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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 4:05 PM

Ignite Modification Date: 2025-12-26 @ 4:32 PM

Study NCT ID: NCT04071366

Status: COMPLETED

Last Update Posted: 2024-03-26

First Post: 2019-08-26

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080424', 'term': 'Cytokine Release Syndrome'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718170', 'term': 'itacitinib'}, {'id': 'C000603457', 'term': 'INCB039110'}, {'id': 'D016219', 'term': 'Immunotherapy, Adoptive'}, {'id': 'C000629083', 'term': 'axicabtagene ciloleucel'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs collected from Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2 have been reported. Deaths occurring up to the end of the study (Day 180) or until early study withdrawal have been reported.', 'description': 'Treatment-emergent adverse events (TEAES), defined as any AEs unless the AEs could unequivocally be defined as not treatment emergent, have been reported for members of the Safety Evaluable Set (all enrolled participants who received at least 1 dose of study drug).', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 4, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 35, 'seriousNumAtRisk': 35, 'deathsNumAffected': 9, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Part 1: Itacitinib 200 mg + Any IEC', 'description': 'Participants being treated with Kymriah, Yescarta, and Tecartus (Day 0; per prescribing information), IEC therapies for hematologic malignancies, received itacitinib 200 mg once daily for 30 days (Day -3 to Day 26).', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 63, 'seriousNumAtRisk': 63, 'deathsNumAffected': 15, 'seriousNumAffected': 12}, {'id': 'EG004', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'deathsNumAffected': 2, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Affect lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Blood fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 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16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Pneumonia necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Sinusitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}, {'term': 'VIth nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Developed ≥Grade 2 Cytokine Release Syndrome (CRS) by Day 14 After Immune Effector Cell (IEC) Therapy, Assessed by Using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '38.3'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '72.3'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '36.9'}, {'value': '17.4', 'groupId': 'OG003', 'lowerLimit': '5.0', 'upperLimit': '38.8'}, {'value': '56.5', 'groupId': 'OG004', 'lowerLimit': '34.5', 'upperLimit': '76.8'}]}]}], 'analyses': [{'pValue': '0.0030', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in CRS rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.6463', 'ciUpperLimit': '-0.1363', 'statisticalMethod': 'One-sided Z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in CRS rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.6073', 'ciUpperLimit': '-0.1231', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in CRS rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.1778', 'ciUpperLimit': '0.2299', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 14 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 2 CRS: temperature ≥38°C not attributable to any other cause, defined as fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressin, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., continuous positive airway pressure \\[CPAP\\], bilevel intermittent positive air pressure \\[BiPAP\\], intubation, mechanical ventilation).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Analysis Set (EAS): all participants who received at least 1 dose of study drug and received IEC therapy. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) by Day 28 After IEC Therapy, Assessed by Using the ICANS Consensus Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '58.7'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '72.3'}, {'value': '45.7', 'groupId': 'OG002', 'lowerLimit': '28.8', 'upperLimit': '63.4'}, {'value': '13.0', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '33.6'}, {'value': '34.8', 'groupId': 'OG004', 'lowerLimit': '16.4', 'upperLimit': '57.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of ICANS Using the ICANS Consensus Grading, Regardless of CRS, by Day 28 After IEC Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '6.5', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with ICANS onset by Day 28 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of ICANS Occurring by Day 28 After IEC Therapy Using the ICANS Consensus Grading, Regardless of CRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '1.5', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '16'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '13'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS. Duration of ICANS occurring by Day 28 corresponds to the sum of days with non-zero grade ICANS by Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with ICANS onset by Day 28 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of All Grades of CRS by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '1.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '8'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '3.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with CRS onset by Day 28 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of All Grades of CRS Occurring by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '11'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '1', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to Day 56 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with CRS onset by Day 28 were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Grade of CRS at 48 Hours After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '64.6'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '65.1'}, {'value': '48.6', 'groupId': 'OG002', 'lowerLimit': '31.4', 'upperLimit': '66.0'}, {'value': '26.1', 'groupId': 'OG003', 'lowerLimit': '10.2', 'upperLimit': '48.4'}, {'value': '30.4', 'groupId': 'OG004', 'lowerLimit': '13.2', 'upperLimit': '52.