Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-21 @ 1:19 AM
Study NCT ID:
NCT01301456
Status:
COMPLETED
Last Update Posted:
2018-02-09
First Post:
2011-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov', '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': {'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.', 'otherNumAtRisk': 15, 'otherNumAffected': 8, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.', 'otherNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.', 'otherNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.', 'otherNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.', 'otherNumAtRisk': 7, 'otherNumAffected': 4, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Stage 2: PF-04856883 12.0 mg', 'description': 'Participants received single dose of PF-04856883 12.0 mg subcutaneous injection on Day 1, 8, 15 and 22 in Stage 2.', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.', 'otherNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus genital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG008', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '5', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36mg Single Dose', 'description': 'Participants received subcutaneous injection of PF-04856883 4 mg by a 4-week follow up period in Stage 1'}, {'id': 'OG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG008', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': 'Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG008', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Maximum PR Interval IFB: >=25 or 50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Maximum QTcB Interval IFB: 30-<60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Maximum QTcF Interval IFB: 30-<60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': "ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (\\>=) 25 percent (%) increase when baseline greater than (\\>)200 milliseconds (msec); or increase \\>=50% when baseline less than or equal to (\\<=200) msec; 2) QRS interval: \\>=25% increase when baseline \\>100 msec; \\>=50% increase when baseline \\<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - \\<480 msec, 480 - \\<500 msec \\>=500; absolute change 30 - \\<60, \\>=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Sign Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG008', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50', 'description': 'Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (\\<) 40 beats per minute (bpm) or greater than (\\>) 120 bpm, standing/supine systolic pulse \\< 40 bpm or \\> 140 bpm, systolic blood pressure of \\>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \\<90 mmHg, diastolic blood pressure \\>=20 mmHg change from baseline and diastolic blood pressure \\<50 mm Hg.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG008', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '7', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': 'Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) \\<0.8\\*lower limit of the reference range (LLRR); leukocytes \\<0.6\\*LLRR or \\>1.5\\*ULRR; platelet count \\<0.5\\*LLRR or \\>1.75\\*upper limit of the reference range (ULRR); total neutrophils (absolute \\[abs\\]), lymphocytes (abs) \\<0.8\\*LLRR or \\>1.2\\*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) \\>1.2\\*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin \\>1.5\\*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \\>3\\*ULRR, albumin, total protein \\<0.8\\*LLRR or \\>1.2\\*ULRR; blood urea nitrogen (BUN), creatinine \\>1.3\\*ULRR; glucose (fasting) \\<0.6\\*LLRR or \\>1.5\\*ULRR; uric acid \\>1.2\\* ULRR; sodium \\<0.95\\*LLRR or \\>1.05\\*ULRR; potassium, chloride, bicarbonate, calcium \\<0.9\\*LLRR or \\>1.1\\*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =\\>20/ high-power field (HPF).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '181.2', 'spread': '85', 'groupId': 'OG000'}, {'value': '324.7', 'spread': '61', 'groupId': 'OG001'}, {'value': '793.7', 'spread': '65', 'groupId': 'OG002'}, {'value': '1855', 'spread': '66', 'groupId': 'OG003'}, {'value': '1776', 'spread': '21', 'groupId': 'OG004'}, {'value': '2006', 'spread': '52', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Day 1 (n =5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '1369', 'spread': '17', 'groupId': 'OG000'}, {'value': '1203', 'spread': '20', 'groupId': 'OG001'}, {'value': '1027', 'spread': '29', 'groupId': 'OG002'}, {'value': '1407', 'spread': '29', 'groupId': 'OG003'}]}]}, {'title': 'Day 22 (n =5, 7, 5, 6)', 'categories': [{'measurements': [{'value': '1802', 'spread': '33', 'groupId': 'OG000'}, {'value': '2757', 'spread': '26', 'groupId': 'OG001'}, {'value': '3030', 'spread': '42', 'groupId': 'OG002'}, {'value': '3046', 'spread': '24', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '168', 'groupId': 'OG000', 'lowerLimit': '72.0', 'upperLimit': '336'}, {'value': '120', 'groupId': 'OG001', 'lowerLimit': '48.0', 'upperLimit': '168'}, {'value': '120', 'groupId': 'OG002', 'lowerLimit': '48.0', 'upperLimit': '168'}, {'value': '120', 'groupId': 'OG003', 'lowerLimit': '48.0', 'upperLimit': '120'}, {'value': '120', 'groupId': 'OG004', 'lowerLimit': '72.0', 'upperLimit': '168'}, {'value': '122', 'groupId': 'OG005', 'lowerLimit': '120', 'upperLimit': '168'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Day 1 (n =5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000', 'lowerLimit': '336', 'upperLimit': '336'}, {'value': '336', 'groupId': 'OG001', 'lowerLimit': '335', 'upperLimit': '336'}, {'value': '335', 'groupId': 'OG002', 'lowerLimit': '24.1', 'upperLimit': '336'}, {'value': '336', 'groupId': 'OG003', 'lowerLimit': '336', 'upperLimit': '336'}]}]}, {'title': 'Day 22 (n =5, 7, 5, 6)', 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '72.0'}, {'value': '72.0', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '72.0'}, {'value': '72.0', 'groupId': 'OG002', 'lowerLimit': '48.0', 'upperLimit': '72.1'}, {'value': '60.0', 'groupId': 'OG003', 'lowerLimit': '0.000', 'upperLimit': '120'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '44920', 'spread': '112', 'groupId': 'OG000'}, {'value': '95190', 'spread': '76', 'groupId': 'OG001'}, {'value': '295200', 'spread': '46', 'groupId': 'OG002'}, {'value': '527100', 'spread': '53', 'groupId': 'OG003'}, {'value': '711300', 'spread': '13', 'groupId': 'OG004'}, {'value': '652000', 'spread': '50', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Day 1 (n =5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '85370', 'spread': '38', 'groupId': 'OG000'}, {'value': '99780', 'spread': '41', 'groupId': 'OG001'}, {'value': '89390', 'spread': '35', 'groupId': 'OG002'}, {'value': '91130', 'spread': '27', 'groupId': 'OG003'}]}]}, {'title': 'Day 22 (n =5, 7, 5, 6)', 'categories': [{'measurements': [{'value': '269000', 'spread': '32', 'groupId': 'OG000'}, {'value': '377400', 'spread': '28', 'groupId': 'OG001'}, {'value': '396300', 'spread': '28', 'groupId': 'OG002'}, {'value': '430500', 'spread': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22', 'description': 'Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL/F) of PF-04856883: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.14', 'spread': '84', 'groupId': 'OG000'}, {'value': '84.08', 'spread': '59', 'groupId': 'OG001'}, {'value': '40.60', 'spread': '68', 'groupId': 'OG002'}, {'value': '34.13', 'spread': '35', 'groupId': 'OG003'}, {'value': '33.73', 'spread': '14', 'groupId': 'OG004'}, {'value': '55.32', 'spread': '42', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'description': 'It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.', 'unitOfMeasure': 'milliliter per hour (mL/hr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL/F) of PF-04856883: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.67', 'spread': '28', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not estimable since values were below the limit of quantification.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not estimable since values were below the limit of quantification.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not estimable since values were below the limit of quantification.