Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-24 @ 3:16 PM
Study NCT ID:
NCT02782468
Status:
COMPLETED
Last Update Posted:
2023-11-03
First Post:
2016-05-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Pevonedistat in Adult East Asian Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C539933', 'term': 'pevonedistat'}, {'id': 'D001374', 'term': 'Azacitidine'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'TEAEs were adverse events that started after first dose through 30 days after the last dose of study drug: single agent arms (up to Cycle 19 [up to Day 429]) (Cycle=21 days); combination arms (up to Cycle 65 [up to Day 1850]) (Cycle=28 days)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 2, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Age-related macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Allergic transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arterial fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacillus bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 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injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malignant peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mesenteric panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose through 30 days after the last dose of study drug: single agent arms (up to Cycle 19 [up to Day 429]) (Cycle=21 days); combination arms (up to Cycle 65 [up to Day 1850]) (Cycle=28 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all enrolled participants who received at least 1 dose of any study drug, pevonedistat or azacitidine.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities (DLTs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 During Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (Cycle length = 21 days [single agent arms]; 28 days [combination arms])', 'description': 'DLT: Any of following events considered possibly related to study drug(s) by investigator: Grade (G) 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis; G3 diarrhea occurred despite maximal supportive therapy; G3 arthralgia/myalgia despite use of optimal analgesia; G3 nonhematologic toxicity with exceptions: 1) Brief fatigue, 2) hypophosphatemia; Persistent elevations of transaminases/bilirubin above G2 beyond 2 days between doses; Other study drug-related nonhematologic toxicities G2 or greater, required a dose reduction/discontinuation of pevonedistat. G3 or greater hematologic toxicities, including G3 or 4 febrile neutropenia, considered DLTs if: A delay in initiation of Cycle 2 due to lack of adequate recovery from treatment-related toxicity: 1) Of more than (\\>) 4 weeks due to hematologic toxicity believed not related to leukemic infiltration. Bone marrow (BM) evaluation may have been required. 2) Of \\>2 weeks due to nonhematologic toxicities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The DLT evaluable population was defined as all participants who either experienced DLT during Cycle 1 or received all scheduled doses of study drug during Cycle 1 without DLT.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Abnormal Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Cycle 19 (up to Day 399) in single agent arms (Cycle=21days) and Cycle 65 (up to Day 1820) in combination arms (Cycle=28 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all enrolled participants who received at least 1 dose of any study drug, pevonedistat or azacitidine.'}, {'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '253', 'spread': '37.6', 'groupId': 'OG000'}, {'value': '410', 'spread': '45.5', 'groupId': 'OG001'}, {'value': '67.0', 'spread': '5.9', 'groupId': 'OG002'}, {'value': '160', 'spread': '25.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and pevonedistat concentration-time data to reliably estimate PK parameters by noncompartmental analysis methods and who had not received any excluded concomitant medications per the protocol.'}, {'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '252', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '453', 'spread': '38.7', 'groupId': 'OG001'}, {'value': '76.1', 'spread': '17.6', 'groupId': 'OG002'}, {'value': '170', 'spread': '33.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 5: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and pevonedistat concentration-time data to reliably estimate PK parameters by noncompartmental analysis methods and who had not received any excluded concomitant medications per the protocol. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '1515', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '2163', 'spread': '25.7', 'groupId': 'OG001'}, {'value': '647', 'spread': '41.3', 'groupId': 'OG002'}, {'value': '1224', 'spread': '14.