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 2 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥Grade 2 CRS by Day 28 After First IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '38.3'}, {'value': '41.7', 'groupId': 'OG001', 'lowerLimit': '15.2', 'upperLimit': '72.3'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '36.9'}, {'value': '21.7', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '43.7'}, {'value': '56.5', 'groupId': 'OG004', 'lowerLimit': '34.5', 'upperLimit': '76.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. The exact 95% confidence interval (2-sided) was calculated using the Clopper-Pearson method.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Except CRS and ICANS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from at Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. For purposes of analysis, all AEs were considered TEAEs unless the AE could unequivocally be defined as not treatment emergent.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Evaluable Set: all enrolled participants who received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'title': 'Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}, {'value': '26.6', 'groupId': 'OG002'}, {'value': '31.8', 'groupId': 'OG003'}, {'value': '13.6', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '16.7', 'groupId': 'OG002'}, {'value': '9.1', 'groupId': 'OG003'}, {'value': '4.5', 'groupId': 'OG004'}]}]}, {'title': 'Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '26.7', 'groupId': 'OG002'}, {'value': '36.4', 'groupId': 'OG003'}, {'value': '18.2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28 of Parts 1 and 2', 'description': 'Cytopenia is characterized by low levels of white blood cells, red blood cells, or platelets. Analysis used laboratory counts at Day 28.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Hospital Admissions for Participants With CRS and/or ICANS by the End of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'timeFrame': 'up to Day 180 of Parts 1 and 2', 'description': 'The number of hospital admissions was assessed through study completion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data have not been reported, as the outcome measure is exploratory.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Hospital Stay for Participants With CRS and/or ICANS by End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'timeFrame': 'up to Day 180 of Parts 1 and 2', 'description': 'The duration of hospital stays was assessed through study completion.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data have not been reported as the outcome measure is exploratory.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Treated With Tocilizumab for CRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}, {'value': '17.4', 'groupId': 'OG003'}, {'value': '65.2', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 56 of Parts 1 and 2', 'description': "Tocilizumab and/or corticosteroids for CRS Grade 1 was not allowed per the protocol. However, tocilizumab may have been given as rescue medication for CRS Grade 1 if no improvement was observed within 72 hours from onset, and the participant's medical condition required intervention per investigator judgment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Requiring More Than 1 Dose of Dexamethasone (or Equivalent) for ICANS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'OG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'OG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'OG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '22.9', 'groupId': 'OG002'}, {'value': '4.3', 'groupId': 'OG003'}, {'value': '30.4', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to Day 30 of Parts 1 and 2', 'description': 'Dexamethasone use as rescue medication for ICANS was assessed.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'EAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'FG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'FG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'FG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'FG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}], 'periods': [{'title': 'Part 1: Open-label (29 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Part 2: Randomized (29 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'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': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Declined Further Treatment; Entered Hospice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Itacitinib 200 Milligrams (mg) QD + Kymriah', 'description': 'Participants being treated with Kymriah (Day 0; per prescribing information), an immune effector cell (IEC) therapy for hematologic malignancies, received itacitinib 200 mg once daily (QD) for 30 days (Day -3 to Day 26).'}, {'id': 'BG001', 'title': 'Part 1: Itacitinib 200 mg QD + Tecartus', 'description': 'Participants being treated with Tecartus (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'BG002', 'title': 'Part 1: Itacitinib 200 mg QD + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information), an IEC therapy for hematologic malignancies, received itacitinib 200 mg QD for 30 days (Day -3 to Day 26).'}, {'id': 'BG003', 'title': 'Part 2: Itacitinib 200 mg BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma received itacitinib 200 mg twice daily (BID) for 30 days (Day -3 to Day 26).'}, {'id': 'BG004', 'title': 'Part 2: Placebo BID + Yescarta', 'description': 'Participants being treated with Yescarta (Day 0; per prescribing information) for relapsed or refractory large B-cell lymphoma or follicular lymphoma BID for 30 days (Day -3 to Day 26).