Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT04621227
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2020-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000731016', 'term': 'danuglipron'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)', 'description': 'SAEs and non-serious AEs were recorded on the CRF. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24 hours of awareness. The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Rosuvastatin 10mg (Period 1)', 'description': 'Participants received rosuvastatin 10mg QD on Day 1 in Period 1.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Midazolam 2mg (Period 2)', 'description': 'Participants received midazolam 2mg QD on Day 1 in Period 2.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 2, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-06882961 Titration up to 120mg BID (Period 3)', 'description': 'Participants received PF-06882961 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28 in Period 3.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 13, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)', 'description': 'Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 6, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PF-06882961 120mg BID + Midazolam 2mg (Period 5)', 'description': 'Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 5, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PF-06882961 Titration up to 200mg BID (Period 6)', 'description': 'Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)', 'description': 'Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 7, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'PF-06882961 200mg BID + Midazolam 2mg (Period 8)', 'description': 'Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 8, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, 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'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Muscle discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'seriousEvents': [{'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 10mg (Period 1)', 'description': 'Participants received rosuvastatin 10mg QD on Day 1 in Period 1.'}, {'id': 'OG001', 'title': 'PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)', 'description': 'Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.'}, {'id': 'OG002', 'title': 'PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)', 'description': 'Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.17', 'spread': '43', 'groupId': 'OG000'}, {'value': '72.15', 'spread': '50', 'groupId': 'OG001'}, {'value': '100.90', 'spread': '40', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '202.94', 'ciLowerLimit': '167.14', 'ciUpperLimit': '246.41', 'groupDescription': 'Comparison for AUClast (PF-06882961 120mg BID + rosuvastatin 10mg \\[Period 4\\] vs Rosuvastatin 10mg \\[Period 1\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The ratio and 90% confidence interval were expressed as percentages.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Geometric Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '283.73', 'ciLowerLimit': '233.68', 'ciUpperLimit': '344.51', 'groupDescription': 'Comparison for AUClast (PF-06882961 200mg BID + rosuvastatin 10mg \\[Period 7\\] vs Rosuvastatin 10mg \\[Period 1\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The ratio and 90% confidence interval were expressed as percentages.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7', 'description': 'AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants who received at least 1 dose of rosuvastatin and had at least 1 of the PK parameters of interest calculated.'}, {'type': 'PRIMARY', 'title': 'AUClast of Midazolam in Periods 2, 5 and 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Midazolam 2mg (Period 2)', 'description': 'Participants received midazolam 2mg QD on Day 1 in Period 2.'}, {'id': 'OG001', 'title': 'PF-06882961 120mg BID + Midazolam 2mg (Period 5)', 'description': 'Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.'}, {'id': 'OG002', 'title': 'PF-06882961 200mg BID + Midazolam 2mg (Period 8)', 'description': 'Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.24', 'spread': '27', 'groupId': 'OG000'}, {'value': '19.98', 'spread': '49', 'groupId': 'OG001'}, {'value': '20.21', 'spread': '48', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Geometric Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '50.57', 'ciLowerLimit': '42.27', 'ciUpperLimit': '60.50', 'groupDescription': 'Comparison for AUClast (PF-06882961 120mg BID + midazolam 2mg \\[Period 5\\] vs Midazolam 2mg \\[Period 2\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The ratio and 90% confidence interval were expressed as percentages.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted Geometric Mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '50.56', 'ciLowerLimit': '42.06', 'ciUpperLimit': '60.78', 'groupDescription': 'Comparison for AUClast (PF-06882961 200mg BID + midazolam 2mg \\[Period 8\\] vs Midazolam 2mg \\[Period 2\\])', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The ratio and 90% confidence interval were expressed as percentages.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post midazolam dose on Day 1 in Periods 2, 5, and 8', 'description': 'AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants who received at least 1 dose of rosuvastatin and had at least 1 of the PK parameters of interest calculated.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 10mg (Period 1)', 'description': 'Participants received rosuvastatin 10mg QD on Day 1 in Period 1.'