Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-04-19 @ 12:06 AM
Study NCT ID:
NCT02315066
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2014-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D000098943', 'term': 'Uveal Melanoma'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577122', 'term': 'utomilumab'}]}}, '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': 'A decision was made by the sponsor to terminate further enrollment to the study on 03 Oct 2018 due to business reasons. The decision to terminate study enrollment was not based on any safety or regulatory concerns.'}}, 'adverseEventsModule': {'timeFrame': 'AEs: The informed consent date to either 60 days after the last dosing date or the date when all drug-related toxicities are resolved, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B). SAEs: The informed consent date to either 98 days after the first dosing date or up to 60 days after the last dosing date, whichever is later (maximum of approximately 2.25 years for patients in Part A and 3.8 years for patients in Part B).', 'description': 'Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 7, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 6, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 11, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 10, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 9, 'seriousNumAffected': 7}, {'id': 'EG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 9, 'seriousNumAffected': 6}, {'id': 'EG008', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 10, 'seriousNumAffected': 5}, {'id': 'EG009', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 8, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 10, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 7, 'seriousNumAffected': 5}, {'id': 'EG012', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 8, 'seriousNumAffected': 5}, {'id': 'EG013', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'deathsNumAffected': 22, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 6}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 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30, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 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{'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.0'}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], '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': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The first 2 cycles of treatment (Day 1 up to Day 28)', 'description': 'DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \\>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population for this outcome measure included all enrolled participants who received at least two cycles of study medication and who did not have major treatment deviations during first two cycles.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'Number of Participants with all-causality TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}]}, {'title': 'Number of Participants with treatment-related TEAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}]}, {'title': 'Number of Participants with treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Number of Participants with all-causality SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.', 'description': 'Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least one full or partial IV infusion of study drug PF-04518600.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Abnormalities in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Hematocrit (%) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Platelets (10**3/mm**3) < 0.5 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'White Blood Cell Count (10**3/mm**3) < 0.6 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'White Blood Cell Count (10**3/mm**3) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], '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'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Lymphocytes (Absolute(Abs)) (10**3/mm**3) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '8', 'groupId': 'OG007'}]}]}, {'title': 'Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Lymphocytes (%) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}]}, {'title': 'Lymphocytes (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], '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'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Neutrophils (%) <0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Neutrophils (%) >1.2x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'PTT (sec) > 1.1 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Basophils (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Basophils (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Eosinophils (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Monocytes (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, 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'0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Phosphate (mg/dL) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'T4 (free) (ng/dL) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'T4 (free) (ng/dL) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'TSH (UIU/mL) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'TSH (UIU/mL) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}]}, {'title': 'Glucose (mg/dL) < 0.6 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Glucose (mg/dL) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Creatine Kinase (CK) (U/L) > 2.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Amylase (U/L) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Lipase (U/L) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Urine Protein (Qual) >= 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'Urine Blood/ hemoglobin(Hgb) (Qual) >= 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Urine RBC (/high power field (HPF)) >= 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Urine WBC (/HPF) >= 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Urine Epithelial Cells (/HPF) >= 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '13', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Urine Casts (/low power field(LPF) > 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Urine Granular Casts (/LPF) > 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Urine Hyaline Casts (/LPF) >1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Urine Bacteria (/HPF) > 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)', 'description': 'Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \\[protein, blood\\], microscopy \\[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\\], miscellaneous \\[urine casts and bacteria\\]).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With DLTs in Part B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The First 2 Cycles of Treatment (Day 1 up to Day 28)', 'description': 'DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \\>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population for this outcome measure included all enrolled participants who received at least two cycles of study medication and who did not have major treatment deviations during first two cycles.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'Number of Participants with all-causality TEAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}]}, {'title': 'Number of Participants with treatment-related TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Number of Participants with treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Number of Participants with all-causality SAEs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'AEs: The informed consent date up to the last dosing date + 60 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.', 'description': 'Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Abnormalities in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'Hemoglobin (g/dL) < 0.8 x lower limit of normal (LLN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Hematocrit (%) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Platelets (10**3/mm**3) < 0.5 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Platelets (10**3/mm**3) > 1.75 x upper limit of normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'White Blood Cell Count (10**3/mm**3) < 0.6 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], '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 Cell Count (10**3/mm**3) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Lymphocytes (Abs) (10**3/mm**3) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': 'Lymphocytes (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Lymphocytes (%) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}]}, {'title': 'Lymphocytes (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Total Neutrophils (Abs) (10**3/mm**3) < 0.8 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Total Neutrophils (Abs) (10**3/mm**3) > 1.2 x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Neutrophils (%) <0.8x LLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Neutrophils (%) >1.2x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Basophils (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Basophils (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Eosinophils (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'Eosinophils (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Monocytes (Abs) (10**3/mm**3) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Monocytes (%) > 1.2 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'PTT (sec) > 1.1 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Prothrombin (PT) (sec) > 1.1 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'PT International Ratio (INR) > 1.1 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Total Bilirubin (mg/dL) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Direct Bilirubin (mg/dL) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Indirect Bilirubin (mg/dL) > 1.5 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Aspartate Aminotransferase (AST) (IU/L) > 3.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Alanine Aminotransferase (ALT) (IU/L) > 3.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Gamma GT (IU/L) > 3.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Alkaline Phosphatase (IU/L) > 3.0 x ULN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, 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'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Urine Granular Casts (/LPF) > 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}], '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': 'Urine Hyaline Casts (/LPF) >1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Urine Bacteria (/HPF) > 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], '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': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)', 'description': 'Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \\[protein, blood\\], microscopy \\[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\\], miscellaneous \\[urine casts and bacteria\\]).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'ORR per RECIST v1.1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'ORR per irRECIST', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9.1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.\n\nCR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \\<10 mm.\n\nPR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nOverall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \\<10 mm.\n\nOverall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.4'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '4.2'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '24.0'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '8.3'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '1.3', 'upperLimit': '5.6'}, {'value': '4.8', 'comment': 'The upper limit was not estimable. Because the upper limit for PFS based on Kaplan-Meier method was not reached.', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': 'NA'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '1.5', 'upperLimit': '3.7'}, {'value': '2.8', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose', 'description': 'PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.\n\nPD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.4'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '6.5'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '24.0'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '8.3'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '1.2', 'upperLimit': '5.6'}, {'value': '8.3', 'comment': 'The upper limit was not estimable. Because the upper limit for TTP based on Kaplan-Meier method was not reached.', 'groupId': 'OG005', 'lowerLimit': '1.2', 'upperLimit': 'NA'}, {'value': '3.2', 'groupId': 'OG006', 'lowerLimit': '1.5', 'upperLimit': '3.7'}, {'value': '2.8', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '3.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose', 'description': 'TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Having Stable Disease (SD) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.4', 'comment': 'Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '21.4', 'comment': 'Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median value and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.