Viewing Study NCT02573259

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Ignite Creation Date: 2025-12-24 @ 2:39 PM

Ignite Modification Date: 2025-12-24 @ 2:40 PM

Study NCT ID: NCT02573259

Status: COMPLETED

Last Update Posted: 2021-12-13

First Post: 2015-10-06

Is Possible Gene Therapy: False

Has Adverse Events: True

Brief Title: A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Singapore']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 28 days after last dose of study drug (up to a maximum of 237 weeks).', 'description': 'The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 6, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 5, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 6, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'deathsNumAffected': 10, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Part 1: PF-06801591 IV Total', 'description': 'Participants received PF-06801591 IV every 3 weeks for 21-day cycles in Part 1. (up to a maximum of of 233 weeks)', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'deathsNumAffected': 18, 'seriousNumAffected': 10}, {'id': 'EG006', 'title': 'Part 1: PF-06801591 IV and SC Total', 'description': 'Participants received PF-06801591 IV every 3 weeks for 21-day cycles or SC every 4 weeks for 28-day cycles in Part 1. (up to a maximum of 233 weeks)', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 39, 'seriousNumAtRisk': 40, 'deathsNumAffected': 28, 'seriousNumAffected': 13}, {'id': 'EG007', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 59, 'seriousNumAtRisk': 68, 'deathsNumAffected': 33, 'seriousNumAffected': 18}, {'id': 'EG008', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 33, 'seriousNumAtRisk': 38, 'deathsNumAffected': 21, 'seriousNumAffected': 13}, {'id': 'EG009', 'title': 'Part 2: PF-06801591 NSCLC and UC Total', 'description': 'Participants with NSCLC or UC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles in Part 2. (up to a maximum of 126 weeks)', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 92, 'seriousNumAtRisk': 106, 'deathsNumAffected': 54, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Bundle branch block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 11}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 9}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 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'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 106, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)', 'description': 'DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \\>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \\<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \\>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT analysis population included all enrolled participants who received at least 1 dose of study treatment and who did not have major treatment deviations during Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG005', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG006', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}]}, {'title': 'Participants with maximum Grade 3 or 4 AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}]}, {'title': 'Participants with maximum Grade 5 AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)', 'description': 'AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A 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. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG005', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG006', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'Participants with AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}]}, {'title': 'Participants with SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Participants with maximum of Grade 3 or 4 AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Participants with maximum of Grade 5 AEs', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)', 'description': 'Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG005', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG006', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'ANEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}]}, {'title': 'HEMOGLOBIN INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 3', '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'}]}, {'title': 'Grade 4', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}]}, {'title': 'LYMPHOCYTE COUNT DECREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'LYMPHOCYTE COUNT INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 3', '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'}]}, {'title': 'Grade 4', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}]}, {'title': 'NEUTROPHIL COUNT DECREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 2', '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'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'PLATELET COUNT DECREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}, {'title': 'Grade 2', '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'}]}, {'title': 'Grade 3', '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'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'WHITE BLOOD CELL DECREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}, {'value': '34', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'ALANINE AMINOTRANSFERASE INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'ALKALINE PHOSPHATASE INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '36', 'groupId': 'OG005'}, {'value': '21', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}, {'title': 'Grade 2', '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'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'BLOOD BILIRUBIN INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, 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'0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'CPK INCREASED', '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': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '3', 'groupId': 'OG005'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG005'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG005'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG005'}]}, {'title': 'Grade 4', 