Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT01200394
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2010-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619499', 'term': 'PF-00489791'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 16 (follow-up)', '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. AEs included both non-serious (AEs) and serious adverse events (SAEs)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 35, 'seriousNumAtRisk': 64, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.', 'otherNumAtRisk': 192, 'deathsNumAtRisk': 192, 'otherNumAffected': 104, 'seriousNumAtRisk': 192, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eye infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mastitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lip injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Injury, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neurodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neuropathic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Immobile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Procedural hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 192, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '195.130', 'spread': '171.8116', 'groupId': 'OG000'}, {'value': '182.378', 'spread': '156.5097', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.072', 'spread': '176.4360', 'groupId': 'OG000'}, {'value': '-6.539', 'spread': '128.4866', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9889', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.843', 'ciLowerLimit': '0.728', 'ciUpperLimit': '0.975', 'pValueComment': 'Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than 0% reduction in UACR compared to placebo.', 'estimateComment': 'Geometric mean ratio and corresponding 95% credible intervals were calculated.', 'groupDescription': 'Analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic blood pressure (BP) as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2402', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Posterior distribution was used to calculate a probability (presented as P-value) that PF-00489791 has a greater than or equal to 20% reduction in UACR compared to placebo.', 'groupDescription': 'ANCOVA model within an outlier robust Bayesian framework on normal logarithmic scale with treatment as fixed effect, baseline UACR and baseline supine systolic BP as covariate. Values were back-transformed from log scale. Model used informative prior distribution for placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (Day 5, 6, 7)', 'description': 'UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \\[Day 5, 6 of Week 12\\], and with last sample collected on the morning of scheduled clinic visit \\[Day 7 of Week 12\\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.', 'unitOfMeasure': 'mg/mmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.805', 'spread': '161.7282', 'groupId': 'OG000'}, {'value': '-14.268', 'spread': '94.8469', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.772', 'spread': '162.0838', 'groupId': 'OG000'}, {'value': '-2.546', 'spread': '179.5896', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.500', 'spread': '202.7600', 'groupId': 'OG000'}, {'value': '2.802', 'spread': '107.9582', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0382', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8759', 'ciLowerLimit': '0.7727', 'ciUpperLimit': '0.9927', 'groupDescription': 'Week 3: Mixed model repeated measures (MMRM) on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8311', 'ciLowerLimit': '0.7208', 'ciUpperLimit': '0.9584', 'groupDescription': 'Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8816', 'ciLowerLimit': '0.7427', 'ciUpperLimit': '1.0465', 'groupDescription': 'Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)', 'description': 'UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \\[Day 5, 6 of specified Week\\], and with last sample collected on the morning of scheduled clinic visit \\[Day 7 of specified Week\\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.', 'unitOfMeasure': 'mg/mmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '282.208', 'spread': '259.8496', 'groupId': 'OG000'}, {'value': '261.015', 'spread': '220.5260', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.302', 'spread': '247.4490', 'groupId': 'OG000'}, {'value': '-26.883', 'spread': '161.0038', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.278', 'spread': '256.7216', 'groupId': 'OG000'}, {'value': '10.699', 'spread': '290.5749', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.632', 'spread': '283.9874', 'groupId': 'OG000'}, {'value': '-5.371', 'spread': '207.3333', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.880', 'spread': '332.0766', 'groupId': 'OG000'}, {'value': '20.299', 'spread': '190.3546', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0297', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8565', 'ciLowerLimit': '0.7450', 'ciUpperLimit': '0.9847', 'groupDescription': 'Week 3: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0305', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8524', 'ciLowerLimit': '0.7376', 'ciUpperLimit': '0.9850', 'groupDescription': 'Week 6: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7937', 'ciLowerLimit': '0.6717', 