}, {'id': 'OG001', 'title': 'Midazolam 2mg (Period 2)', 'description': 'Participants received midazolam 2mg QD on Day 1 in Period 2.'}, {'id': 'OG002', 'title': 'PF-06882961 Titration up to 120mg BID (Period 3)', 'description': 'Participants received PF-06882961 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28 in Period 3.'}, {'id': 'OG003', 'title': 'PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)', 'description': 'Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.'}, {'id': 'OG004', 'title': 'PF-06882961 120mg BID + Midazolam 2mg (Period 5)', 'description': 'Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.'}, {'id': 'OG005', 'title': 'PF-06882961 Titration up to 200mg BID (Period 6)', 'description': 'Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.'}, {'id': 'OG006', 'title': 'PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)', 'description': 'Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.'}, {'id': 'OG007', 'title': 'PF-06882961 200mg BID + Midazolam 2mg (Period 8)', 'description': 'Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.'}], 'classes': [{'title': 'All-causality TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 10mg (Period 1)', 'description': 'Participants received rosuvastatin 10mg QD on Day 1 in Period 1.'}, {'id': 'OG001', 'title': 'Midazolam 2mg (Period 2)', 'description': 'Participants received midazolam 2mg QD on Day 1 in Period 2.'}, {'id': 'OG002', 'title': 'PF-06882961 Titration up to 120mg BID (Period 3)', 'description': 'Participants received PF-06882961 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28 in Period 3.'}, {'id': 'OG003', 'title': 'PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)', 'description': 'Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.'}, {'id': 'OG004', 'title': 'PF-06882961 120mg BID + Midazolam 2mg (Period 5)', 'description': 'Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.'}, {'id': 'OG005', 'title': 'PF-06882961 Titration up to 200mg BID (Period 6)', 'description': 'Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.'}, {'id': 'OG006', 'title': 'PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)', 'description': 'Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.'}, {'id': 'OG007', 'title': 'PF-06882961 200mg BID + Midazolam 2mg (Period 8)', 'description': 'Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)', 'description': "Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 10mg (Period 1)', 'description': 'Participants received rosuvastatin 10mg QD on Day 1 in Period 1.'}, {'id': 'OG001', 'title': 'Midazolam 2mg (Period 2)', 'description': 'Participants received midazolam 2mg QD on Day 1 in Period 2.'}, {'id': 'OG002', 'title': 'PF-06882961 Titration up to 120mg BID (Period 3)', 'description': 'Participants received PF-06882961 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28 in Period 3.'}, {'id': 'OG003', 'title': 'PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)', 'description': 'Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.'}, {'id': 'OG004', 'title': 'PF-06882961 120mg BID + Midazolam 2mg (Period 5)', 'description': 'Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.'}, {'id': 'OG005', 'title': 'PF-06882961 Titration up to 200mg BID (Period 6)', 'description': 'Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.'}, {'id': 'OG006', 'title': 'PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)', 'description': 'Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.'}, {'id': 'OG007', 'title': 'PF-06882961 200mg BID + Midazolam 2mg (Period 8)', 'description': 'Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.'}], 'classes': [{'title': 'Pulse rate value <40bpm', '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'}]}]}, {'title': 'Pulse rate value >120bpm', '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': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Supine diastolic BP value <50mmHg', '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'}]}]}, {'title': 'Supine diastolic BP change >=20mmHg increase', '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'}]}]}, {'title': 'Supine diastolic BP change >=20mmHg decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Supine systolic BP value <90mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Supine systolic BP change >=30mmHg increase', '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'}]}]}, {'title': 'Supine systolic BP change >=30mmHg decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)', 'description': 'Single, supine vital signs assessments included systolic blood pressure (BP), diastolic BP and pulse rate. Abnormality in vital signs included: pulse rate \\<40 beats per minute (bpm) or \\>120bpm; supine diastolic BP \\<50 millimeter of mercury (mmHg), increase and decrease in change from BL of \\>=20mmHg; supine systolic blood pressure \\<90mmHg, increase and decrease in change from BL of \\>=30mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.'}], 'classes': [{'title': 'Period 3 Day 1 / PF-06882961 titration up to 120 mg BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Period 3 Day 8 / PF-06882961 titration up to 120 mg BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.56', 'groupId': 'OG000'}]}]}, {'title': 'Period 3 Day 15 / PF-06882961 titration up to 120 mg BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Period 3 Day 22 / PF-06882961 titration up to 120 mg BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Period 4 Day 1 / PF-06882961 120 mg BID + rosuvastatin 10 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '1.87', 'groupId': 'OG000'}]}]}, {'title': 'Period 6 Day 1 / PF-06882961 titration up to 200 mg BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '2.18', 'groupId': 'OG000'}]}]}, {'title': 'Period 6 Day 9 / PF-06882961 titration up to 200 mg BID', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Period 7 Day 1 / PF-06882961 200 mg BID + rosuvastatin 10 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.1', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200 mg BID + midazolam 2 mg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '3.15', 'groupId': 'OG000'}]}]}, {'title': 'Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.7', 'spread': '3.