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{'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'GGT INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'HYPERCALCEMIA', 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'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'HYPERKALEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': 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{'value': '55', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'HYPERNATREMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 3', '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'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'HYPOALBUMINEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}]}, {'title': 'HYPOCALCEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 3', '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'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'HYPOGLYCEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}, {'value': '32', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}, {'title': 'Grade 2', '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'}]}, {'title': 'Grade 3', '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'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'HYPOKALEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}, {'value': '33', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'HYPOMAGNESEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '29', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'HYPONATREMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'HYPOPHOSPHATEMIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'LIPASE INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '50', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'SERUM AMYLASE INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}, {'title': 'Grade 3', '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': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'PROTEINURIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 4', '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'}]}]}, {'title': 'ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}]}, {'title': 'INR INCREASED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '68', 'groupId': 'OG005'}, {'value': '36', 'groupId': 'OG006'}]}], 'categories': [{'title': 'Grade 0', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}]}, {'title': 'Grade 1', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}, {'title': 'Grade 2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade 4', 'measurements': [{'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG005'}, {'value': 'NA', 'comment': 'CTCAE grade not defined.', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)', 'description': 'Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \\[GGT\\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \\[INR\\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '27.5'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '34.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '19.4', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '30.9'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '37.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'ORR was defined as percentage of participants with objective response (OR) of complete response (CR) and partial response (PR) based on irRECIST. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'title': 'Cycle 1 Day 1', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG000'}, {'value': '21.52', 'spread': '23', 'groupId': 'OG001'}, {'value': '69.63', 'spread': '28', 'groupId': 'OG002'}, {'value': '217.2', 'spread': '36', 'groupId': 'OG003'}, {'value': '21.24', 'spread': '50', 'groupId': 'OG004'}]}]}, {'title': 'Cycle 4 Day 1', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG000'}, {'value': '30.10', 'spread': '16', 'groupId': 'OG001'}, {'value': '86.34', 'spread': '52', 'groupId': 'OG002'}, {'value': '402.6', 'spread': '42', 'groupId': 'OG003'}, {'value': '56.48', 'spread': '29', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1', 'description': 'Cmax was the maximum concentration after dose administration observed directly from the data.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants treated who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'AUClast of PF-06801591 in Part 1.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG000'}, {'value': '4700', 'spread': '41', 'groupId': 'OG001'}, {'value': '14770', 'spread': '27', 'groupId': 'OG002'}, {'value': '46780', 'spread': '49', 'groupId': 'OG003'}, {'value': '9923', 'spread': '65', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1', 'description': 'Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1', 'unitOfMeasure': 'ug*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants treated who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of PF-06801591 - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG001'}, {'value': '0.006045', 'spread': '57', 'groupId': 'OG002'}, {'value': '0.004984', 'spread': '14', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1', 'description': 'CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants treated who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1', 'description': 'Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL\\*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity.', 'unitOfMeasure': 'L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV administration and had sufficient information to estimate at least 1 of the pharmacokinetic (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 who had reportable parameter values of Vss.'}, {'type': 'SECONDARY', 'title': 'Accumulation Ratio (Rac) of PF-06801591 - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and geometric coefficient of variation were not reported for n \\< 3.', 'groupId': 'OG002'}, {'value': '2.360', 'spread': '12', 'groupId': 'OG003'}, {'value': '2.073', 'spread': '31', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1', 'description': 'Rac was calculated by (Cycle 4 AUCtau) / (Cycle 1 AUCtau). AUCtau was Area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for Q3W IV dosing and tau = 672 hours for every 4 weeks (Q4W) SC dosing.