Viewing Study NCT04447027

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 5:11 AM
Ignite Modification Date: 2025-12-26 @ 4:17 AM
Study NCT ID: NCT04447027
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-08-01
First Post: 2020-06-24
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C087123', 'term': 'romidepsin'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'C000709231', 'term': 'cc-486'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D004562', 'term': 'Electrocardiography'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D013129', 'term': 'Spinal Puncture'}, {'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D014463', 'term': 'Ultrasonography'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.roschewski@nih.gov', 'phone': '240-760-6183', 'title': 'Dr. Mark J. Roschewski', 'organization': 'National Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality was monitored/assessed at a median follow-up of 20.4 months. Adverse Events was monitored/assessed from the first study intervention, Study Day 1 through 30 days after the last intervention, or disease progression, up to 3.5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 16, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 14, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 18, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood and lymphatic system disorders - Other, specify: low iron level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'CPK increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Electrocardiogram QT corrected interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Esophageal varices hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye disorders - Other, specify: Corneal Thinning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye disorders - Other, specify: Itchy eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye disorders - Other, specify: Light Sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Eye disorders - Other, specify: double vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Gastrointestinal disorders - Other, specify: Increased thirst, Intermittent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Herpes simplex reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hoarseness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperphosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 14, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Investigations - Other, specify: Decreased iron', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Laryngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 21, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Mucosal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Muscle cramp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Musculoskeletal and connective tissue disorder - Other, specify: Fracture, compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nail infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nervous system disorders - Other, specify: Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 19, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 23, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 14, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vulval infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'seriousEvents': [{'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hepatobiliary disorders - Other, specify: Drug-Induced Liver Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Neoplasms benign, malignant and unspecified', 'notes': '(incl cysts and polyps) - Other, specify: Tumor flare reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'All participants who completed at least one cycle (21 days) of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': 'The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22).', 'unitOfMeasure': 'mg/day', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}, {'value': '1', 'groupId': 'OG013'}, {'value': '3', 'groupId': 'OG014'}, {'value': '3', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': "Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level -1: Serious AE's"}, {'id': 'OG001', 'title': "Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide - Non-Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level -1: Non-Serious AE's"}, {'id': 'OG002', 'title': "Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 1: Serious AE's"}, {'id': 'OG003', 'title': "Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide - Non-Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 1: Non-Serious AE's"}, {'id': 'OG004', 'title': "Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 2: Serious AE's"}, {'id': 'OG005', 'title': "Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide - Non-Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 2: Non-Serious AE's"}, {'id': 'OG006', 'title': "Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 3: Serious AE's"}, {'id': 'OG007', 'title': "Arm 1, Cohort 1, Dose Level 3 Dose Escalation - Non-Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 3: Non-Serious AE's"}, {'id': 'OG008', 'title': "Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 4: Serious AE's"}, {'id': 'OG009', 'title': "Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide - Non-Serious AE's", 'description': "Arm 1, Cohort 1, Dose Level 4: Non-Serious AE's"}, {'id': 'OG010', 'title': "Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Serious AE's", 'description': "Arm 2, Cohort 2, Dose Level 2: Serious AE's"}, {'id': 'OG011', 'title': "Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide - Non-Serious AE's", 'description': "Arm 2, Cohort 2, Dose Level 2: Non-Serious AE's"}, {'id': 'OG012', 