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15 and 22, Period 4 Day 1, Period 6 Days 1 and 9, Period 7 Day 1, Period 8 Day 2, and at Follow Up visit (Days 68-71)', 'description': 'Changes from Baseline in body weight of the participants were measured.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable body weight data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin 10mg (Period 1)', 'description': 'Participants received rosuvastatin 10mg QD on Day 1 in Period 1.'}, {'id': 'OG001', 'title': 'Midazolam 2mg (Period 2)', 'description': 'Participants received midazolam 2mg QD on Day 1 in Period 2.'}, {'id': 'OG002', 'title': 'PF-06882961 Titration up to 120mg BID (Period 3)', 'description': 'Participants received PF-06882961 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28 in Period 3.'}, {'id': 'OG003', 'title': 'PF-06882961 120mg BID + Rosuvastatin 10mg (Period 4)', 'description': 'Participants received PF-06882961 120mg BID on Days 1-4, and rosuvastatin 10mg QD on Day 1 in Period 4.'}, {'id': 'OG004', 'title': 'PF-06882961 120mg BID + Midazolam 2mg (Period 5)', 'description': 'Participants received PF-06882961 120mg BID and midazolam 2mg QD on Day 1 in Period 5.'}, {'id': 'OG005', 'title': 'PF-06882961 Titration up to 200mg BID (Period 6)', 'description': 'Participants received PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16 in Period 6.'}, {'id': 'OG006', 'title': 'PF-06882961 200mg BID + Rosuvastatin 10mg (Period 7)', 'description': 'Participants received PF-06882961 200mg BID on Days 1-4 and rosuvastatin 10mg QD on Day 1 in Period 7.'}, {'id': 'OG007', 'title': 'PF-06882961 200mg BID + Midazolam 2mg (Period 8)', 'description': 'Participants received PF-06882961 200mg BID and midazolam 2mg QD on Day 1 in Period 8.'}], 'classes': [{'title': 'PR interval value>=300 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'QRS interval value>=140 msec', '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'}]}]}, {'title': 'QRS interval %change >=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': '0', 'groupId': 'OG007'}]}]}, {'title': 'QTcF value >450 and <=480 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'QTcF value >480 and <=500 msec', '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'}]}]}, {'title': 'QTcF value >500 msec', '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'}]}]}, {'title': 'QTcF change >30 and <=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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'QTcF change >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': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)', 'description': 'ECG assessments included pulse rate (PR), QT, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \\>= 300msec, or BL \\>200msec and \\>=25% increase from BL, or BL \\<=200msec and \\>=50% increase from BL; QRS interval value \\>= 140msec, or percent change from BL \\>=50%; QTcF value \\>400 and \\<=480msec, or \\>480 and \\<=500 msec, or \\>500msec, or change from BL\\>30 and \\<=60msec, or change from BL \\>60msec.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable ECG data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.'}], 'classes': [{'title': 'BL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL (Past 12 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 3 Day 1 / PF-06882961 titration up to 120mg BID (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 3 Day 8 / PF-06882961 titration up to 120mg BID (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 3 Day 15 / PF-06882961 titration up to 120mg BID (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 3 Day 22 / PF-06882961 titration up to 120mg BID (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 4 Day 1 / PF-06882961 120mg BID + rosuvastatin 10mg (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 6 Day 1 / PF-06882961 titration up to 200mg BID (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 6 Day 9 / PF-06882961 titration up to 200mg BID (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 6 Day 16 / PF-06882961 titration up to 200mg BID (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Early Termination (ET) (Since last visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination', 'description': 'The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts towards imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts/behavior"), 4: suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). In this outcome, number of participants with positive response (response of "yes") to suicidal behavior, ideation, or any self-injurious behavior were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.'