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants treated who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation were not reported for n\\<3.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Mean and standard deviation were not reported for n\\<3.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1', 'description': 't1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all enrolled participants in Part 1 who received study drug following IV or SC administration and 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 who had reportable parameter values of t1/2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG002', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG005', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG006', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (maximum of 851 days)', 'description': 'Number of participants with ADA positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was ADA positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were ADA positive at baseline but did not become boosted post-treatment were considered as ADA negative.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG002', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG005', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG006', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment (maximum of 851 days)', 'description': 'Number of participants with NAb positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were NAb positive at baseline but did not become boosted post-treatment were considered as NAb negative.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result. NAb-negative participants included participants who were ADA negative or ADA-positive participants who tested negative in the NAb assay.'}, {'type': 'SECONDARY', 'title': 'Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.1'}, {'value': '0.56', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.0'}, {'value': '0.02', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.32', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.0'}]}]}, {'title': 'Cycle 1 Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.2'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.1'}]}]}, {'title': 'Cycle 1 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.6'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.57', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '4.5'}]}]}, {'title': 'Cycle 1 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.48', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.82', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.0'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.0'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.2'}, {'value': '0.47', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '4.7'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.1'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.05', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '23.2'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '2.1'}]}]}, {'title': 'Cycle 4 Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.7'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}, {'title': 'Cycle 4 Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.31', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '3.2'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '1.2'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '1.5'}]}]}, {'title': 'EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.7'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.5'}, {'value': '0.17', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '2.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing)', 'description': 'PD-1 RO by sasanlimab was measured by the reduction of free receptor on the surface of CD8+ effector cells (CD3+, CD4-, CD8+, CD45RA+, CCR7-, CD279+) and CD8+ effector memory cells (CD3+, CD4-, CD8+, CD45RA-, CCR7-, CD279+) presented in pre- and postdose whole blood samples by flow cytometry. Percentage of baseline (ie, normalized change from baseline) PD-1 RO were calculated as \\[(percentage of cells at Cycle X Day X)/(percentage of cells at baseline)\\]\\*100, and are reported for this outcome measure. Baseline was defined as the most recent non-missing value prior to dosing.', 'unitOfMeasure': 'Percentage of Baseline', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all enrolled participants with at least 1 of the pharmacodynamic/biomarker parameters evaluated at pre- and/or post dose.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment in Part 1 (maximum of 1606 days)', 'description': 'Number of participants achieving confirmed OR based on RECIST version 1.1 in Part 1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of treatment in Part 1 (maximum of 1606 days)', 'description': 'Number of participants achieving confirmed OR based on irRECIST in Part 1. OR = irCR + irPR. Overall immune related complete response (irCR) was defined as 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. Overall immune related partial response (irPR) was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases \\>=30%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])', 'description': 'This was a combined group of PF-06801591 0.5, 1, 3, and 10 mg/kg (IV) in Part 1. Participants received PF-06801591 0.5, 1, 3, or 10 mg/kg IV every 3 weeks for 21-day cycles. (up to a maximum of 233 weeks).'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG002', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG003', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'RECIST v1.1', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '8.3'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '6.0'}, {'value': '3.7', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '5.5'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '3.8'}]}]}, {'title': 'irRECIST', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '13.8'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '13.7'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '8.2'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '14.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of treatment (maximum of 1606 days)', 'description': 'PFS was defined as the time from initiation of study intervention to first documentation of tumor progression or to death due to any cause, whichever occurred first. PFS was analyzed by the Kaplan-Meier approach for each tumor type. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'OG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'OG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'OG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG005', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG006', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'RECIST v1.1', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable for n\\<2.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not estimable for n\\<2.', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': 'NA'}, {'value': '24.3', 'groupId': 'OG002', 'lowerLimit': '13.8', 'upperLimit': '34.9'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '8.8'}, {'value': '6.0', 'groupId': 'OG004', 'lowerLimit': '3.8', 'upperLimit': '7.3'}, {'value': '6.5', 'groupId': 'OG005', 'lowerLimit': '3.7', 'upperLimit': '10.1'}, {'value': '8.5', 'comment': 'Not estimable.', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': 'NA'}]}]}, {'title': 'irRECIST', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable for n\\<2.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Not estimable for n\\<2.', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': 'NA'}, {'value': '29.0', 'groupId': 'OG002', 'lowerLimit': '20.0', 'upperLimit': '37.9'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '8.8'}, {'value': '13.7', 'groupId': 'OG004', 'lowerLimit': '3.3', 'upperLimit': '13.7'}, {'value': '7.5', 'groupId': 'OG005', 'lowerLimit': '5.4', 'upperLimit': '18.4'}, {'value': '14.5', 'comment': 'Not estimable.', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of treatment (maximum of 1606 days)', 'description': 'DOSD was analyzed by the Kaplan-Meier approach for each tumor type. Stable disease (SD) was defined as not qualifying for complete response (CR), partial response (PR), or progression. All target lesions must have been assessed. Stable could follow PR only in the rare case that the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer held. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \\< 10 mm). All target lesions must have been assessed. PR 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 was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: PF-06801591 0.5-10 mg/kg (Intravenously [IV])', 'description': 'This was a combined group of PF-06801591 0.5, 1, 3, and 10 mg/kg (IV) in Part 1. Participants received PF-06801591 0.5, 1, 3, or 10 mg/kg IV every 3 weeks for 21-day cycles. (up to a maximum of 233 weeks).'}, {'id': 'OG001', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'OG002', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG003', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.7', 'comment': 'Not estimable.', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable.', 'groupId': 'OG001'}, {'value': '21.8', 'comment': 'Not estimable.', 'groupId': 'OG002', 'lowerLimit': '5.8', 'upperLimit': 'NA'}, {'value': '13.9', 'comment': 'Not estimable.', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': 'NA'}]}]}, {'title': 'irRECIST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.0', 'comment': 'Not estimable.', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable.', 'groupId': 'OG001'}, {'value': '22.1', 'comment': 'Not estimable.', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable.', 'groupId': 'OG003', 'lowerLimit': '4.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of treatment (maximum of 1606 days)', 'description': 'DOR was defined as the time from start date (which was the date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death. DOR was only applicable to those participants with an objective response.'}, {'type': 'SECONDARY', 'title': 'Time to Response (TTR) Based on RECIST Version 1.1 - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '12.0'}, {'value': '2.33', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'TTR was the time to confirmed or unconfirmed complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1 by tumor type. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \\< 10 mm). All target lesions must have been assessed. PR 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 was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.', 'unitOfMeasure': 'Months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'RECIST v1.1', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '5.7'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '8.5'}]}]}, {'title': 'irRECIST', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '10.3'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '19.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'TTP was the time to objective progression. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. TTP was analyzed by the Kaplan-Meier approach for each tumor type.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Median Time to Death - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'comment': 'Not estimable.', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': 'NA'}, {'value': '10.9', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '19.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'Median time to death was analyzed by the Kaplan-Meier approach for each tumor type.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received at least 1 dose of study medication, had measurable disease baseline assessment (within 28 days prior to study entry) and at least 1 post baseline assessment or disease progression, global deterioration of health status, or death.'}, {'type': 'SECONDARY', 'title': 'Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '0.773', 'groupId': 'OG000', 'lowerLimit': '0.647', 'upperLimit': '0.859'}, {'value': '0.711', 'groupId': 'OG001', 'lowerLimit': '0.527', 'upperLimit': '0.833'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0.547', 'groupId': 'OG000', 'lowerLimit': '0.407', 'upperLimit': '0.667'}, {'value': '0.471', 'groupId': 'OG001', 'lowerLimit': '0.290', 'upperLimit': '0.633'}]}]}, {'title': '2 Years', 'categories': [{'measurements': [{'value': '0.403', 'groupId': 'OG000', 'lowerLimit': '0.265', 'upperLimit': '0.537'}, {'value': '0.286', 'groupId': 'OG001', 'lowerLimit': '0.127', 'upperLimit': '0.467'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'Probability of survival was calculated from the product-limit method.