'ciUpperLimit': '0.9378', 'groupDescription': 'Week 12: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1151', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8634', 'ciLowerLimit': '0.7190', 'ciUpperLimit': '1.0368', 'groupDescription': 'Week 16: MMRM on normal logarithmic scale with baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)', 'description': 'UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \\[Day 5, 6 of Week 3, 6, 12, 16\\], and with last sample collected on the morning of scheduled clinic visit \\[Day 7 of Week 3, 6, 12, 16\\]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.', 'unitOfMeasure': 'mg/mmol', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.575', 'spread': '11.9122', 'groupId': 'OG000'}, {'value': '37.740', 'spread': '9.8834', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.069', 'spread': '6.2868', 'groupId': 'OG000'}, {'value': '-0.156', 'spread': '4.6044', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.930', 'spread': '5.3513', 'groupId': 'OG000'}, {'value': '-0.755', 'spread': '5.2701', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.435', 'spread': '5.3757', 'groupId': 'OG000'}, {'value': '-1.463', 'spread': '5.1074', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.915', 'spread': '5.9005', 'groupId': 'OG000'}, {'value': '-1.659', 'spread': '6.0659', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3585', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9816', 'ciLowerLimit': '0.9434', 'ciUpperLimit': '1.0214', 'groupDescription': 'Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7475', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9939', 'ciLowerLimit': '0.9577', 'ciUpperLimit': '1.0315', 'groupDescription': 'Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9866', 'ciLowerLimit': '0.9488', 'ciUpperLimit': '1.0259', 'groupDescription': 'Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9146', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0024', 'ciLowerLimit': '0.9588', 'ciUpperLimit': '1.0481', 'groupDescription': 'Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3, 6, 12, 16 (follow-up)', 'description': 'The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\\^2) = 175\\*(sCr/88.4)\\^-1.154\\*(Age)\\^-0.203\\*(0.742 if female)\\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Supine Systolic BP, Week 0', 'categories': [{'measurements': [{'value': '137.20', 'groupId': 'OG000', 'lowerLimit': '135.01', 'upperLimit': '139.40'}, {'value': '131.81', 'groupId': 'OG001', 'lowerLimit': '130.53', 'upperLimit': '133.10'}]}]}, {'title': 'Supine Diastolic BP, Week 0', 'categories': [{'measurements': [{'value': '76.98', 'groupId': 'OG000', 'lowerLimit': '75.53', 'upperLimit': '78.42'}, {'value': '73.27', 'groupId': 'OG001', 'lowerLimit': '72.43', 'upperLimit': '74.11'}]}]}, {'title': 'Supine Mean BP, Week 0', 'categories': [{'measurements': [{'value': '107.27', 'groupId': 'OG000', 'lowerLimit': '105.66', 'upperLimit': '108.88'}, {'value': '102.68', 'groupId': 'OG001', 'lowerLimit': '101.74', 'upperLimit': '103.62'}]}]}, {'title': 'Supine Systolic BP, Week 3', 'categories': [{'measurements': [{'value': '136.68', 'groupId': 'OG000', 'lowerLimit': '134.30', 'upperLimit': '139.05'}, {'value': '136.15', 'groupId': 'OG001', 'lowerLimit': '134.74', 'upperLimit': '137.56'}]}]}, {'title': 'Supine Diastolic BP, Week 3', 'categories': [{'measurements': [{'value': '76.78', 'groupId': 'OG000', 'lowerLimit': '75.25', 'upperLimit': '78.31'}, {'value': '77.18', 'groupId': 'OG001', 'lowerLimit': '76.27', 'upperLimit': '78.10'}]}]}, {'title': 'Supine Mean BP, Week 3', 'categories': [{'measurements': [{'value': '107.06', 'groupId': 'OG000', 'lowerLimit': '105.32', 'upperLimit': '108.80'}, {'value': '106.90', 'groupId': 'OG001', 'lowerLimit': '105.86', 'upperLimit': '107.94'}]}]}, {'title': 'Supine Systolic BP, Week 6', 'categories': [{'measurements': [{'value': '137.41', 'groupId': 'OG000', 'lowerLimit': '134.90', 'upperLimit': '139.93'}, {'value': '136.94', 'groupId': 'OG001', 'lowerLimit': '135.42', 'upperLimit': '138.45'}]}]}, {'title': 'Supine Diastolic BP, Week 6', 'categories': [{'measurements': [{'value': '76.88', 'groupId': 'OG000', 'lowerLimit': '75.32', 'upperLimit': '78.43'}, {'value': '76.41', 'groupId': 'OG001', 'lowerLimit': '75.48', 'upperLimit': '77.35'}]}]}, {'title': 'Supine Mean BP, Week 6', 'categories': [{'measurements': [{'value': '107.37', 'groupId': 'OG000', 'lowerLimit': '105.58', 'upperLimit': '109.15'}, {'value': '106.70', 'groupId': 'OG001', 'lowerLimit': '105.62', 'upperLimit': '107.77'}]}]}, {'title': 'Supine Systolic BP, Week 12', 'categories': [{'measurements': [{'value': '136.89', 'groupId': 'OG000', 'lowerLimit': '133.73', 'upperLimit': '140.06'}, {'value': '137.70', 'groupId': 'OG001', 'lowerLimit': '135.79', 'upperLimit': '139.60'}]}]}, {'title': 'Supine Diastolic BP, Week 12', 'categories': [{'measurements': [{'value': '77.32', 'groupId': 'OG000', 'lowerLimit': '75.51', 'upperLimit': '79.13'}, {'value': '76.69', 'groupId': 'OG001', 'lowerLimit': '75.61', 'upperLimit': '77.78'}]}]}, {'title': 'Supine Mean BP, Week 12', 'categories': [{'measurements': [{'value': '107.41', 'groupId': 'OG000', 'lowerLimit': '105.27', 'upperLimit': '109.55'}, {'value': '107.14', 'groupId': 'OG001', 'lowerLimit': '105.85', 'upperLimit': '108.42'}]}]}, {'title': 'Supine Systolic BP, Week 16', 