Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-03-03 @ 7:50 AM
Study NCT ID:
NCT02179918
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2014-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C577122', 'term': 'utomilumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to strategic reasons before any expansion cohort patient was enrolled.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'eventGroups': [{'id': 'EG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oral discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Presbyoesophagus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 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3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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{'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First 2 cycles of treatment up to 24 months', 'description': 'Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) \\<1000/mm3 with a single temperature of \\>38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade\\>=3 neutropenic infection; Grade\\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade\\>=3 toxicities (non-laboratory); Grade\\>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade\\>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The DLT evaluable set was a subset of the safety analysis set and included all participants who were eligible, received both study treatments and who either experienced a DLT during the first 2 cycles of PF-05082566 or completed the 2 cycles' DLT observation period."}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': 'AE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'Grade 5', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Grade1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'Grade 5', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'AE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'Grade 5', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'Anemia Grade 0-1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Anemia Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Anemia Grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Hemoglobin Increased Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Hemoglobin Increased Grade 2', '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'}]}]}, {'title': 'Hemoglobin Increased Grade 3-4', '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'}]}]}, {'title': 'Lymphocyte Count Increased Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Lymphocyte Count Increased Grade 2', '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'}]}]}, {'title': 'Lymphocyte Count Increased Grade 3-4', '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'}]}]}, {'title': 'Lymphopenia Grade 0-1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Lymphopenia Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Lymphopenia Grade 3-4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Neutrophils (Absolute) Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Neutrophils (Absolute) Grade 2', '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'}]}]}, {'title': 'Neutrophils (Absolute) Grade 3-4', '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'}]}]}, {'title': 'Platelets Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Platelets Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Platelets Grade 3-4', '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'}]}]}, {'title': 'White Blood Cells Grade 0-1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'White Blood Cells Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'White Blood Cells Grade 3-4', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'Alanine Aminotransferase (ALT) Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'ALT Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'ALT Grade 3-4', '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'}]}]}, {'title': 'Alkaline Phosphatase Grade 0-1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}, {'title': 'Alkaline Phosphatase Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Alkaline Phosphatase Grade 3-4', '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'}]}]}, {'title': 'Aspartate Aminotransferase (AST) Grade 0-1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'AST Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'AST Grade 3-4', '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'}]}]}, {'title': 'Bilirubin (Total) Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Bilirubin (Total) Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Bilirubin (Total) Grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Creatinine Grade 0-1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Creatinine Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Creatinine Grade 3-4', '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'}]}]}, {'title': 'Hypercalcemia Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Hypercalcemia Grade 2', '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'}]}]}, {'title': 'Hypercalcemia Grade 3-4', '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'}]}]}, {'title': 'Hyperglycemia Grade 0-1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'Hyperglycemia Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Hyperglycemia Grade 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Hyperkalemia Grade 0', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Hyperkalemia Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Hyperkalemia Grade 3-4', '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'}]}]}, {'title': 'Hypermagnesemia Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Hypermagnesemia Grade 2', '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'}]}]}, {'title': 'Hypermagnesemia Grade 3-4', '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'}]}]}, {'title': 'Hypernatremia Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Hypernatremia Grade 2', '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'}]}]}, {'title': 'Hypernatremia