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 5: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and pevonedistat concentration-time data to reliably estimate PK parameters by noncompartmental analysis methods and who had not received any excluded concomitant medications per the protocol. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'CL: Total Clearance for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '32.6', 'spread': '41.7', 'groupId': 'OG001'}, {'value': '22.8', 'spread': '48.8', 'groupId': 'OG002'}, {'value': '28.4', 'spread': '23.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])', 'unitOfMeasure': 'liter per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and pevonedistat concentration-time data to reliably estimate PK parameters by noncompartmental analysis methods and who had not received any excluded concomitant medications per the protocol.'}, {'type': 'PRIMARY', 'title': 'CL: Total Clearance for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '34.6', 'groupId': 'OG001'}, {'value': '28.1', 'spread': '38.3', 'groupId': 'OG002'}, {'value': '28.9', 'spread': '23.7', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 5: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])', 'unitOfMeasure': 'liter per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK evaluable population was defined as all enrolled participants who had sufficient dosing in Cycle 1 and pevonedistat concentration-time data to reliably estimate PK parameters by noncompartmental analysis methods and who had not received any excluded concomitant medications per the protocol. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) for Participants With AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '80', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'ORR for AML was defined as the percentage of participants with a complete remission (CR), CR with incomplete blood count recovery (CRi), or partial remission (PR) based on Modified International Working Group (IWG) Response Criteria for AML. CR was defined as participant achieved the morphologic leukemia-free state and had an absolute neutrophil count (ANC) of more than 1,000 per microliter (/mcL) and platelets of greater than or equal to (\\>=) 100,000/mcL. A morphologic leukemia-free state requires less than (\\<) 5 percent (%) blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. CRi was, after chemotherapy, some participants who fulfilled all of the criteria for CR except for residual neutropenia (\\<1,000/mcL) or thrombocytopenia (\\<100,000/mcL). PR designation required all the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to between 5% and 25% in the bone marrow aspirate.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable population was defined as all participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'ORR for Participants With MDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'ORR for MDS: Percentage of participants with CR,PR or hematologic improvement(HI) based on IWG Response Criteria. CR: BM:\\<=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted peripheral blood: hemoglobin (Hgb)\\>=11 gram per deciliter (g/dL),platelets\\>=100\\*10\\^9/L,neutrophils \\>=1.0\\*10\\^9/L, blasts 0%. PR:CR criteria if abnormal before treatment except: BM blasts decreased by \\>=50% from pretreatment but still\\>5%; cellularity, morphology not relevant. HI criteria: Erythroid response:Hgb up by \\>=1.5 g/dL; transfused RBC reduced by at least 4 red blood cell (RBC) transfusions/8 weeks comparatively last 8 weeks; Platelet response: Increase of \\>=30\\*10\\^9/L for participants starting with \\>20\\*10\\^9/L platelets; increase from \\<20\\*10\\^9/L to \\>20\\*10\\^9/L and by 100%; Neutrophil response: At least 100% and absolute increase \\>0.5\\*10\\^9/L; Progression/relapse after HI: Granulocytes/platelets decreased by 50% from maximum; Hgb reduced by \\>=1.5 g/dL; transfusion dependence.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable population was defined as all participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR for Participants With AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'CR was defined as participant achieved the morphologic leukemia-free state and had an ANC of more than 1,000/mcL and platelets of \\>=100,000/mcL. A morphologic leukemia-free state requires \\<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. CR assessment was based on IWG Response Criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable population was defined as all participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With CR for Participants With MDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'OG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'CR was defined as participant with bone marrow: less than or equal to (\\<=) 5% myeloblasts with normal maturation of all cell lines; persistent dysplasia was noted peripheral blood: Hgb \\>=11 g/dL, platelets \\>=100\\*10\\^9/L, neutrophils \\>=1.0\\*10\\^9 per liter (/L), blasts 0%. CR assessment was based on IWG Response Criteria.