'categories': [{'measurements': [{'value': '138.38', 'groupId': 'OG000', 'lowerLimit': '135.51', 'upperLimit': '141.25'}, {'value': '138.89', 'groupId': 'OG001', 'lowerLimit': '137.15', 'upperLimit': '140.63'}]}]}, {'title': 'Supine Diastolic BP, Week 16', 'categories': [{'measurements': [{'value': '77.25', 'groupId': 'OG000', 'lowerLimit': '75.59', 'upperLimit': '78.92'}, {'value': '77.90', 'groupId': 'OG001', 'lowerLimit': '76.90', 'upperLimit': '78.91'}]}]}, {'title': 'Supine Mean BP, Week 16', 'categories': [{'measurements': [{'value': '108.00', 'groupId': 'OG000', 'lowerLimit': '106.10', 'upperLimit': '109.91'}, {'value': '108.47', 'groupId': 'OG001', 'lowerLimit': '107.31', 'upperLimit': '109.62'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.39', 'ciLowerLimit': '-7.94', 'ciUpperLimit': '-2.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2942', 'groupDescription': 'Supine Systolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.71', 'ciLowerLimit': '-5.38', 'ciUpperLimit': '-2.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.8490', 'groupDescription': 'Supine Diastolic BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.59', 'ciLowerLimit': '-6.46', 'ciUpperLimit': '-2.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9489', 'groupDescription': 'Supine Mean BP, Week 0: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-3.29', 'ciUpperLimit': '2.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4056', 'groupDescription': 'Supine Systolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6564', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '2.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9089', 'groupDescription': 'Supine Diastolic BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-2.20', 'ciUpperLimit': '1.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0334', 'groupDescription': 'Supine Mean BP, Week 3: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7491', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-3.42', 'ciUpperLimit': '2.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4926', 'groupDescription': 'Supine Systolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-2.29', 'ciUpperLimit': '1.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9235', 'groupDescription': 'Supine Diastolic BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-2.75', 'ciUpperLimit': '1.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0582', 'groupDescription': 'Supine Mean BP, Week 6: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6695', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '-2.90', 'ciUpperLimit': '4.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.8764', 'groupDescription': 'Supine Systolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5607', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-2.74', 'ciUpperLimit': '1.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0730', 'groupDescription': 'Supine Diastolic BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8297', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-2.78', 'ciUpperLimit': '2.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.2722', 'groupDescription': 'Supine Mean BP, Week 12: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7644', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-2.85', 'ciUpperLimit': '3.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7065', 'groupDescription': 'Supine Systolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '2.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9917', 'groupDescription': 'Supine Diastolic BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6838', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '2.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.1355', 'groupDescription': 'Supine Mean BP, Week 16: MMRM model included baseline, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. The unstructured covariance matrix was used to estimate variances and covariance within participant across time points.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 0, 3, 6, 12, 16 (follow-up)', 'description': "Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + (\\[systolic blood pressure - diastolic blood pressure\\]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart.", 'unitOfMeasure': 'millimeter of mercury (mmHg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '164.929', 'spread': '42.0837', 'groupId': 'OG000'}, {'value': '163.637', 'spread': '42.9529', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.232', 'spread': '23.9961', 'groupId': 'OG000'}, {'value': '2.691', 'spread': '20.6884', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.158', 'spread': '18.0835', 'groupId': 'OG000'}, {'value': '4.974', 'spread': '21.7977', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.139', 'spread': '20.7198', 'groupId': 'OG000'}, {'value': '8.110', 'spread': '22.3709', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.527', 'spread': '28.5175', 'groupId': 'OG000'}, {'value': '9.269', 'spread': '26.6470', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3, 6, 12, 16 (follow-up)', 'description': 'Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).', 'unitOfMeasure': 'micromole per liter (mcmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '177.88', 'spread': '231.154', 'groupId': 'OG000'}, {'value': '213.37', 