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22', 'description': 'It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.', 'unitOfMeasure': 'mL/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '18760', 'spread': '90', 'groupId': 'OG000'}, {'value': '21710', 'spread': '59', 'groupId': 'OG001'}, {'value': '9191', 'spread': '51', 'groupId': 'OG002'}, {'value': '7127', 'spread': '40', 'groupId': 'OG003'}, {'value': '8437', 'spread': '17', 'groupId': 'OG004'}, {'value': '10010', 'spread': '67', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'unitOfMeasure': 'milliliter (mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '9550', 'spread': '29', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not estimable since values were below the limit of quantification.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not estimable since values were below the limit of quantification.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data was not estimable since values were below the limit of quantification.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22', 'unitOfMeasure': 'mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '146.3', 'spread': '13.614', 'groupId': 'OG000'}, {'value': '179.7', 'spread': '14.572', 'groupId': 'OG001'}, {'value': '147.0', 'spread': '18.520', 'groupId': 'OG002'}, {'value': '133.8', 'spread': '23.936', 'groupId': 'OG003'}, {'value': '173.7', 'spread': '7.0238', 'groupId': 'OG004'}, {'value': '131.6', 'spread': '45.883', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '149.4', 'spread': '21.870', 'groupId': 'OG000'}, {'value': '135.0', 'spread': '43.980', 'groupId': 'OG001'}, {'value': '143.8', 'spread': '20.565', 'groupId': 'OG002'}, {'value': '145.0', 'spread': '37.000', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all randomized participants who had received at least one dose of study treatment and had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'title': 'Baseline (n =15, 5, 6, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '656.35', 'spread': '114.496', 'groupId': 'OG000'}, {'value': '834.03', 'spread': '158.952', 'groupId': 'OG001'}, {'value': '712.11', 'spread': '88.942', 'groupId': 'OG002'}, {'value': '796.14', 'spread': '208.733', 'groupId': 'OG003'}, {'value': '660.64', 'spread': '110.833', 'groupId': 'OG004'}, {'value': '652.20', 'spread': '48.707', 'groupId': 'OG005'}, {'value': '636.57', 'spread': '119.662', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)', 'categories': [{'measurements': [{'value': '7.72', 'spread': '89.366', 'groupId': 'OG000'}, {'value': '77.82', 'spread': '125.011', 'groupId': 'OG001'}, {'value': '-89.38', 'spread': '58.909', 'groupId': 'OG002'}, {'value': '-101.47', 'spread': '31.725', 'groupId': 'OG003'}, {'value': '-68.05', 'spread': '111.431', 'groupId': 'OG004'}, {'value': '-141.27', 'spread': '15.975', 'groupId': 'OG005'}, {'value': '-153.04', 'spread': '41.501', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 8 (n =15, 5, 5, 6, 7, 5, 6)', 'categories': [{'measurements': [{'value': '-4.82', 'spread': '75.396', 'groupId': 'OG000'}, {'value': '10.37', 'spread': '158.368', 'groupId': 'OG001'}, {'value': '0.85', 'spread': '125.384', 'groupId': 'OG002'}, {'value': '-82.51', 'spread': '48.898', 'groupId': 'OG003'}, {'value': '-28.36', 'spread': '61.456', 'groupId': 'OG004'}, {'value': '-123.43', 'spread': '68.219', 'groupId': 'OG005'}, {'value': '-39.60', 'spread': '85.256', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3 and 8', 'description': 'Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC', 'unitOfMeasure': 'milligram*hour per deciliter (mg*hr/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Baseline (n =7, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '606.49', 'spread': '158.249', 'groupId': 'OG000'}, {'value': '811.36', 'spread': '131.145', 'groupId': 'OG001'}, {'value': '756.17', 'spread': '240.430', 'groupId': 'OG002'}, {'value': '800.66', 'spread': '206.776', 'groupId': 'OG003'}, {'value': '723.57', 'spread': '220.872', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 3 (n =7, 4, 5, 6, 5)', 'categories': [{'measurements': [{'value': '44.41', 'spread': '74.405', 'groupId': 'OG000'}, {'value': '-97.03', 'spread': '55.692', 'groupId': 'OG001'}, {'value': '-103.00', 'spread': '118.759', 'groupId': 'OG002'}, {'value': '-98.38', 'spread': '114.644', 'groupId': 'OG003'}, {'value': '-68.52', 'spread': '153.127', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 15 (n =7, 4, 6, 6, 6)', 'categories': [{'measurements': [{'value': '-18.48', 'spread': '50.874', 'groupId': 'OG000'}, {'value': '-265.64', 'spread': '89.889', 'groupId': 'OG001'}, {'value': '-293.04', 'spread': '163.074', 'groupId': 'OG002'}, {'value': '-254.54', 'spread': '144.897', 'groupId': 'OG003'}, {'value': '-240.65', 'spread': '252.349', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 24 (n =7, 4, 7, 6, 5)', 'categories': [{'measurements': [{'value': '-6.20', 'spread': '46.238', 'groupId': 'OG000'}, {'value': '-146.61', 'spread': '78.863', 'groupId': 'OG001'}, {'value': '-207.12', 'spread': '89.687', 'groupId': 'OG002'}, {'value': '-242.35', 'spread': '231.302', 'groupId': 'OG003'}, {'value': '-121.13', 'spread': '258.528', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 29 (n =7, 4, 7, 6, 5)', 'categories': [{'measurements': [{'value': '30.08', 'spread': '59.490', 'groupId': 'OG000'}, {'value': '-55.43', 'spread': '74.973', 'groupId': 'OG001'}, {'value': '-157.54', 'spread': '88.652', 'groupId': 'OG002'}, {'value': '-192.97', 'spread': '185.056', 'groupId': 'OG003'}, {'value': '-106.58', 'spread': '171.297', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 50 (n =7, 3, 6, 6, 6)', 'categories': [{'measurements': [{'value': '50.26', 'spread': '81.717', 'groupId': 'OG000'}, {'value': '-48.82', 'spread': '80.733', 'groupId': 'OG001'}, {'value': '-33.77', 'spread': '250.859', 'groupId': 'OG002'}, {'value': '-125.06', 'spread': '217.403', 'groupId': 'OG003'}, {'value': '-23.99', 'spread': '123.611', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 15, 24, 29 and 50', 'description': 'Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'mg*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'title': 'Baseline (n =15, 5, 6, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '222.18', 'spread': '139.981', 'groupId': 'OG000'}, {'value': '227.07', 'spread': '142.547', 'groupId': 'OG001'}, {'value': '210.80', 'spread': '95.536', 'groupId': 'OG002'}, {'value': '235.84', 'spread': '130.071', 'groupId': 'OG003'}, {'value': '105.34', 'spread': '19.118', 'groupId': 'OG004'}, {'value': '257.73', 'spread': '127.358', 'groupId': 'OG005'}, {'value': '283.59', 'spread': '156.831', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)', 'categories': [{'measurements': [{'value': '68.79', 'spread': '115.555', 'groupId': 'OG000'}, {'value': '22.99', 'spread': '32.706', 'groupId': 'OG001'}, {'value': '35.09', 'spread': '57.093', 'groupId': 'OG002'}, {'value': '12.15', 'spread': '54.495', 'groupId': 'OG003'}, {'value': '59.06', 'spread': '94.643', 'groupId': 'OG004'}, {'value': '83.82', 'spread': '70.182', 'groupId': 'OG005'}, {'value': '13.72', 'spread': '98.682', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)', 'categories': [{'measurements': [{'value': '34.23', 'spread': '103.279', 'groupId': 'OG000'}, {'value': '22.05', 'spread': '89.419', 'groupId': 'OG001'}, {'value': '39.96', 'spread': '38.941', 'groupId': 'OG002'}, {'value': '-50.51', 'spread': '40.624', 'groupId': 'OG003'}, {'value': '38.04', 'spread': '15.736', 'groupId': 'OG004'}, {'value': '-0.36', 'spread': '50.674', 'groupId': 'OG005'}, {'value': '1.08', 'spread': '47.135', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3 and 8', 'description': 'Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'milliUnit*hour per liter (mU*hr/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Baseline (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '175.26', 'spread': '62.218', 'groupId': 'OG000'}, {'value': '176.65', 'spread': '76.040', 'groupId': 'OG001'}, {'value': '267.29', 'spread': '111.497', 'groupId': 'OG002'}, {'value': '162.96', 'spread': '111.688', 'groupId': 'OG003'}, {'value': '190.64', 'spread': '83.945', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 3 (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '38.32', 'spread': '62.135', 'groupId': 'OG000'}, {'value': '13.29', 'spread': '55.764', 'groupId': 'OG001'}, {'value': '19.50', 'spread': '134.651', 'groupId': 'OG002'}, {'value': '27.99', 'spread': '32.655', 'groupId': 'OG003'}, {'value': '87.67', 'spread': '124.052', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 15 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-16.77', 'spread': '20.530', 'groupId': 