'title': "Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's", 'description': "Arm 2, Cohort 2, Dose Level 4: Serious AE's"}, {'id': 'OG013', 'title': "Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's", 'description': "Arm 2, Cohort 2, Dose Level 4: Non-Serious AE's"}, {'id': 'OG014', 'title': "Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Serious AE's", 'description': "Arm 3, Cohort 2, Dose Level 4: Serious AE's"}, {'id': 'OG015', 'title': "Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide - Non-Serious AE's", 'description': "Arm 3, Cohort 2, Dose Level 4: Non-Serious AE's"}], 'classes': [{'title': 'Grade 1 Heart failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 1 Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 2 Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 2 Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 2 Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 2 Neoplasms benign, malignant&unspecified(incl cysts&polyps)Other specify tumor flare reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 2 Pain in extremity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 3 Anemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 3 Anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 3 Atrial fibrillation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 3 Adrenal insufficiency', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 3 Blood bilirubin increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 3 Hepatobiliary disorders - Other specify, Drug-Induced liver injury', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 3 Rhabdomyolysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Grade 4 Adrenal insufficiency', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Rate and severity of AEs will be summarized by grade and type of toxicity. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1 Dose Escalation Related to Lenalidomide', 'description': 'Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to lenalidomide.'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to Romidepsin', 'description': 'Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to romidepsin.'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level -1 - Dose Escalation Related to CC-486 (5-azacitidine)', 'description': 'Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level -1: Dose Escalation Related to Any Combination', 'description': 'Arm 1, Cohort 1, Dose Level -1: adverse events possibly related to any combination.'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Lenalidomide', 'description': 'Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to lenalidomide.'}, {'id': 'OG005', 'title': 'Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Romidepsin', 'description': 'Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to romidepsin.'}, {'id': 'OG006', 'title': 'Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to CC-486 (5-azacitidine)', 'description': 'Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG007', 'title': 'Arm 1, Cohort 1, Dose Level 1 - Dose Expansion Related to Any Combination', 'description': 'Arm 1, Cohort 1, Dose Level 1: adverse events possibly related to any combination.'}, {'id': 'OG008', 'title': 'Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Lenalidomide', 'description': 'Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to lenalidomide.'}, {'id': 'OG009', 'title': 'Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Romidepsin', 'description': 'Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to romidepsin.'}, {'id': 'OG010', 'title': 'Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to CC-486 (5-azacitidine)', 'description': 'Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG011', 'title': 'Arm 1, Cohort 1, Dose Level 2 - Dose Escalation Related to Any Combination', 'description': 'Arm 1, Cohort 1, Dose Level 2: adverse events possibly related to any combination.'}], 'classes': [{'title': 'Grade 3 Serious Anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Serious Atrial fibrillation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 4 or 5 Any Serious Adverse Event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Anemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Platelet count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Ejection fraction decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Hypokalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Neutrophil count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-Serious Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious White blood cell decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Weight loss', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}, {'title': 'Grade 4 Non-serious Platelet count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 4 Non-serious Neutrophil count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 4 White blood cell decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation Related to Lenalidomide', 'description': 'Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to lenalidomide.'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to Romidepsin', 'description': 'Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to romidepsin.'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 3 - Dose Escalation Related to CC-486 (5-azacitidine)', 'description': 'Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3: Dose Escalation Related to Any Combination', 'description': 'Arm 1, Cohort 1, Dose Level 3: adverse events possibly related to any combination.'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Lenalidomide', 'description': 'Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to lenalidomide.'