\n\nCR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \\<10 mm) and all target lesions must be assessed.\n\nPR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '14.8'}, {'value': '13.0', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '20.7'}, {'value': '17.6', 'comment': 'The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': 'NA'}, {'value': '9.0', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': '17.2'}, {'value': '7.4', 'groupId': 'OG004', 'lowerLimit': '5.1', 'upperLimit': '19.1'}, {'value': '7.5', 'comment': 'The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.', 'groupId': 'OG005', 'lowerLimit': '0.7', 'upperLimit': 'NA'}, {'value': '15.6', 'comment': 'The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.', 'groupId': 'OG006', 'lowerLimit': '4.2', 'upperLimit': 'NA'}, {'value': '23.9', 'comment': 'The upper limit was not estimable. Because the upper limit for OS based on Kaplan-Meier method was not reached.', 'groupId': 'OG007', 'lowerLimit': '6.5', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'OS was defined as time in months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 30.44.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rates at Months 6, 12, and 24 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'Survival Probability at Month 6', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '30.5', 'upperLimit': '88.7'}, {'value': '88.9', 'groupId': 'OG002', 'lowerLimit': '43.3', 'upperLimit': '98.4'}, {'value': '75.0', 'groupId': 'OG003', 'lowerLimit': '40.8', 'upperLimit': '91.2'}, {'value': '67.7', 'groupId': 'OG004', 'lowerLimit': '34.9', 'upperLimit': '86.5'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '5.8', 'upperLimit': '84.5'}, {'value': '62.5', 'groupId': 'OG006', 'lowerLimit': '31.7', 'upperLimit': '82.5'}, {'value': '83.9', 'groupId': 'OG007', 'lowerLimit': '57.9', 'upperLimit': '94.5'}]}]}, {'title': 'Survival Probability at Month 12', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '91.0'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '14.3', 'upperLimit': '79.6'}, {'value': '55.6', 'groupId': 'OG002', 'lowerLimit': '20.4', 'upperLimit': '80.5'}, {'value': '41.7', 'groupId': 'OG003', 'lowerLimit': '15.2', 'upperLimit': '66.5'}, {'value': '33.8', 'groupId': 'OG004', 'lowerLimit': '10.5', 'upperLimit': '59.4'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '5.8', 'upperLimit': '84.5'}, {'value': '54.7', 'groupId': 'OG006', 'lowerLimit': '25.4', 'upperLimit': '76.6'}, {'value': '58.4', 'groupId': 'OG007', 'lowerLimit': '31.6', 'upperLimit': '77.8'}]}]}, {'title': 'Survival Probability at Month 24', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Number and ranges for 95% CI were not estimable due to both participants in the group have been censored or died before month 24.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Number and ranges for 95% CI were not estimable due to all participants in the group have been censored or died before month 24.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '44.4', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '71.9'}, {'value': 'NA', 'comment': 'Number and ranges for 95% CI were not estimable due to all participants in the group have been censored or died before month 24.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '16.9', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '41.7'}, {'value': '25.0', 'groupId': 'OG005', 'lowerLimit': '0.9', 'upperLimit': '66.5'}, {'value': '27.3', 'groupId': 'OG006', 'lowerLimit': '6.9', 'upperLimit': '53.4'}, {'value': '42.6', 'groupId': 'OG007', 'lowerLimit': '17.7', 'upperLimit': '65.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'Probability of survival at 6, 12, and 24 months after the first dose of study treatment.', 'unitOfMeasure': 'Probability of survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0.231', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG000'}, {'value': '2.871', 'spread': '24', 'groupId': 'OG001'}, {'value': '8.448', 'spread': '17', 'groupId': 'OG002'}, {'value': '36.71', 'spread': '21', 'groupId': 'OG003'}, {'value': '75.91', 'spread': '18', 'groupId': 'OG004'}, {'value': '268.1', 'spread': '20', 'groupId': 'OG005'}, {'value': '8.264', 'spread': '25', 'groupId': 'OG006'}, {'value': '72.05', 'spread': '22', 'groupId': 'OG007'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2.731', 'spread': '54', 'groupId': 'OG001'}, {'value': '11.03', 'spread': '23', 'groupId': 'OG002'}, {'value': '56.15', 'spread': '19', 'groupId': 'OG003'}, {'value': '114.9', 'spread': '22', 'groupId': 'OG004'}, {'value': '401.1', 'spread': '26', 'groupId': 'OG005'}, {'value': '10.27', 'spread': '32', 'groupId': 'OG006'}, {'value': '105.7', 'spread': '23', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmax was defined as maximum observed serum concentration and can be observed directly from data.\n\nCss,max was the Cmax on C3D1.', 'unitOfMeasure': 'microgram/milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '7.59', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG000'}, {'value': '303.5', 'spread': '35', 'groupId': 'OG001'}, {'value': '1350', 'spread': '20', 'groupId': 'OG002'}, {'value': '6218', 'spread': '23', 'groupId': 'OG003'}, {'value': '12810', 'spread': '17', 'groupId': 'OG004'}, {'value': '38220', 'spread': '19', 'groupId': 'OG005'}, {'value': '1375', 'spread': '25', 'groupId': 'OG006'}, {'value': '14360', 'spread': '19', 'groupId': 'OG007'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '299', 'spread': '151', 'groupId': 'OG001'}, {'value': '2072', 'spread': '36', 'groupId': 'OG002'}, {'value': '11610', 'spread': '18', 'groupId': 'OG003'}, {'value': '25600', 'spread': '21', 'groupId': 'OG004'}, {'value': '82710', 'spread': '32', 'groupId': 'OG005'}, {'value': '2236', 'spread': '37', 'groupId': 'OG006'}, {'value': '25380', 'spread': '29', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.', 'unitOfMeasure': 'microgram•hour/milliliter (µg•hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '293.7', 'spread': '34', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 1590,1010.', 'groupId': 'OG002'}, {'value': '23000', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 1580,991.', 'groupId': 'OG006'}, {'value': '22700', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG007'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '380.7', 'spread': '56', 'groupId': 'OG001'}, {'value': '33800', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG004'}, {'value': '1180', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG006'}, {'value': '35000', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '3.410', 'spread': '1.0992', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 5.77,4.83.', 'groupId': 'OG002'}, {'value': '13.1', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG004'}, {'value': '5.67', 'spread': '5.89', 'groupId': 'OG006'}, {'value': '11.9', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG007'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '4.010', 'spread': '1.1370', 'groupId': 'OG001'}, {'value': '10.6', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG004'}, {'value': '5.76', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG006'}, {'value': '11.9', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 't1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.'}, {'type': 'SECONDARY', 'title': 'Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05952', 'spread': '51749', 'groupId': 'OG001'}, {'value': '2.882', 'spread': '61', 'groupId': 'OG002'}, {'value': '17.79', 'spread': '32', 'groupId': 'OG003'}, {'value': '36.14', 'spread': '48', 'groupId': 'OG004'}, {'value': '130', 'spread': '41', 'groupId': 'OG005'}, {'value': '2.968', 'spread': '55', 'groupId': 'OG006'}, {'value': '37.62', 'spread': '47', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.'}, {'type': 'SECONDARY', 'title': 'Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8897', 'spread': '151', 'groupId': 'OG001'}, {'value': '6.166', 'spread': '36', 'groupId': 'OG002'}, {'value': '34.55', 'spread': '18', 'groupId': 'OG003'}, {'value': '76.13', 'spread': '20', 'groupId': 'OG004'}, {'value': '246.1', 'spread': '32', 'groupId': 'OG005'}, {'value': '6.659', 'spread': '37', 'groupId': 'OG006'}, {'value': '75.55', 'spread': '29', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cav was defined as average serum concentration over the dosing interval.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3342', 'spread': '151', 'groupId': 'OG001'}, {'value': '0.1448', 'spread': '48', 'groupId': 'OG002'}, {'value': '0.1291', 'spread': '18', 'groupId': 'OG003'}, {'value': '0.1171', 'spread': '21', 'groupId': 'OG004'}, {'value': '0.1209', 'spread': '32', 'groupId': 'OG005'}, {'value': '0.1739', 'spread': '28', 'groupId': 'OG006'}, {'value': '0.1423', 'spread': '31', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau', 'unitOfMeasure': 'milliliter/hour/kilogram (mL/hr/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.17', 'spread': '19', 'groupId': 'OG001'}, {'value': '55.3', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG004'}, {'value': '79.2', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG006'}, {'value': '94.3', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Vss was defined as volume of distribution at steady state.', 'unitOfMeasure': 'milliliter/kilograms (mL/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '14', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9893', 'spread': '110', 'groupId': 'OG001'}, {'value': '1.543', 'spread': '32', 'groupId': 'OG002'}, {'value': '1.785', 'spread': '12', 'groupId': 'OG003'}, {'value': '1.947', 'spread': '12', 'groupId': 'OG004'}, {'value': '2.161', 'spread': '13', 'groupId': 'OG005'}, {'value': '1.628', 'spread': '19', 'groupId': 'OG006'}, {'value': '1.709', 'spread': '21', 'groupId': 'OG007'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'ADA ever-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'NAb ever-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (maximum of 14 weeks).', 'description': 'ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.'}, {'type': 'SECONDARY', 'title': 'Mean Unbound Cell Surface OX40 in Part A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'OG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}], 'classes': [{'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '54.65', 'spread': '15.203', 'groupId': 'OG000'}, {'value': '51.54', 'spread': '15.670', 'groupId': 'OG001'}, {'value': '44.85', 'spread': '9.407', 'groupId': 'OG002'}, {'value': '41.53', 'spread': '11.797', 'groupId': 'OG003'}, {'value': '48.45', 'spread': '18.597', 'groupId': 'OG004'}, {'value': '47.60', 'spread': '12.181', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4Hours(H))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '33.60', 'spread': '34.083', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '2.621', 'groupId': 'OG001'}, {'value': '0.53', 'spread': '0.869', 'groupId': 'OG002'}, {'value': '11.96', 'spread': '26.576', 'groupId': 'OG003'}, {'value': '0.40', 'spread': '1.047', 'groupId': 'OG004'}, {'value': '-0.25', 'spread': '0.507', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '35.60', 'spread': '31.961', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '1.297', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.859', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '0.221', 'groupId': 'OG003'}, {'value': '0.10', 'spread': '0.469', 'groupId': 'OG004'}, {'value': '0.10', 'spread': '0.141', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '53.90', 'spread': '21.355', 'groupId': 'OG000'}, {'value': '6.21', 'spread': '6.127', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '1.250', 'groupId': 'OG002'}, {'value': '0.30', 'spread': '0.306', 'groupId': 'OG003'}, {'value': '0.70', 'spread': '1.724', 'groupId': 'OG004'}, {'value': '-0.00', 'spread': '0.294', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '32.30', 'spread': '11.738', 'groupId': 'OG000'}, {'value': '15.21', 'spread': '11.219', 'groupId': 'OG001'}, {'value': '3.67', 'spread': '2.511', 'groupId': 'OG002'}, {'value': '0.41', 'spread': '0.745', 'groupId': 'OG003'}, {'value': '0.88', 'spread': '1.881', 'groupId': 'OG004'}, {'value': '-0.03', 'spread': '0.153', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '46.35', 'spread': '11.950', 'groupId': 'OG000'}, {'value': '10.00', 'spread': '6.387', 'groupId': 'OG001'}, {'value': '1.26', 'spread': '1.367', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.098', 'groupId': 'OG003'}, {'value': '0.24', 'spread': '0.720', 'groupId': 'OG004'}, {'value': '-0.03', 'spread': '0.058', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '49.25', 'spread': '21.708', 'groupId': 'OG000'}, {'value': '27.44', 'spread': '24.644', 'groupId': 'OG001'}, {'value': '2.39', 'spread': '3.102', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.223', 'groupId': 'OG003'}, {'value': '0.56', 'spread': '0.940', 'groupId': 'OG004'}, {'value': '-0.20', 'spread': '0.424', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '35.15', 'spread': '35.426', 'groupId': 'OG000'}, {'value': '17.42', 'spread': '18.026', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '2.177', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.151', 'groupId': 'OG003'}, {'value': '0.44', 'spread': '1.043', 'groupId': 'OG004'}, {'value': '-0.27', 'spread': '0.379', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '19.00', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of