'OG000'}, {'value': '-39.16', 'spread': '42.930', 'groupId': 'OG001'}, {'value': '-10.07', 'spread': '172.044', 'groupId': 'OG002'}, {'value': '-51.69', 'spread': '77.925', 'groupId': 'OG003'}, {'value': '-24.36', 'spread': '85.633', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 24 (n =7, 4, 7, 6, 6)', 'categories': [{'measurements': [{'value': '0.23', 'spread': '55.174', 'groupId': 'OG000'}, {'value': '-15.19', 'spread': '38.900', 'groupId': 'OG001'}, {'value': '6.87', 'spread': '184.830', 'groupId': 'OG002'}, {'value': '4.18', 'spread': '51.903', 'groupId': 'OG003'}, {'value': '60.11', 'spread': '189.287', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 29 (n =7, 5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '8.25', 'spread': '55.799', 'groupId': 'OG000'}, {'value': '3.98', 'spread': '11.218', 'groupId': 'OG001'}, {'value': '12.71', 'spread': '115.095', 'groupId': 'OG002'}, {'value': '-1.61', 'spread': '85.866', 'groupId': 'OG003'}, {'value': '15.70', 'spread': '38.476', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 50 (n =7, 5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '8.14', 'spread': '29.909', 'groupId': 'OG000'}, {'value': '-16.64', 'spread': '33.133', 'groupId': 'OG001'}, {'value': '-57.14', 'spread': '116.193', 'groupId': 'OG002'}, {'value': '49.27', 'spread': '81.874', 'groupId': 'OG003'}, {'value': '-26.78', 'spread': '81.518', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 15, 24, 29 and 50', 'description': 'Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'mU*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'title': 'Baseline (n =15, 5, 6, 6, 7,5, 7)', 'categories': [{'measurements': [{'value': '15.53', 'spread': '5.332', 'groupId': 'OG000'}, {'value': '16.63', 'spread': '7.743', 'groupId': 'OG001'}, {'value': '16.43', 'spread': '4.306', 'groupId': 'OG002'}, {'value': '16.80', 'spread': '5.711', 'groupId': 'OG003'}, {'value': '10.64', 'spread': '1.156', 'groupId': 'OG004'}, {'value': '16.17', 'spread': '4.531', 'groupId': 'OG005'}, {'value': '18.37', 'spread': '7.395', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 3 (n =15, 5, 5, 6, 7, 5, 6)', 'categories': [{'measurements': [{'value': '2.15', 'spread': '3.653', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '1.465', 'groupId': 'OG001'}, {'value': '1.65', 'spread': '4.958', 'groupId': 'OG002'}, {'value': '1.05', 'spread': '1.885', 'groupId': 'OG003'}, {'value': '4.30', 'spread': '4.102', 'groupId': 'OG004'}, {'value': '5.34', 'spread': '2.584', 'groupId': 'OG005'}, {'value': '2.34', 'spread': '4.333', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 8 (n =15, 4, 5, 6, 7, 5, 6)', 'categories': [{'measurements': [{'value': '0.79', 'spread': '2.864', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '1.806', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '1.651', 'groupId': 'OG002'}, {'value': '-2.74', 'spread': '1.380', 'groupId': 'OG003'}, {'value': '1.70', 'spread': '1.544', 'groupId': 'OG004'}, {'value': '-0.45', 'spread': '2.883', 'groupId': 'OG005'}, {'value': '-0.38', 'spread': '1.565', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3 and 8', 'description': 'Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Baseline (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '13.47', 'spread': '4.315', 'groupId': 'OG000'}, {'value': '14.59', 'spread': '4.205', 'groupId': 'OG001'}, {'value': '15.63', 'spread': '4.293', 'groupId': 'OG002'}, {'value': '11.74', 'spread': '5.210', 'groupId': 'OG003'}, {'value': '14.14', 'spread': '5.211', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 3 (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '1.68', 'spread': '2.182', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '4.705', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '4.757', 'groupId': 'OG002'}, {'value': '3.16', 'spread': '1.613', 'groupId': 'OG003'}, {'value': '3.49', 'spread': '4.452', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 15 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-1.65', 'spread': '1.493', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '2.821', 'groupId': 'OG001'}, {'value': '-1.92', 'spread': '6.930', 'groupId': 'OG002'}, {'value': '-0.17', 'spread': '4.135', 'groupId': 'OG003'}, {'value': '-0.50', 'spread': '4.871', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 24 (n =7, 4, 7, 6, 6)', 'categories': [{'measurements': [{'value': '0.55', 'spread': '3.518', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '4.312', 'groupId': 'OG001'}, {'value': '-0.99', 'spread': '6.220', 'groupId': 'OG002'}, {'value': '1.63', 'spread': '2.994', 'groupId': 'OG003'}, {'value': '1.21', 'spread': '5.784', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 29 (n =7, 5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '3.864', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '2.545', 'groupId': 'OG001'}, {'value': '-0.59', 'spread': '4.144', 'groupId': 'OG002'}, {'value': '0.59', 'spread': '2.733', 'groupId': 'OG003'}, {'value': '0.41', 'spread': '2.090', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 50 (n =7, 5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '-0.17', 'spread': '1.978', 'groupId': 'OG000'}, {'value': '-1.83', 'spread': '2.015', 'groupId': 'OG001'}, {'value': '-4.10', 'spread': '5.265', 'groupId': 'OG002'}, {'value': '1.06', 'spread': '1.474', 'groupId': 'OG003'}, {'value': '-2.90', 'spread': '3.711', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 3, 15, 24, 29 and 50', 'description': 'Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 2: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'title': 'Baseline (n =15, 5, 6, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '161.67', 'spread': '27.102', 'groupId': 'OG000'}, {'value': '219.60', 'spread': '44.557', 'groupId': 'OG001'}, {'value': '171.17', 'spread': '23.752', 'groupId': 'OG002'}, {'value': '174.00', 'spread': '48.949', 'groupId': 'OG003'}, {'value': '168.57', 'spread': '38.336', 'groupId': 'OG004'}, {'value': '145.60', 'spread': '21.606', 'groupId': 'OG005'}, {'value': '158.14', 'spread': '35.362', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 2 (n =15, 5, 6, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '3.13', 'spread': '11.807', 'groupId': 'OG000'}, {'value': '13.60', 'spread': '32.393', 'groupId': 'OG001'}, {'value': '-18.67', 'spread': '21.011', 'groupId': 'OG002'}, {'value': '-20.50', 'spread': '20.433', 'groupId': 'OG003'}, {'value': '-22.14', 'spread': '34.090', 'groupId': 'OG004'}, {'value': '-35.00', 'spread': '12.369', 'groupId': 'OG005'}, {'value': '-29.71', 'spread': '30.804', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 4 (n =15, 5, 5, 6, 7, 5, 6)', 'categories': [{'measurements': [{'value': '2.73', 'spread': '17.161', 'groupId': 'OG000'}, {'value': '19.60', 'spread': '35.683', 'groupId': 'OG001'}, {'value': '-12.40', 'spread': '17.358', 'groupId': 'OG002'}, {'value': '-10.33', 'spread': '15.744', 'groupId': 'OG003'}, {'value': '-30.71', 'spread': '13.841', 'groupId': 'OG004'}, {'value': '-27.00', 'spread': '8.803', 'groupId': 'OG005'}, {'value': '-28.33', 'spread': '21.942', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 6 (n =15, 5, 4, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '18.80', 'spread': '29.547', 'groupId': 'OG000'}, {'value': '26.40', 'spread': '32.377', 'groupId': 'OG001'}, {'value': '10.25', 'spread': '29.056', 'groupId': 'OG002'}, {'value': '-8.33', 'spread': '27.156', 'groupId': 'OG003'}, {'value': '-6.29', 'spread': '15.850', 'groupId': 'OG004'}, {'value': '-16.80', 'spread': '19.176', 'groupId': 'OG005'}, {'value': '-16.14', 'spread': '22.319', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)', 'categories': [{'measurements': [{'value': '12.13', 'spread': '32.822', 'groupId': 'OG000'}, {'value': '-13.80', 'spread': '46.949', 'groupId': 'OG001'}, {'value': '23.80', 'spread': '56.857', 'groupId': 'OG002'}, {'value': '19.33', 'spread': '16.476', 'groupId': 'OG003'}, {'value': '8.00', 'spread': '21.223', 'groupId': 'OG004'}, {'value': '3.40', 'spread': '27.309', 'groupId': 'OG005'}, {'value': '-2.71', 'spread': '16.530', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 22 (n =14, 4, 5, 6, 6, 5, 7)', 'categories': [{'measurements': [{'value': '11.00', 'spread': '28.205', 'groupId': 'OG000'}, {'value': '23.75', 'spread': '61.163', 'groupId': 'OG001'}, {'value': '33.40', 'spread': '76.064', 'groupId': 'OG002'}, {'value': '11.17', 'spread': '26.446', 'groupId': 'OG003'}, {'value': '2.17', 'spread': '15.065', 'groupId': 