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all the randomized participants who received PF-06801591 and had at least 1 post-dose concentration measurement above the lower limit of quantification (LLQ).'}, {'type': 'SECONDARY', 'title': 'Trough PF-06801591 Concentrations (Ctrough) - Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'OG001', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.97', 'spread': '48', 'groupId': 'OG000'}, {'value': '14.34', 'spread': '73', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.54', 'spread': '37', 'groupId': 'OG000'}, {'value': '20.15', 'spread': '84', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.55', 'spread': '53', 'groupId': 'OG000'}, {'value': '23.77', 'spread': '60', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.58', 'spread': '41', 'groupId': 'OG000'}, {'value': '19.32', 'spread': '186', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.67', 'spread': '36', 'groupId': 'OG000'}, {'value': '17.13', 'spread': '249', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.01', 'spread': '36', 'groupId': 'OG000'}, {'value': '29.88', 'spread': '30', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.29', 'spread': '16', 'groupId': 'OG000'}, {'value': '12.74', 'spread': '770', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.90', 'spread': '22', 'groupId': 'OG000'}, {'value': '22.10', 'spread': '56', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.09', 'spread': '25', 'groupId': 'OG000'}, {'value': '20.17', 'spread': '75', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.16', 'spread': '25', 'groupId': 'OG000'}, {'value': '22.11', 'spread': '55', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.81', 'spread': '16', 'groupId': 'OG000'}, {'value': '38.02', 'spread': '38', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.62', 'spread': '33', 'groupId': 'OG000'}, {'value': '35.17', 'spread': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2', 'description': 'Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who received PF-06801591, had no protocol deviations affecting the pharmacokinetics (PK) assessment, and had at least 1 post-dose concentration measurement above lower limit of quantification.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'FG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'FG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'FG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'FG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'FG005', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'FG006', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '68'}, {'groupId': 'FG006', 'numSubjects': '39'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '68'}, {'groupId': 'FG006', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '58'}, {'groupId': 'FG006', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '32'}, {'groupId': 'FG006', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Participant refused further follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'A total of 147 participants were enrolled in this study, and 146 participants received study treatment. For Part 1, 40 participants were enrolled and treated. For Part 2, 107 participants were enrolled including 68 participants with non small cell lung cancer (NSCLC) and 39 participants with urothelial carcinoma (UC), and 106 participants received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '146', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])', 'description': 'Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)'}, {'id': 'BG001', 'title': 'Part 1: PF-06801591 1 mg/kg (IV)', 'description': 'Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)'}, {'id': 'BG002', 'title': 'Part 1: PF-06801591 3 mg/kg (IV)', 'description': 'Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)'}, {'id': 'BG003', 'title': 'Part 1: PF-06801591 10 mg/kg (IV)', 'description': 'Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)'}, {'id': 'BG004', 'title': 'Part 1: PF-06801591 300 mg (Subcutaneously [SC])', 'description': 'Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)'}, {'id': 'BG005', 'title': 'Part 2: PF-06801591 300 mg (SC) for NSCLC', 'description': 'Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)'}, {'id': 'BG006', 'title': 'Part 2: PF-06801591 300 mg (SC) for UC', 'description': 'Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-44 Years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}]}]}, {'title': '45-64 Years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '66', 'groupId': 'BG007'}]}]}, {'title': '>=65 Years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}, {'value': '76', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '56', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '53', 'groupId': 'BG005'}, {'value': '25', 'groupId': 'BG006'}, {'value': '90', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '50', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}, {'value': '112', 'groupId': 'BG007'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '18', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}, {'value': '29', 'groupId': 'BG007'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline population included all enrolled participants who received at least 1 dose of study treatment. One participant who enrolled in Part 2: PF-06801591 300 mg (SC) for UC arm was not treated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-07', 'size': 6537808, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-13T14:35', 'hasProtocol': True}, {'date': '2020-08-24', 'size': 3247706, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-13T14:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2015-10-06', 'resultsFirstSubmitDate': '2021-09-13', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-29', 'studyFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Dose-Limiting Toxicities (DLT) - Part 1', 'timeFrame': 'Cycle 1 in Part 1 (21 days for IV administration of PF-06801591; 28 days for SC administration of PF-06801591)', 'description': 'DLT was defined as any of the following drug-related adverse events (AEs) occurring during the first cycle (21 days for IV dosing, 28 days for SC dosing) in Part 1: Grade 5 AE; Grade 4 neutropenia lasting \\>5 days from initiation of granulocyte colony stimulating factor; Grade 4 thrombocytopenia with bleeding; Platelet transfusion requirement or a platelet count \\<10,000/uL; Grade 4 non-hematologic AE; Grade 3 AE lasting \\>7 days despite optimal supportive care; Grade 3 central nervous system AE regardless of duration; met criteria for drug induced liver injury. Severity of AEs were graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.'