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Response evaluable population was defined as all participants who received at least 1 dose of study drug, had measurable disease at baseline, and had at least 1 post baseline disease assessment. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 milligram per square meter (mg/m\\^2), infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'FG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'FG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'FG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Initiation of Hematopoietic Stem Cell Transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Symptomatic Deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 8 investigative sites in Japan, Taiwan and South Korea from 16 May 2016 to 25 January 2022.', 'preAssignmentDetails': 'Participants with a historical diagnosis of relapsed/refractory (R/R) acute myeloid leukemia (AML) or R/R higher risk (HR) myelodysplastic syndromes (MDS) (including nonproliferative chronic myelomonocytic leukemia \\[CMML\\]) were enrolled to receive single agent pevonedistat or combination of pevonedistat and azacitidine.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Agent Arm: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat 25 mg/m\\^2, infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'BG001', 'title': 'Single Agent Arm: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat 44 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in each 21-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'BG002', 'title': 'Combination Arm: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'BG003', 'title': 'Combination Arm: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, infusion, intravenously, on Days 1, 3, and 5 along with azacitidine 75 mg/m\\^2, injection, intravenously in Cycle 1 and intravenously or subcutaneously from Cycle 2 onwards, on Days 1 to 5, and Days 8 and 9, followed by a rest period of 19 days, in each 28-day treatment cycle until disease progression or symptomatic deterioration.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'spread': '5.20', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '11.27', 'groupId': 'BG001'}, {'value': '65.0', 'spread': '9.54', 'groupId': 'BG002'}, {'value': '64.9', 'spread': '8.52', 'groupId': 'BG003'}, {'value': '67.9', 'spread': '9.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Korea, South', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Surface Area (BSA)', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.26', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.21', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.04', 'groupId': 'BG002'}, {'value': '1.7', 'spread': '0.18', 'groupId': 'BG003'}, {'value': '1.7', 'spread': '0.20', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'square meter (m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety population was defined as all enrolled participants who received at least 1 dose of any study drug, pevonedistat or azacitidine.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-23', 'size': 18842783, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-12T18:13', 'hasProtocol': True}, {'date': '2018-06-01', 'size': 6943771, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-12T18:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2016-05-20', 'resultsFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-12', 'studyFirstPostDateStruct': {'date': '2016-05-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose through 30 days after the last dose of study drug: single agent arms (up to Cycle 19 [up to Day 429]) (Cycle=21 days); combination arms (up to Cycle 65 [up to Day 1850]) (Cycle=28 days)'}, {'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs) Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 During Cycle 1', 'timeFrame': 'Cycle 1 (Cycle length = 21 days [single agent arms]; 28 days [combination arms])', 'description': 'DLT: Any of following events considered possibly related to study drug(s) by investigator: Grade (G) 3 or greater nausea and/or emesis despite use of optimal antiemetic prophylaxis; G3 diarrhea occurred despite maximal supportive therapy; G3 arthralgia/myalgia despite use of optimal analgesia; G3 nonhematologic toxicity with exceptions: 1) Brief fatigue, 2) hypophosphatemia; Persistent elevations of transaminases/bilirubin above G2 beyond 2 days between doses; Other study drug-related nonhematologic toxicities G2 or greater, required a dose reduction/discontinuation of pevonedistat. G3 or greater hematologic toxicities, including G3 or 4 febrile neutropenia, considered DLTs if: A delay in initiation of Cycle 2 due to lack of adequate recovery from treatment-related toxicity: 1) Of more than (\\>) 4 weeks due to hematologic toxicity believed not related to leukemic infiltration. Bone marrow (BM) evaluation may have been required. 