'OG004'}, {'value': '1.20', 'spread': '18.847', 'groupId': 'OG005'}, {'value': '-0.57', 'spread': '13.377', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 29 (n =14, 5, 5, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '22.00', 'spread': '33.439', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '27.763', 'groupId': 'OG001'}, {'value': '27.80', 'spread': '29.575', 'groupId': 'OG002'}, {'value': '0.33', 'spread': '16.978', 'groupId': 'OG003'}, {'value': '1.57', 'spread': '21.220', 'groupId': 'OG004'}, {'value': '-3.80', 'spread': '22.643', 'groupId': 'OG005'}, {'value': '-2.29', 'spread': '19.551', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 2, 4, 6, 15, 22 and 29', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Baseline (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '148.00', 'spread': '33.317', 'groupId': 'OG000'}, {'value': '186.80', 'spread': '23.059', 'groupId': 'OG001'}, {'value': '191.14', 'spread': '56.153', 'groupId': 'OG002'}, {'value': '187.29', 'spread': '45.756', 'groupId': 'OG003'}, {'value': '158.50', 'spread': '18.447', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 2 (n =5, 4, 7, 7, 5)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '15.281', 'groupId': 'OG000'}, {'value': '-26.75', 'spread': '15.108', 'groupId': 'OG001'}, {'value': '-15.14', 'spread': '21.217', 'groupId': 'OG002'}, {'value': '-23.43', 'spread': '35.142', 'groupId': 'OG003'}, {'value': '-10.40', 'spread': '18.461', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 4 (n =5, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '7.60', 'spread': '6.427', 'groupId': 'OG000'}, {'value': '-14.80', 'spread': '24.284', 'groupId': 'OG001'}, {'value': '-14.86', 'spread': '48.657', 'groupId': 'OG002'}, {'value': '-20.33', 'spread': '22.818', 'groupId': 'OG003'}, {'value': '-1.50', 'spread': '27.384', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 6 (n =7, 4, 7, 7, 6)', 'categories': [{'measurements': [{'value': '-1.71', 'spread': '40.240', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '14.080', 'groupId': 'OG001'}, {'value': '-44.86', 'spread': '38.451', 'groupId': 'OG002'}, {'value': '-8.00', 'spread': '42.942', 'groupId': 'OG003'}, {'value': '-15.83', 'spread': '8.909', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 8 (n =6, 5, 7, 5, 6)', 'categories': [{'measurements': [{'value': '2.50', 'spread': '17.627', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '19.967', 'groupId': 'OG001'}, {'value': '-37.43', 'spread': '42.383', 'groupId': 'OG002'}, {'value': '2.60', 'spread': '73.449', 'groupId': 'OG003'}, {'value': '24.50', 'spread': '47.618', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 22 (n =7, 4, 7, 6, 6)', 'categories': [{'measurements': [{'value': '13.29', 'spread': '15.294', 'groupId': 'OG000'}, {'value': '-4.25', 'spread': '13.817', 'groupId': 'OG001'}, {'value': '-39.57', 'spread': '25.468', 'groupId': 'OG002'}, {'value': '-14.17', 'spread': '38.270', 'groupId': 'OG003'}, {'value': '-0.33', 'spread': '51.181', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 23 (n =7, 4, 6, 6, 5)', 'categories': [{'measurements': [{'value': '7.71', 'spread': '23.894', 'groupId': 'OG000'}, {'value': '-27.25', 'spread': '27.293', 'groupId': 'OG001'}, {'value': '-40.33', 'spread': '18.327', 'groupId': 'OG002'}, {'value': '-17.50', 'spread': '73.519', 'groupId': 'OG003'}, {'value': '-24.00', 'spread': '29.967', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 25 (n =7, 5, 6, 6, 5)', 'categories': [{'measurements': [{'value': '13.43', 'spread': '13.113', 'groupId': 'OG000'}, {'value': '-16.60', 'spread': '43.443', 'groupId': 'OG001'}, {'value': '-44.67', 'spread': '27.667', 'groupId': 'OG002'}, {'value': '-23.33', 'spread': '52.936', 'groupId': 'OG003'}, {'value': '-16.20', 'spread': '36.513', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 27 (n =7, 5, 6, 6, 5)', 'categories': [{'measurements': [{'value': '8.57', 'spread': '21.110', 'groupId': 'OG000'}, {'value': '-21.60', 'spread': '15.821', 'groupId': 'OG001'}, {'value': '-37.33', 'spread': '17.963', 'groupId': 'OG002'}, {'value': '-34.67', 'spread': '35.803', 'groupId': 'OG003'}, {'value': '12.00', 'spread': '71.039', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 30 (n =7, 5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '2.43', 'spread': '12.739', 'groupId': 'OG000'}, {'value': '-14.20', 'spread': '17.908', 'groupId': 'OG001'}, {'value': '-22.29', 'spread': '26.171', 'groupId': 'OG002'}, {'value': '-9.33', 'spread': '32.898', 'groupId': 'OG003'}, {'value': '15.40', 'spread': '37.964', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 36 (n =6, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-10.50', 'spread': '32.415', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '37.846', 'groupId': 'OG001'}, {'value': '1.86', 'spread': '25.373', 'groupId': 'OG002'}, {'value': '-5.83', 'spread': '32.009', 'groupId': 'OG003'}, {'value': '27.67', 'spread': '59.594', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 43 (n =7, 5, 5, 6, 6)', 'categories': [{'measurements': [{'value': '18.71', 'spread': '22.552', 'groupId': 'OG000'}, {'value': '12.80', 'spread': '29.064', 'groupId': 'OG001'}, {'value': '13.20', 'spread': '17.254', 'groupId': 'OG002'}, {'value': '-1.17', 'spread': '41.787', 'groupId': 'OG003'}, {'value': '8.33', 'spread': '18.991', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Baseline (n =7, 5, 7, 7 ,6)', 'categories': [{'measurements': [{'value': '166.19', 'spread': '35.437', 'groupId': 'OG000'}, {'value': '212.43', 'spread': '52.764', 'groupId': 'OG001'}, {'value': '205.56', 'spread': '51.907', 'groupId': 'OG002'}, {'value': '202.43', 'spread': '38.900', 'groupId': 'OG003'}, {'value': '186.13', 'spread': '33.839', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 30 (n =7, 5, 7, 6 ,5)', 'categories': [{'measurements': [{'value': '172.36', 'spread': '38.825', 'groupId': 'OG000'}, {'value': '191.20', 'spread': '43.953', 'groupId': 'OG001'}, {'value': '172.24', 'spread': '48.067', 'groupId': 'OG002'}, {'value': '174.08', 'spread': '41.437', 'groupId': 'OG003'}, {'value': '192.87', 'spread': '58.037', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-21.16', 'ciLowerLimit': '-43.26', 'ciUpperLimit': '0.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.766', 'groupDescription': 'Day 30', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-34.18', 'ciLowerLimit': '-54.20', 'ciUpperLimit': '-14.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.189', 'groupDescription': 'Day 30', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.044', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-33.67', 'ciLowerLimit': '-54.50', 'ciUpperLimit': '-12.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '15.806', 'groupDescription': 'Day 30', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.857', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.93', 'ciLowerLimit': '-24.16', 'ciUpperLimit': '18.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.111', 'groupDescription': 'Day 30', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 30', 'description': 'A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Day 29 (n =7, 5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.547', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.288', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '0.212', 'groupId': 'OG002'}, {'value': '-0.42', 'spread': '0.440', 'groupId': 'OG003'}, {'value': '-0.40', 'spread': '0.430', 'groupId': 'OG004'}]}]}, {'title': 'Day 50 (n =6, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.769', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.335', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.326', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '0.754', 'groupId': 'OG003'}, {'value': '-0.40', 'spread': '0.580', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.419', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.21', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.251', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.077', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.41', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.224', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.147', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.34', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.230', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.086', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.43', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.244', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 