}, {'id': 'OG005', 'title': 'Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Romidepsin', 'description': 'Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to romidepsin.'}, {'id': 'OG006', 'title': 'Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to CC-486 (5-azacitidine)', 'description': 'Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG007', 'title': 'Arm 1, Cohort 1, Dose Level 4 - Dose Escalation Related to Any Combination', 'description': 'Arm 1, Cohort 1, Dose Level 4: adverse events possibly related to any combination.'}], 'classes': [{'title': 'Grade 3 Serious Blood bilirubin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Serious Hepatobiliary disorders - Other specify, Drug-Induced liver injury', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Serious Rhabdomyolysis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Any Grade 4 and/or 5 Serious Adverse Event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Acute kidney injury', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Alanine aminotransferase increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Aspartate aminotransferase increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Blood bilirubin increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious CPK increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Fatigue', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Hypotension', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Non-serious Neutrophil count decreased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 Platelet count decreased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 3 White blood cell decreased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4 CPK increased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4 Lymphocyte count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 2, Cohort 2, Dose Level 2 - Dose Expansion Related to Lenalidomide', 'description': 'Arm 2, Cohort 2, Dose Level 2: adverse events possibly related to lenalidomide.'}, {'id': 'OG001', 'title': 'Arm 2, Cohort 2, Dose Level 2 - Dose Expansion Related to Romidepsin', 'description': 'Arm 2, Cohort 2, Dose Level 2: adverse events possibly related to romidepsin.'}, {'id': 'OG002', 'title': 'Arm 2, Cohort 2, Dose Level 2 - Dose Expansion Related to CC-486 (5-azacitidine)', 'description': 'Arm 2, Cohort 2, Dose Level 2: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG003', 'title': 'Arm 2, Cohort 2, Dose Level 2 - Dose Expansion Related to Any Combination', 'description': 'Arm 2, Cohort 2, Dose Level 2: adverse events possibly related to any combination.'}, {'id': 'OG004', 'title': 'Arm 2, Cohort 2, Dose Level 4 - Dose Expansion Related to Lenalidomide', 'description': 'Arm 2, Cohort 2, Dose Level 4: adverse events possibly related to lenalidomide.'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 4 - Dose Expansion Related to Romidepsin', 'description': 'Arm 2, Cohort 2, Dose Level 4: adverse events possibly related to romidepsin.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4 - Dose Expansion Related to CC-486 (5-azacitidine)', 'description': 'Arm 2, Cohort 2, Dose Level 4: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG007', 'title': 'Arm 2, Cohort 2, Dose Level 4 - Dose Expansion Related to Any Combination', 'description': 'Arm 2, Cohort 2, Dose Level 4: adverse events possibly related to any combination.'}, {'id': 'OG008', 'title': 'Arm 3, Cohort 2, Dose Level 4 - Dose Expansion Related to Lenalidomide', 'description': 'Arm 3, Cohort 2, Dose Level 4: adverse events possibly related to lenalidomide.'}, {'id': 'OG009', 'title': 'Arm 3, Cohort 2, Dose Level 4 - Dose Expansion Related to Romidepsin', 'description': 'Arm 3, Cohort 2, Dose Level 4: adverse events possibly related to romidepsin.'}, {'id': 'OG010', 'title': 'Arm 3, Cohort 2, Dose Level 4 - Dose Expansion Related to CC-486 (5-azacitidine)', 'description': 'Arm 3, Cohort 2, Dose Level 4: adverse events possibly related to CC-486 (5-azacitidine).'}, {'id': 'OG011', 'title': 'Arm 3, Cohort 2, Dose Level 4 - Dose Expansion Related to Any Combination', 'description': 'Arm 3, Cohort 2, Dose Level 4: adverse events possibly related to any combination.'}], 'classes': [{'title': 'Any Grade 3, 4, and/or 5 Serious Adverse Event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Anemia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Anorexia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Non-serious Hypokalemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 3 Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 4 Neutrophil count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Grade 4 Platelet count decreased', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (Complete Response + Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '52.7'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '18.0'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '34.8'}, {'value': '66', 'groupId': 'OG003', 'lowerLimit': '64.0', 'upperLimit': '68.0'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '50', 'groupId': 'OG005', 'lowerLimit': '47.3', 'upperLimit': '52.7'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG007', 'lowerLimit': '97.3', 'upperLimit': '100'}]}]}, {'title': 'Partial Response', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '52.7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '33.3', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '34.8'}, {'value': '66', 'groupId': 'OG003', 'lowerLimit': '64.0', 'upperLimit': '68.0'}, {'value': '100', 'groupId': 'OG004', 'lowerLimit': '98', 'upperLimit': '100'}, {'value': '50', 'groupId': 'OG005', 'lowerLimit': '47.3', 