2) Of \\>2 weeks due to nonhematologic toxicities.'}, {'measure': 'Number of Participants With Clinically Significant Abnormal Laboratory Values', 'timeFrame': 'Baseline up to Cycle 19 (up to Day 399) in single agent arms (Cycle=21days) and Cycle 65 (up to Day 1820) in combination arms (Cycle=28 days)'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])'}, {'measure': 'Cmax: Maximum Observed Plasma Concentration for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 5', 'timeFrame': 'Cycle 1 Day 5: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])'}, {'measure': 'AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 5', 'timeFrame': 'Cycle 1 Day 5: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])'}, {'measure': 'CL: Total Clearance for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 1', 'timeFrame': 'Cycle 1 Day 1: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])'}, {'measure': 'CL: Total Clearance for Pevonedistat When Administered Alone and in Combination With Azacitidine on Cycle 1 Day 5', 'timeFrame': 'Cycle 1 Day 5: pre-infusion and at multiple time points (up to 48 hours) post-infusion (Cycle length = 21 days [single agent arms]; 28 days [combination arms])'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR) for Participants With AML', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'ORR for AML was defined as the percentage of participants with a complete remission (CR), CR with incomplete blood count recovery (CRi), or partial remission (PR) based on Modified International Working Group (IWG) Response Criteria for AML. CR was defined as participant achieved the morphologic leukemia-free state and had an absolute neutrophil count (ANC) of more than 1,000 per microliter (/mcL) and platelets of greater than or equal to (\\>=) 100,000/mcL. A morphologic leukemia-free state requires less than (\\<) 5 percent (%) blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. CRi was, after chemotherapy, some participants who fulfilled all of the criteria for CR except for residual neutropenia (\\<1,000/mcL) or thrombocytopenia (\\<100,000/mcL). PR designation required all the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to between 5% and 25% in the bone marrow aspirate.'}, {'measure': 'ORR for Participants With MDS', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'ORR for MDS: Percentage of participants with CR,PR or hematologic improvement(HI) based on IWG Response Criteria. CR: BM:\\<=5% myeloblasts with normal maturation of all cell lines; persistent dysplasia noted peripheral blood: hemoglobin (Hgb)\\>=11 gram per deciliter (g/dL),platelets\\>=100\\*10\\^9/L,neutrophils \\>=1.0\\*10\\^9/L, blasts 0%. PR:CR criteria if abnormal before treatment except: BM blasts decreased by \\>=50% from pretreatment but still\\>5%; cellularity, morphology not relevant. HI criteria: Erythroid response:Hgb up by \\>=1.5 g/dL; transfused RBC reduced by at least 4 red blood cell (RBC) transfusions/8 weeks comparatively last 8 weeks; Platelet response: Increase of \\>=30\\*10\\^9/L for participants starting with \\>20\\*10\\^9/L platelets; increase from \\<20\\*10\\^9/L to \\>20\\*10\\^9/L and by 100%; Neutrophil response: At least 100% and absolute increase \\>0.5\\*10\\^9/L; Progression/relapse after HI: Granulocytes/platelets decreased by 50% from maximum; Hgb reduced by \\>=1.5 g/dL; transfusion dependence.'}, {'measure': 'Percentage of Participants With CR for Participants With AML', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'CR was defined as participant achieved the morphologic leukemia-free state and had an ANC of more than 1,000/mcL and platelets of \\>=100,000/mcL. A morphologic leukemia-free state requires \\<5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. CR assessment was based on IWG Response Criteria.'