free CD4+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG000'}, {'value': '22.54', 'spread': '20.118', 'groupId': 'OG001'}, {'value': '0.44', 'spread': '0.391', 'groupId': 'OG002'}, {'value': '-0.07', 'spread': '0.153', 'groupId': 'OG003'}, {'value': '0.57', 'spread': '1.069', 'groupId': 'OG004'}, {'value': '0.20', 'spread': '0.283', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '24.3', 'spread': '15.719', 'groupId': 'OG001'}, {'value': '0.67', 'spread': '0.603', 'groupId': 'OG002'}, {'value': '0.10', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of free CD4+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG003'}, {'value': '0.80', 'spread': '1.386', 'groupId': 'OG004'}, {'value': '-0.25', 'spread': '0.354', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Central Memory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '53.20', 'spread': '1.838', 'groupId': 'OG000'}, {'value': '31.13', 'spread': '22.871', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '0.252', 'groupId': 'OG002'}, {'value': '-0.18', 'spread': '0.150', 'groupId': 'OG003'}, {'value': '0.85', 'spread': '1.061', 'groupId': 'OG004'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '66.95', 'spread': '22.698', 'groupId': 'OG000'}, {'value': '57.26', 'spread': '18.236', 'groupId': 'OG001'}, {'value': '55.18', 'spread': '10.939', 'groupId': 'OG002'}, {'value': '45.67', 'spread': '12.565', 'groupId': 'OG003'}, {'value': '42.72', 'spread': '9.957', 'groupId': 'OG004'}, {'value': '49.25', 'spread': '15.295', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '46.55', 'spread': '41.366', 'groupId': 'OG000'}, {'value': '3.41', 'spread': '2.948', 'groupId': 'OG001'}, {'value': '0.65', 'spread': '0.771', 'groupId': 'OG002'}, {'value': '12.92', 'spread': '28.499', 'groupId': 'OG003'}, {'value': '0.13', 'spread': '0.333', 'groupId': 'OG004'}, {'value': '0.08', 'spread': '0.222', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '44.35', 'spread': '36.275', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '5.863', 'groupId': 'OG001'}, {'value': '2.70', 'spread': '3.344', 'groupId': 'OG002'}, {'value': '0.10', 'spread': '0.238', 'groupId': 'OG003'}, {'value': '0.01', 'spread': '0.107', 'groupId': 'OG004'}, {'value': '-0.05', 'spread': '0.071', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '61.40', 'spread': '21.072', 'groupId': 'OG000'}, {'value': '11.50', 'spread': '8.179', 'groupId': 'OG001'}, {'value': '1.34', 'spread': '1.646', 'groupId': 'OG002'}, {'value': '0.66', 'spread': '1.037', 'groupId': 'OG003'}, {'value': '0.42', 'spread': '0.624', 'groupId': 'OG004'}, {'value': '0.08', 'spread': '0.222', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '51.55', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '20.17', 'spread': '12.575', 'groupId': 'OG001'}, {'value': '4.83', 'spread': '3.810', 'groupId': 'OG002'}, {'value': '1.13', 'spread': '1.908', 'groupId': 'OG003'}, {'value': '0.58', 'spread': '0.697', 'groupId': 'OG004'}, {'value': '-0.10', 'spread': '0.173', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '54.70', 'spread': '20.648', 'groupId': 'OG000'}, {'value': '19.42', 'spread': '10.402', 'groupId': 'OG001'}, {'value': '2.91', 'spread': '2.195', 'groupId': 'OG002'}, {'value': '0.23', 'spread': '0.390', 'groupId': 'OG003'}, {'value': '0.14', 'spread': '0.385', 'groupId': 'OG004'}, {'value': '0.30', 'spread': '0.458', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '60.20', 'spread': '24.183', 'groupId': 'OG000'}, {'value': '32.47', 'spread': '23.479', 'groupId': 'OG001'}, {'value': '3.49', 'spread': '4.759', 'groupId': 'OG002'}, {'value': '0.37', 'spread': '0.556', 'groupId': 'OG003'}, {'value': '0.16', 'spread': '0.422', 'groupId': 'OG004'}, {'value': '-0.05', 'spread': '0.071', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '45.95', 'spread': '41.083', 'groupId': 'OG000'}, {'value': '24.00', 'spread': '18.939', 'groupId': 'OG001'}, {'value': 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{'title': 'Free, CD4+ Effector Memory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '58.05', 'spread': '9.263', 'groupId': 'OG000'}, {'value': '47.80', 'spread': '21.140', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.351', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '0.436', 'groupId': 'OG003'}, {'value': '0.50', 'spread': '0.424', 'groupId': 'OG004'}]}]}, {'title': 'Free, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 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'4.28', 'spread': '4.129', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.462', 'groupId': 'OG002'}, {'value': '0.20', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of free CD8+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG003'}, {'value': '1.13', 'spread': '1.966', 'groupId': 'OG004'}, {'value': '-0.10', 'spread': '0.000', 'groupId': 'OG005'}]}]}, {'title': 'Free, CD8+ Effector Memory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.05', 'spread': '1.202', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '7.218', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.624', 'groupId': 'OG002'}, {'value': '-0.05', 'spread': '0.058', 'groupId': 'OG003'}, {'value': '1.00', 'spread': '1.414', 'groupId': 'OG004'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '28.85', 'spread': '0.778', 'groupId': 'OG000'}, {'value': '40.18', 'spread': '12.164', 'groupId': 'OG001'}, {'value': '34.51', 'spread': '10.649', 'groupId': 'OG002'}, {'value': '42.13', 'spread': '18.565', 'groupId': 'OG003'}, {'value': '41.98', 'spread': '12.160', 'groupId': 'OG004'}, {'value': '38.35', 'spread': '9.019', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '26.85', 'spread': '0.212', 'groupId': 'OG000'}, {'value': '36.30', 'spread': '10.886', 'groupId': 'OG001'}, {'value': '34.46', 'spread': '11.679', 'groupId': 'OG002'}, {'value': '42.89', 'spread': '13.179', 'groupId': 'OG003'}, {'value': '40.23', 'spread': '8.245', 'groupId': 'OG004'}, {'value': '40.55', 'spread': '9.219', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '31.30', 'spread': '1.980', 'groupId': 'OG000'}, {'value': '35.28', 'spread': '14.278', 'groupId': 'OG001'}, {'value': '34.92', 'spread': '5.867', 'groupId': 'OG002'}, {'value': '40.88', 'spread': '11.313', 'groupId': 'OG003'}, {'value': '45.69', 'spread': '6.950', 'groupId': 'OG004'}, {'value': '38.43', 'spread': '6.543', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27.55', 'spread': '3.606', 'groupId': 'OG000'}, {'value': '40.33', 'spread': '15.040', 'groupId': 'OG001'}, {'value': '38.21', 'spread': '4.342', 'groupId': 'OG002'}, {'value': '43.15', 'spread': '9.439', 'groupId': 'OG003'}, {'value': '52.44', 'spread': '5.264', 'groupId': 'OG004'}, {'value': '35.77', 'spread': '14.935', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '28.85', 'spread': '2.758', 'groupId': 'OG000'}, {'value': '39.14', 'spread': '12.053', 'groupId': 'OG001'}, {'value': '33.46', 'spread': '11.820', 'groupId': 'OG002'}, {'value': '37.88', 'spread': '11.844', 'groupId': 'OG003'}, {'value': '44.57', 'spread': '13.038', 'groupId': 'OG004'}, {'value': '39.25', 'spread': '20.718', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '30.40', 'spread': '0.566', 'groupId': 'OG000'}, {'value': '34.08', 'spread': '8.806', 'groupId': 'OG001'}, {'value': '32.47', 'spread': '13.862', 'groupId': 'OG002'}, {'value': '38.61', 'spread': '13.391', 'groupId': 'OG003'}, {'value': '41.61', 'spread': '11.904', 'groupId': 'OG004'}, {'value': '41.10', 'spread': '15.125', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '34.40', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total, CD127lo regulatory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG000'}, {'value': '36.50', 'spread': '6.840', 'groupId': 'OG001'}, {'value': '36.40', 'spread': '4.627', 'groupId': 'OG002'}, {'value': '32.20', 'spread': '7.105', 'groupId': 'OG003'}, {'value': '41.88', 'spread': '12.275', 'groupId': 'OG004'}, {'value': '35.85', 'spread': '0.354', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38.64', 'spread': '5.538', 'groupId': 'OG001'}, {'value': '35.20', 'spread': '3.350', 'groupId': 'OG002'}, {'value': '25.70', 'spread': '9.051', 'groupId': 'OG003'}, {'value': '45.23', 'spread': '9.955', 'groupId': 'OG004'}, {'value': '48.25', 'spread': '12.799', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD127lo Regulatory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '35.30', 'spread': '2.404', 'groupId': 'OG000'}, {'value': '34.00', 'spread': '16.913', 'groupId': 'OG001'}, {'value': '28.12', 'spread': '16.961', 'groupId': 'OG002'}, {'value': '38.10', 'spread': '10.006', 'groupId': 'OG003'}, {'value': '45.20', 'spread': '10.611', 'groupId': 'OG004'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '49.90', 'spread': '3.536', 'groupId': 'OG000'}, {'value': '50.61', 'spread': '16.877', 'groupId': 'OG001'}, {'value': '44.38', 'spread': '9.798', 'groupId': 'OG002'}, {'value': '45.35', 'spread': '13.300', 'groupId': 'OG003'}, {'value': '52.28', 'spread': '16.746', 'groupId': 'OG004'}, {'value': '33.23', 'spread': '16.607', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '56.45', 'spread': '6.010', 'groupId': 'OG000'}, {'value': '52.19', 'spread': '16.212', 'groupId': 'OG001'}, {'value': '48.00', 'spread': '14.287', 'groupId': 'OG002'}, {'value': '51.86', 'spread': '10.272', 'groupId': 'OG003'}, {'value': '44.77', 'spread': '24.667', 'groupId': 'OG004'}, {'value': '36.05', 'spread': '16.733', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '52.85', 'spread': '11.384', 'groupId': 'OG000'}, {'value': '52.74', 'spread': '14.199', 'groupId': 'OG001'}, {'value': '48.67', 'spread': '8.943', 'groupId': 'OG002'}, {'value': '39.77', 'spread': '12.347', 'groupId': 'OG003'}, {'value': '45.11', 'spread': '21.747', 'groupId': 'OG004'}, {'value': '21.00', 'spread': '4.101', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '49.75', 'spread': '18.880', 'groupId': 'OG000'}, {'value': '46.47', 'spread': '14.885', 'groupId': 'OG001'}, {'value': '39.07', 'spread': '13.011', 'groupId': 'OG002'}, {'value': '45.09', 'spread': '10.489', 'groupId': 'OG003'}, {'value': '38.22', 'spread': '20.166', 'groupId': 'OG004'}, {'value': '27.70', 'spread': '13.124', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '49.90', 'spread': '9.758', 'groupId': 'OG000'}, {'value': '41.43', 'spread': '14.750', 'groupId': 'OG001'}, {'value': '41.21', 'spread': '9.855', 'groupId': 'OG002'}, {'value': '45.70', 'spread': '10.567', 'groupId': 'OG003'}, {'value': '45.17', 'spread': '16.509', 'groupId': 'OG004'}, {'value': '23.30', 'spread': '11.811', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '50.85', 'spread': '8.132', 'groupId': 'OG000'}, {'value': '49.08', 'spread': '20.277', 'groupId': 'OG001'}, {'value': '46.00', 'spread': '7.485', 'groupId': 'OG002'}, {'value': '41.00', 'spread': '12.981', 'groupId': 'OG003'}, {'value': '34.40', 'spread': '17.363', 'groupId': 'OG004'}, {'value': '23.27', 'spread': '26.999', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '49.75', 'spread': '13.223', 'groupId': 'OG000'}, {'value': '50.04', 'spread': '13.227', 'groupId': 'OG001'}, {'value': '40.76', 'spread': '18.801', 'groupId': 'OG002'}, {'value': '42.94', 'spread': '11.357', 'groupId': 'OG003'}, {'value': '37.22', 'spread': '19.773', 'groupId': 'OG004'}, {'value': '35.65', 'spread': '31.183', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '54.95', 'spread': '8.839', 'groupId': 'OG000'}, {'value': '45.20', 'spread': '16.005', 'groupId': 'OG001'}, {'value': '41.20', 'spread': '20.054', 'groupId': 'OG002'}, {'value': '42.87', 'spread': '10.049', 'groupId': 'OG003'}, {'value': '39.30', 'spread': '13.509', 'groupId': 'OG004'}, {'value': '37.37', 'spread': '16.783', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '37.20', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD4+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG000'}, {'value': '47.52', 'spread': '15.688', 'groupId': 'OG001'}, {'value': '41.42', 'spread': '11.115', 'groupId': 'OG002'}, {'value': '43.43', 'spread': '5.788', 'groupId': 'OG003'}, {'value': '30.37', 'spread': '15.309', 'groupId': 'OG004'}, {'value': '32.15', 'spread': '19.304', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '53.80', 'spread': '9.098', 'groupId': 'OG001'}, {'value': '36.67', 'spread': '2.589', 'groupId': 'OG002'}, {'value': '39.90', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD4+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG003'}, {'value': '27.27', 'spread': '23.200', 'groupId': 'OG004'}, {'value': '49.00', 'spread': '27.294', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Central Memory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '52.75', 'spread': '13.789', 'groupId': 'OG000'}, {'value': '46.70', 'spread': '12.775', 'groupId': 'OG001'}, {'value': '24.80', 'spread': '23.435', 'groupId': 'OG002'}, {'value': '41.38', 'spread': '6.111', 'groupId': 'OG003'}, {'value': '34.65', 'spread': '11.526', 'groupId': 'OG004'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '59.60', 'spread': '16.546', 'groupId': 'OG000'}, {'value': '56.10', 'spread': '15.093', 'groupId': 'OG001'}, {'value': '43.38', 'spread': '23.693', 'groupId': 'OG002'}, {'value': '47.03', 'spread': '13.816', 'groupId': 'OG003'}, {'value': '40.25', 'spread': '12.277', 'groupId': 'OG004'}, {'value': '41.58', 'spread': '15.879', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '60.65', 'spread': '17.607', 'groupId': 