}], 'classes': [{'title': 'BL Little Interest/Pleasure in Things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL Feeling Down Depressed or Hopeless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL Trouble Falling or Staying Asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'BL Feeling Tired or Little Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': 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Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 6 Day 16 / PF-06882961 titration up to 200mg BID Poor Appetite or Overeating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 6 Day 16 / PF-06882961 titration up to 200mg BID Feeling Bad About Yourself', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several 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'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Down Depressed or Hopeless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Falling or Staying Asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Tired or Little Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Poor Appetite or Overeating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Feeling Bad About Yourself', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Trouble Concentrating on Things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Moving Slowly or Fidgety/Restless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Period 8 Day 2 / PF-06882961 200mg BID + midazolam 2mg Thoughts You Be Better Off Dead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Little Interest/Pleasure in Things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Feeling Down Depressed or Hopeless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Trouble Falling or Staying Asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Feeling Tired or Little Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Poor Appetite or Overeating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Feeling Bad About Yourself', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Trouble Concentrating on Things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Moving Slowly or Fidgety/Restless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up Thoughts You Be Better Off Dead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Little Interest/Pleasure in Things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Feeling Down Depressed or Hopeless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Trouble Falling or Staying Asleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Feeling Tired or Little Energy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Poor Appetite or Overeating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Feeling Bad About Yourself', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Trouble Concentrating on Things', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Moving Slowly or Fidgety/Restless', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'ET Thoughts You Be Better Off Dead', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Not At All', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Several Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'More Than Half The Days', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Nearly Every Day', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination', 'description': 'The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 \\[not at all\\] to 3 \\[nearly every day\\]. Higher score=greater severity).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.'}], 'periods': [{'title': 'Period 1 (5 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 3 (29 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician decision due to inappropriate behavior and noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Period 4 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 5 (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 6 (16 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 7 (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 8 (2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: rosuvastatin 10mg once daily (QD) on Day 1; Period 2: midazolam 2mg QD on Day 1; Period 3: PF-06882961 (danuglipron) 10mg twice a day (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-28; Period 4: PF-06882961 120mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 5: PF-06882961 120mg BID + midazolam 2mg QD on Day 1; Period 6: PF-06882961 140mg BID on Days 1-4, 160mg BID on Days 5-8, 180mg BID on Days 9-12, and 200mg BID on Days 13-16; Period 7: PF-06882961 200mg BID on Days 1-4 + rosuvastatin 10mg QD on Day 1; Period 8: PF-06882961 200mg BID + midazolam 2mg QD on Day 1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '11.34', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<18 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '18-44 Years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '45-65 Years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants who received at least 1 dose of study intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-07', 'size': 6274726, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-05T10:33', 'hasProtocol': True}, {'date': '2021-05-24', 'size': 1829244, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-05T10:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-23', 'studyFirstSubmitDate': '2020-11-03', 'resultsFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2020-11-03', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-23', 'studyFirstPostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7', 'timeFrame': 'At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7', 'description': 'AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.'}, {'measure': 'AUClast of Midazolam in Periods 2, 5 and 8', 'timeFrame': 'At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post midazolam dose on Day 1 in Periods 2, 5, and 8', 'description': 'AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study drug (Day 1) to telephone Follow Up (Days 89-96) (approximately up to 96 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.'