}, {'measure': 'Number of Participants With All-Causality Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)', 'description': 'AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. A 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. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.'}, {'measure': 'Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) - Part 1 and Part 2', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)', 'description': 'Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related AEs and SAEs were determined by the investigator. Grades of severity were defined by CTCAE v4.03. Grades of severity were defined by CTCAE v4.03. Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities - Part 1 and Part 2', 'timeFrame': 'Baseline up to 28 days after last dose of study treatment (maximum of 1634 days)', 'description': 'Following parameters were analyzed for laboratory examination: hematology (anemia, hemoglobin increased, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased); chemistries (increase of alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, blood bilirubin, CPK, creatinine, gamma-glutamyl transferase \\[GGT\\], lipase, and serum amylase); urinalysis (proteinuria); coagulation (activated partial thromboplastin time prolonged, international normalized ratio \\[INR\\] increased). Grades of severity were defined by CTCAE v4.03. Grade 0 = No Change from normal or reference range (this grade is not included in the CTCAE v4.03 document but may used in certain circumstances). Grade 1 = mild adverse event (AE). Grade 2 = moderate AE; Grade 3 = severe AE. Grade 4 = life-threatening consequences; urgent intervention indicated. Grade 5 = death related to AE.'}, {'measure': 'Objective Response Rate (ORR) Based on RECIST Version 1.1 - Part 2', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'ORR was defined as percentage of participants with confirmed objective response (OR) of complete response (CR) and partial response (PR) based on RECIST version 1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.'}, {'measure': 'Objective Response Rate (ORR) Based on Immune Related RECIST (irRECIST) - Part 2', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'ORR was defined as percentage of participants with objective response (OR) of complete response (CR) and partial response (PR) based on irRECIST. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of PF-06801591 - Part 1', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1', 'description': 'Cmax was the maximum concentration after dose administration observed directly from the data.'}, {'measure': 'AUClast of PF-06801591 in Part 1.', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1', 'description': 'Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1'}, {'measure': 'Clearance (CL) of PF-06801591 - Part 1', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1', 'description': 'CL for IV dosing. CL was calculated by dose / AUCtau for Cycles 1 and 4 IV dosing. AUCtau was defined as area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for every 3 weeks (Q3W) IV dosing reporting arm.'}, {'measure': 'Volume of Distribution at Steady State (Vss) of PF-06801591 - Part 1', 'timeFrame': 'Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1, and pre-dose and 1 hour post dose on Cycle 4 Day 1 in Part 1', 'description': 'Steady state volume of distribution of PF-0680159 for IV dosing. Vss was calculated by CL\\*MRT. CL was the clearance for IV dosing. MRT was the mean residence time calculated for a single IV dose as AUMCinf/AUCinf - (DOF/2). AUMCinf was the area under the moment curve from time 0 extrapolated to infinity. DOF was the duration of infusion. AUCinf was the area under the serum concentration time profile from time 0 extrapolated to infinity.'}, {'measure': 'Accumulation Ratio (Rac) of PF-06801591 - Part 1', 'timeFrame': 'Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1', 'description': 'Rac was calculated by (Cycle 4 AUCtau) / (Cycle 1 AUCtau). AUCtau was Area under the serum concentration time profile from time zero to time tau, the dosing interval, where tau = 504 hours for Q3W IV dosing and tau = 672 hours for every 4 weeks (Q4W) SC dosing.'}, {'measure': 'Terminal Elimination Half-Life (t1/2) of PF-06801591 - Part 1', 'timeFrame': 'Pre-dose and 1 hour post dose on Day 1 of Cycles 1 and 4 in Part 1', 'description': 't1/2 was calculated by Loge(2)/kel. kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.'}, {'measure': 'Number of Participants With Anti-Drug Antibody (ADA) Against PF-06801591 - Part 1 and Part 2', 'timeFrame': 'Baseline up to end of treatment (maximum of 851 days)', 'description': 'Number of participants with ADA positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was ADA positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were ADA positive at baseline but did not become boosted post-treatment were considered as ADA negative.'}, {'measure': 'Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2', 'timeFrame': 'Baseline up to end of treatment (maximum of 851 days)', 'description': 'Number of participants with NAb positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were NAb positive at baseline but did not become boosted post-treatment were considered as NAb negative.'