'upperLimit': '52.7'}, {'value': '0', 'groupId': 'OG006', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '50', 'groupId': 'OG007', 'lowerLimit': '47.3', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'The response rate will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \\<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '5.8'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.0'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.7', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '4.3'}, {'value': '9.2', 'groupId': 'OG004', 'lowerLimit': '8.6', 'upperLimit': '10.0'}, {'value': '3.6', 'groupId': 'OG005', 'lowerLimit': '3.3', 'upperLimit': '3.9'}, {'value': '13.1', 'groupId': 'OG006', 'lowerLimit': '13.1', 'upperLimit': '13.1'}, {'value': '3.4', 'groupId': 'OG007', 'lowerLimit': '3.0', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to a median of 13.1 months', 'description': 'PFS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Progressive disease is \\>20% increase in the sum of longest diameters of target lesions. Disease relapse is defined as new areas of disease or \\>50% increase in growth of target lesion.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complete Response Rate (CRR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '16.6', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '18.0'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG005', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '100', 'groupId': 'OG006', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '50', 'groupId': 'OG007', 'lowerLimit': '47.3', 'upperLimit': '52.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'CRR will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \\<10mm.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '6.4'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.1', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '2.4'}, {'value': '6.0', 'groupId': 'OG004', 'lowerLimit': '5.7', 'upperLimit': '6.3'}, {'value': '3.4', 'groupId': 'OG005', 'lowerLimit': '3.0', 'upperLimit': '3.8'}, {'value': '11.7', 'groupId': 'OG006', 'lowerLimit': '11.7', 'upperLimit': '11.7'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '1.1', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to a median of 11.7 months', 'description': 'DOR will be determined and reported along with a 95% confidence interval. DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \\<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. Progressive disease is \\>20% increase in the sum of longest diameters of target lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '9.3'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.0'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.5', 'groupId': 'OG005', 'lowerLimit': '3.9', 'upperLimit': '5.1'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'The median was not reached as there were not enough events.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to a median of 8.7 months', 'description': 'OS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. OS is defined as the time from the date of study enrollment until time of death from any cause.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 3.5 years', 'description': 'Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With a Dose-limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'OG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'OG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '00', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day -7 until end of cycle 1 (normally day 22)', 'description': 'A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22). Grade 4 is life threatening, and Grade 5 is death related to adverse event. Serious toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1\n\nArm 1, Dose Level -1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'FG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1\n\nArm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'FG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2\n\nArm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'FG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3\n\nArm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'FG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4\n\nArm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'FG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2\n\nArm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'FG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4\n\nArm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'FG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4\n\nArm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'FG008', 'title': 'Dose Level -2 Lenalidomide', 'description': 'No participants were enrolled on this dose level. Dose Level-2: Lenalidomide 0 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 10 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10.'}], 'periods': [{'title': 'Dose Escalation', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Refused further treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Dose Expansion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1, Cohort 1, Dose Level -1, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level -1 Arm 1, Dose Level-1: Lenalidomide 2.5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 200 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'BG001', 'title': 'Arm 1, Cohort 1, Dose Level 1, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 1 Arm 1, Dose Level 1: Lenalidomide 5 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'BG002', 'title': 'Arm 1, Cohort 1, Dose Level 2, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 2 Arm 1, Dose Level 2: Lenalidomide 10 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'BG003', 'title': 'Arm 1, Cohort 1, Dose Level 3 Dose Escalation', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 3 Arm 1, Dose Level 3: Lenalidomide 15 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'BG004', 'title': 'Arm 1, Cohort 1, Dose Level 4, Dose Escalation Lenalidomide', 'description': 'T-cell Malignancies, Dose Escalation, Arm 1, Dose Level 4 Arm 1, Dose Level 4: Lenalidomide 20 mg Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies for determination of maximum tolerated dose (MTD).'