'spread': '274.409', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.81', 'spread': '260.140', 'groupId': 'OG000'}, {'value': '-54.06', 'spread': '349.817', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.33', 'spread': '345.304', 'groupId': 'OG000'}, {'value': '-68.59', 'spread': '333.378', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-36.20', 'spread': '281.523', 'groupId': 'OG000'}, {'value': '-11.87', 'spread': '328.482', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.54', 'spread': '134.752', 'groupId': 'OG000'}, {'value': '-31.32', 'spread': '299.546', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9282', 'ciLowerLimit': '0.7297', 'ciUpperLimit': '1.1807', 'groupDescription': 'Week 3: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7998', 'ciLowerLimit': '0.6402', 'ciUpperLimit': '0.9990', 'groupDescription': 'Week 6: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0435', 'ciLowerLimit': '0.8211', 'ciUpperLimit': '1.3262', 'groupDescription': 'Week 12: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3733', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1154', 'ciLowerLimit': '0.8761', 'ciUpperLimit': '1.4201', 'groupDescription': 'Week 16: MMRM on normal logarithmic scale with change from baseline as response variable and baseline, baseline supine systolic BP, visit, treatment, baseline by visit interaction and treatment by visit interaction as fixed effects. Unstructured covariance matrix was used to estimate variances and covariance within participant across time points. Values were back-transformed from log scale.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 3, 6, 12, 16 (follow-up)', 'description': 'TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.019', 'spread': '3.4924', 'groupId': 'OG000'}, {'value': '4.330', 'spread': '8.6809', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.183', 'spread': '3.4600', 'groupId': 'OG000'}, {'value': '0.106', 'spread': '7.4909', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.317', 'spread': '2.9508', 'groupId': 'OG000'}, {'value': '-0.102', 'spread': '6.3317', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 16 (follow-up)', 'description': 'The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).', 'unitOfMeasure': 'milligram per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.659', 'spread': '0.4122', 'groupId': 'OG000'}, {'value': '1.695', 'spread': '0.4497', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.096', 'spread': '0.1844', 'groupId': 'OG000'}, {'value': '0.070', 'spread': '0.2890', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.104', 'spread': '0.3234', 'groupId': 'OG000'}, {'value': '0.075', 'spread': '0.3176', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 16 (follow-up)', 'description': 'Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Versus Time Summary of PF-00489791', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': '4 hours post-dose at Day 1 of Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6540', 'spread': '0.33644', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose at Day 1 of Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4156', 'spread': '0.44674', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose at Day 1 of Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9772', 'spread': '0.59610', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose at Day 1 of Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3514', 'spread': '0.40417', 'groupId': 'OG000'}]}]}, {'title': '4 hours post-dose at Day 1 of Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9274', 'spread': '0.52405', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose at Day 1 of Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3930', 'spread': '0.41593', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6', 'unitOfMeasure': 'microgram per millilitre (microgram/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic analysis set included all randomized and treated participants with at least 1 measured PF-00489791 concentration. Here, "Number analyzed" signifies number of participants evaluable for specified categories. This outcome measure was planned not to be analyzed for Placebo reporting arm.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.13', 'spread': '1.023', 'groupId': 'OG000'}, {'value': '7.39', 'spread': '1.135', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.856', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.975', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.009', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.986', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 16 (follow-up)', 'description': 'Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1).', 'unitOfMeasure': 'percentage of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Supine SBP <90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Standing SBP <90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP <50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Standing DBP <50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Supine Pulse Rate <40 bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Increase in Supine SBP >=30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Increase in Standing SBP >=30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Increase in Supine DBP >=20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Increase