}, {'measure': 'Percentage of Baseline PD-1 Receptor Occupancy (RO) by PF-06801591 - Part 1', 'timeFrame': 'Baseline, Days 1, 8, 15, 21 of Cycle 1, Day 1 of Cycles 2, 3, 5, Days 1, 15, 21 of Cycle 4, and end of treatment (EOT) in Part 1 (cycle = 21 days for IV dosing; cycle = 28 days for SC dosing)', 'description': 'PD-1 RO by sasanlimab was measured by the reduction of free receptor on the surface of CD8+ effector cells (CD3+, CD4-, CD8+, CD45RA+, CCR7-, CD279+) and CD8+ effector memory cells (CD3+, CD4-, CD8+, CD45RA-, CCR7-, CD279+) presented in pre- and postdose whole blood samples by flow cytometry. Percentage of baseline (ie, normalized change from baseline) PD-1 RO were calculated as \\[(percentage of cells at Cycle X Day X)/(percentage of cells at baseline)\\]\\*100, and are reported for this outcome measure. Baseline was defined as the most recent non-missing value prior to dosing.'}, {'measure': 'Number of Participants Achieving Objective Response (OR) Based on RECIST Version 1.1 - Part 1', 'timeFrame': 'Baseline up to end of treatment in Part 1 (maximum of 1606 days)', 'description': 'Number of participants achieving confirmed OR based on RECIST version 1.1 in Part 1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \\< 10 mm). All target lesions must be assessed. PR was defined as \\>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. The short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must be assessed.'}, {'measure': 'Number of Participants Achieving Objective Response (OR) Based on irRECIST - Part 1', 'timeFrame': 'Baseline up to end of treatment in Part 1 (maximum of 1606 days)', 'description': 'Number of participants achieving confirmed OR based on irRECIST in Part 1. OR = irCR + irPR. Overall immune related complete response (irCR) was defined as 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. Overall immune related partial response (irPR) was defined as sum of the diameters (longest for non nodal lesions, shortest for nodal lesions) of target and new measurable lesions decreases \\>=30%.'}, {'measure': 'Progression-Free Survival (PFS) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2', 'timeFrame': 'Baseline up to end of treatment (maximum of 1606 days)', 'description': 'PFS was defined as the time from initiation of study intervention to first documentation of tumor progression or to death due to any cause, whichever occurred first. PFS was analyzed by the Kaplan-Meier approach for each tumor type. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.'}, {'measure': 'Duration of Stable Disease (DOSD) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2', 'timeFrame': 'Baseline up to end of treatment (maximum of 1606 days)', 'description': 'DOSD was analyzed by the Kaplan-Meier approach for each tumor type. Stable disease (SD) was defined as not qualifying for complete response (CR), partial response (PR), or progression. All target lesions must have been assessed. Stable could follow PR only in the rare case that the sum increased by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer held. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \\< 10 mm). All target lesions must have been assessed. PR 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 was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.'}, {'measure': 'Duration of Response (DOR) Based on RECIST Version 1.1 and irRECIST - Part 1 and Part 2', 'timeFrame': 'Baseline up to end of treatment (maximum of 1606 days)', 'description': 'DOR was defined as the time from start date (which was the date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. As this outcome measure was a secondary endpoint defined in the protocol to investigate preliminary signal of efficacy, the results were analyzed and are reported for Part 1 dose-escalation groups combined to provide more statistically meaningful results, instead of results analyzed by dose level with very limited number of participants in each group.'}, {'measure': 'Time to Response (TTR) Based on RECIST Version 1.1 - Part 2', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'TTR was the time to confirmed or unconfirmed complete response (CR) or partial response (PR) based on investigator assessment per RECIST v1.1 by tumor type. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must have decreased to normal size (short axis \\< 10 mm). All target lesions must have been assessed. PR 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 was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. All target lesions must have been assessed.'}, {'measure': 'Time to Progression (TTP) Based on RECIST Version 1.1 and irRECIST - Part 2', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'TTP was the time to objective progression. Objective progression was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm. TTP was analyzed by the Kaplan-Meier approach for each tumor type.'}, {'measure': 'Median Time to Death - Part 2', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'Median time to death was analyzed by the Kaplan-Meier approach for each tumor type.'}, {'measure': 'Probability of Survival at 6 Months, 1 Year, and 2 Years - Part 2', 'timeFrame': 'Baseline up to end of treatment in Part 2 (maximum of 851 days)', 'description': 'Probability of survival was calculated from the product-limit method.'}, {'measure': 'Trough PF-06801591 Concentrations (Ctrough) - Part 2', 'timeFrame': 'Pre-dose on Day 1 of Cycles 2-6, 9, 12, 15, 18, 21, 24, and Follow-up Day 28 in Part 2', 'description': 'Trough PF-06801591 Concentrations (Ctrough) - Part 2. Ctrough was directly observed from data.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['efficacy', 'safety', 'pharmacokinetics', 'pharmacodynamics', 'open label', 'dose response', 'multiple ascending dose', 'immunogenicity', 'recommended phase 2 dose', 'subcutaneous'], 'conditions': ['Part 1', 'MELANOMA', 'SCCHN', 'OVCA', 'SARCOMA', 'OTHER SOLID TUMORS', 'Part 1 and 2', 'NSCLC', 'UROTHELIAL CARCINOMA']}, 'referencesModule': {'references': [{'pmid': '39671539', 'type': 'DERIVED', 'citation': 'Sako C, Duan C, Maresca K, Kent S, Schmidt TG, Aerts HJWL, Parikh RB, Simon GR, Jordan P. Real-World and Clinical Trial Validation of a Deep Learning Radiomic Biomarker for PD-(L)1 Immune Checkpoint Inhibitor Response in Advanced Non-Small Cell Lung Cancer. JCO Clin Cancer Inform. 2024 Dec;8:e2400133. doi: 10.1200/CCI.24.00133. Epub 2024 Dec 13.'}, {'pmid': '34694529', 'type': 'DERIVED', 'citation': 'Hu-Lieskovan S, Braiteh F, Grilley-Olson JE, Wang X, Forgie A, Bonato V, Jacobs IA, Chou J, Johnson ML. Association of Tumor Mutational Burden and Immune Gene Expression with Response to PD-1 Blockade by Sasanlimab Across Tumor Types and Routes of Administration. Target Oncol. 