}, {'measure': 'Percentage of Participants With CR for Participants With MDS', 'timeFrame': 'From first dose up to 30 days after last dose of study drug or before start of subsequent antineoplastic therapy, whichever comes earlier up to Cycle 19 (up to Day 429, single agent)(Cycle=21 days) and Cycle 65 (up to Day 1850, combination)(Cycle=28 days)', 'description': 'CR was defined as participant with bone marrow: less than or equal to (\\<=) 5% myeloblasts with normal maturation of all cell lines; persistent dysplasia was noted peripheral blood: Hgb \\>=11 g/dL, platelets \\>=100\\*10\\^9/L, neutrophils \\>=1.0\\*10\\^9 per liter (/L), blasts 0%. CR assessment was based on IWG Response Criteria.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Leukemia, Myeloid, Acute', 'Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'pmid': '35545778', 'type': 'DERIVED', 'citation': 'Handa H, Cheong JW, Onishi Y, Iida H, Kobayashi Y, Kim HJ, Chiou TJ, Izutsu K, Tsukurov O, Zhou X, Faessel H, Yuan Y, Sedarati F, Faller DV, Kimura A, Wu SJ. Pevonedistat in East Asian patients with acute myeloid leukemia or myelodysplastic syndromes: a phase 1/1b study to evaluate safety, pharmacokinetics and activity as a single agent and in combination with azacitidine. J Hematol Oncol. 2022 May 11;15(1):56. doi: 10.1186/s13045-022-01264-w.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of pevonedistat administered as a single agent and in combination with azacitidine in adult east Asian participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS).', 'detailedDescription': 'The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people with myelodysplastic syndromes MDS (including nonproliferative chronic myelomonocytic leukemia \\[CMML\\]) and AML (acute myeloid leukaemia) as a single-agent and in combination treatment with azacitidine. This study will look at the safety and tolerability, the recommended phase 2/phase 3 dose of pevonedistat administered in combination with azacitidine, pharmacokinetics and response to treatment in participants who take single agent pevonedistat compared to participants who take pevonedistat and azacitidine.\n\nThe study will enroll approximately 37 participants. Participants will be assigned into one of the four treatment groups which will remain disclosed to the patient and study doctor during the study. Participants will be first enrolled at single-agent low dose level (25 mg/m\\^2). If this dose is tolerable, participants will be enrolled in parallel at single-agent higher dose level (44 mg/m\\^2) and in combination treatment cohorts.\n\n* Pevonedistat 25 mg/m\\^2\n* Pevonedistat 44 mg/m\\^2\n* Pevonedistat 10 mg/m\\^2 and azacitidine 75 mg/m\\^2 combination\n* Pevonedistat 20 mg/m\\^2 and azacitidine 75 mg/m\\^2 combination Participants will receive pevonedistat infusion intravenously and azacitidine via intravenous or subcutaneous route.\n\nThis multi-center trial will be conducted in Japan, Korea and Taiwan. The overall time to participate in this study is approximately 24 months. Participants will attend the End of Study (EOS) visit for safety, 30 days after receiving their last dose of study drug or before the start of subsequent antineoplastic therapy (other than hydroxyurea).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria include, in part:\n\n1. East Asian patients aged 18 years or older (or minimum age of legal consent consistent with local regulations) when written study informed consent is obtained must meet 1 of the following diagnosis criteria for either the Single-Agent Arm or the Combination Arm (additional restrictions apply to the Single Agent Arm):\n\n a. Are male and female participants with WHO-defined AML, including leukemia secondary to prior chemotherapy or resulting from an antecedent hematologic disorder, who have failed to achieve CR or who have relapsed after prior therapy (R/R) and are not candidates for potentially curative treatment, or ii. Are male and female participants aged 60 years or older with previously untreated AML who have bone marrow blasts \\<30% and who are not candidates for standard induction chemotherapy, or iii. Are male and female participants with WHO-defined MDS that meets the IPSS-R criteria for the very high, high, or intermediate risk group, for whom standard curative, life-prolonging treatment does not exist or is no longer effective (R/R), or iv. Are male and female participants with previously untreated MDS that meets the IPSS-R criteria for the very high, high, or intermediate risk group, or vi. Are male and female participants with WHO-defined CMML-2 or CMML-1 that meets the IPSS-R criteria for the very high, high, or intermediate risk group CMML-1 participants must have bone marrow blasts \\>=5%\n2. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n3. Able to undergo bone marrow aspiration and biopsy at Screening.\n\nExclusion Criteria include, in part:\n\n1. Acute promyelocytic leukemia (as diagnosed by morphologic examination of bone marrow, by fluorescent in situ hybridization or cytogenetics \\[t (15:17)\\] of peripheral blood or bone marrow, or by other accepted analysis) or AML associated with t (9;22) karyotypes or molecular.