in Standing DBP >=20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Supine SBP >=30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Standing SBP >=30 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Supine DBP >=20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Standing DBP >=20 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 16 (follow-up)', 'description': 'Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than \\[\\<\\] 90 mmHg and increase or decrease of greater than or equal to \\[\\>=\\] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (\\<50 mmHg and increase or decrease of \\>=20 mmHg compared to baseline value), supine pulse rate (\\>120 beats per minute \\[bpm\\] or \\<40 bpm), standing pulse rate (\\>140 bpm or \\<40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set consists of all participants who received at least 1 dose of study medication. Here, 'Number analyzed' = Participants evaluable at specified time points for each arm, respectively."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Edema and Fluid Overload', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'Week 0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0, 3, 6, 12, 16 (follow-up)', 'description': 'Participants were assessed for signs of edema and fluid overload.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consists of all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Increased Use of Diuretics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 16 (follow-up)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consists of all participants who received at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 16 (follow-up)', 'description': 'Criteria for laboratory test abnormalities: Hematology (hemoglobin \\[\\<0.8\\*lower limit of normal{LLN}\\], hematocrit \\[\\<0.8\\*LLN\\], red blood cells \\[\\<0.8\\*LLN\\], platelet \\[\\<0.5\\*LLN/\\>1.75\\*upper limit of normal{ULN}\\], white blood cells \\[\\<0.6\\*LLN/\\>1.5\\*ULN\\], lymphocytes \\[\\<0.8\\*LLN/\\>1.2\\*ULN\\], neutrophils \\[\\<0.8\\*LLN/\\>1.2\\*ULN\\], basophils \\[\\>1.2\\*ULN\\], eosinophils \\[\\>1.2\\*ULN\\], monocytes \\[\\>1.2\\*ULN\\]); Liver Function (total/direct/indirect bilirubin \\[\\>1.5\\*ULN\\], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase \\[\\>3.0\\*ULN\\]); Renal Function (blood urea nitrogen/ creatinine \\[\\>1.3\\*ULN\\], uric acid \\[\\>1.2\\*ULN\\]); Electrolytes (sodium \\[\\<0.95\\*LLN/\\>1.05\\*ULN\\], potassium, chloride, calcium, bicarbonate \\[\\<0.9\\*LLN/\\>1.1\\*ULN\\]); Clinical Chemistry (glucose \\[\\<0.6\\*LLN/\\>1.5\\*ULN\\], glycosylated hemoglobin \\[\\>1.3\\*ULN\\], Creatine Kinase \\[\\>2.0\\*ULN\\], Amylase, Lipase\\[\\>1.5\\*ULN\\]).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set consists of all participants who received at least 1 dose of study medication. Here 'N' (Overall Number of Participants Analyzed) signifies participants evaluable for this measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 16 (follow-up)', 'description': 'An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: 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 medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set consists of all participants who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '164'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-00489791 tablet orally once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'PF-00489791 20 mg', 'description': 'PF-00489791 20 milligram (mg) tablet orally once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Full analysis set included all randomized participants who received at least 1 dose of study medication and had at least 1 post-dose efficacy measurement.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'dispFirstSubmitDate': '2017-08-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2010-09-10', 'dispFirstSubmitQcDate': '2017-08-09', 'resultsFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2010-09-10', 'dispFirstPostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-18', 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16', 'timeFrame': 'Baseline, Week 12, 16 (follow-up)', 'description': 'Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1).'}, {'measure': 'Number of Participants With Vital Signs Abnormalities', 'timeFrame': 'Baseline up to Week 16 (follow-up)', 'description': 'Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than \\[\\<\\] 90 mmHg and increase or decrease of greater than or equal to \\[\\>=\\] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (\\<50 mmHg and increase or decrease of \\>=20 mmHg compared to baseline value), supine pulse rate (\\>120 beats per minute \\[bpm\\] or \\<40 bpm), standing pulse rate (\\>140 bpm or \\<40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported.'}, {'measure': 'Number of Participants With Edema and Fluid Overload', 'timeFrame': 'Week 0, 3, 6, 12, 16 (follow-up)', 'description': 'Participants were assessed for signs of edema and fluid overload.'