}, {'id': 'BG005', 'title': 'Arm 2, Cohort 2, Dose Level 2, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 2 Arm 2, Dose Level 2: Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'BG006', 'title': 'Arm 2, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 2, Dose Level 4 Arm 2, Dose Level 4: Lenalidomide by oral intake at maximum tolerated dose (MTD) Day 1-10 (7 days lead in for first cycle); CC-486 (5azacitidine) 300 mg by mouth (PO Day) 1 to 10; Romidepsin 12 mg/m\\^2 intravenous (IV) Day 1 and day 10; Dexamethasone 40 mg PO Day 1 and day 10. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'BG007', 'title': 'Arm 3, Cohort 2, Dose Level 4, Dose Expansion Lenalidomide', 'description': 'T-cell Malignancies, Dose Expansion, Arm 3, Dose Level 4 Arm 3, Dose Level 4: Lenalidomide 20 mg maximum tolerated dose (MTD) by oral intake at on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, Romidepsin at 12 mg/m\\^2 by intravenous (IV) infusion on Day 1 and day 10; and Dexamethasone at 40 mg by oral intake on days 1 and 10 of each cycle. Relapsed/refractory mature T cell malignancies enrolled after maximum tolerated dose (MTD) is determined.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '15.56', 'groupId': 'BG000'}, {'value': '63.17', 'spread': '11.46', 'groupId': 'BG001'}, {'value': '55.67', 'spread': '8.07', 'groupId': 'BG002'}, {'value': '46.33', 'spread': '14.19', 'groupId': 'BG003'}, {'value': '46.67', 'spread': '16.29', 'groupId': 'BG004'}, {'value': '66.5', 'spread': '9.19', 'groupId': 'BG005'}, {'value': '65', 'spread': '0', 'groupId': 'BG006'}, {'value': '62.67', 'spread': '21.73', 'groupId': 'BG007'}, {'value': '58', 'spread': '13.46', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}]}, {'title': 'More Than One Race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}, {'title': 'Race Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '23', 'groupId': 'BG008'}]}]}, {'title': 'Ethnicity Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '26', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-08-26', 'size': 1384038, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-26T08:55', 'hasProtocol': True}, {'date': '2023-09-26', 'size': 354746, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-03-26T08:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2020-06-24', 'resultsFirstSubmitDate': '2025-05-05', 'studyFirstSubmitQcDate': '2020-06-24', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-30', 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).', 'timeFrame': 'up to 3.5 years', 'description': 'Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.'}, {'measure': 'Number of Participants With a Dose-limiting Toxicity (DLT)', 'timeFrame': 'Day -7 until end of cycle 1 (normally day 22)', 'description': 'A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22). Grade 4 is life threatening, and Grade 5 is death related to adverse event. Serious toxicity was assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).'}], 'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': '21 days', 'description': 'The MTD is the dose level at which no more than 1 of up to 6 participants experience dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT is defined as any treatment-emergent and related severe (grade ≥3) toxicity related to lenalidomide, romidepsin and/or CC-486 (5-azacitidine) and occurring during the maximum tolerated dose (MTD) observation time, defined as day -7 until end of cycle 1 (normally day 22).'}, {'measure': "Rate and Severity of Serious and/or Non-serious Adverse Events (AE's) by Grade and Type of Toxicity", 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Rate and severity of AEs will be summarized by grade and type of toxicity. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.'}, {'measure': 'Number of Treatment Emergent Grades 3, 4 and/or 5 Adverse Events Possibly Related to Drug Grouped by Severity', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.'}, {'measure': 'Arm 1, Cohort 1, Dose Level -1, 1, and 2 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.'}, {'measure': 'Arm 1, Cohort 1, Dose Level 3, and Arm 1, Cohort 1, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.'}, {'measure': 'Arm 2, Cohort 2, Dose Level 2 and 4; and Arm 3, Cohort 2, Dose Level 4 Treatment Emergent Serious Grades 3, 4, and/or 5 Adverse Events Possibly Related to Drug Grouped by Relationship to the Study Drug and/or Combination', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'Treatment emergent grades 3, 4, and/or 5 adverse events possibly related grouped by relationship to the study drug (e.g., lenalidomide, romidepsin, CC-486 (5-azacitidine) in any combinations) assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (Complete Response + Partial Response)', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'The response rate will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \\<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR.'