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.8', 'spread': '15.22', 'groupId': 'BG000'}, {'value': '66.2', 'spread': '12.08', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '10.21', 'groupId': 'BG002'}, {'value': '63.2', 'spread': '13.37', 'groupId': 'BG003'}, {'value': '62.0', 'spread': '9.93', 'groupId': 'BG004'}, {'value': '64.18', 'spread': '11.87', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '78', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'American-Indian/Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Captured as "Other" in Database', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-08', 'size': 1157364, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-26T12:27', 'hasProtocol': True}, {'date': '2023-05-08', 'size': 614389, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-26T12:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Part 1 is not masked (open label). Part 2 is double blinded (participant, investigator)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Part 1: Singe Group Assignment Part 2: Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2019-08-26', 'resultsFirstSubmitDate': '2024-01-26', 'studyFirstSubmitQcDate': '2019-08-26', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-26', 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Hospital Admissions for Participants With CRS and/or ICANS by the End of the Study', 'timeFrame': 'up to Day 180 of Parts 1 and 2', 'description': 'The number of hospital admissions was assessed through study completion.'}, {'measure': 'Duration of Hospital Stay for Participants With CRS and/or ICANS by End of Study', 'timeFrame': 'up to Day 180 of Parts 1 and 2', 'description': 'The duration of hospital stays was assessed through study completion.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Who Developed ≥Grade 2 Cytokine Release Syndrome (CRS) by Day 14 After Immune Effector Cell (IEC) Therapy, Assessed by Using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading', 'timeFrame': 'up to Day 14 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 2 CRS: temperature ≥38°C not attributable to any other cause, defined as fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressin, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., continuous positive airway pressure \\[CPAP\\], bilevel intermittent positive air pressure \\[BiPAP\\], intubation, mechanical ventilation).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) by Day 28 After IEC Therapy, Assessed by Using the ICANS Consensus Grading', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.'}, {'measure': 'Time to Onset of ICANS Using the ICANS Consensus Grading, Regardless of CRS, by Day 28 After IEC Therapy', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS.'}, {'measure': 'Duration of ICANS Occurring by Day 28 After IEC Therapy Using the ICANS Consensus Grading, Regardless of CRS', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'Participants were monitored for signs and symptoms of ICANS, if symptoms developed at any point after IEC. ICANS Consensus Grading Criteria were used to assess 5 domains of neurotoxicity: orientation (orient to year, month, city, and hospital), naming (naming 3 objects), following commands (follow commands such as: show me 2 fingers or close your eyes and stick out your tongue), writing (ability to write a standard sentence), and attention (count backwards from 100 by 10). Each domain is associated with a certain number of points, which are summed to generate a total score. Score 10: no impairment; score 7-9: Grade 1 ICANS; score 3-6: Grade 2 ICANS; score 0-2: Grade 3 ICANS. Duration of ICANS occurring by Day 28 corresponds to the sum of days with non-zero grade ICANS by Day 28.'}, {'measure': 'Time to Onset of All Grades of CRS by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).'}, {'measure': 'Duration of All Grades of CRS Occurring by Day 28 After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'timeFrame': 'up to Day 56 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).'}, {'measure': 'Percentage of Participants With Any Grade of CRS at 48 Hours After IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'timeFrame': 'up to Day 2 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).'}, {'measure': 'Percentage of Participants With ≥Grade 2 CRS by Day 28 After First IEC Therapy, Assessed by Using ASBMT CRS Consensus Grading', 'timeFrame': 'up to Day 28 of Parts 1 and 2', 'description': 'The ASBMT CRS Consensus Grading Criteria was used to assess the severity of CRS. Grade 1: fever; either no hypotention and/or no hypoxia. Grade 2 CRS: fever; hypotension not requiring vasopressors, and/or; hypoxia requiring low-flow nasal cannula (oxygen delivered at ≤6 liters/minute) or blow-by. Grade 3 CRS: fever; hypotension requiring one vasopressor with or without vasopressinc, and/or; hypoxyia requiring high-flow nasal cannula (oxygen delivered at \\>6 liters/minute), facemask, nonrebreather mask, or Venturi mask. Grade 4 CRS: fever; hypotension requiring multiple vasopressors (excluding vasopressin), and/or; hypoxia requiring positive pressure (e.g., CPAP, BiPAP, intubation, mechanical ventilation).'}, {'measure': 'Number of Participants With Any Treatment-emergent Adverse Event (TEAE) Except CRS and ICANS', 'timeFrame': 'from at Day -3 through the duration of safety follow-up (up to Day 56) for Parts 1 and 2', 'description': 'An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. For purposes of analysis, all AEs were considered TEAEs unless the AE could unequivocally be defined as not treatment emergent.'}, {'measure': 'Percentage of Participants With Any ≥Grade 3 Cytopenias Ongoing at Day 28', 'timeFrame': 'Day 28 of Parts 1 and 2', 'description': 'Cytopenia is characterized by low levels of white blood cells, red blood cells, or platelets. Analysis used laboratory counts at Day 28.'