2021 Nov;16(6):773-787. doi: 10.1007/s11523-021-00833-2. Epub 2021 Oct 25.'}, {'pmid': '31145415', 'type': 'DERIVED', 'citation': 'Johnson ML, Braiteh F, Grilley-Olson JE, Chou J, Davda J, Forgie A, Li R, Jacobs I, Kazazi F, Hu-Lieskovan S. Assessment of Subcutaneous vs Intravenous Administration of Anti-PD-1 Antibody PF-06801591 in Patients With Advanced Solid Tumors: A Phase 1 Dose-Escalation Trial. JAMA Oncol. 2019 Jul 1;5(7):999-1007. doi: 10.1001/jamaoncol.2019.0836.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B8011001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Protocol B8011001 is a Phase 1, open-label, multi-center, multiple-dose, dose escalation and expansion, safety, pharmacokinetics (PK), and pharmacodynamics (PD) study of PF-06801591 in previously treated adult patients with locally advanced or metastatic melanoma, SCCHN, ovarian carcinoma, sarcoma, NSCLC, urothelial carcinoma or other solid tumors. This is a 2 Part study whereby the safety and tolerability of increasing dose levels of intravenous (IV) or subcutaneous (SC) PF-06801591 was assessed in Part 1. Part 2 expansion is designed to further evaluate the safety and efficacy of SC PF-06801591 in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose.', 'detailedDescription': 'Protocol B8011001 is a Phase 1, two part, open-label, multi center, multiple-dose, safety, efficacy, PK, and PD study of PF-06801591 administered intravenously (IV) or subcutaneous (SC) in previously treated adult patients with locally advanced or metastatic melanoma, squamous cell carcinoma head and neck (SCCHN), ovarian carcinoma, sarcoma, non-small cell lung carcinoma (NSCLC), urothelial carcinoma or other solid tumors.\n\nThe first part of the study, Part 1 dose escalation, was designed to assess the safety and tolerability of increasing dose levels of IV or SC administered PF-06801591 to establish the maximum tolerated dose (MTD) using a modified Toxicity Probability Interval (mTPI) design. Part 2 expansion is designed to further evaluate the safety and efficacy of 300 mg of PF-06801591 administered SC once every 4 weeks in patients with NSCLC or urothelial carcinoma as well as confirm the recommended Phase 2 dose (RP2D). Part 1 enrollment has completed, enrollment will only be allowed for Part 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (Part 2 Only):\n\n* Histological or cytological diagnosis of locally advanced or metastatic NSCLC or urothelial carcinoma who have progressed on or were intolerant to standard of care systemic therapy, or for whom standard of care systemic therapy was refused (refusal must be documented) or unavailable.\n* No prior treatment with anti-PD-1 or anti-PD-L1 therapy.\n* NSCLC patients whose tumor is not known to have ALK or EGFR mutations must have progressed on or after no more than 1 prior line of platinum-containing systemic therapy or were intolerant or refused standard of care systemic therapy.\n* NSCLC patients whose tumor is known to have ALK or EGFR mutation must have received prior systemic therapies that only include 1 or more lines of ALK or EGFR targeting drugs and chemotherapy limited to 1 line of a platinum-based regimen and they must have progressed on or after both types of therapies.\n* Urothelial carcinoma patients must have received up to 2 lines of prior systemic therapy and progressed on or after, experienced disease recurrence within 12 months of neoadjuvant or adjuvant treatment, were intolerant to, ineligible or refused platinum-containing systemic therapy. If urothelial cancer patients are treatment naïve and eligible for platinum-containing systemic therapy but are refusing platinum chemotherapy, they must also be documented to have previous PD-L1 high status.\n* Provide archived tumor tissue sample taken within the past 2 years or provide a fresh tumor biopsy sample.\n* At least one measurable lesion as defined by RECIST version 1.1.\n* Adequate renal, liver, thyroid and bone marrow function.\n* Performance status 0 or 1.\n* Patient is capable of receiving study treatment for at least 8 weeks.\n\nExclusion Criteria (Part 2 Only)\n\n* Active brain or leptomeningeal metastases.\n* Active, known or suspected autoimmune disease. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy or prior allogeneic bone marrow or hematopoietic stem cell transplant.\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Patients with a history of interstitial lung disease, non-infectious pneumonitis, or active pulmonary tuberculosis. Those with active lung infections requiring treatment are also excluded.\n* History of Grade ≥3 immune mediated AE (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy.\n* Active hepatitis B or C, HIV/AIDS.\n* Other potentially metastatic malignancy within past 5 years.'}, 'identificationModule': {'nctId': 'NCT02573259', 'briefTitle': 'A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND EXPANSION STUDY OF PF-06801591 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC MELANOMA, SQUAMOUS CELL HEAD AND NECK CANCER, OVARIAN CANCER, SARCOMA, NON-SMALL CELL LUNG CANCER, UROTHELIAL CARCINOMA OR OTHER SOLID TUMORS.', 'orgStudyIdInfo': {'id': 'B8011001'}, 'secondaryIdInfos': [{'id': '2016-003314-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 PF-06801591', 'description': '0.5 mg/kg IV every 21 days (Part 1)', 'interventionNames': ['Drug: PF-06801591']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 PF-06801591', 'description': '1.0 mg/kg IV every 21 days (Part 1)', 'interventionNames': ['Drug: PF-06801591']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 PF-06801591', 'description': '3.0 mg/kg IV every 21 days (Part 1)', 'interventionNames': ['Drug: PF-06801591']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4 PF-06801591', 'description': '10 mg/kg IV every 21 days (Part 1)', 'interventionNames': ['Drug: PF-06801591']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5 PF-06801591', 'description': '300 mg SC every 28 days (Part 1 and 2)', 'interventionNames': ['Drug: 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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'}}}}