16', 'description': 'Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 112 days after last dose of study treatment (up to 169 days)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Values', 'timeFrame': 'Baseline up to Week 24', 'description': 'Criteria:Hemoglobin(Hgb),hematocrit,red blood cell(RBC)count:less than(\\<)0.8\\*lower limit of normal(LLN), mean cell Hgb,mean corpuscular volume,mean corpuscular Hgb concentration,mean platelet volume:\\<0.9\\*LLNor\\>1.1\\*upper limit of normal(ULN),platelet:\\<0.5\\*LLN \\>1.75\\* ULN, lymphocyte,neutrophil:\\<0.8\\*LLN or\\>1.2\\*ULN,basophil, eosinophil,monocyte:\\>1.2\\*ULN;bilirubin(total, direct,)\\>1.5\\*ULN, aspartate and alanine aminotransferase,alkaline phosphatase:\\> 3.0\\*ULN;gamma GT\\>3.0;cholestrol,triglycerides:\\>1.3\\*ULN; total protein, albumin:\\<0.8\\*LLN or\\>1.2\\*ULN ;blood urea nitrogen,creatinine:\\>1.3\\*ULN,uric acid\\>1.2\\*ULN;sodium \\<0.95\\*LLNor\\>1.05\\*ULN,potassium,chloride,calcium,bicarbonate, magnesium:\\<0.9\\*LLN or \\>1.1\\*ULN;phosphate\\<0.8\\*LLN or\\>1.2\\*ULN;glucose \\<0.6\\*LLNor\\>1.5\\*ULN,glycosylated Hgb\\>1.3\\*ULN,creatine kinase \\>2.0\\*ULN;urine(specific gravity\\<1.003or\\>1.030;pH \\<4.8or\\>8;glucose,ketone,proteins,blood/Hgb,bilirubin,nitrite\\>=1;WBC, RBC≥20/HPF;hyaline cast≥1;epithelial cell\\>=6;bacteria \\>1);serum pregnancy \\>=1.'}, {'measure': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to Week 24', 'description': "Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented."}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline Physical Examination', 'timeFrame': 'Baseline up to Week 24', 'description': 'Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.'}, {'measure': 'Number of Participants With Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline up to Week 24', 'description': 'Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.'}, {'measure': 'Number of Participants With Anti Drug Antibody (ADA) for Tanezumab', '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).'}, {'measure': 'Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12, 16 and 24', 'description': 'Neurologic examination assessed 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 in order to complete the NIS. The NIS consists of 74 items (37 items assessed on the right side and 37 items assessed on the left side). Each item was rated on a scale of either 0 to 4 or 0 to 2 points, which were summed to calculate a total score. The NIS total score ranges from 0 to 244, where higher scores represent greater impairment.'}, {'measure': 'Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline, Week 16', 'description': "The NSC (Neuropathy symptoms and change) is a standardized instrument and has been used to evaluate participants for number of symptoms of peripheral neuropathy. The NSC score included 38 (muscle weakness, Q1-19; sensation, Q20-29; and autonomic symptoms, Q30-38) symptom questions where the participants indicated experiencing the number of symptoms (to any severity). The score ranged from 0 to 38, with higher scores indicated more symptoms. The change score is the participant's comparison of the symptoms at last evaluation to the symptoms at onset. A change from baseline \\> 0 indicated increased neuropathy."}, {'measure': 'Change From Baseline in Quantitative Sensory Testing (QST) at Week 16', 'timeFrame': 'Baseline, Week 16', 'description': "QST was performed on dorsum of foot and anterior thigh (at midpoint of a line from inguinal crease to midpoint of patella) to assess and quantify sensory function in lower extremity. Parameters were selected to assess small fiber function such as cooling detection threshold (mainly small diameter myelinated fibers, A delta), heat pain detection threshold (A delta and C fiber functions), and large fiber function via vibration detection threshold. normal deviate scores derived from a normal distribution of a reference population. A standard deviate score of 0 corresponds to 50th percentile of control population. Standard deviate score 1.96 corresponds to 95th percentile of normal distribution and -1.96 corresponds to 5th percentile of normal distribution. A normal deviate score indicated how many standard deviations higher (in case of positive normal deviate score) or lower (in case of negative normal deviate score) participant's value was relative to mean of reference population."}, {'measure': 'Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF', 'timeFrame': 'Baseline, Week 16', 'description': 'IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. IENF density was assessed from skin biopsies taken from the distal calves and distal thigh.'}, {'measure': 'Plasma Tanezumab Concentration', 'timeFrame': 'Baseline(Day 1), Week 2, 4, 8, 12, 16, 24'}, {'measure': 'Serum Nerve Growth Factor (NGF)', 'timeFrame': 'Day 1, Week 8, 16, 24', 'description': 'Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetic peripheral neuropathy', 'tanezumab', 'diabetic neuropathies', 'diabetic polyneuropathy', 'diabetic neuropathy painful'], 'conditions': ['Diabetic Peripheral Neuropathy']}, 'referencesModule': {'references': [{'pmid': '25594611', 'type': 'DERIVED', 'citation': 'Bramson C, Herrmann DN, Carey W, Keller D, Brown MT, West CR, Verburg KM, Dyck PJ. Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain. Pain Med. 2015 Jun;16(6):1163-76. doi: 10.1111/pme.12677. Epub 2015 Jan 16.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091031&StudyName=A%20Study%20Of%20The%20Analgesic%20%28Pain-Relief%29%20Effects%20Of%20Tanezumab%20In%20Adult%20Patients%20With%20Diabetic%20Peripheral%20Neuropathy%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.', 'detailedDescription': 'This study was terminated on 18 November 2010 following a US FDA clinical hold for the tanezumab diabetic peripheral neuropathy clinical study which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization.\n* Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes.\n* Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.\n* A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening.\n* Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.\n\nExclusion Criteria:\n\n* Painful neuropathies other than diabetic peripheral neuropathy.\n* Other types of diabetic neuropathies.\n* Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening are not eligible for participation.\n* Patients with fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain.\n* Patients with a present (current) history of sciatica are not eligible for participation.\n* The presence of pain conditions that cannot be distinguished from diabetic peripheral neuropathy such as peripheral vascular disease.\n* Amputations dues to diabetes.\n* Patient with any clinically significant medical condition or laboratory abnormalities.\n* History, diagnosis, or signs and symptoms of clinically significant neurological diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).\n* History, diagnosis, or signs and symptoms of clinically significant psychiatric diseases (such as bipoar disorder or schizophrenia).\n* History of known alcohol, analgesic or drug abuse within 2 years of Screening.\n* Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study."}, 'identificationModule': {'nctId': 'NCT01087203', 'briefTitle': 'A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY', 'orgStudyIdInfo': {'id': 'A4091031'}, 'secondaryIdInfos': [{'id': 'DPN PHASE 2B', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 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