}, {'measure': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)', 'timeFrame': 'From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)', 'description': "Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion."}, {'measure': 'Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria', 'timeFrame': 'From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)', 'description': 'Single, supine vital signs assessments included systolic blood pressure (BP), diastolic BP and pulse rate. Abnormality in vital signs included: pulse rate \\<40 beats per minute (bpm) or \\>120bpm; supine diastolic BP \\<50 millimeter of mercury (mmHg), increase and decrease in change from BL of \\>=20mmHg; supine systolic blood pressure \\<90mmHg, increase and decrease in change from BL of \\>=30mmHg.'}, {'measure': 'Change From Baseline in Body Weight', 'timeFrame': 'At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15 and 22, Period 4 Day 1, Period 6 Days 1 and 9, Period 7 Day 1, Period 8 Day 2, and at Follow Up visit (Days 68-71)', 'description': 'Changes from Baseline in body weight of the participants were measured.'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria', 'timeFrame': 'From BL (Day 1, the last pre-dose measurement in Period 1) to Follow Up visit (Days 68-71) (approximately up to 71 days)', 'description': 'ECG assessments included pulse rate (PR), QT, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \\>= 300msec, or BL \\>200msec and \\>=25% increase from BL, or BL \\<=200msec and \\>=50% increase from BL; QRS interval value \\>= 140msec, or percent change from BL \\>=50%; QTcF value \\>400 and \\<=480msec, or \\>480 and \\<=500 msec, or \\>500msec, or change from BL\\>30 and \\<=60msec, or change from BL \\>60msec.'}, {'measure': 'Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination', 'description': 'The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts towards imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts/behavior"), 4: suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). In this outcome, number of participants with positive response (response of "yes") to suicidal behavior, ideation, or any self-injurious behavior were reported.'}, {'measure': 'Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'At BL (Period 1 Day 1), on Period 3 Days 1, 8, 15, and 22, Period 4 Day 1, Period 6 Days 1, 9, and 16, Period 8 Day 2, at Follow Up visit (Days 68-71) and Early Termination', 'description': 'The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 \\[not at all\\] to 3 \\[nearly every day\\]. Higher score=greater severity).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3421007', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity', 'detailedDescription': 'This study is designed to look at the effect of two doses of PF 06882961 (120 milligram (mg) twice a day (BID) and 200 mg BID) on the levels of one dose of rosuvastatin 10 mg and one dose of midazolam 2 mg, in otherwise healthy, adult participants with obesity. Total duration of study from screening to the telephone visit will be approximately 17 weeks, of which up to 63 days will be inpatient. All subjects take (i) Rosuvastatin alone, Midazolam alone, PF 06882961 alone (120 mg BID), PF 06882961 (120 mg BID) + Rosuvastatin, PF 06882961 (120 mg BID) + Midazolam, PF 06882961 (200 mg BID) alone, PF 06882961 (200 mg BID) + Rosuvastatin, PF 06882961 (200 mg BID)+ Midazolam in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.\n* Stable body weight, defined as \\<5 kg change (per participant report) for 90 days before Screening\n\nExclusion Criteria:\n\n* Known prior participation in a trial involving PF-06882961.\n* Known intolerance or hypersensitivity to GLP-1R agonists.\n* Known hypersensitivity to rosuvastatin or midazolam.\n* Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at screening. Note: prior diagnoses of gestational diabetes during pregnancy only are eligible if they meet the other eligibility criteria\n* Any lifetime history of a suicide attempt.\n* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.\n* Participation in a formal weight reduction program (eg, Weight Watchers) within 90 days prior to Screening.'}, 'identificationModule': {'nctId': 'NCT04621227', 'briefTitle': 'Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN -LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ROSUVASTATIN AND MIDAZOLAM IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OBESITY', 'orgStudyIdInfo': {'id': 'C3421007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Period 1', 'description': 'Participants will receive the following treatments in this sequence : (i)Rosuvastatin alone (one dose of 10 mg), (ii) Midazolam alone (one dose of 2mg), (iii) PF 06882961 alone (120 mg twice daily), (iv) PF 06882961 (120 mg twice daily) + Rosuvastatin (one dose of 10mg), (v) PF 06882961 (120 mg) + Midazolam (one dose of 2 mg), (vi) PF 06882961 (200 mg) alone, (vii) PF 06882961 (200 mg) + Rosuvastatin (one dose of 10 mg), (viii) PF 06882961 (200 mg)+ Midazolam (one dose of 2 mg) in the study.', 'interventionNames': ['Drug: PF-06882961', 'Drug: Rosuvastatin', 'Drug: Midazolam']}], 'interventions': [{'name': 'PF-06882961', 'type': 'DRUG', 'description': '120 mg and 200 mg BID', 'armGroupLabels': ['Period 1']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': '10 mg single dose', 'armGroupLabels': ['Period 1']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': '2mg single dose', 'armGroupLabels': ['Period 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}