Grade 3-4', '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'}]}]}, {'title': 'Hypoalbuminemia Grade 0-1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}]}, {'title': 'Hypoalbuminemia Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Hypoalbuminemia Grade 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Hypocalcemia Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Hypocalcemia Grade 2', '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'}]}]}, {'title': 'Hypocalcemia Grade 3', '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'}]}]}, {'title': 'Hypoglycemia Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Hypoglycemia Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Hypoglycemia Grade 3-4', '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'}]}]}, {'title': 'Hypokalemia Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': 'Hypokalemia Grade 2', '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'}]}]}, {'title': 'Hypokalemia Grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Hypomagnesemia Grade 0-1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Hypomagnesemia Grade 2', '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'}]}]}, {'title': 'Hypomagnesemia Grade 3-4', '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'}]}]}, {'title': 'Hyponatremia Grade 0-1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'Hyponatremia Grade 2', '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'}]}]}, {'title': 'Hyponatremia Grade 3-4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Hypophosphatemia Grade 0-1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Hypophosphatemia Grade 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Hypophosphatemia Grade 3-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was used, which was defined as all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'ECOG Performance Status worst to 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'ECOG Performance Status worst to 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'ECOG Performance Status worst to 3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'ECOG Performance Status worst to 4 and 5', '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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 study treatment, the participant was classified according to the first treatment received.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.628', 'spread': '25', 'groupId': 'OG000'}, {'value': '18.70', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.', 'groupId': 'OG001'}, {'value': '29.80', 'spread': '16', 'groupId': 'OG002'}, {'value': '60.35', 'spread': '39', 'groupId': 'OG003'}, {'value': '95.57', 'spread': '16', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion', 'description': 'Maximum PF-05082566 observed serum concentration.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of MK-3475', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '63350', 'spread': '22', 'groupId': 'OG000'}, {'value': '71300', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.', 'groupId': 'OG001'}, {'value': '61090', 'spread': '7', 'groupId': 'OG002'}, {'value': '51920', 'spread': 'NA', 'comment': 'Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 46000 and 58600 ng/mL, respectively', 'groupId': 'OG003'}, {'value': '62030', 'spread': '32', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During Cycle 5 Day 1 at pre-dose; and end of infusion.', 'description': 'Maximum MK-3475 observed serum concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Time for Cmax (Tmax) of PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.98'}, {'value': '5.40', 'groupId': 'OG001', 'lowerLimit': '5.40', 'upperLimit': '5.40'}, {'value': '1.07', 'groupId': 'OG002', 'lowerLimit': '1.03', 'upperLimit': '2.03'}, {'value': '1.08', 'groupId': 'OG003', 'lowerLimit': '1.07', 'upperLimit': '1.25'}, {'value': '1.15', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'Time to reach PF-05082566 maximum observed serum concentration.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7489', 'spread': '33', 'groupId': 'OG000'}, {'value': '1.210', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.', 'groupId': 'OG001'}, {'value': '1.664', 'spread': '35', 'groupId': 'OG002'}, {'value': '5.167', 'spread': 'NA', 'comment': 'Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable.Individual subject values are 4.32 and 6.18 µg/mL, respectively.', 'groupId': 'OG003'}, {'value': '7.796', 'spread': '9', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 pre-dose concentration during multiple dosing', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '18460', 'spread': '33', 'groupId': 'OG000'}, {'value': '19200', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.', 'groupId': 'OG001'}, {'value': '20390', 'spread': '15', 'groupId': 'OG002'}, {'value': '11250', 'spread': '78', 'groupId': 'OG003'}, {'value': '17280', 'spread': '46', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During Cycle 5 Day 1 at pre-dose; and end of infusion.', 'description': 'MK-3475 pre-dose concentration during multiple dosing', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration analysis set was a subset of the safety analysis set and included participants who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLOQ) for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life （t½）of PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '179.3', 'spread': '24.338', 'groupId': 'OG000'}, {'value': '173.0', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the standard deviation was not applicable.', 'groupId': 'OG001'}, {'value': '144.7', 'spread': '31.628', 'groupId': 'OG002'}, {'value': '174.5', 'spread': 'NA', 'comment': 'Only 2 participant were analyzed, therefore the standard deviation was not applicable. Individual subject values are 141and 208 hour, respectively.', 'groupId': 'OG003'}, {'value': '164.8', 'spread': '49.564', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 terminal half-life', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Study