\n2. More than 3 prior lines of therapy (Combination Arm only).\n3. Prior therapy with hypomethylating agents (example, azacitidine, decitabine). (Combination Arm only).\n4. Is eligible for a hematopoietic stem cell transplant.\n5. Is a female participant who is lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.\n6. Had treatment with any investigational products within 14 days before the first dose of any study drug.\n7. Has known hypersensitivity to azacitidine or mannitol (Combination Arm only).\n8. Has known central nervous system involvement.\n9. Had systemic antineoplastic therapy or radiotherapy within 14 days before the first dose of any study drug, except for hydroxyurea.'}, 'identificationModule': {'nctId': 'NCT02782468', 'briefTitle': 'A Study of Pevonedistat in Adult East Asian Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1/1b, Open-label Study of Pevonedistat (MLN4924, TAK-924) as Single Agent and in Combination With Azacitidine in Adult East Asian Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)', 'orgStudyIdInfo': {'id': 'Pevonedistat-1012'}, 'secondaryIdInfos': [{'id': 'U1111-1166-8630', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1, Cohort 1: Pevonedistat 25 mg/m^2', 'description': 'Pevonedistat, 25 milligram per square meter (mg/m\\^2), 60-minute infusion, intravenously, on Days 1, 3 and 5, followed by a rest period of 16 days, in 21-day treatment cycles.', 'interventionNames': ['Drug: Pevonedistat 25 mg/m^2']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 1, Cohort 2: Pevonedistat 44 mg/m^2', 'description': 'Pevonedistat, 44 mg/m\\^2, 60-minute infusion, intravenously, on Days 1, 3, and 5, followed by a rest period of 16 days, in 21-day treatment cycles.', 'interventionNames': ['Drug: Pevonedistat 44 mg/m^2']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2, Cohort 1: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 10 mg/m\\^2, 60-minute infusion, intravenously, on Days 1, 3, and 5 and azacitidine 75 mg/m\\^2, on Days 1 to 5, and Days 8 and 9, intravenously or subcutaneously, followed by a rest period of 19 days, in 28-day treatment cycles.', 'interventionNames': ['Drug: Pevonedistat 10 mg/m^2', 'Drug: Azacitidine 75 mg/m^2']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2, Cohort 2: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2', 'description': 'Pevonedistat 20 mg/m\\^2, 60-minute infusion, intravenously, on Days 1, 3, and 5 and azacitidine 75 mg/m\\^2, on Days 1 to 5, and Days 8 and 9, intravenously or subcutaneously, followed by a rest period of 19 days, in 28-day treatment cycles.', 'interventionNames': ['Drug: Pevonedistat 20 mg/m^2', 'Drug: Azacitidine 75 mg/m^2']}], 'interventions': [{'name': 'Pevonedistat 25 mg/m^2', 'type': 'DRUG', 'description': 'Pevonedistat 25 mg/m\\^2 intravenous infusion.', 'armGroupLabels': ['Arm 1, Cohort 1: Pevonedistat 25 mg/m^2']}, {'name': 'Pevonedistat 44 mg/m^2', 'type': 'DRUG', 'description': 'Pevonedistat 44 mg/m\\^2 intravenous infusion.', 'armGroupLabels': ['Arm 1, Cohort 2: Pevonedistat 44 mg/m^2']}, {'name': 'Pevonedistat 10 mg/m^2', 'type': 'DRUG', 'description': 'Pevonedistat 10 mg/m\\^2 intravenous infusion.', 'armGroupLabels': ['Arm 2, Cohort 1: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2']}, {'name': 'Pevonedistat 20 mg/m^2', 'type': 'DRUG', 'description': 'Pevonedistat 20 mg/m\\^2 intravenous infusion.', 'armGroupLabels': ['Arm 2, Cohort 2: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2']}, {'name': 'Azacitidine 75 mg/m^2', 'type': 'DRUG', 'description': 'Azacitidine 75 mg/m\\^2 intravenous or subcutaneous formulation.', 'armGroupLabels': ['Arm 2, Cohort 1: Pevonedistat 10 mg/m^2+ Azacitidine 75 mg/m^2', 'Arm 2, Cohort 2: Pevonedistat 20 mg/m^2+ Azacitidine 75 mg/m^2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maebashi', 'country': 'Japan', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Nagoya', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Sendai', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '519-763', 'city': 'Jeonnam', 'country': 'South Korea', 'facility': 'Chonnam National University Hwasun Hospital'}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University Health System - PPDS', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Seoul St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '10048', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/takeda/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': "Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.", 'accessCriteria': 'IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}