'OG000'}, {'value': '58.76', 'spread': '16.535', 'groupId': 'OG001'}, {'value': '50.53', 'spread': '13.385', 'groupId': 'OG002'}, {'value': '47.82', 'spread': '15.437', 'groupId': 'OG003'}, {'value': '31.28', 'spread': '15.021', 'groupId': 'OG004'}, {'value': '38.68', 'spread': '19.538', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '57.00', 'spread': '19.658', 'groupId': 'OG000'}, {'value': '59.39', 'spread': '15.181', 'groupId': 'OG001'}, {'value': '52.93', 'spread': '9.347', 'groupId': 'OG002'}, {'value': '37.09', 'spread': '14.705', 'groupId': 'OG003'}, {'value': '31.91', 'spread': '17.122', 'groupId': 'OG004'}, {'value': '24.25', 'spread': '19.728', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '56.20', 'spread': '18.526', 'groupId': 'OG000'}, {'value': '50.57', 'spread': '12.243', 'groupId': 'OG001'}, {'value': '45.09', 'spread': '11.917', 'groupId': 'OG002'}, {'value': '44.00', 'spread': '13.558', 'groupId': 'OG003'}, {'value': '31.87', 'spread': '18.013', 'groupId': 'OG004'}, {'value': '33.43', 'spread': '10.754', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '58.45', 'spread': '18.173', 'groupId': 'OG000'}, {'value': '49.54', 'spread': '12.391', 'groupId': 'OG001'}, {'value': '51.86', 'spread': '9.906', 'groupId': 'OG002'}, {'value': '44.06', 'spread': '12.694', 'groupId': 'OG003'}, {'value': '35.20', 'spread': '14.024', 'groupId': 'OG004'}, {'value': '30.40', 'spread': '12.382', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '56.40', 'spread': '15.274', 'groupId': 'OG000'}, {'value': '62.78', 'spread': '19.629', 'groupId': 'OG001'}, {'value': '51.01', 'spread': '14.110', 'groupId': 'OG002'}, {'value': '43.93', 'spread': '14.824', 'groupId': 'OG003'}, {'value': '33.48', 'spread': '21.662', 'groupId': 'OG004'}, {'value': '31.60', 'spread': '21.458', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '56.50', 'spread': '18.526', 'groupId': 'OG000'}, {'value': '56.11', 'spread': '14.652', 'groupId': 'OG001'}, {'value': '46.63', 'spread': '22.926', 'groupId': 'OG002'}, {'value': '43.71', 'spread': '14.276', 'groupId': 'OG003'}, {'value': '35.08', 'spread': '19.484', 'groupId': 'OG004'}, {'value': '42.35', 'spread': '21.708', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '60.85', 'spread': '15.344', 'groupId': 'OG000'}, {'value': '51.48', 'spread': '21.069', 'groupId': 'OG001'}, {'value': '45.60', 'spread': '23.497', 'groupId': 'OG002'}, {'value': '42.40', 'spread': '13.966', 'groupId': 'OG003'}, {'value': '41.88', 'spread': '16.112', 'groupId': 'OG004'}, {'value': '31.67', 'spread': '18.151', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '44.00', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD4+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG000'}, {'value': '49.92', 'spread': '11.834', 'groupId': 'OG001'}, {'value': '48.54', 'spread': '14.165', 'groupId': 'OG002'}, {'value': '51.03', 'spread': '10.119', 'groupId': 'OG003'}, {'value': '29.60', 'spread': '7.754', 'groupId': 'OG004'}, {'value': '33.40', 'spread': '30.830', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '55.98', 'spread': '10.071', 'groupId': 'OG001'}, {'value': '38.67', 'spread': '12.438', 'groupId': 'OG002'}, {'value': '44.80', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD4+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG003'}, {'value': '22.10', 'spread': '18.857', 'groupId': 'OG004'}, {'value': '59.75', 'spread': '12.092', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD4+ Effector Memory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '62.50', 'spread': '20.789', 'groupId': 'OG000'}, {'value': '63.00', 'spread': '21.165', 'groupId': 'OG001'}, {'value': '21.43', 'spread': '17.010', 'groupId': 'OG002'}, {'value': '29.83', 'spread': '12.258', 'groupId': 'OG003'}, {'value': '36.80', 'spread': '12.869', 'groupId': 'OG004'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.55', 'spread': '4.879', 'groupId': 'OG000'}, {'value': '12.00', 'spread': '10.795', 'groupId': 'OG001'}, {'value': '9.02', 'spread': '5.270', 'groupId': 'OG002'}, {'value': '16.30', 'spread': '11.546', 'groupId': 'OG003'}, {'value': '12.82', 'spread': '4.961', 'groupId': 'OG004'}, {'value': '15.63', 'spread': '20.503', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 1 (4H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '10.35', 'spread': '6.859', 'groupId': 'OG000'}, {'value': '11.34', 'spread': '11.046', 'groupId': 'OG001'}, {'value': '9.00', 'spread': '5.355', 'groupId': 'OG002'}, {'value': '18.72', 'spread': '14.591', 'groupId': 'OG003'}, {'value': '10.03', 'spread': '8.477', 'groupId': 'OG004'}, {'value': '15.23', 'spread': '15.784', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '7.30', 'spread': '5.940', 'groupId': 'OG000'}, {'value': '10.33', 'spread': '9.138', 'groupId': 'OG001'}, {'value': '8.65', 'spread': '6.783', 'groupId': 'OG002'}, {'value': '12.27', 'spread': '10.298', 'groupId': 'OG003'}, {'value': '11.93', 'spread': '8.826', 'groupId': 'OG004'}, {'value': '23.95', 'spread': '34.295', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': '1.131', 'groupId': 'OG000'}, {'value': '9.53', 'spread': '7.607', 'groupId': 'OG001'}, {'value': '9.03', 'spread': '10.168', 'groupId': 'OG002'}, {'value': '15.81', 'spread': '9.926', 'groupId': 'OG003'}, {'value': '9.55', 'spread': '7.987', 'groupId': 'OG004'}, {'value': '10.65', 'spread': '15.910', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.70', 'spread': '7.495', 'groupId': 'OG000'}, {'value': '9.56', 'spread': '10.163', 'groupId': 'OG001'}, {'value': '9.50', 'spread': '12.278', 'groupId': 'OG002'}, {'value': '14.83', 'spread': '11.588', 'groupId': 'OG003'}, {'value': '10.42', 'spread': '7.695', 'groupId': 'OG004'}, {'value': '2.67', 'spread': '1.570', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '8.70', 'spread': '5.798', 'groupId': 'OG000'}, {'value': '12.13', 'spread': '11.505', 'groupId': 'OG001'}, {'value': '10.19', 'spread': '13.521', 'groupId': 'OG002'}, {'value': '12.89', 'spread': '8.212', 'groupId': 'OG003'}, {'value': '10.38', 'spread': '10.295', 'groupId': 'OG004'}, {'value': '2.77', 'spread': '3.109', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.05', 'spread': '4.738', 'groupId': 'OG000'}, {'value': '12.11', 'spread': '7.990', 'groupId': 'OG001'}, {'value': '10.49', 'spread': '11.153', 'groupId': 'OG002'}, {'value': '14.19', 'spread': '9.905', 'groupId': 'OG003'}, {'value': '9.86', 'spread': '9.571', 'groupId': 'OG004'}, {'value': '6.20', 'spread': '4.525', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.05', 'spread': '1.626', 'groupId': 'OG000'}, {'value': '11.55', 'spread': '8.232', 'groupId': 'OG001'}, {'value': '11.29', 'spread': '13.434', 'groupId': 'OG002'}, {'value': '13.90', 'spread': '8.309', 'groupId': 'OG003'}, {'value': '10.34', 'spread': '8.769', 'groupId': 'OG004'}, {'value': '3.00', 'spread': '1.900', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 4 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.90', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD8+ central memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not be calculated.', 'groupId': 'OG000'}, {'value': '11.54', 'spread': '10.077', 'groupId': 'OG001'}, {'value': '13.42', 'spread': '8.546', 'groupId': 'OG002'}, {'value': '13.60', 'spread': '10.942', 'groupId': 'OG003'}, {'value': '12.07', 'spread': '12.360', 'groupId': 'OG004'}, {'value': '4.75', 'spread': '3.041', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) Cycle 7 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '16.35', 'spread': '10.850', 'groupId': 'OG001'}, {'value': '8.03', 'spread': '1.528', 'groupId': 'OG002'}, {'value': '21.60', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD8+ central memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation valuewas not calculated.', 'groupId': 'OG003'}, {'value': '11.97', 'spread': '12.051', 'groupId': 'OG004'}, {'value': '6.30', 'spread': '2.263', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Central Memory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.85', 'spread': '3.182', 'groupId': 'OG000'}, {'value': '13.77', 'spread': '10.845', 'groupId': 'OG001'}, {'value': '3.87', 'spread': '5.065', 'groupId': 'OG002'}, {'value': '15.08', 'spread': '12.687', 'groupId': 'OG003'}, {'value': '9.90', 'spread': '13.576', 'groupId': 'OG004'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.35', 'spread': '2.051', 'groupId': 'OG000'}, {'value': '3.66', 'spread': '3.062', 'groupId': 'OG001'}, {'value': '3.25', 'spread': '2.091', 'groupId': 'OG002'}, {'value': '5.35', 'spread': '4.700', 'groupId': 'OG003'}, {'value': '3.82', 'spread': '3.207', 'groupId': 'OG004'}, {'value': '24.48', 'spread': '26.779', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 1 (4H)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.80', 'spread': '1.697', 'groupId': 'OG000'}, {'value': '4.31', 'spread': '3.611', 'groupId': 'OG001'}, {'value': '2.67', 'spread': '2.081', 'groupId': 'OG002'}, {'value': '4.86', 'spread': '5.229', 'groupId': 'OG003'}, {'value': '2.80', 'spread': '3.454', 'groupId': 'OG004'}, {'value': '22.53', 'spread': '26.873', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '0.990', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '3.873', 'groupId': 'OG001'}, {'value': '2.73', 'spread': '2.004', 'groupId': 'OG002'}, {'value': '3.57', 'spread': '4.130', 'groupId': 'OG003'}, {'value': '3.14', 'spread': '3.347', 'groupId': 'OG004'}, {'value': '11.70', 'spread': '15.839', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.60', 'spread': '1.273', 'groupId': 'OG000'}, {'value': '3.54', 'spread': '2.463', 'groupId': 'OG001'}, {'value': '3.36', 'spread': '5.108', 'groupId': 'OG002'}, {'value': '4.50', 'spread': '4.727', 'groupId': 'OG003'}, {'value': '2.57', 'spread': '3.222', 'groupId': 'OG004'}, {'value': '17.88', 'spread': '20.990', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.25', 'spread': '2.616', 'groupId': 'OG000'}, {'value': '4.70', 'spread': '4.031', 'groupId': 'OG001'}, {'value': '3.77', 'spread': '6.125', 'groupId': 'OG002'}, {'value': '4.53', 'spread': '4.511', 'groupId': 'OG003'}, {'value': '3.12', 'spread': '3.539', 'groupId': 'OG004'}, {'value': '13.10', 'spread': '19.341', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.778', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '3.524', 'groupId': 'OG001'}, {'value': '3.56', 'spread': '5.524', 'groupId': 'OG002'}, {'value': '4.06', 'spread': '4.008', 'groupId': 'OG003'}, {'value': '4.16', 'spread': '5.786', 'groupId': 'OG004'}, {'value': '19.07', 'spread': '30.641', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.697', 'groupId': 'OG000'}, {'value': '5.14', 'spread': '4.446', 'groupId': 'OG001'}, {'value': '3.69', 'spread': '5.607', 'groupId': 'OG002'}, {'value': '4.33', 'spread': '3.693', 'groupId': 'OG003'}, {'value': '3.14', 'spread': '3.884', 'groupId': 'OG004'}, {'value': '30.45', 'spread': '38.537', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.70', 'spread': '0.990', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '4.388', 'groupId': 'OG001'}, {'value': '3.50', 'spread': '5.568', 'groupId': 'OG002'}, {'value': '4.57', 'spread': '4.340', 'groupId': 'OG003'}, {'value': '3.64', 'spread': '3.832', 'groupId': 'OG004'}, {'value': '18.67', 'spread': '27.050', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 4 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD8+ effector memory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG000'}, {'value': '4.66', 'spread': '5.283', 'groupId': 'OG001'}, {'value': '5.94', 'spread': '5.734', 'groupId': 'OG002'}, {'value': '8.23', 'spread': '4.900', 'groupId': 'OG003'}, {'value': '3.33', 'spread': '5.024', 'groupId': 'OG004'}, {'value': '2.60', 'spread': '0.990', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) Cycle 7 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6.18', 'spread': '4.811', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '1.952', 'groupId': 'OG002'}, {'value': '7.80', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total CD8+ effector memory T cells on cycle 7 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG003'}, {'value': '3.67', 'spread': '5.755', 'groupId': 'OG004'}, {'value': '35.40', 'spread': '46.528', 'groupId': 'OG005'}]}]}, {'title': 'Total, CD8+ Effector Memory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.70', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '4.957', 'groupId': 'OG001'}, {'value': '0.57', 'spread': '0.306', 'groupId': 'OG002'}, {'value': '1.95', 'spread': '1.605', 'groupId': 'OG003'}, {'value': '1.25', 'spread': '1.061', 'groupId': 'OG004'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '34.10', 'spread': '0.283', 'groupId': 'OG000'}, {'value': '40.98', 'spread': '10.428', 'groupId': 'OG001'}, {'value': '38.67', 'spread': '8.521', 'groupId': 'OG002'}, {'value': '41.20', 'spread': '16.148', 'groupId': 'OG003'}, {'value': '46.55', 'spread': '10.978', 'groupId': 'OG004'}, {'value': '41.18', 'spread': '8.761', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '27.15', 'spread': '4.172', 'groupId': 'OG000'}, {'value': '39.53', 'spread': '7.635', 'groupId': 'OG001'}, {'value': '37.20', 'spread': '8.902', 'groupId': 'OG002'}, {'value': '44.29', 'spread': '11.058', 'groupId': 'OG003'}, {'value': '44.80', 'spread': '7.508', 'groupId': 'OG004'}, {'value': '42.40', 'spread': '7.165', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '35.70', 'spread': '5.940', 'groupId': 'OG000'}, {'value': '42.29', 'spread': '13.590', 