}, {'measure': 'Progression-free Survival (PFS) in Months Reported Along With a 95% Confidence Interval', 'timeFrame': 'up to a median of 13.1 months', 'description': 'PFS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Progressive disease is \\>20% increase in the sum of longest diameters of target lesions. Disease relapse is defined as new areas of disease or \\>50% increase in growth of target lesion.'}, {'measure': 'Complete Response Rate (CRR)', 'timeFrame': '6 cycles (each cycle is 28 days)', 'description': 'CRR will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \\<10mm.'}, {'measure': 'Duration of Response (DOR) in Months Reported Along With a 95% Confidence Interval', 'timeFrame': 'up to a median of 11.7 months', 'description': 'DOR will be determined and reported along with a 95% confidence interval. DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented. Response was measured by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria. Complete response (CR) is disappearance of all target lesions and all nodes with long axis \\<10mm. Partial response (PR) is a ≥30% decrease in the sum of longest diameters of target lesions but not a CR. Progressive disease is \\>20% increase in the sum of longest diameters of target lesions.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'up to a median of 8.7 months', 'description': 'OS will be estimated using the Kaplan-Meier curve and reported along with a 95% confidence interval. OS is defined as the time from the date of study enrollment until time of death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunomodulatory Drugs (IMiDs)', 'TCM', 'ALCL', 'Histone Deacetylase Inhibitors (HDACi)'], 'conditions': ['Cutaneous T-Cell Lymphoma', 'Mature T-cell Malignancies', 'Peripheral T-Cell Lymphoma', 'Relapsed/ Refractory T-cell Malignancies']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-C-0127.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nMature T-cell malignancies (TCMs) are a rare group of cancers that usually do not have effective treatments or cures. Because of this, participants with TCMs often relapse and have a poor overall prognosis. This trial is testing if combining several drugs against TCMs can be a more effective.\n\nPrimary Objective:\n\nTo test if the combination of romidepsin, CC-486 (5-azacitidine), dexamethasone, and lenalidomide (RAdR) can be given safely to participants with relapsed or treatment refractory TCM.\n\nOther (Secondary) Objective:\n\nMeasure the activity of this combination treatment.\n\nEligibility:\n\nPeople age 18 and older who have a failed or relapsed after standard treatments for mature TCMs.\n\nDesign:\n\nParticipants will be screened for eligibility by performing the following tests or procedures:\n\nPhysical exam\n\nMedical history\n\nMedicine review\n\nBlood and urine tests\n\nSymptom review\n\nBone marrow examination\n\nTotal Body imaging scans or x-rays\n\nTumor biopsy\n\nParticipants will have blood tests during treatment to make sure their blood cell counts are okay.\n\nRomidepsin is infused through an intravenous (IV) placed in one of the veins usually in the arm. Lenalidomide, dexamethasone, and CC-486 (5-azacitidine) are pills or capsules taken by mouth.\n\nParticipants are asked to keep a diary of when they take their pills to make sure they are taking these medicines properly.\n\nParticipants will have tumor imaging scans after every 2nd cycle (or 6 weeks) to check if the treatment is working. If the doctors are concerned the cancer has spread to the brain and/or spine, they will have scans of the area(s) and a sampling of the fluid around the brain/spine which is obtained through a small needle inserted into the lower part of the back for a short time to collect the fluid. This procedure is called a spinal tap or lumbar puncture.\n\nParticipants who have tumor in their skin will have repeat exams of their skin and sometimes photographs taken of these areas to see if the treatment is working.\n\nParticipants will also be asked to give blood, saliva, and sometimes have optional biopsies of their tumor where these tests are done for research purposes.\n\nAfter they have completed the protocol treatment (6 cycles), they will be asked to return to clinic 30 days after treatment has ended, then every other month (or 60 days) for the first 6 months, then every 3 months (90 days) for 2 years, and then every 6 months for years 2 to 4 after completing treatment. After 4.5 years, they will be seen once a year.', 'detailedDescription': 'Background:\n\n* Mature T-cell malignancies (TCM) are rare and heterogeneous group of leukemias and lymphomas accounting for 5 to 10% of all lymphomas in the US\n* Patients with systemic TCM are most commonly treated with a CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone)-like regimens, that produce long-term progression-free survival in about 30% of these cases\n* Patients with relapsed/refractory (R/R) TCM have very poor prognosis with median overall survival of less than 1 year. Treatment options for R/R TCM are very few and of limited efficacy, thus novel treatment strategies are urgently needed.\n* Mutations in epigenetic regulators are common in aggressive TCMs and standard treatment with histone deacetylase inhibitors (HDACi) such as romidepsin show modest clinical activity with single agent the overall response (ORR) around 25%\n* Combination of romidepsin and 5-azacitidine (hypomethylating agents) was synergistic in preclinical models, and has demonstrated high clinical activity with an ORR of 79%\n* Many TCMs rely on The Ikaros-dependent nuclear factor κB (NF-κB)/interferon regulatory factor 4 (IRF4) signaling pathway to maintain proliferation, which is why lenalidomide, which induces degradation of Ikaros and downregulates IRF4, has single agent activity in R/R TCM with overall response rate (ORR) of 26% to 42%, depending on the subtype.