29 and 50', 'description': 'HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'title': 'Baseline (n =15, 5, 6, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '270.60', 'spread': '34.618', 'groupId': 'OG000'}, {'value': '289.20', 'spread': '48.329', 'groupId': 'OG001'}, {'value': '279.67', 'spread': '30.507', 'groupId': 'OG002'}, {'value': '304.83', 'spread': '45.155', 'groupId': 'OG003'}, {'value': '263.43', 'spread': '34.942', 'groupId': 'OG004'}, {'value': '259.80', 'spread': '53.644', 'groupId': 'OG005'}, {'value': '273.71', 'spread': '36.036', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '1.13', 'spread': '14.461', 'groupId': 'OG000'}, {'value': '20.20', 'spread': '10.986', 'groupId': 'OG001'}, {'value': '4.20', 'spread': '18.295', 'groupId': 'OG002'}, {'value': '5.67', 'spread': '13.095', 'groupId': 'OG003'}, {'value': '4.29', 'spread': '16.720', 'groupId': 'OG004'}, {'value': '-13.60', 'spread': '23.554', 'groupId': 'OG005'}, {'value': '-12.29', 'spread': '10.579', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)', 'categories': [{'measurements': [{'value': '-5.67', 'spread': '17.839', 'groupId': 'OG000'}, {'value': '-20.40', 'spread': '25.393', 'groupId': 'OG001'}, {'value': '-16.40', 'spread': '13.502', 'groupId': 'OG002'}, {'value': '-9.17', 'spread': '25.135', 'groupId': 'OG003'}, {'value': '13.33', 'spread': '24.188', 'groupId': 'OG004'}, {'value': '-9.60', 'spread': '22.267', 'groupId': 'OG005'}, {'value': '-3.00', 'spread': '11.165', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '19.627', 'groupId': 'OG000'}, {'value': '8.40', 'spread': '30.876', 'groupId': 'OG001'}, {'value': '7.20', 'spread': '29.660', 'groupId': 'OG002'}, {'value': '-4.50', 'spread': '16.109', 'groupId': 'OG003'}, {'value': '15.86', 'spread': '24.024', 'groupId': 'OG004'}, {'value': '1.40', 'spread': '17.344', 'groupId': 'OG005'}, {'value': '-4.43', 'spread': '18.867', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 15 and 29', 'unitOfMeasure': 'micromole per liter (mcmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Baseline (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '281.14', 'spread': '57.875', 'groupId': 'OG000'}, {'value': '309.40', 'spread': '47.600', 'groupId': 'OG001'}, {'value': '301.14', 'spread': '43.690', 'groupId': 'OG002'}, {'value': '291.29', 'spread': '37.911', 'groupId': 'OG003'}, {'value': '303.67', 'spread': '47.272', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 8 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-5.29', 'spread': '19.678', 'groupId': 'OG000'}, {'value': '-8.20', 'spread': '11.100', 'groupId': 'OG001'}, {'value': '-12.14', 'spread': '12.668', 'groupId': 'OG002'}, {'value': '-9.17', 'spread': '23.043', 'groupId': 'OG003'}, {'value': '-10.17', 'spread': '21.720', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 15 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-1.86', 'spread': '21.146', 'groupId': 'OG000'}, {'value': '-8.20', 'spread': '15.707', 'groupId': 'OG001'}, {'value': '-39.29', 'spread': '21.077', 'groupId': 'OG002'}, {'value': '-11.67', 'spread': '24.047', 'groupId': 'OG003'}, {'value': '-14.67', 'spread': '33.037', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 22 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-7.43', 'spread': '13.176', 'groupId': 'OG000'}, {'value': '-18.20', 'spread': '20.462', 'groupId': 'OG001'}, {'value': '-37.86', 'spread': '19.945', 'groupId': 'OG002'}, {'value': '-24.67', 'spread': '20.925', 'groupId': 'OG003'}, {'value': '-27.50', 'spread': '25.399', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 29 (n =7, 5, 7, 6, 4)', 'categories': [{'measurements': [{'value': '-4.43', 'spread': '27.098', 'groupId': 'OG000'}, {'value': '-26.60', 'spread': '22.612', 'groupId': 'OG001'}, {'value': '-37.57', 'spread': '14.976', 'groupId': 'OG002'}, {'value': '-32.67', 'spread': '28.507', 'groupId': 'OG003'}, {'value': '-41.00', 'spread': '29.855', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 50 (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '-6.86', 'spread': '20.732', 'groupId': 'OG000'}, {'value': '-8.80', 'spread': '14.446', 'groupId': 'OG001'}, {'value': '-6.43', 'spread': '20.871', 'groupId': 'OG002'}, {'value': '-12.43', 'spread': '26.732', 'groupId': 'OG003'}, {'value': '-5.67', 'spread': '31.258', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.663', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '4.11', 'ciLowerLimit': '-8.16', 'ciUpperLimit': '16.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.326', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.825', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.89', 'ciLowerLimit': '-13.03', 'ciUpperLimit': '9.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.472', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.878', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.36', 'ciLowerLimit': '-10.20', 'ciUpperLimit': '12.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.791', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.936', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.72', 'ciLowerLimit': '-10.89', 'ciUpperLimit': '12.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.829', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.959', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.68', 'ciLowerLimit': '-16.46', 'ciUpperLimit': '17.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.037', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-32.46', 'ciLowerLimit': '-48.07', 'ciUpperLimit': '-16.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.872', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.833', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-2.61', 'ciLowerLimit': '-18.67', 'ciUpperLimit': '13.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.212', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.565', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-7.21', 'ciLowerLimit': '-23.47', 'ciUpperLimit': '9.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.365', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.703', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.75', 'ciLowerLimit': '-16.52', 'ciUpperLimit': '9.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.713', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-25.46', 'ciLowerLimit': '-37.07', 'ciUpperLimit': '-13.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.827', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.253', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-10.60', 'ciLowerLimit': '-22.51', 'ciUpperLimit': '1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.061', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.128', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-14.47', 'ciLowerLimit': '-26.57', 'ciUpperLimit': '-2.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.198', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-15.15', 'ciLowerLimit': '-30.17', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.421', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.012', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-28.17', 'ciLowerLimit': '-41.84', 'ciUpperLimit': '-14.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.393', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.047', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-22.48', 'ciLowerLimit': '-36.65', 'ciUpperLimit': '-8.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '10.773', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.023', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-28.63', 'ciLowerLimit': '-44.19', 'ciUpperLimit': '-13.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.837', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '5.08', 'ciLowerLimit': '-12.77', 'ciUpperLimit': '22.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '13.576', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.666', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '5.40', 'ciLowerLimit': '-10.86', 'ciUpperLimit': '21.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.365', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.807', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-3.05', 'ciLowerLimit': '-19.27', 'ciUpperLimit': '13.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.333', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.603', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '6.79', 'ciLowerLimit': '-10.15', 'ciUpperLimit': '23.