}, {'measure': 'Number of Participants With Increased Use of Diuretics', 'timeFrame': 'Baseline up to Week 16 (follow-up)'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Baseline up to Week 16 (follow-up)', 'description': 'Criteria for laboratory test abnormalities: Hematology (hemoglobin \\[\\<0.8\\*lower limit of normal{LLN}\\], hematocrit \\[\\<0.8\\*LLN\\], red blood cells \\[\\<0.8\\*LLN\\], platelet \\[\\<0.5\\*LLN/\\>1.75\\*upper limit of normal{ULN}\\], white blood cells \\[\\<0.6\\*LLN/\\>1.5\\*ULN\\], lymphocytes \\[\\<0.8\\*LLN/\\>1.2\\*ULN\\], neutrophils \\[\\<0.8\\*LLN/\\>1.2\\*ULN\\], basophils \\[\\>1.2\\*ULN\\], eosinophils \\[\\>1.2\\*ULN\\], monocytes \\[\\>1.2\\*ULN\\]); Liver Function (total/direct/indirect bilirubin \\[\\>1.5\\*ULN\\], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase \\[\\>3.0\\*ULN\\]); Renal Function (blood urea nitrogen/ creatinine \\[\\>1.3\\*ULN\\], uric acid \\[\\>1.2\\*ULN\\]); Electrolytes (sodium \\[\\<0.95\\*LLN/\\>1.05\\*ULN\\], potassium, chloride, calcium, bicarbonate \\[\\<0.9\\*LLN/\\>1.1\\*ULN\\]); Clinical Chemistry (glucose \\[\\<0.6\\*LLN/\\>1.5\\*ULN\\], glycosylated hemoglobin \\[\\>1.3\\*ULN\\], Creatine Kinase \\[\\>2.0\\*ULN\\], Amylase, Lipase\\[\\>1.5\\*ULN\\]).'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Week 16 (follow-up)', 'description': 'An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: 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 medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs)'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12', 'timeFrame': 'Baseline, Week 12 (Day 5, 6, 7)', 'description': 'UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \\[Day 5, 6 of Week 12\\], and with last sample collected on the morning of scheduled clinic visit \\[Day 7 of Week 12\\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16', 'timeFrame': 'Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)', 'description': 'UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \\[Day 5, 6 of specified Week\\], and with last sample collected on the morning of scheduled clinic visit \\[Day 7 of specified Week\\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.'}, {'measure': 'Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16', 'timeFrame': 'Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)', 'description': 'UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \\[Day 5, 6 of Week 3, 6, 12, 16\\], and with last sample collected on the morning of scheduled clinic visit \\[Day 7 of Week 3, 6, 12, 16\\]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.'}, {'measure': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16', 'timeFrame': 'Baseline, Week 3, 6, 12, 16 (follow-up)', 'description': 'The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\\^2) = 175\\*(sCr/88.4)\\^-1.154\\*(Age)\\^-0.203\\*(0.742 if female)\\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).'}, {'measure': 'Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16', 'timeFrame': 'Week 0, 3, 6, 12, 16 (follow-up)', 'description': "Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + (\\[systolic blood pressure - diastolic blood pressure\\]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart."}, {'measure': 'Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16', 'timeFrame': 'Baseline, Week 3, 6, 12, 16 (follow-up)', 'description': 'Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).'}, {'measure': 'Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16', 'timeFrame': 'Baseline, Week 3, 6, 12, 16 (follow-up)', 'description': 'TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).'}, {'measure': 'Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16', 'timeFrame': 'Baseline, Week 12, 16 (follow-up)', 'description': 'The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).'}, {'measure': 'Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16', 'timeFrame': 'Baseline, Week 12, 16 (follow-up)', 'description': 'Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).'}, {'measure': 'Plasma Concentration Versus Time Summary of PF-00489791', 'timeFrame': 'Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic nephropathy', 'chronic kidney disease', 'PF-00489791', 'phosphodiesterase', 'PDE5'], 'conditions': ['Diabetic Nephropathies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7331011&StudyName=A%20Phase%202%2C%20Placebo-Controlled%20Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20PF-00489791%20In%20Patients%20With%20Type%202%20Diabetes%20And%20Overt%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.\n* Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.\n* Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.\n\nExclusion Criteria:\n\n* Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.\n* Subjects with poorly controlled diabetes mellitus, defined as HbA1C \\>9%.\n* Subjects on combination ACE inhibitor/ARB therapy.'}, 'identificationModule': {'nctId': 'NCT01200394', 'briefTitle': 'A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY', 'orgStudyIdInfo': {'id': 'A7331011'}, 'secondaryIdInfos': [{'id': '2010-021358-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-00489791', 'interventionNames': ['Drug: PF-00489791']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-00489791', 'type': 'DRUG', 'description': 'Tablet, 20 mg once daily for 12 weeks', 'armGroupLabels': ['PF-00489791']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablet, placebo once daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Saadat Ansari Internal Medicine', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35805', 'city': 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