'groupId': 'OG001'}, {'value': '36.97', 'spread': '7.219', 'groupId': 'OG002'}, {'value': '45.23', 'spread': '11.181', 'groupId': 'OG003'}, {'value': '49.74', 'spread': '10.086', 'groupId': 'OG004'}, {'value': '40.57', 'spread': '3.415', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 2 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '30.95', 'spread': '3.465', 'groupId': 'OG000'}, {'value': '44.45', 'spread': '14.962', 'groupId': 'OG001'}, {'value': '40.53', 'spread': '6.707', 'groupId': 'OG002'}, {'value': '46.71', 'spread': '10.444', 'groupId': 'OG003'}, {'value': '56.66', 'spread': '12.388', 'groupId': 'OG004'}, {'value': '39.93', 'spread': '16.671', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '31.50', 'spread': '9.051', 'groupId': 'OG000'}, {'value': '42.69', 'spread': '14.259', 'groupId': 'OG001'}, {'value': '35.62', 'spread': '13.117', 'groupId': 'OG002'}, {'value': '42.36', 'spread': '9.707', 'groupId': 'OG003'}, {'value': '50.30', 'spread': '10.907', 'groupId': 'OG004'}, {'value': '46.75', 'spread': '19.728', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 3 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '34.30', 'spread': '3.536', 'groupId': 'OG000'}, {'value': '38.83', 'spread': '8.536', 'groupId': 'OG001'}, {'value': '35.78', 'spread': '13.922', 'groupId': 'OG002'}, {'value': '41.69', 'spread': '10.489', 'groupId': 'OG003'}, {'value': '47.16', 'spread': '13.427', 'groupId': 'OG004'}, {'value': '41.70', 'spread': '13.089', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 4 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '35.30', 'spread': 'NA', 'comment': 'There was only one participant with an assessment of total FOXP3+ regulatory T cells on cycle 4 day 1 (pre-dose), therefore the deviation value was not calculated.', 'groupId': 'OG000'}, {'value': '38.83', 'spread': '8.658', 'groupId': 'OG001'}, {'value': '41.89', 'spread': '10.092', 'groupId': 'OG002'}, {'value': '35.78', 'spread': '10.316', 'groupId': 'OG003'}, {'value': '46.00', 'spread': '11.665', 'groupId': 'OG004'}, {'value': '55.70', 'spread': '14.001', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) Cycle 7 Day 1 (pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '41.80', 'spread': '3.149', 'groupId': 'OG001'}, {'value': '41.23', 'spread': '6.725', 'groupId': 'OG002'}, {'value': '28.70', 'spread': '0.849', 'groupId': 'OG003'}, {'value': '43.40', 'spread': '5.145', 'groupId': 'OG004'}, {'value': '52.35', 'spread': '15.344', 'groupId': 'OG005'}]}]}, {'title': 'Total, FOXP3+ Regulatory T Cells (%) End of treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38.50', 'spread': '3.960', 'groupId': 'OG000'}, {'value': '37.88', 'spread': '15.626', 'groupId': 'OG001'}, {'value': '35.60', 'spread': '19.987', 'groupId': 'OG002'}, {'value': '43.94', 'spread': '10.685', 'groupId': 'OG003'}, {'value': '48.57', 'spread': '7.596', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1', 'description': 'Mean unbound cell surface OX40 in peripheral blood was measured to characterize the degree of target engagement (TE) by PF-04518600 at baseline and multiple doses.', 'unitOfMeasure': 'percentage of baseline concentration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis Population included all enrolled participants with at least 1 of the OX40 evaluated at pre and/or post dose.'}, {'type': 'SECONDARY', 'title': 'ORR Assessed by RECIST Version 1.1 and irRECIST in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'ORR per RECIST v1.1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3.3', 'groupId': 'OG005'}]}]}, {'title': 'ORR per irRECIST', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3.3', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.\n\nCR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \\<10 mm.\n\nPR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nOverall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \\<10 mm.\n\nOverall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median PFS in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.7'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.2'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '5.5'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '2.7'}, {'value': '1.4', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '2.8'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '1.7', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.\n\nPD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median TTP in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '2.7'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.2'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '5.5'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '2.7'}, {'value': '1.4', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '2.8'}, {'value': '3.3', 'groupId': 'OG005', 'lowerLimit': '1.7', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Having SD in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median DoR in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.8', 'comment': 'Ranges for 95% CI were not estimable due to less than 50% participants in this cohort achieved CR or PR.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and ranges for 95% CI were not estimable due to no participants in this cohort achieved CR or PR.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.\n\nCR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \\<10 mm) and all target lesions must be assessed.\n\nPR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Median OS in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '14.3'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '22.1'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '22.1'}, {'value': '11.4', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '21.1'}, {'value': '5.4', 'groupId': 'OG004', 'lowerLimit': '1.2', 'upperLimit': '11.4'}, {'value': '12.0', 'groupId': 'OG005', 'lowerLimit': '4.7', 'upperLimit': '16.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'OS was defined as time in weeks or months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 7 or 30.44 if in months.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rates at Months 6, 12, and 24 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'Survival Probability at Month 6', 'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '83.5'}, {'value': '61.4', 'groupId': 'OG001', 'lowerLimit': '26.6', 'upperLimit': '83.5'}, {'value': '72.7', 'groupId': 'OG002', 'lowerLimit': '37.1', 'upperLimit': '90.3'}, {'value': '58.4', 'groupId': 'OG003', 'lowerLimit': '22.7', 'upperLimit': '82.3'}, {'value': '45.0', 'groupId': 'OG004', 'lowerLimit': '13.9', 'upperLimit': '72.4'}, {'value': '63.9', 'groupId': 'OG005', 'lowerLimit': '43.2', 'upperLimit': '78.8'}]}]}, {'title': 'Survival Probability at Month 12', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '58.6'}, {'value': '36.8', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '65.7'}, {'value': '51.9', 'groupId': 'OG002', 'lowerLimit': '19.8', 'upperLimit': '76.7'}, {'value': '43.8', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '72.7'}, {'value': '11.3', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '39.1'}, {'value': '51.9', 'groupId': 'OG005', 'lowerLimit': '31.8', 'upperLimit': '68.8'}]}]}, {'title': 'Survival Probability at Month 24', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '36.4'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '41.4'}, {'value': '20.8', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '48.7'}, {'value': 'NA', 'comment': 'Number and ranges for 95% CI were not estimable due to all 11 participants in the group have been censored or died before month 24.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '11.3', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '39.1'}, {'value': '6.7', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '25.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'Probability of survival at 6, 12, and 24 months after the first dose of study treatment.', 'unitOfMeasure': 'Probability of survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 full or partial IV infusion of study drug PF-04518600 and PF-05082566.'}, {'type': 'SECONDARY', 'title': 'Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.290', 'spread': '19', 'groupId': 'OG000'}, {'value': '6.965', 'spread': '23', 'groupId': 'OG001'}, {'value': '7.644', 'spread': '23', 'groupId': 'OG002'}, {'value': '19.63', 'spread': '26', 'groupId': 'OG003'}, {'value': '62.45', 'spread': '31', 'groupId': 'OG004'}, {'value': '10.20', 'spread': '24', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.779', 'spread': '29', 'groupId': 'OG000'}, {'value': '9.049', 'spread': '21', 'groupId': 'OG001'}, {'value': '9.359', 'spread': '31', 'groupId': 'OG002'}, {'value': '19.76', 'spread': '45', 'groupId': 'OG003'}, {'value': '81.49', 'spread': '51', 'groupId': 'OG004'}, {'value': '10.53', 'spread': '39', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmax was defined as maximum observed serum concentration and can be observed directly from data.\n\nCss,max was the Cmax on C3D1.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.'}, {'type': 'SECONDARY', 'title': 'AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '270.7', 'spread': '27', 'groupId': 'OG000'}, {'value': '1022', 'spread': '29', 'groupId': 'OG001'}, {'value': '1177', 'spread': '23', 'groupId': 'OG002'}, {'value': '3089', 'spread': '19', 'groupId': 'OG003'}, {'value': '10100', 'spread': '19', 'groupId': 'OG004'}, {'value': '1624', 'spread': '30', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '340.2', 'spread': '73', 'groupId': 'OG000'}, {'value': '1739', 'spread': '26', 'groupId': 'OG001'}, {'value': '2239', 'spread': '18', 'groupId': 'OG002'}, {'value': '4034', 'spread': '35', 'groupId': 'OG003'}, {'value': '19190', 'spread': '48', 'groupId': 'OG004'}, {'value': '2291', 'spread': '45', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.', 'unitOfMeasure': 'µg.hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.'}, {'type': 'SECONDARY', 'title': 'AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '283.5', 'spread': '31', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 1380,992.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 1800,1700.', 'groupId': 'OG002'}, {'value': '9480', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG004'}, {'value': '1657', 'spread': '22', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 257,228.', 'groupId': 'OG000'}, {'value': '2710', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG003'}, {'value': '1130', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.'}, {'type': 'SECONDARY', 'title': 't1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.104', 'spread': '1.2263', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and Standard Deviation was not calculated for n\\<3. And the individual values were 5.58,5.85.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and Standard Deviation was not calculated for n\\<3. And the individual values were 6.98,6.1.', 'groupId': 'OG002'}, {'value': '5.61', 'spread': 'NA', 'comment': 'Standard Deviation was not calculated for n\\<3.', 'groupId': 'OG004'}, {'value': '5.260', 'spread': '0.76772', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Mean and Standard Deviation was not calculated for n\\<3. And the individual values were 2.72,3.16.', 'groupId': 'OG000'}, {'value': '4.72', 'spread': 'NA', 'comment': 'Standard Deviation was not calculated for n\\<3.', 'groupId': 'OG003'}, {'value': '3.87', 'spread': 'NA', 'comment': 'Standard Deviation was not calculated for n\\<3.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 't1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.'}, {'type': 'SECONDARY', 'title': 'Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2591', 'spread': '148', 'groupId': 'OG000'}, {'value': '2.266', 'spread': '39', 'groupId': 'OG001'}, {'value': '1.074', 'spread': '21520', 'groupId': 'OG002'}, {'value': '5.327', 'spread': '101', 'groupId': 'OG003'}, {'value': '30.59', 'spread': '38', 'groupId': 'OG004'}, {'value': '2.671', 'spread': '155', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.'}, {'type': 'SECONDARY', 'title': 'Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.013', 'spread': '73', 'groupId': 'OG000'}, {'value': '5.175', 'spread': '26', 'groupId': 'OG001'}, {'value': '6.664', 'spread': '18', 'groupId': 'OG002'}, {'value': '12', 'spread': '35', 'groupId': 'OG003'}, {'value': '57.15', 'spread': '48', 'groupId': 'OG004'}, {'value': '6.815', 'spread': '45', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cav was defined as average serum concentration over the dosing interval.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.'}, {'type': 'SECONDARY', 'title': 'CL of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2944', 'spread': '73', 'groupId': 'OG000'}, {'value': '0.1725', 'spread': '26', 'groupId': 'OG001'}, {'value': '0.1339', 'spread': '18', 'groupId': 'OG002'}, {'value': '0.2481', 'spread': '35', 'groupId': 'OG003'}, {'value': '0.1566', 'spread': '48', 'groupId': 'OG004'}, {'value': '0.1861', 'spread': '47', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau', 'unitOfMeasure': 'mL/hr/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.'}, {'type': 'SECONDARY', 'title': 'Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 42.6,46.1.', 'groupId': 'OG000'}, {'value': '67.4', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG003'}, {'value': '54.3', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Vss was defined as volume of distribution at steady state.', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.'