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.877', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 15, 22, 29 and 50', 'unitOfMeasure': 'mcmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'title': 'Baseline (n =15, 5, 6, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '8.17', 'spread': '5.021', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '2.831', 'groupId': 'OG001'}, {'value': '5.77', 'spread': '1.306', 'groupId': 'OG002'}, {'value': '5.35', 'spread': '3.683', 'groupId': 'OG003'}, {'value': '6.20', 'spread': '5.440', 'groupId': 'OG004'}, {'value': '12.04', 'spread': '5.133', 'groupId': 'OG005'}, {'value': '11.84', 'spread': '8.122', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 8 (n =15, 5, 5, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.895', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.727', 'groupId': 'OG001'}, {'value': '0.64', 'spread': '0.639', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '0.596', 'groupId': 'OG003'}, {'value': '0.73', 'spread': '0.632', 'groupId': 'OG004'}, {'value': '0.00', 'spread': '1.584', 'groupId': 'OG005'}, {'value': '0.97', 'spread': '0.629', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 15 (n =15, 5, 5, 6, 6, 5, 7)', 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.047', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '1.711', 'groupId': 'OG001'}, {'value': '1.50', 'spread': '1.321', 'groupId': 'OG002'}, {'value': '-0.32', 'spread': '1.143', 'groupId': 'OG003'}, {'value': '1.07', 'spread': '1.111', 'groupId': 'OG004'}, {'value': '0.32', 'spread': '1.608', 'groupId': 'OG005'}, {'value': '1.17', 'spread': '0.780', 'groupId': 'OG006'}]}]}, {'title': 'Change at Day 29 (n =15, 5, 5, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '0.46', 'spread': '1.608', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.820', 'groupId': 'OG001'}, {'value': '-0.52', 'spread': '3.192', 'groupId': 'OG002'}, {'value': '-0.62', 'spread': '1.492', 'groupId': 'OG003'}, {'value': '0.97', 'spread': '1.467', 'groupId': 'OG004'}, {'value': '0.36', 'spread': '1.499', 'groupId': 'OG005'}, {'value': '0.66', 'spread': '1.110', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 15 and 29', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG004', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Baseline (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '7.66', 'spread': '4.351', 'groupId': 'OG000'}, {'value': '6.32', 'spread': '3.517', 'groupId': 'OG001'}, {'value': '8.09', 'spread': '6.240', 'groupId': 'OG002'}, {'value': '7.59', 'spread': '5.538', 'groupId': 'OG003'}, {'value': '3.95', 'spread': '1.291', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 8 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.663', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.962', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.570', 'groupId': 'OG002'}, {'value': '-0.08', 'spread': '1.599', 'groupId': 'OG003'}, {'value': '0.90', 'spread': '0.502', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 15 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '1.376', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '1.512', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '0.641', 'groupId': 'OG002'}, {'value': '0.32', 'spread': '2.483', 'groupId': 'OG003'}, {'value': '0.63', 'spread': '1.481', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 22 (n =7, 5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.289', 'groupId': 'OG000'}, {'value': '1.14', 'spread': '0.518', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '1.034', 'groupId': 'OG002'}, {'value': '0.95', 'spread': '3.086', 'groupId': 'OG003'}, {'value': '1.28', 'spread': '2.046', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 29 (n =7, 5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '0.36', 'spread': '1.765', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '0.730', 'groupId': 'OG001'}, {'value': '1.83', 'spread': '1.241', 'groupId': 'OG002'}, {'value': '1.50', 'spread': '2.900', 'groupId': 'OG003'}, {'value': '1.60', 'spread': '2.827', 'groupId': 'OG004'}]}]}, {'title': 'Change at Day 50 (n =7, 5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '0.40', 'spread': '2.106', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '2.381', 'groupId': 'OG001'}, {'value': '-0.30', 'spread': '1.294', 'groupId': 'OG002'}, {'value': '1.64', 'spread': '2.985', 'groupId': 'OG003'}, {'value': '0.92', 'spread': '2.076', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.387', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.48', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '1.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.551', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.309', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.52', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '1.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.501', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.956', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.03', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.518', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.089', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.96', 'ciLowerLimit': '0.24', 'ciUpperLimit': '1.67', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.542', 'groupDescription': 'Day 8: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.434', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.73', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '1.95', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.923', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.150', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.25', 'ciLowerLimit': '0.14', 'ciUpperLimit': '2.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.841', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.752', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.27', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '1.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.861', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.492', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.62', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '1.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.888', 'groupDescription': 'Day 15: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.00', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '2.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.064', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.110', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.60', 'ciLowerLimit': '0.33', 'ciUpperLimit': '2.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.970', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.461', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.74', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '2.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.993', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.286', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.11', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '2.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.021', 'groupDescription': 'Day 22: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.09', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '2.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.172', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.48', 'ciLowerLimit': '0.07', 'ciUpperLimit': '2.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.069', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.342', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.06', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '2.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.092', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.272', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.27', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '2.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.129', 'groupDescription': 'Day 29: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.979', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.04', 'ciLowerLimit': '-1.77', 'ciUpperLimit': '1.70', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.317', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.568', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.70', 'ciLowerLimit': '-2.27', 'ciUpperLimit': '0.