\n* Lenalidomide synergizes with romidepsin and enhances tumor cell death in TCM cell lines, predicting that the addition of lenalidomide to the established romidepsin/ CC-486 (5-azacitidine) combination will further improve efficacy.\n\nObjectives:\n\n-To determine the safety and toxicity profile and the maximum tolerated dose (MTD) of the four-drug combination of CC-486 (5-azacitidine), romidepsin, lenalidomide and dexamethasone in patients with TCM\n\nEligibility:\n\n* Refractory/relapsed TCM (excluding in Cutaneous T-Cell Lymphoma) defined as follows:\n\n * Patients with systemic disease\n * Have received at least one line of prior therapy\n * Must have received brentuximab vedotin if the disease is anaplastic large cell lymphoma or cluster of differentiation 30 (CD30)-positive cutaneous T-cell lymphoma\n* Age \\>= 18 years of age\n* Eastern Cooperative Oncology Group performance status of \\<= 2 (or \\<= 3 if decrease is due to the disease)\n* Histologically or cytologically confirmed relapsed and/or refractory mature TCM\n* Adequate organ and marrow function\n\nDesign:\n\n* Open-label, single-center, uncontrolled Phase 1 study\n* 3 + 3 design will be used to determine the maximum tolerated dose (MTD) of dose-escalated lenalidomide with fixed dose of romidepsin and CC-486 (5-azacitidine)\n* An expansion cohort of 9 patients will be evaluated at the MTD\n* Maximum 6 cycles (28-day cycle) of combination therapy\n* To explore all dose levels, including further evaluation in a dose expansion cohort, the accrual ceiling will be set at 30 patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* INCLUSION CRITERIA:\n* Patients must have relapsed after or progressed during at least one line of prior systemic therapy (which may include allogeneic stem cell transplantation) for mature T or NK/T neoplasm, i.e. have relapsed and/or refractory mature T and natural killer (NK) neoplasm per 2016 World Health Organization (WHO) classification excluding chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, and Cutaneous T-Cell Lymphoma.\n* T or NK/T neoplasm from initial diagnosis or recurrence must be histologically or cytologically proven and diagnosis be confirmed by the Laboratory of Pathology, National Cancer Institute (NCI),\n* Patients with anaplastic large cell lymphoma (ALCL) or cluster of differentiation (CD30) positive mycosis fungoides (MF) or Sézary syndrome (SS) must have relapsed after or become intolerant to prior anti-CD30 targeting therapy treatment with brentuximab vedotin\n* For patients without circulating leukemia/lymphoma cells detectable by flow cytometry, a formalin fixed tissue block or 15 slides of tumor sample (archival or fresh) must be available at enrollment for performance of correlative studies. NOTE: Patients without circulating malignant cells must be willing to have a tumor biopsy if prior tissue or adequate archival tissue is not available (i.e., post-enrollment and prior to treatment).\n* Disease must be measurable with at least one measurable lesion by response evaluation criteria in lymphoma (RECIL) 2017 or Modified Severity-Weighted Assessment Tool (mSWAT) criteria, or have an abnormal clonal T-cell population detectable by peripheral blood flow cytometry\n* Age \\>18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\<=2, or \\<= 3 if the decreased performance status is deemed to be due to disease and not residual toxicity from prior therapy or other causes.\n* Adequate organ and marrow function as defined below:\n\n * Absolute neutrophil count \\>= 1,000/mcL\n * Platelets \\>= 75,000/mcL\n * Total bilirubin \\<= 1.5 X institutional upper limit of normal (ULN)\n * Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) \\<= 2.5 X institutional upper limit of normal (ULN)\n * Serum Creatinine \\<= 1.5 mg/dL OR\n * Creatinine Clearance \\>= 60 mL/min/1.73 m\\^2 as calculated by direct measurement of 24-hour urine for creatinine clearance\n* Negative serum or urine pregnancy test at screening for women of childbearing potential (WOCBP) NOTE: WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. WOCBP must have a negative pregnancy test (hemoglobin (HCG) blood or urine) during screening.\n* All study participants must be registered into the mandatory Revlimid REMS(R) program and be willing and able to comply with the requirements of the Risk Evaluation and Mitigation Strategy (REMS(R) program.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after completion of treatment for women, and for at least 3 months after completion of treatment for men. Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(R) program.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving any other investigational agents.\n* Anti-cancer treatment within 2 weeks prior to enrollment. (4 weeks for monoclonal antibodies and 6 weeks for nitrosoureas or mitomycin C).\n* Patients who have received two of the following drugs at any point: lenalidomide, romidepsin, and 5-azacitidine. Patients who have received only one of the three drugs remain eligible.\n* Patients with a diagnosis of cutaneous T-cell lymphoma (CTCL) are excluded from participation in the expansion cohort.\n* Other malignancy that requires ongoing systemic hormonal therapy, chemotherapy, or immunotherapy.\n* History of allergic reactions or known or suspected hypersensitivity attributed to compounds of similar chemical or biologic composition to lenalidomide, romidepsin and 5-azacitidine\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.