Drug of PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4120', 'spread': '32', 'groupId': 'OG000'}, {'value': '0.5000', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.', 'groupId': 'OG001'}, {'value': '0.5182', 'spread': '41', 'groupId': 'OG002'}, {'value': '0.3894', 'spread': 'NA', 'comment': 'Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable.Individual subject values are 0.254 and 0.597 mL/hr/kg, respectively.', 'groupId': 'OG003'}, {'value': '0.4763', 'spread': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'Clearance of PF-05082566', 'unitOfMeasure': 'mL/hr/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.4', 'spread': '45', 'groupId': 'OG000'}, {'value': '112.0', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.', 'groupId': 'OG001'}, {'value': '104.0', 'spread': '18', 'groupId': 'OG002'}, {'value': '93.19', 'spread': 'NA', 'comment': 'Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 52.0 and 167 mL/kg, respectively.', 'groupId': 'OG003'}, {'value': '104.6', 'spread': '13', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 volume of distribution at steady state', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': '1093', 'spread': '32', 'groupId': 'OG000'}, {'value': '1800', 'spread': 'NA', 'comment': 'Only 1 participant was analyzed, therefore the geometric coefficient of variation was not applicable.', 'groupId': 'OG001'}, {'value': '3477', 'spread': '41', 'groupId': 'OG002'}, {'value': '9253', 'spread': 'NA', 'comment': 'Only 2 participants were analyzed, therefore the geometric coefficient of variation was not applicable. Individual subject values are 6030 and 14200 µg•hr/mL, respectively.', 'groupId': 'OG003'}, {'value': '10480', 'spread': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau)', 'unitOfMeasure': 'µg•hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least 1 of the PK parameters of interest for PF-05082566 or MK-3475.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'Pre-dose ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'ADA Anytime', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'Treatment-induced ADA', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Treatment-boosted ADA', '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'}]}]}, {'title': 'Overall ADA Incidence', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter', 'description': 'ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer\\<6.23; Positive ADA: titer\\>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment).', 'description': 'ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity analysis set was a subset of the safety analysis set and included participants who have at least 1 ADA sample collected for either PF-05082566 or MK 3475.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Objective Tumor Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'OG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'OG005', 'title': 'Total', 'description': 'Sum across the participants from all arms. PF-05082566 was administered as a 1 hour intravenous infusion at a dose of 0.45 mg/kg, 0.9 mg/kg, 1.8 mg/kg, 3.6 mg/kg, 5 mg/kg, respectively and then the MK-3475 as a 30 minute intravenous infusion at a dose of 2 mg/kg was co-administrated.'}], 'classes': [{'title': 'Complete response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Stable disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': 'Objective progression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Objective response rate (CR+PR)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated.', 'description': 'Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression\\<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)\\>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all participants who received at least 1 dose of study drug. Participants were classified according to the study treatment actually received. If a participant received more than 1 treatment the participant was classified according to the first treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg every 3 weeks (q3wks) on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'FG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'FG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'FG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'FG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Subject refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-05082566 0.45 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.45 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'BG001', 'title': 'PF-05082566 0.9 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 0.9 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'BG002', 'title': 'PF-05082566 1.8 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 1.8 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'BG003', 'title': 'PF-05082566 3.6 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 3.6 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF-05082566 infusion.'}, {'id': 'BG004', 'title': 'PF-05082566 5 mg/kg + MK-3475 2 mg/kg', 'description': 'PF-05082566 was administered as a 1-hour intravenous infusion at a dose of 5 mg/kg q3wks on Day 1 of each dosing cycle. MK-3475 as a 30-minute intravenous infusion at a dose of 2 mg/kg q3wks started 30 minutes after completion of PF- 05082566 infusion.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '15.4', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '51.7', 'spread': '22', 'groupId': 'BG002'}, {'value': '54.7', 'spread': '21', 'groupId': 'BG003'}, {'value': '58.8', 'spread': '19.4', 'groupId': 'BG004'}, {'value': '58.0', 'spread': '16.