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.201', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.311', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.24', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '2.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.201', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.710', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.47', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '2.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.260', 'groupDescription': 'Day 50: Repeated measures analysis of change is performed with change from baseline as dependent variable, treatment as a factor and baseline as covariate.', 'statisticalMethod': 'Mixed meal tolerance test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, 15, 22, 29 and 50', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis population included all enrolled participants who had received at least 1 dose of study treatment and have at least 1 pharmacodynamic parameter. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA): Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG001', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG002', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG003', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG004', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'OG005', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}], 'classes': [{'title': 'Day 1 (n =5, 6, 6, 7, 5, 7)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 29 (n =5, 5, 6, 6, 5, 7)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and 29', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participant With Anti-Drug Antibodies (ADA): Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG001', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG002', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'OG003', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'classes': [{'title': 'Day 1 (n =5, 7, 7, 6)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 (n =5, 7, 6, 5)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Day 50 (n =5, 7, 6, 6)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, 29 and 50', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'FG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 milligram (mg) subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'FG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'FG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'FG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'FG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'FG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'FG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'FG008', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'FG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'FG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'FG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '6'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '7'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Data for reporting arm Placebo 1a and 1b in stage 1 was planned to be pooled during analysis, as per protocol. Study consisted of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '84', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'Stage 1: PF-04856883 Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneously injection once on Day 1 in Stage 1.'}, {'id': 'BG001', 'title': 'Stage 1: PF-04856883 4 mg', 'description': 'Participants received PF-04856883 4 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'BG002', 'title': 'Stage 1: PF-04856883 8 mg', 'description': 'Participants received PF-04856883 8 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'BG003', 'title': 'Stage 1: PF-04856883 12 mg', 'description': 'Participants received PF-04856883 12 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'BG004', 'title': 'Stage 1: PF-04856883 18 mg', 'description': 'Participants received PF-04856883 18 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'BG005', 'title': 'Stage 1: PF-04856883 24 mg', 'description': 'Participants received PF-04856883 24 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'BG006', 'title': 'Stage 1: PF-04856883 36 mg', 'description': 'Participants received PF-04856883 36 mg subcutaneous injection once on Day 1 in Stage 1.'}, {'id': 'BG007', 'title': 'Stage 2: Placebo', 'description': 'Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'BG008', 'title': 'Stage 2: PF-04856883 12 mg', 'description': 'Participants received single dose of PF-04856883 12 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'BG009', 'title': 'Stage 2: PF-04856883 12 mg + 12 mg + 24 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 12 mg, 24 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'BG010', 'title': 'Stage 2: PF-04856883 8 mg + 8 mg + 16 mg + 24 mg', 'description': 'Participants received single dose of PF-04856883 8 mg, 8 mg, 16 mg, 24 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'BG011', 'title': 'Stage 2: PF-04856883 12 mg + 20 mg + 28 mg + 36 mg', 'description': 'Participants received single dose of PF-04856883 12 mg, 20 mg, 28 mg, 36 mg subcutaneous injection on Day 1, 8, 15 and 22 respectively in Stage 2.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}, {'title': 'Between 18 and 64 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '71', 'groupId': 'BG012'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '13', 'groupId': 'BG012'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '84', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who were randomized.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-28', 'studyFirstSubmitDate': '2011-02-09', 'resultsFirstSubmitDate': '2017-04-13', 'studyFirstSubmitQcDate': '2011-02-21', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-28', 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinically Significant Physical Examination Findings', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': 'Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.'}, {'measure': 'Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': "ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (\\>=) 25 percent (%) increase when baseline greater than (\\>)200 milliseconds (msec); or increase \\>=50% when baseline less than or equal to (\\<=200) msec; 2) QRS interval: \\>=25% increase when baseline \\>100 msec; \\>=50% increase when baseline \\<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - \\<480 msec, 480 - \\<500 msec \\>=500; absolute change 30 - \\<60, \\>=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline."}, {'measure': 'Number of Participants With Vital Sign Abnormalities', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50', 'description': 'Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (\\<) 40 beats per minute (bpm) or greater than (\\>) 120 bpm, standing/supine systolic pulse \\< 40 bpm or \\> 140 bpm, systolic blood pressure of \\>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \\<90 mmHg, diastolic blood pressure \\>=20 mmHg change from baseline and diastolic blood pressure \\<50 mm Hg.'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements', 'timeFrame': 'Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50', 'description': 'Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) \\<0.8\\*lower limit of the reference range (LLRR); leukocytes \\<0.6\\*LLRR or \\>1.5\\*ULRR; platelet count \\<0.5\\*LLRR or \\>1.75\\*upper limit of the reference range (ULRR); total neutrophils (absolute \\[abs\\]), lymphocytes (abs) \\<0.8\\*LLRR or \\>1.2\\*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) \\>1.2\\*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin \\>1.5\\*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \\>3\\*ULRR, albumin, total protein \\<0.8\\*LLRR or \\>1.2\\*ULRR; blood urea nitrogen (BUN), creatinine \\>1.3\\*ULRR; glucose (fasting) \\<0.6\\*LLRR or \\>1.5\\*ULRR; uric acid \\>1.2\\* ULRR; sodium \\<0.95\\*LLRR or \\>1.05\\*ULRR; potassium, chloride, bicarbonate, calcium \\<0.9\\*LLRR or \\>1.1\\*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =\\>20/ high-power field (HPF).'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}, {'measure': 'Area Under the Concentration Time Curve From Time Zero to Time Tau (AUCtau) of PF-04856883: Stage 2', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168 hours postdose Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168 hours postdose Day 22', 'description': 'Area under the serum concentration-time curve from time 0 to tau (AUCtau), where tau was the dosing interval of 168 hours.'