}, {'type': 'SECONDARY', 'title': 'Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.374', 'spread': '31', 'groupId': 'OG000'}, {'value': '1.593', 'spread': '26', 'groupId': 'OG001'}, {'value': '1.762', 'spread': '12', 'groupId': 'OG002'}, {'value': '1.361', 'spread': '37', 'groupId': 'OG003'}, {'value': '1.861', 'spread': '31', 'groupId': 'OG004'}, {'value': '1.413', 'spread': '31', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.'}, {'type': 'SECONDARY', 'title': 'Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '4.018', 'spread': '33', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '39', 'groupId': 'OG001'}, {'value': '20.33', 'spread': '43', 'groupId': 'OG002'}, {'value': '17.63', 'spread': '33', 'groupId': 'OG003'}, {'value': '19.02', 'spread': '29', 'groupId': 'OG004'}, {'value': '3.232', 'spread': '22', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2.909', 'spread': '47', 'groupId': 'OG000'}, {'value': '2.554', 'spread': '79', 'groupId': 'OG001'}, {'value': '20.02', 'spread': '22', 'groupId': 'OG002'}, {'value': '17.94', 'spread': '39', 'groupId': 'OG003'}, {'value': '17.84', 'spread': '54', 'groupId': 'OG004'}, {'value': '2.726', 'spread': '47', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmax was defined as maximum observed serum concentration and can be observed directly from data.\n\nCss,max was the Cmax on C3D1.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmax.'}, {'type': 'SECONDARY', 'title': 'AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '789.4', 'spread': '23', 'groupId': 'OG000'}, {'value': '596', 'spread': '43', 'groupId': 'OG001'}, {'value': '2465', 'spread': '33', 'groupId': 'OG002'}, {'value': '2289', 'spread': '25', 'groupId': 'OG003'}, {'value': '2839', 'spread': '15', 'groupId': 'OG004'}, {'value': '561.8', 'spread': '53', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 916,464.', 'groupId': 'OG000'}, {'value': '343.7', 'spread': '225', 'groupId': 'OG001'}, {'value': '2765', 'spread': '77', 'groupId': 'OG002'}, {'value': '673.9', 'spread': '1191', 'groupId': 'OG003'}, {'value': '2621', 'spread': '31', 'groupId': 'OG004'}, {'value': '232.1', 'spread': '1524', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.', 'unitOfMeasure': 'µg•hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCtau.'}, {'type': 'SECONDARY', 'title': 'AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1011', 'spread': '20', 'groupId': 'OG000'}, {'value': '831', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG001'}, {'value': '2801', 'spread': '25', 'groupId': 'OG002'}, {'value': '2252', 'spread': '34', 'groupId': 'OG003'}, {'value': '3137', 'spread': '15', 'groupId': 'OG004'}, {'value': '626.4', 'spread': '47', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '467', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG000'}, {'value': '1950', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 2360,2970.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 624,725.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).', 'unitOfMeasure': 'μg*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for AUCinf.'}, {'type': 'SECONDARY', 'title': 't1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'CYCLE1/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11.37', 'spread': '0.58595', 'groupId': 'OG000'}, {'value': '5.44', 'spread': 'NA', 'comment': 'Standard Deviation was not calculated for n\\<3.', 'groupId': 'OG001'}, {'value': '7.769', 'spread': '2.2299', 'groupId': 'OG002'}, {'value': '6.873', 'spread': '1.9954', 'groupId': 'OG003'}, {'value': '8.27', 'spread': '2.2945', 'groupId': 'OG004'}, {'value': '6.632', 'spread': '2.5566', 'groupId': 'OG005'}]}]}, {'title': 'CYCLE3/DAY1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5.25', 'spread': 'NA', 'comment': 'Standard Deviation was not calculated for n\\<3.', 'groupId': 'OG000'}, {'value': '2.59', 'spread': 'NA', 'comment': 'Standard Deviation was not calculated for n\\<3.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and Standard Deviation was not calculated for n\\<3. And the individual values were 13,3.88.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Mean and Standard Deviation was not calculated for n\\<3. And the individual values were 5.76,5.8.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 't1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for t1/2.'}, {'type': 'SECONDARY', 'title': 'Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03294', 'spread': '1302300', 'groupId': 'OG000'}, {'value': '0.002776', 'spread': '3859511', 'groupId': 'OG001'}, {'value': '0.08612', 'spread': '1346874', 'groupId': 'OG002'}, {'value': '0.0413', 'spread': '2825205', 'groupId': 'OG003'}, {'value': '0.3123', 'spread': '56629', 'groupId': 'OG004'}, {'value': '0.0007531', 'spread': '117304', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cmin.'}, {'type': 'SECONDARY', 'title': 'Cav of Utomilumab Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 1.36,0.691.', 'groupId': 'OG000'}, {'value': '0.5119', 'spread': '225', 'groupId': 'OG001'}, {'value': '4.119', 'spread': '77', 'groupId': 'OG002'}, {'value': '1.004', 'spread': '1189', 'groupId': 'OG003'}, {'value': '3.903', 'spread': '31', 'groupId': 'OG004'}, {'value': '0.3453', 'spread': '1524', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cav was defined as average serum concentration over the dosing interval.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Cav.'}, {'type': 'SECONDARY', 'title': 'CL of Utomilumab Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 0.0218,0.04.', 'groupId': 'OG000'}, {'value': '0.05817', 'spread': '225', 'groupId': 'OG001'}, {'value': '0.03615', 'spread': '77', 'groupId': 'OG002'}, {'value': '0.1483', 'spread': '1187', 'groupId': 'OG003'}, {'value': '0.03813', 'spread': '31', 'groupId': 'OG004'}, {'value': '0.08619', 'spread': '1525', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau', 'unitOfMeasure': 'mL/hr/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for CL.'}, {'type': 'SECONDARY', 'title': 'Vss of Utomilumab Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG000'}, {'value': '4.22', 'spread': 'NA', 'comment': 'Geometric CV was not calculated for n\\<3.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 13.4,4.18.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 6.46,5.02.', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Vss was defined as volume of distribution at steady state.', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Vss.'}, {'type': 'SECONDARY', 'title': 'Rac of Utomilumab Following Multiple Doses on C3D1 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric Mean and Geometric CV was not calculated for n\\<3. And the individual values were 1.23,0.493.', 'groupId': 'OG000'}, {'value': '0.5441', 'spread': '120', 'groupId': 'OG001'}, {'value': '1.091', 'spread': '69', 'groupId': 'OG002'}, {'value': '0.2673', 'spread': '1381', 'groupId': 'OG003'}, {'value': '0.9041', 'spread': '26', 'groupId': 'OG004'}, {'value': '0.391', 'spread': '886', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest. Number of participants analyzed represents the total number of participants in each treatment group in the PK parameter analysis population. Number analyzed represents the number of participants contributing to the summary statistics for Rac.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ADA and NAb Against PF-04518600 in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'ADA ever-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}]}]}, {'title': 'NAb ever-positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (maximum of 14 weeks).', 'description': 'ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ADA and NAb Against Utomilumab in Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG001', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG002', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG003', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG004', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'OG005', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'classes': [{'title': 'ADA ever-positive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'NAb ever-positive', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (maximum of 14 weeks).', 'description': 'ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all enrolled participants with at least 1 of the ADA or NAb evaluated at pre- and/or post dose, and measurable PK concentrations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'FG008', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'FG009', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'FG010', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'FG011', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'FG012', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'FG013', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '16'}, {'groupId': 'FG007', 'numSubjects': '19'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '12'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '11'}, {'groupId': 'FG012', 'numSubjects': '11'}, {'groupId': 'FG013', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '13'}, {'groupId': 'FG007', 'numSubjects': '14'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '11'}, {'groupId': 'FG012', 'numSubjects': '10'}, {'groupId': 'FG013', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '8'}, {'groupId': 'FG010', 'numSubjects': '10'}, {'groupId': 'FG011', 'numSubjects': '7'}, {'groupId': 'FG012', 'numSubjects': '8'}, {'groupId': 'FG013', 'numSubjects': '21'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Subject refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '2'}, {'groupId': 'FG013', 'numSubjects': '4'}]}, {'type': 'Study ongoing at date of cut-off', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Part A (PF-04518600 monotherapy) included Part A1 and Part A2 Part B(PF-04518600 plus utomilumab \\[PF-05082566\\] combination therapy) included Part B1 and Part B2', 'preAssignmentDetails': 'A total of 174 participants were enrolled in this study, and 174 of them received study treatment. For Part A, 87 participants were enrolled and treated with PF-04518600 at several dose levels. For Part B, 87 participants were enrolled and treated with PF-04518600+utomilumab at several dose levels.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}, {'value': '11', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}, {'value': '12', 'groupId': 'BG010'}, {'value': '11', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '30', 'groupId': 'BG013'}, {'value': '174', 'groupId': 'BG014'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A1: PF-04518600 0.01mg/kg', 'description': 'Participants received PF-04518600 0.01mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG001', 'title': 'Part A1: PF-04518600 0.1mg/kg', 'description': 'Participants received PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG002', 'title': 'Part A1: PF-04518600 0.3mg/kg', 'description': 'Participants received PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG003', 'title': 'Part A1: PF-04518600 1.5mg/kg', 'description': 'Participants received PF-04518600 1.5mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG004', 'title': 'Part A1: PF-04518600 3.0mg/kg', 'description': 'Participants received PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG005', 'title': 'Part A1: PF-04518600 10mg/kg', 'description': 'Participants received PF-04518600 10mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG006', 'title': 'Part A2: PF-04518600 30mg', 'description': 'Participants received PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG007', 'title': 'Part A2: PF-04518600 250mg', 'description': 'Participants received PF-04518600 250mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks up to a maximum of 14 weeks.'}, {'id': 'BG008', 'title': 'Part B1: PF-04518600 0.1mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.1mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'BG009', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'BG010', 'title': 'Part B1: PF-04518600 0.3mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 0.3mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'BG011', 'title': 'Part B1: PF-04518600 1.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 1.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'BG012', 'title': 'Part B1: PF-04518600 3.0mg/kg + PF-05082566 100mg', 'description': 'Participants received PF-05082566 100mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 3.0mg/kg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'BG013', 'title': 'Part B2: PF-04518600 30mg + PF-05082566 20mg', 'description': 'Participants received PF-05082566 20mg IV over about 60 minutes on Day 1 of every 28 days and PF-04518600 30mg IV over about 60 minutes on Day 1 of each cycle of 2 weeks. On cycles whereby both PF-04518600 and PF-05082566 were to be administered on the same day, PF-04518600 were administered after, but no sooner than 30 minutes after completion of the PF-05082566 infusion in absence of infusion reaction and after post PF-05082566 and pre PF-04518600 pharmacokinetic blood draws.'