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population included all participants who were assigned to study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-08', 'size': 3660486, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-23T10:25', 'hasProtocol': True}, {'date': '2017-03-20', 'size': 2874462, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-23T10:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-25', 'studyFirstSubmitDate': '2014-06-30', 'resultsFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2014-06-30', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-23', 'studyFirstPostDateStruct': {'date': '2014-07-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-Limiting Toxicities (DLT) of PF-05082566 in Combination With MK-3475', 'timeFrame': 'First 2 cycles of treatment up to 24 months', 'description': 'Severity of adverse events (AEs) was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For the purpose of dose escalation, any of the following AEs occurring during the DLT observation period that were attributable to one or both study drugs were classified as DLTs. 1) Hematologic: Grade 4 neutropenia; Febrile neutropenia, defined as absolute neutrophil count (ANC) \\<1000/mm3 with a single temperature of \\>38.3C(101F) or a sustained temperature of 38C (100.4F) for more than 1 hour; Grade\\>=3 neutropenic infection; Grade\\>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia. 2) Non hematologic: Grade\\>=3 toxicities (non-laboratory); Grade\\>=3 nausea, vomiting or diarrhea despite maximal medical therapy; Grade 4 aspartate aminotransferase (AST) and alanine aminotransferase (ALT). 3) Other (non-AST/ALT) non-hematologic Grade\\>=3 laboratory value. 4) Inability to complete 2 infusions of MK-3475 and PF-05082566 during the DLT observation period.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (All Causalities)', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by National Cancer Institute (NCI) CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (PF-05082566-related)', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (MK-3475-related)', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs) and Treatment Emergent Adverse Events (TEAEs) by Maximum CTCAE Grade (Both-related)', 'timeFrame': 'Baseline up to 90 days after the last dose of study drug, approximately 27 months', 'description': 'An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device, regardless of its causal relationship with study treatment. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity were counted as treatment emergent. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was indicated death related to AE.'}, {'measure': 'Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Hematology)', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'The hematology laboratory test included: absolute neutrophil count, hemoglobin, platelet count, white blood cell with differential, coagulation panel, urinalysis and pregnancy test. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with hematology laboratory test was assessed.'}, {'measure': 'Number of Participants With Laboratory Test Values Meeting Categorical Summarization Criteria by Maximum CTCAE Grade (Chemistries)', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'The chemical laboratory test included: sodium, potassium, total calcium, creatinine, albumin, alanine aminotransferase, alanine aminotransferase, glucose, phosphorus, magnesium, total bilirubin, blood urea nitrogen, alkaline phosphatase, lactate dehydrogenase, immunoglobulin G, total protein, uric acid, thyroid function assessments, hepatitis B and C tests. Laboratory results were categorical summarized according to the NCI-CTCAE criteria version 4.03. The total number of participants with chemistry laboratory test was assessed.'}, {'measure': 'Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'Vital sign summaries included all vital sign assessments from the on-treatment period. All vital sign parameters including blood pressure (BP) and weight were summarized using actual values and changes from baseline for each visit over time. The changes computed were the differences from baseline. The participants meeting criteria of potential clinical concern were judged by investigator.'}, {'measure': 'Number of Participants With Shift From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Worst on Study', 'timeFrame': 'Baseline up to 28 days after the last dose of study drug, approximately 25 months', 'description': 'The ECOG shift from baseline to highest score during the on-treatment period was summarized by treatment group.ECOG Performance Status included 0, 1, 2, 3, and 4 grades. Grade 1 was Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 was Ambulatory and capable of all self care but unable to carry out any work activities.Up and about more than 50% of waking hours. Grade 3 was capable of only limited self care, confined to bed or chair more than 50% of waking hours. Grade 4 was completely disabled. Cannot carry on any self care. Totally confined to bed or chair.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of PF-05082566', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion', 'description': 'Maximum PF-05082566 observed serum concentration.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of MK-3475', 'timeFrame': 'During Cycle 5 Day 1 at pre-dose; and end of infusion.', 'description': 'Maximum MK-3475 observed serum concentration.'}, {'measure': 'Time for Cmax (Tmax) of PF-05082566', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'Time to reach PF-05082566 maximum observed serum concentration.'