}, {'measure': 'Percentage of Participants Who Were Treated With Tocilizumab for CRS', 'timeFrame': 'up to Day 56 of Parts 1 and 2', 'description': "Tocilizumab and/or corticosteroids for CRS Grade 1 was not allowed per the protocol. However, tocilizumab may have been given as rescue medication for CRS Grade 1 if no improvement was observed within 72 hours from onset, and the participant's medical condition required intervention per investigator judgment."}, {'measure': 'Percentage of Participants Requiring More Than 1 Dose of Dexamethasone (or Equivalent) for ICANS', 'timeFrame': 'up to Day 30 of Parts 1 and 2', 'description': 'Dexamethasone use as rescue medication for ICANS was assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cytokine release syndrome', 'immune effector cell-associated neurotoxicity syndrome', 'Janus kinase inhibitor', 'immune effector cell therapy'], 'conditions': ['Cytokine Release Syndrome']}, 'referencesModule': {'references': [{'pmid': '40090005', 'type': 'DERIVED', 'citation': 'Frigault MJ, Maziarz RT, Park JH, Lazaryan A, Shah NN, Svoboda J, Lekakis L, Reshef R, Phillips CL, Burke L, Lei J, Pratta M, Morariu-Zamfir R, DiPersio JF. Itacitinib for the prevention of IEC therapy-associated CRS: results from the 2-part phase 2 INCB 39110-211 study. Blood. 2025 Jul 24;146(4):422-436. doi: 10.1182/blood.2024026586.'}, {'pmid': '32998963', 'type': 'DERIVED', 'citation': "Huarte E, O'Connor RS, Peel MT, Nunez-Cruz S, Leferovich J, Juvekar A, Yang YO, Truong L, Huang T, Naim A, Milone MC, Smith PA. Itacitinib (INCB039110), a JAK1 Inhibitor, Reduces Cytokines Associated with Cytokine Release Syndrome Induced by CAR T-cell Therapy. Clin Cancer Res. 2020 Dec 1;26(23):6299-6309. doi: 10.1158/1078-0432.CCR-20-1739. Epub 2020 Sep 30."}]}, 'descriptionModule': {'briefSummary': '"The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning to receive an approved immune effector cell (IEC) therapy for hematologic malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part 1: Eligible to receive any IEC therapy for any approved indication.\n* Part 2: Eligible to receive Yescarta for relapsed or refractory large B-cell lymphoma or follicular lymphoma.\n* Eastern Cooperative Oncology Group performance status 0 to 1.\n* Willingness to avoid pregnancy or fathering children\n\nExclusion Criteria:\n\n* Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal, opportunistic) of any origin.\n* Evidence of active hepatitis B virus or hepatitis C virus infection.\n* Known human immunodeficiency virus.\n* Active acute or chronic graft-versus-host disease requiring systemic therapy.\n* Concurrent use of chronic systemic steroids or immunosuppressant medications.\n* Any unresolved toxicity ≥ Grade 2 (except stable Grade 2 peripheral neuropathy or alopecia) from previous anticancer therapy.\n* Known history or prior diagnosis of immunologic or inflammatory/autoimmune disease affecting the central nervous system (CNS) and unrelated to their disease under study or previous treatment.\n* Clinically significant or uncontrolled cardiac disease.\n* Acute lymphoblastic leukemia participants with protocol-defined CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia.\n* Diffuse large B-cell lymphoma participants must have no signs or symptoms of CNS disease or detectable evidence of CNS disease; participants who have been previously treated for CNS disease but have no evidence of disease at screening are eligible.\n* Laboratory values at screening outside the protocol-defined ranges.'}, 'identificationModule': {'nctId': 'NCT04071366', 'briefTitle': 'A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 2 Study of Itacitinib, for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy', 'orgStudyIdInfo': {'id': 'INCB 39110-211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Open Label Itacitinib Once Daily', 'description': 'During Part 1, all participants receive itacitinib 200mg once daily (open label) for 30 days. The study population will include participants receiving any approved IEC for an approved indication.', 'interventionNames': ['Drug: Itacitinib', 'Drug: Immune effector cell therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Double-Blind Itacitinib Twice Daily', 'description': 'During Part 2, participants will be randomized to receive itacitinib 200mg or placebo twice daily for 30 days. The study population also includes participants who are receiving Yescarta for relapsed or refractory large B-cell lymphoma or follicular lymphoma.', 'interventionNames': ['Drug: Itacitinib', 'Drug: Placebo', 'Biological: Yescarta']}], 'interventions': [{'name': 'Itacitinib', 'type': 'DRUG', 'otherNames': ['INCB039110'], 'description': 'Part 1: Itacitinib 200 mg once daily for 30 days. Part 2: Itacitinib 200 mg twice daily for 30 days.', 'armGroupLabels': ['Part 1: Open Label Itacitinib Once Daily', 'Part 2: Double-Blind Itacitinib Twice Daily']}, {'name': 'Immune effector cell therapy', 'type': 'DRUG', 'otherNames': ['CAR-T cell therapy'], 'description': 'Participants will receive IEC therapy that is approved by the health authority in the country where the study is being conducted for any approved hematologic indication.', 'armGroupLabels': ['Part 1: Open Label Itacitinib Once Daily']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive placebo twice daily.', 'armGroupLabels': ['Part 2: Double-Blind Itacitinib Twice Daily']}, {'name': 'Yescarta', 'type': 'BIOLOGICAL', 'otherNames': ['axicabtagene ciloleucel KTE-C19'], 'description': 'Eligible participants are receiving Yescarta (An infusion of chimeric antigen receptor (CAR)-transduced autologous T cells) for relapsed or refractory larbe B-cell lymphoma or follicular lymphoma intravenously.', 'armGroupLabels': ['Part 2: Double-Blind Itacitinib Twice Daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Childrens Hospital Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Peter Langmuir, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}