\n* Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\\< 6 months prior to enrollment), myocardial infarction (\\< 6 months prior to enrollment), unstable angina, congestive heart failure (\\>= New York Heart Association Classification Class II), congenital long QT syndrome, or other serious cardiac arrhythmia including 2nd degree atrio ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min).\n* Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes.\n* Uncontrolled hypertension, i.e., blood pressure (BP) of \\>=160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria.\n* Triplicate average baseline QT corrected for heart rate by Fridericia's (QTcF) interval \\>= 480 ms\n* Patients taking drugs leading to significant QT prolongation Note: A 5 half-life washout period must have elapsed following the use of these drugs prior to administration of romidepsin.\n* Concomitant use of rifampin and other strong cytochrome P450 3A4 (CYP3A4) inhibitors and inducers within 2 weeks prior to starting protocol therapy.\n* Other severe acute or chronic medical conditions including psychiatric conditions such as recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n* Pregnant or lactating women. Pregnant women are excluded from this study because lenalidomide is a Class X agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, breastfeeding should be discontinued if the mother is treated with lenalidomide. These potential risks may also apply to other agents used in this study."}, 'identificationModule': {'nctId': 'NCT04447027', 'briefTitle': 'Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Phase 1 Study of Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies', 'orgStudyIdInfo': {'id': '200127'}, 'secondaryIdInfos': [{'id': '20-C-0127'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1- Experimental Treatment: Dose Escalation', 'description': 'Lenalidomide by oral intake at escalating doses of 5, 10, 15, or 20 mg/day on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, romidepsin at 12mg/m\\^2 by intravenous (IV) infusion on Day 1 and 10 and dexamethasone at 40mg by oral intake on days 1 and 10 of each cycle, to determine maximum tolerated dose (MTD).', 'interventionNames': ['Drug: Romidepsin', 'Drug: Lenalidomide', 'Drug: CC-486 (5-azacitidine)', 'Drug: Dexamethasone', 'Diagnostic Test: EKG', 'Procedure: Bone Marrow Aspiration/Biopsy', 'Diagnostic Test: MRI', 'Procedure: Lumbar Puncture', 'Diagnostic Test: TTE']}, {'type': 'EXPERIMENTAL', 'label': '2 - Experimental Treatment: Dose Expansion', 'description': 'Lenalidomide by oral intake at maximum tolerated dose (MTD) on days -7 to 10 of each 21-day cycle (max 6 cycles) with CC-486 (5-azacitidine) at 300mg/day by oral intake on days 1-10, romidepsin at 12mg/m\\^2 by intravenous (IV) infusion on Day 1 and 10 and dexamethasone at 40mg by oral intake on days 1 and 10 of each cycle', 'interventionNames': ['Drug: Romidepsin', 'Drug: Lenalidomide', 'Drug: CC-486 (5-azacitidine)', 'Drug: Dexamethasone', 'Diagnostic Test: EKG', 'Procedure: Bone Marrow Aspiration/Biopsy', 'Diagnostic Test: MRI', 'Procedure: Lumbar Puncture', 'Diagnostic Test: TTE']}], 'interventions': [{'name': 'Romidepsin', 'type': 'DRUG', 'otherNames': ['Istodax'], 'description': 'Romidepsin (12mg/ m\\^2) will be administered on days 1 and 10 of each cycle through a peripheral or central intravenous catheter for 6 cycles.', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'otherNames': ['REVLIMID'], 'description': 'Lenalidomide will be administered by oral intake in a dose-escalation with a starting dose of 5mg daily, a second dose level of 10mg daily, a third dose level at 15mg daily, and a fourth dose level at 20mg daily on days -7 to day 10 of first cycle. After the second cycle, lenalidomide will be given from day 1 to day 10 in each cycle for up to 6 cycles.', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'CC-486 (5-azacitidine)', 'type': 'DRUG', 'otherNames': ['ONUREG'], 'description': 'CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 6 cycles.', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['azacitidine tablets'], 'description': 'Dexamethasone, 40mg, by mouth (PO), will be given on days 1 and 10 of each cycle.', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'EKG', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Electrocardiogram'], 'description': 'Screening', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'Bone Marrow Aspiration/Biopsy', 'type': 'PROCEDURE', 'otherNames': ['BM Aspiration/Bx'], 'description': 'Baseline, end of treatment and disease progression, and Day 30 (+7).', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Magnetic resonance imaging'], 'description': 'Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'Lumbar Puncture', 'type': 'PROCEDURE', 'otherNames': ['LP'], 'description': 'Baseline, every 2 cycles, end of treatment and disease progression, and follow-up.', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}, {'name': 'TTE', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Transthoracic echocardiogram'], 'description': 'Screening', 'armGroupLabels': ['1- Experimental Treatment: Dose Escalation', '2 - Experimental Treatment: Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Mark J Roschewski, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Clinical data will be available during the study and indefinitely. Genomic data will be available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active', 'ipdSharing': 'YES', 'description': 'All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. In addition, all large-scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).', 'accessCriteria': 'Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data will be made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mark Roschewski, M.D.', 'investigatorAffiliation': 'National Cancer Institute (NCI)'}}}}