}, {'measure': 'Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 pre-dose concentration during multiple dosing'}, {'measure': 'Pre-dose Concentration During Multiple Dosing (Ctrough) of MK-3475', 'timeFrame': 'During Cycle 5 Day 1 at pre-dose; and end of infusion.', 'description': 'MK-3475 pre-dose concentration during multiple dosing'}, {'measure': 'Terminal Half-life （t½）of PF-05082566', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 terminal half-life'}, {'measure': 'Clearance (CL) of Study Drug of PF-05082566', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'Clearance of PF-05082566'}, {'measure': 'Volume of Distribution at Steady State (Vss) of PF-05082566', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 volume of distribution at steady state'}, {'measure': 'Area Under the Serum Concentration-time Curve From Time 0 to Time Tau, the Dosing Interval, Where Tau = 504 Hours (21 Days) [AUCtau] for PF-05082566', 'timeFrame': 'During Cycle 5 on Day 1 at pre-dose, end of infusion, and at 2, 6, and 24 hours after the start of infusion, day 8 (168 hours) and day 15 (336 hours) after start of infusion.', 'description': 'PF-05082566 area under the serum concentration-time curve (AUC) from time 0 to time tau, the dosing interval, where tau = 504 hours (21 days) (AUCtau)'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibody (ADA) of PF-05082566', 'timeFrame': 'Pre-dose (Day 1), Cycles 1, 3, 5, 7, and subsequently pre-dose (Day 1) every 2 cycles up to Cycle 12, and every 4 cycles thereafter', 'description': 'ADA blood samples were assayed for anti-PF-05082566 antibodies using a validated analytical method in compliance with Pfizer (anti-PF-05082566) standard operating procedures (SOPs). ADA data was listed and summarized for PF 05082566 by dose. Negative ADA: titer\\<6.23; Positive ADA: titer\\>=6.23.Treatment-induced ADA = ADA developed de novo (seroconversion) following biologic drug administration. Treatment-boosted ADA = pre-existing ADA that were boosted to a higher level following biologic drug administration.'}, {'measure': 'Number of Participants With Positive Anti-Drug Antibody (ADA) of MK-3475', 'timeFrame': 'Pre-dose in Cycles 1, 3, 5, 7 and subsequently pre dose every 2 cycles up to Cycle 12 and every 4 cycles thereafter and 28 days, and during follow-up (3 months and 6 months after the end of MK-3475 treatment).', 'description': 'ADA blood samples were assayed for anti-MK-3475 antibodies using a validated analytical method in compliance with Merck (anti-MK-3475) SOPs.'}, {'measure': 'Number of Participants With Objective Tumor Response', 'timeFrame': 'Baseline, at Week 9, and then every 6 weeks up to 90 days after the last dose of study drug, approximately 27 months. For those patients who achieved a confirmed PR or CR, tumor assessments could be conducted as clinically indicated.', 'description': 'Objective response (OR) was defined as complete response (CR) or partial response (PR) according to RECIST version 1.1 from the date of first dose of study treatment until documented disease progression.CR = at least 2 determinations of CR at least 4 weeks apart and before progression; PR = at least 2 determinations of PR or better at least 4 weeks apart and before progression (and not qualifying for a CR); Progression of disease (PD) = progression\\<=12 weeks after the date of first dose of study treatment (and not qualifying for CR, PR, SD or non-CR/non-PD); Stable disease (SD) (applicable only to participants with measurable disease at baseline) = at least 1 SD assessment (or better)\\>=6 weeks after the date of first dose of study treatment and before progression (and not qualifying for CR or PR). Both CR and PR were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumors'], 'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1641003&StudyName=A%20Study%20Of%204-1BB%20Agonist%20PF-05082566%20Plus%20PD-1%20Inhibitor%20MK-3475%20In%20Patients%20With%20Solid%20Tumors%20%28B1641003/KEYNOTE-0036%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in combination with MK-3475, a PD-1 inhibitor in patients with solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no standard therapy is available.\n* Measurable disease per RECIST v1.1.\n* Adequate bone marrow, renal and liver functioning\n\nExclusion Criteria:\n\n* CNS primary malignancies, active seizure disorder or spinal cord compression, or carcinomatous meningitis.\n* History of any of the following toxicities associated with a prior immunotherapy:\n\n * Grade 3 immune mediated adverse event that was considered related to previous immunotherapy and required immune suppressive therapy;\n * Grade 2 hepatic function related adverse event that persisted more than 1 week, was considered related to immunotherapy, or required treatment discontinuation or immunosuppressive therapy\n* Any of the following within the 12 months prior to registration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.\n* History of or known presence of extensive, disseminated/bilateral or Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, or pulmonary fibrosis, but not including a history of prior radiation pneumonitis. Patients with clinically significant lung disease requiring oxygen therapy (eg, COPD).'}, 'identificationModule': {'nctId': 'NCT02179918', 'briefTitle': 'A Study Of 4-1BB Agonist PF-05082566 Plus PD-1 Inhibitor MK-3475 In Patients With Solid Tumors (B1641003/KEYNOTE-0036)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1B STUDY OF THE 4-1BB AGONIST PF-05082566 IN COMBINATION WITH THE PD-1 INHIBITOR MK-3475 IN PATIENTS WITH ADVANCED SOLID TUMORS', 'orgStudyIdInfo': {'id': 'B1641003'}, 'secondaryIdInfos': [{'id': 'KEYNOTE-0036'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-05082566 +MK-3475', 'description': 'PF-05082566 +MK-3475', 'interventionNames': ['Drug: PF-05082566', 'Drug: MK-3475']}], 'interventions': [{'name': 'PF-05082566', 'type': 'DRUG', 'description': 'Starting dose of 0.45 mg/kg q3wks IV, dose escalation', 'armGroupLabels': ['PF-05082566 +MK-3475']}, {'name': 'MK-3475', 'type': 'DRUG', 'otherNames': ['pembrolizumab'], 'description': '2 mg/kg q3wks, IV', 'armGroupLabels': ['PF-05082566 +MK-3475']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Administration Office', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Reagan UCLA Medical Center, Drug Information Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology-Oncology Clinic', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Oncology Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Smilow Cancer Center at Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Smilow Cancer Hospital at Yale-New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], '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'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}