}, {'id': 'BG014', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than 18 years old', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}]}]}, {'title': '18 to 44 years old (18-44)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '11', 'groupId': 'BG014'}]}]}, {'title': '45 to 64 years old (45-64)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '14', 'groupId': 'BG013'}, {'value': '85', 'groupId': 'BG014'}]}]}, {'title': '65 years old and more than 65 years old (>＝65)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '7', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '13', 'groupId': 'BG013'}, {'value': '78', 'groupId': 'BG014'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '9', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}, {'value': '49', 'groupId': 'BG014'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '20', 'groupId': 'BG013'}, {'value': '125', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '16', 'groupId': 'BG014'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '11', 'groupId': 'BG011'}, {'value': '11', 'groupId': 'BG012'}, {'value': '24', 'groupId': 'BG013'}, {'value': '143', 'groupId': 'BG014'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '15', 'groupId': 'BG014'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'WHITE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '10', 'groupId': 'BG010'}, {'value': '8', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '20', 'groupId': 'BG013'}, {'value': '117', 'groupId': 'BG014'}]}]}, {'title': 'BLACK', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}, {'value': '6', 'groupId': 'BG014'}]}]}, {'title': 'ASIAN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}, {'value': '30', 'groupId': 'BG014'}]}]}, {'title': 'OTHER', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}, {'value': '10', 'groupId': 'BG014'}]}]}, {'title': 'UNSPECIFIED', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '2', 'groupId': 'BG013'}, {'value': '11', 'groupId': 'BG014'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '6.7', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '26.4', 'spread': '4.9', 'groupId': 'BG002'}, {'value': '28.9', 'spread': '5.7', 'groupId': 'BG003'}, {'value': '25.9', 'spread': '4.5', 'groupId': 'BG004'}, {'value': '22.8', 'spread': '1.9', 'groupId': 'BG005'}, {'value': '26.2', 'spread': '3.7', 'groupId': 'BG006'}, {'value': '25.5', 'spread': '6.0', 'groupId': 'BG007'}, {'value': '25.3', 'spread': '5.2', 'groupId': 'BG008'}, {'value': '26.7', 'spread': '7.6', 'groupId': 'BG009'}, {'value': '25.5', 'spread': '7.4', 'groupId': 'BG010'}, {'value': '25.0', 'spread': '5.2', 'groupId': 'BG011'}, {'value': '23.5', 'spread': '5.9', 'groupId': 'BG012'}, {'value': '25.2', 'spread': '5.3', 'groupId': 'BG013'}, {'value': '25.2', 'spread': '5.9', 'groupId': 'BG014'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms per meter squared (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The baseline analysis population included all enrolled patients who received at least one full or partial IV infusion of study drug PF-04518600.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-02', 'size': 9350003, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-10T14:22', 'hasProtocol': True}, {'date': '2018-03-12', 'size': 3664496, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-10T14:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2014-12-04', 'resultsFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2014-12-09', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-18', 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1', 'timeFrame': 'The first 2 cycles of treatment (Day 1 up to Day 28)', 'description': 'DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \\>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.'}, {'measure': 'Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) and Serious Adverse Event(SAEs), Treatment-Related TEAEs and SAEs in Part A', 'timeFrame': 'AEs: The informed consent date up to the last dosing date + 28 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.', 'description': 'Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities in Part A', 'timeFrame': 'The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)', 'description': 'Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \\[protein, blood\\], microscopy \\[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\\], miscellaneous \\[urine casts and bacteria\\]).'}, {'measure': 'Number of Participants With DLTs in Part B1', 'timeFrame': 'The First 2 Cycles of Treatment (Day 1 up to Day 28)', 'description': 'DLT was defined as any of the following adverse events occurring in the first two cycle of treatment (28 days), unless there was a clear alternative explanation: hematologic: grade 4 neutropenia lasting \\>7 days, febrile neutropenia; grade ≥3 neutropenic infection; grade ≥3 thrombocytopenia with clinically significant bleeding or requiring medical intervention; grade 4 thrombocytopenia; grade 4 anemia; grade ≥3 anemia related to hemolysis or autoimmune disease. non hematologic: grade ≥3 toxicities that were considered clinically significant, including cytokine release syndrome, infusion reactions and allergic reactions, except those that had not been maximally treated or could be easily treated. The severity of adverse events was graded as per common terminology criteria for adverse events(CTCAE) version 4.03, and there were no DLTs reported.'}, {'measure': 'Number of Participants With All-causality TEAEs and SAEs, and Treatment-Related TEAEs and SAEs in Part B', 'timeFrame': 'AEs: The informed consent date up to the last dosing date + 60 days or all drug-related toxicities resolved date. SAEs: The informed consent date through first dosing date + 98 days or up to the last dosing date + 60 days, and any post-reporting period.', 'description': 'Adverse event (AE) was graded by the investigator according to CTCAE version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA): Grade 3 (Severe) events=unacceptable or intolerable events. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. Treatment-emergent events=between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. TEAEs were defined as those with initial onset or increasing in severity after the first dose of study medication. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities in Part B', 'timeFrame': 'The first dosing date to the earlier date between the last dosing date + 35 days and the first new anti-cancer therapy date (if applicable)', 'description': 'Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, partial thromboplastin time (PTT), Prothrombin (PT), PT international ratio); liver function (aspartate aminotransferase(AST), alanine aminotransferase(ALT), total bilirubin, gamma-glutamyl transpeptidase(GT), alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium , phosphate, magnesium); clinical chemistry (glucose, creatine kinase, thyroxine (T4), thyroid stimulating hormone(TSH)), Amylase, Lipase), urinalysis (dipstick \\[protein, blood\\], microscopy \\[urine red blood cell (RBC), white blood cell (WBC), Epithelial Cells\\], miscellaneous \\[urine casts and bacteria\\]).'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Assessed by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 and Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST) in Part A', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.\n\nCR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \\<10 mm.\n\nPR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nOverall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \\<10 mm.\n\nOverall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.'}, {'measure': 'Kaplan-Meier Estimate of Median Progression-Free Survival (PFS) in Part A', 'timeFrame': 'Baseline up to 24 months post first dose', 'description': 'PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.\n\nPD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.'}, {'measure': 'Kaplan-Meier Estimate of Median Time to Progression (TTP) in Part A', 'timeFrame': 'Baseline up to 24 months post first dose', 'description': 'TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.'}, {'measure': 'Number of Participants Having Stable Disease (SD) in Part A', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.'}, {'measure': 'Kaplan-Meier Estimate of Median Duration of Response (DoR) in Part A', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.\n\nCR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \\<10 mm) and all target lesions must be assessed.\n\nPR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.'}, {'measure': 'Kaplan-Meier Estimate of Median Overall Survival (OS) in Part A', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'OS was defined as time in months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 30.44.'}, {'measure': 'Overall Survival Rates at Months 6, 12, and 24 in Part A', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'Probability of survival at 6, 12, and 24 months after the first dose of study treatment.'}, {'measure': 'Maximum Serum Concentration (Cmax) of PF-04518600 Following Single Dose on Cycle 1 Day 1 (C1D1) and Steady-State Maximum Serum Concentration(Css,Max) Following Multiple Doses on Cycle 3 Day 1 (C3D1) in Part A', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmax was defined as maximum observed serum concentration and can be observed directly from data.\n\nCss,max was the Cmax on C3D1.'}, {'measure': 'Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.'}, {'measure': 'Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).'}, {'measure': 'Terminal Half-Life (t1/2) of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part A', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 't1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.'}, {'measure': 'Lowest Serum Concentration Observed During the Dosing Interval (Cmin) of PF-04518600 Following Multiple Doses on C3D1 in Part A.', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.'}, {'measure': 'Average Serum Concentration Over the Dosing Interval (Cav) of PF-04518600 Following Multiple Doses on C3D1 in Part A', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cav was defined as average serum concentration over the dosing interval.'}, {'measure': 'Clearance (CL) of PF-04518600 Following Multiple Doses on C3D1 in Part A', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau'}, {'measure': 'Apparent Volume of Distribution at Steady State (Vss) of PF-04518600 Following Multiple Doses on C3D1 in Part A.', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Vss was defined as volume of distribution at steady state.'}, {'measure': 'Accumulation Ratio (Rac) of PF-04518600 at C3D1 Following Multiple Doses on C3D1 in Part A', 'timeFrame': 'For Part A1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1, and 4 hours post dose on Day 1 of Cycles 3; For Par A2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.'}, {'measure': 'Number of Participants With Anti Drug Antibody (ADA) and Neutralizing Antibody (NAb) Against PF-04518600 in Part A', 'timeFrame': 'Baseline up to end of treatment (maximum of 14 weeks).', 'description': 'ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.'}, {'measure': 'Mean Unbound Cell Surface OX40 in Part A1', 'timeFrame': 'Pre-dose, 4 and 24 hours post dose on Cycle 1 Day 1, and Day 8 on Cycles 1 to 3, then pre-dose on Cycles 4 and 7 and end of treatment in Part A1', 'description': 'Mean unbound cell surface OX40 in peripheral blood was measured to characterize the degree of target engagement (TE) by PF-04518600 at baseline and multiple doses.'}, {'measure': 'ORR Assessed by RECIST Version 1.1 and irRECIST in Part B', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'ORR was defined as the percentage of patients with best overall response (BOR) of CR or PR relative to the appropriate analysis set.\n\nCR: Complete response is defined (per RECIST 1.1) as disappearance of all target and non target lesions. Any pathological lymph nodes (whether target or non target) must have reduction in short axis to \\<10 mm.\n\nPR: Partial response is difined (per RECIST 1.1) as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nOverall immune related complete response (irCR): Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to \\<10 mm.\n\nOverall immune related partial response (irPR): Sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases ≥30%.'}, {'measure': 'Kaplan-Meier Estimate of Median PFS in Part B', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'PFS was defined as the time from randomization date to date of first documentation of progressive disease(PD) based on RECIST, irRECIST or death due to any cause.\n\nPD was progression documented after start date and not qualifying as CR, PR or SD per RECIST.'}, {'measure': 'Kaplan-Meier Estimate of Median TTP in Part B', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'TTP was defined as the time from start date to the date of the first documentation of PD. PD was documented after start date and not qualifying as CR, PR or SD per RECIST.'}, {'measure': 'Number of Participants Having SD in Part B', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'SD was defined as persistence of any non target lesions and/or tumor marker level above the normal limits.'}, {'measure': 'Kaplan-Meier Estimate of Median DoR in Part B', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'DoR was defined as the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause for patients with an objective response.