}, {'measure': 'Apparent Clearance (CL/F) of PF-04856883: Stage 1', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1', 'description': 'It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 1 only.'}, {'measure': 'Apparent Clearance (CL/F) of PF-04856883: Stage 2', 'timeFrame': 'predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22', 'description': 'It was calculated by dividing dose with AUC (0 - ∞) where AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). Outcome measure was planned to be analyzed in Stage 2 only. Data was not estimable if values were below the limit of quantification.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 1', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of PF-04856883: Stage 2', 'timeFrame': 'predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22'}, {'measure': 'Terminal Elimination Half- Life (t1/2) of PF-04856883: Stage 1', 'timeFrame': 'predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1'}, {'measure': 'Terminal Elimination Half-life (t1/2) of PF-04856883: Stage 2', 'timeFrame': 'predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22'}, {'measure': 'Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1', 'timeFrame': 'Baseline, Day 3 and 8', 'description': 'Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC'}, {'measure': 'Change From Baseline in Post-prandial Glucose Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2', 'timeFrame': 'Baseline, Day 3, 15, 24, 29 and 50', 'description': 'Change from baseline in post-prandial area under the plasma glucose concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1', 'timeFrame': 'Baseline, Day 3 and 8', 'description': 'Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in Insulin Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2', 'timeFrame': 'Baseline, Day 3, 15, 24, 29 and 50', 'description': 'Change from baseline in post-prandial plasma insulin AUC under the plasma insulin concentration versus time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3 and 8: Stage 1', 'timeFrame': 'Baseline, Day 3 and 8', 'description': 'Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in C-Peptide Area Under the Curve (AUC) After Mixed Meal Tolerance Test (MMTT) at Day 3, 15, 24, 29 and 50: Stage 2', 'timeFrame': 'Baseline, Day 3, 15, 24, 29 and 50', 'description': 'Change from baseline in post-prandial area under the plasma C-peptide concentration time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 15, 22 and 29: Stage 1', 'timeFrame': 'Baseline, Day 2, 4, 6, 15, 22 and 29'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43: Stage 2', 'timeFrame': 'Baseline, Day 2, 4, 6, 8, 22, 23, 25, 27, 30, 36 and 43'}, {'measure': 'Change From Baseline in 24 Hours Glucose Normalized Area Under the Curve (NAUC) Profile at Day 30: Stage 2', 'timeFrame': 'Baseline, Day 30', 'description': 'A normalized area under the curve (NAUC) were computed by dividing the AUC by the amount of time between the last time point captured and the first time point captured.'}, {'measure': 'Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29 and 50: Stage 2', 'timeFrame': 'Baseline, Day 29 and 50', 'description': 'HbA1c is a measure of the glycosylated hemoglobin. Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Outcome measure was planned to analyzed only for Stage 2.'}, {'measure': 'Change From Baseline in Fructosamine Levels at Day 8, 15 and 29: Stage 1', 'timeFrame': 'Baseline, Day 8, 15 and 29'}, {'measure': 'Change From Baseline in Fructosamine Levels at Day 8, 15, 22, 29 and 50: Stage 2', 'timeFrame': 'Baseline, Day 8, 15, 22, 29 and 50'}, {'measure': 'Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15 and 29: Stage 1', 'timeFrame': 'Baseline, Day 8, 15 and 29'}, {'measure': 'Change From Baseline in 1, 5 Anhydroglucitol at Day 8, 15, 22, 29 and 50: Stage 2', 'timeFrame': 'Baseline, Day 8, 15, 22, 29 and 50'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA): Stage 1', 'timeFrame': 'Day 1 and 29'}, {'measure': 'Number of Participant With Anti-Drug Antibodies (ADA): Stage 2', 'timeFrame': 'Day 1, 29 and 50'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Type 2 Diabetes', 'CVX-096'], 'conditions': ['Diabetes Mellitus', 'Diabetes Mellitus, Type 2', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1111002&StudyName=Single-Dose%20And%20Multiple-Dose%20Safety%20And%20Tolerability%20Study%20Of%20PF-04856883%20In%20Type%202%20Diabetic%20Adult%20Females%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of Type 2 diabetes and currently being treated with high dose metformin\n* BMI between 22.0 and 40.0 kg/m2\n* HbA1c between 7.0-10.0%\n* Fasting C-peptide \\>1.21 ng/mL\n\nExclusion Criteria:\n\n* History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications\n* Treatment with anti-diabetic therapies other than metformin\n* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody\n* Males or women of childbearing potential'}, 'identificationModule': {'nctId': 'NCT01301456', 'briefTitle': 'Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'B1111002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Arm 1 (Stage 1A)', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 2 (Stage 1A)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 3 (Stage 1A)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 4 (Stage 1A)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Arm 5 (Stage 1B)', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 6 (Stage 1B)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 7 (Stage 1B)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 8 (Stage 1B)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Arm 9 (Stage 2)', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 10 (Stage 2)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 11 (Stage 2)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 12 (Stage 2)', 'interventionNames': ['Biological: PF-04856883']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 13 (Stage 2)', 'interventionNames': ['Biological: PF-04856883']}], 'interventions': [{'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Single subcutaneous injection of placebo', 'armGroupLabels': ['Treatment Arm 1 (Stage 1A)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Single subcutaneous injection of PF-04856883', 'armGroupLabels': ['Treatment Arm 2 (Stage 1A)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Single subcutaneous injection of PF-04856883', 'armGroupLabels': ['Treatment Arm 3 (Stage 1A)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Single subcutaneous injection of PF-04856883', 'armGroupLabels': ['Treatment Arm 4 (Stage 1A)']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Single subcutaneous injection of placebo', 'armGroupLabels': ['Treatment Arm 5 (Stage 1B)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Single subcutaneous injection of PF-04856883', 'armGroupLabels': ['Treatment Arm 6 (Stage 1B)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Single subcutaneous injection of PF-04856883', 'armGroupLabels': ['Treatment Arm 7 (Stage 1B)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Single subcutaneous injection of PF-04856883', 'armGroupLabels': ['Treatment Arm 8 (Stage 1B)']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Multiple weekly subcutaneous injections of placebo for 3 weeks', 'armGroupLabels': ['Treatment Arm 9 (Stage 2)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks', 'armGroupLabels': ['Treatment Arm 10 (Stage 2)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks', 'armGroupLabels': ['Treatment Arm 11 (Stage 2)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks', 'armGroupLabels': ['Treatment Arm 12 (Stage 2)']}, {'name': 'PF-04856883', 'type': 'BIOLOGICAL', 'otherNames': ['CVX-096'], 'description': 'Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks', 'armGroupLabels': ['Treatment Arm 13 (Stage 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Elite Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Center for Medical Research', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'ICON Clinical Pharmacology, LLC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '19139', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CRI Worldwide, LLC', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Healthcare Discoveries LLC d/b/a ICON Development Solutions', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}