\n\nCR was defined as complete disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \\<10 mm) and all target lesions must be assessed.\n\nPR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter is used in the sum for target nodes, while the longest diameter is used in the sum for all other target lesions and all target lesions must be assessed.'}, {'measure': 'Kaplan-Meier Estimate of Median OS in Part B', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'OS was defined as time in weeks or months from the start of study treatment to date of death due to any cause. OS was calculated as the death date or last known alive date (if death date unavailable) minus the date of first dose of study medication plus 1 divided by 7 or 30.44 if in months.'}, {'measure': 'Overall Survival Rates at Months 6, 12, and 24 in Part B', 'timeFrame': 'Baseline up to 24 months post first dose.', 'description': 'Probability of survival at 6, 12, and 24 months after the first dose of study treatment.'}, {'measure': 'Cmax of PF-04518600 Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmax was defined as maximum observed serum concentration and can be observed directly from data.\n\nCss,max was the Cmax on C3D1.'}, {'measure': 'AUCtau of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.'}, {'measure': 'AUCinf of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).'}, {'measure': 't1/2 of PF-04518600 Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 't1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.'}, {'measure': 'Cmin of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.'}, {'measure': 'Cav of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cav was defined as average serum concentration over the dosing interval.'}, {'measure': 'CL of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau'}, {'measure': 'Vss of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Vss was defined as volume of distribution at steady state.'}, {'measure': 'Rac of PF-04518600 Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.'}, {'measure': 'Cmax of Utomilumab Following Single Dose on C1D1 and Css,Max Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmax was defined as maximum observed serum concentration and can be observed directly from data.\n\nCss,max was the Cmax on C3D1.'}, {'measure': 'AUCtau of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCtau was defined as area under the concentration curve from time 0 to end of dosing interval where dosing interval was 2 weeks.'}, {'measure': 'AUCinf of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'AUCinf was defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It was obtained from AUC (0-t) plus AUC (t-inf).'}, {'measure': 't1/2 of Utomilumab Following Single Dose on C1D1 and Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 't1/2 was defined as the time measured for the serum concentration to decrease by one half of the initial concentration.'}, {'measure': 'Cmin of Utomilumab Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cmin was defined as Lowest concentration observed during the dosing interval and can be observed directly from data.'}, {'measure': 'Cav of Utomilumab Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Cav was defined as average serum concentration over the dosing interval.'}, {'measure': 'CL of Utomilumab Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Drug clearance was a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). CL=Dose/AUCss,tau'}, {'measure': 'Vss of Utomilumab Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Vss was defined as volume of distribution at steady state.'}, {'measure': 'Rac of Utomilumab Following Multiple Doses on C3D1 in Part B', 'timeFrame': 'For Part B1, pre-dose, 1, 4, and 24 hours post dose on C1D1, pre-dose, 1 hour post dose on Day 1 of Cycles 3; For Part B2, pre-dose, 1, and 4 hours post dose on C1D1, pre-dose and 1 hour post dose on Day 1 of Cycles 3.', 'description': 'Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from Cycle 3 Day 1 divided by AUC from Cycle1 Day 1.'}, {'measure': 'Number of Participants With ADA and NAb Against PF-04518600 in Part B', 'timeFrame': 'Baseline up to end of treatment (maximum of 14 weeks).', 'description': 'ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.'}, {'measure': 'Number of Participants With ADA and NAb Against Utomilumab in Part B', 'timeFrame': 'Baseline up to end of treatment (maximum of 14 weeks).', 'description': 'ADA never-positive was defined as no positive ADA results at any time point. ADA ever-positive was defined as at least one positive ADA result at any time point. nAb never-positive was defined as no positive nAb results at any time point and nAb ever-positive was defined as at least one positive nAb result at any time point.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'PF-04518600', 'PF-05082566', 'solid tumors', 'tumors', 'neoplasm metastasis', 'Phase 1', 'hepatocellular carcinoma', 'HCC', 'liver cancer', 'ocular melanoma', 'melanoma', 'clear cell renal cell carcinoma', 'RCC', 'kidney cancer', 'head and neck squamous cell carcinoma', 'HNSCC', 'head and neck cancer', 'cervical cancer', 'cancer of the cervix', 'gastric cancer', 'stomach cancer', 'non small cell lung cancer', 'NSCLC', 'lung cancer', 'urothelial bladder carcinoma', 'bladder cancer', 'OX40', '4-1BB'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '36302562', 'type': 'DERIVED', 'citation': 'Hamid O, Chiappori AA, Thompson JA, Doi T, Hu-Lieskovan S, Eskens FALM, Ros W, Diab A, Spano JP, Rizvi NA, Wasser JS, Angevin E, Ott PA, Forgie A, Yang W, Guo C, Chou J, El-Khoueiry AB. First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. J Immunother Cancer. 2022 Oct;10(10):e005471. doi: 10.1136/jitc-2022-005471.'}, {'pmid': '34615725', 'type': 'DERIVED', 'citation': 'Diab A, Hamid O, Thompson JA, Ros W, Eskens FALM, Doi T, Hu-Lieskovan S, Klempner SJ, Ganguly B, Fleener C, Wang X, Joh T, Liao K, Salek-Ardakani S, Taylor CT, Chou J, El-Khoueiry AB. A Phase I, Open-Label, Dose-Escalation Study of the OX40 Agonist Ivuxolimab in Patients with Locally Advanced or Metastatic Cancers. Clin Cancer Res. 2022 Jan 1;28(1):71-83. doi: 10.1158/1078-0432.CCR-21-0845. Epub 2021 Oct 6.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0601002&StudyName=', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the safety and tolerability at increasing dose levels of PF-04518600 alone or in combination wtih PF-05082566 in patients with select advanced or metastatic carcinoma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Part A1 only: Patients with histological or cytological diagnosis of HNSCC, HCC, melanoma, or clear cell RCC who progressed on or are intolerant to standard therapy, for which no standard therapy is available or who decline standard therapy.\n* Part A2 only: Patients with histological or cytological diagnosis of advanced/metastatic HCC who are treatment naïve and have declined standard of care, or have had at least 1 prior line of systemic therapy. Prior anti PD L1/PD 1 therapy is allowed.\n* Part B1 only: Patients with histological or cytological diagnosis of NSCLC, HNSCC, melanoma, urothelial bladder carcinoma (including renal pelvis, ureters, urinary bladder, and urethra), gastric or squamous cell carcinoma of the uterine cervix who progressed on or are intolerant to standard therapy, for which no standard therapy is available, or who decline standard therapy.\n* Part B2\n\nArm 1 only:\n\n1. Ocular melanoma patients with advanced/metastatic disease, or\n2. Cutaneous/acral melanoma patients with advanced/metastatic disease who have received checkpoint inhibitor (anti PD L1, anti PD 1, or anti CTLA4) based treatment on which disease progressed. \\[Note: Checkpoint inhibitor may have been part of a combination therapy, as long as the combination did not contain OX40 or 4 1BB agonist.\\] Any questions on prior treatment may be discussed with the Sponsor.\n\nArm 2 only:\n\n* Histological or cytological diagnosis of NSCLC with advanced/metastatic disease. Patients must have previously received prior anti PD L1 or anti PD 1 mAb on which disease progressed. \\[Note: Previous anti PD L1 or anti PD 1 mAb may have been part of a combination therapy, eg, in combination with chemotherapy, as long as the combination did not contain OX40 or 4 1BB agonist.\\]\n* Performance Status of 0 or 1 - Adequate bone marrow, kidney and liver function\n\nExclusion Criteria:\n\n* Brain metastases requiring steroids\n* Major surgery, Radiation therapy within 4 weeks of starting study treatment (except: palliative radiotherapy to a limited field is allowed after consultation with sponsor's medical monitor at any time during study participation, including during screening), or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)\n* Active and clinically significant bacterial, fungal, or viral infection\n* History of active autoimmune disorders\n* History of immune-mediated adverse events requiring immunosuppressive therapy or were grade 3 or higher related to prior immune-modulatory therapy\n* Prior treatment with an OX40 agonist and 4-1BB agonist (for Part B1/B2)\n* Prior anthracycline treatment and at risk of cardiac failure (New York Heart Association Class 2)"}, 'identificationModule': {'nctId': 'NCT02315066', 'briefTitle': 'Study Of OX40 Agonist PF-04518600 Alone And In Combination With 4-1BB Agonist PF-05082566', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, DOSE ESCALATION STUDY OF PF-04518600 AS A SINGLE AGENT AND IN COMBINATION WITH PF-05082566 IN PATIENTS WITH SELECTED LOCALLY ADVANCED OR METASTATIC CANCERS', 'orgStudyIdInfo': {'id': 'B0601002'}, 'secondaryIdInfos': [{'id': '2014-004107-75', 'type': 'EUDRACT_NUMBER'}, {'id': 'B0601002', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': 'OX40', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04518600', 'description': 'OX40 agonist', 'interventionNames': ['Drug: PF-04518600']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04518600 plus PF-05082566', 'description': 'OX40 (CD134) agonist plus 4-1BB (CD137) agonist', 'interventionNames': ['Drug: PF-04518600 plus PF-05082566']}], 'interventions': [{'name': 'PF-04518600', 'type': 'DRUG', 'description': 'Part A1 - PF-04518600 will be administered intravenously every 14 days in cohorts of 2 or more patients starting at a dose of 0.01 mg/kg. Increases in dose will continue until MTD is determined', 'armGroupLabels': ['PF-04518600']}, {'name': 'PF-04518600', 'type': 'DRUG', 'description': 'Part A2 - patients with hepatocellular carcinoma will be randomized to receive treatment with PF-04518600 at various doses administered intravenously', 'armGroupLabels': ['PF-04518600']}, {'name': 'PF-04518600 plus PF-05082566', 'type': 'DRUG', 'description': 'Part B1 -In cohorts of 2 or more patients, PF-04518600 will be administered intravenously every 2 weeks starting at a dose of 0.1 mg/kg and PF-05082566 will be administered intravenously 4 weeks starting at a dose of 20 mg. Increases in dose will continue until MTD is determined.', 'armGroupLabels': ['PF-04518600 plus PF-05082566']}, {'name': 'PF-04518600 plus PF-05082566', 'type': 'DRUG', 'description': 'Part B2 - patients with select tumor types (ocular melanoma, cutaneous/acral melanoma or non-small cell lung cancer) will be treated at dose levels based on the OBD selected in Part 1.', 'armGroupLabels': ['PF-04518600 plus PF-05082566']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Hospital of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC+USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Ronald Regan Medical 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': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Medical Imaging Center of Southern California, Inc.', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Santa Monica UCLA Hematology & Oncology Clinic', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06030-2205', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Health, Pharmacy', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'UConn Health, Neag Comprehensive Cancer Center', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center & Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital (MGH)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital (BWH)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center (BIDMC)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute (DFCI)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02150', 'city': 'Chelsea', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General/Chelsea HealthCare Center', 'geoPoint': {'lat': 42.39176, 'lon': -71.03283}}, {'zip': '01923', 'city': 'Danvers', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mass General/North Shore Center for Outpatient Care', 'geoPoint': {'lat': 42.57509, 'lon': -70.93005}}, {'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mass General West', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center - Herbert Irving Pavilion', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital-Pathology', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'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}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Groupe hospitalier Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'The Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1066 EC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Slotervaart Hospital/Antoni van Leeuwenhoek', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}