Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT02775903
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2016-05-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)
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': 'D001374', 'term': 'Azacitidine'}, {'id': 'C000613593', 'term': 'durvalumab'}], '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': 'Clinical.Trials@bms.com', 'phone': 'Please email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "Protocol Amendment 03 was introduced on 05 Mar 2019. At the Investigator's discretion, participants meeting all the continuation criteria were eligible to enter the optional extension phase to continue to benefit from treatment with subcutaneous azacitidine and/or durvalumab. Participants started the extension phase at the time of their next regularly scheduled dosing cycle for study drug azacitidine or azacitidine and durvalumab."}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality was assessed from the participants first dose to their study completion (up to approximately 66 months) SAEs and Other AEs were assessed from first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine (up to approximately 66 months)', 'eventGroups': [{'id': 'EG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 38, 'seriousNumAtRisk': 38, 'deathsNumAffected': 22, 'seriousNumAffected': 34}, {'id': 'EG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 40, 'seriousNumAtRisk': 41, 'deathsNumAffected': 27, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 63, 'seriousNumAtRisk': 64, 'deathsNumAffected': 48, 'seriousNumAffected': 56}, {'id': 'EG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 60, 'seriousNumAtRisk': 62, 'deathsNumAffected': 42, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Mouth haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Injection site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 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'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Panniculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Toxic skin eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MDS Cohort: Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '47.22', 'upperLimit': '76.59'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '32.51', 'upperLimit': '62.72'}]}]}], 'analyses': [{'pValue': '0.1838', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wald asymptotic two-sided test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 239 days (AZA) and 215 days (DUR) in the AZA + DUR group and 210 days in the AZA alone group.', 'description': 'Overall response rate (ORR) is defined as the percentage of participants achieving a complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI) based on International Working Group (IWG) 2006 response criteria for MDS and central review. CR: ≤ 5% myeloblasts in bone marrow (BM), and peripheral blood: hemoglobin ≥ 11 g/dL; platelets ≥ 100 × 10⁹/L; neutrophils ≥ 1.0 × 10⁹/L; blasts 0% PR: BM blasts decreased by ≥ 50% but still \\> 5%; peripheral blood as for CR mCR: BM ≤ 5% myeloblasts and decrease by ≥ 50% HI: Any of the following: •Hemoglobin increase by ≥ 1.5 g/dL or reduction of units of red blood cell (RBC) transfusions of at least 4 RBC transfusions/8 weeks compared with pretreatment •Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value \\> 20 × 10⁹/L or increase from \\< 20 × 10⁹/L to \\> 20 × 10⁹/L and by at least 100% •At least 100% increase in neutrophils and an absolute increase of \\> 0.5 × 10⁹/L', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the MDS cohort; participants who discontinued before 6 cycles of treatment without achieving overall response were counted as non-responders.'}, {'type': 'PRIMARY', 'title': 'AML Cohort: Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000', 'lowerLimit': '19.89', 'upperLimit': '42.61'}, {'value': '35.4', 'groupId': 'OG001', 'lowerLimit': '23.76', 'upperLimit': '47.01'}]}]}], 'analyses': [{'pValue': '0.6180', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wald asymptotic two-sided test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 198 days (AZA) and 171 days (DUR) in the AZA + DUR group and 203 days in the AZA alone group.', 'description': 'Overall response rate for AML is defined as the percentage of participants achieving an overall response of morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) based on modified IWG 2003 response criteria for AML and central review. CR: The following conditions must be met: •Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L •Platelet count ≥ 100 x10⁹/L •The bone marrow should contain less than 5% blast cells; •Auer rods should not be detectable; •No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. CRi: Defined as a morphologic complete remission but the ANC count may be \\< 1.0 x10⁹/L and/or the platelet count may be \\< 100 x10⁹/L.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in the AML cohort; participants who discontinued before 6 cycles of treatment without achieving overall response were counted as non-responders.'}, {'type': 'SECONDARY', 'title': 'MDS Cohort: Kaplan Meier Estimate of Time to First Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '20.9'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '26.1'}]}]}], 'analyses': [{'pValue': '0.7016', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor)', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the earliest date any response (up to approximately 34 months)', 'description': 'Time to first response is defined as the time from randomization to the earliest date any response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) based on International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized in the MDS cohort'}, {'type': 'SECONDARY', 'title': 'MDS Cohort: Kaplan Meier Estimate of Relapse-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6076', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months)', 'description': 'Relapse-free survival is defined as the time from the date of first documented response (complete remission (CR), partial remission (PR)) to the date of disease relapse or death from any cause, whichever occurred first according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy. Relapse after CR or PR is defined as at least one of the following: •Return to pretreatment bone marrow blast % •Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets •Reduction in hemoglobin concentration by ≥ 1.5 g/dL or transfusion dependence. Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized in the MDS cohort who had a CR or PR'}, {'type': 'SECONDARY', 'title': 'MDS Cohort: Percentage of Participants Who Achieved a Cytogenetic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'groupId': 'OG000', 'lowerLimit': '26.26', 'upperLimit': '68.98'}, {'value': '34.8', 'groupId': 'OG001', 'lowerLimit': '15.32', 'upperLimit': '54.25'}]}]}], 'analyses': [{'pValue': '0.3840', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wald asymptotic two-sided test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to approximately 34 months', 'description': 'Cytogenetic response is defined as the percentage of participants who achieved a complete cytogenetic response or partial cytogenetic response according to the International Working Group (IWG) 2006 response criteria and central review. Complete cytogenetic response: Disappearance of the baseline chromosomal abnormality without appearance of new abnormalities. Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized in the MDS cohort evaluable for cytogenetic response (ie, participants with baseline cytogenetic abnormalities).'}, {'type': 'SECONDARY', 'title': 'MDS Cohort: Kaplan-Meier Estimate of Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '10.2'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '11.2'}]}]}], 'analyses': [{'pValue': '0.8961', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the first documented progressive disease (PD), relapse, or death due to any cause (up to approximately 34 months)', 'description': 'Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD), relapse, or death due to any cause during or after the treatment period, whichever occurred first, according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Progressive disease is defined as follows: - an increase in BM blasts relative to nadir: •If nadir less than 5% blasts: ≥ 50% increase in blasts to \\> 5% blasts •If nadir 5% - 10% blasts: ≥ 50% increase in blasts to \\> 10% blasts •If nadir 10% - 20% blasts: ≥ 50% increase in blasts to \\> 20% blasts •If nadir 20% - 30% blasts: ≥ 50% increase in blasts to \\> 30% blasts And any of the following: •At least 50% decrement from maximum remission/response levels in granulocytes or platelets •Reduction in Hgb concentration by ≥ 2 g/dL •Transfusion dependence', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized in the MDS cohort (PFS was a pre-specified secondary outcome measure in the MDS cohort only).'}, {'type': 'SECONDARY', 'title': 'MDS Cohort: Kaplan-Meier Estimate of Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '47.4'}, {'value': '39.7', 'groupId': 'OG001', 'lowerLimit': '26.3', 'upperLimit': '73.1'}]}]}], 'analyses': [{'pValue': '0.3591', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the first overall response, or death (up to approximately 34 months)', 'description': 'Duration of response is defined as the time from when the first overall response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) was observed until relapse, progressive disease (PD), or death, as defined by the International Working Group (IWG) 2006 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized in the MDS cohort with an overall response (CR, mCR, PR, or HI)'}, {'type': 'SECONDARY', 'title': 'MDS Cohort: Kaplan-Meier Estimate of Time to AML Transformation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': 'NA'}, {'value': '27.7', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.9031', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date the participant had documented transformation to AML (up to approximately 34 months)', 'description': 'Participants were monitored for transformation to acute myeloid leukemia (AML) until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Time to transformation to AML is defined as the time from the date of randomization until the date the participant had documented transformation to AML (defined as at least 30% of myeloblasts in the bone marrow). Participants with no transformation to AML were censored at the date of their last disease assessment.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized in the MDS cohort.'}, {'type': 'SECONDARY', 'title': 'MDS Cohort: Percentage of Participants With Disease Transformation to AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial (up to approximately 34 months)', 'description': 'Disease transformation to acute myeloid leukemia (AML) is defined as at least 30% myeloblasts in the bone marrow. Participants were monitored for transformation to AML until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Participants with no transformation to AML were censored at the date of their last disease assessment.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized in the MDS cohort'}, {'type': 'SECONDARY', 'title': 'AML Cohort: Kaplan Meier Estimate of Time to First Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': 'NA'}, {'value': '25.3', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '43.0'}]}]}], 'analyses': [{'pValue': '0.2409', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (very intermediate vs poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization and the earliest date any response (up to approximately 34 months)', 'description': 'Time to first response is defined as the time between the date of randomization and the earliest date any response (CR or CRi) was observed based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized in the AML cohort'}, {'type': 'SECONDARY', 'title': 'AML Cohort: Kaplan Meier Estimate of Relapse-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '15.0'}, {'value': '12.2', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '19.3'}]}]}], 'analyses': [{'pValue': '0.0688', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months)', 'description': 'Relapse-free survival is defined as time from the date of first documented response (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) to the date of disease relapse or death from any cause, whichever occurred first based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized in the AML cohort with a response (CR or CRi)'}, {'type': 'SECONDARY', 'title': 'AML Cohort: Percentage of Participants Who Achieved a Complete Cytogenetic Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '19.85'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '5.84', 'upperLimit': '26.16'}]}]}], 'analyses': [{'pValue': '0.4894', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wald asymptotic two-sided test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to approximately 34 months)', 'description': 'Complete cytogenetic response (CyCR) based on the modified International Working Group (IWG) 2003 response criteria is defined as morphologic complete remission with a reversion to a normal karyotype. The following conditions must be met: • Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L • Platelet count ≥ 100 x10⁹/L • The bone marrow should contain less than 5% blast cells; • Auer rods should not be detectable; • No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. AND • Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases). Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized in the AML cohort evaluable for cytogenetic response (ie participants with baseline cytogenetic abnormalities).'}, {'type': 'SECONDARY', 'title': 'AML Cohort: Percentage of Participants With Hematologic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '30.09', 'upperLimit': '54.29'}, {'value': '38.5', 'groupId': 'OG001', 'lowerLimit': '26.63', 'upperLimit': '50.29'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization up to approximately 34 months', 'description': 'Hematological improvement was defined as participants with a erythroid response (HI-E), platelet response (HI-P) or neutrophil response (HI-NE) for at least 8 weeks, according to the IWG 2006 response criteria: Hi-E (in participants with pretreatment hemoglobin \\< 11 g/dL or red blood cell (RBC)-transfusion dependent): Hemoglobin increase of ≥ 1.5 g/dL, or reduction in units of RBC transfusions of at least 4 RBC transfusions/8 weeks compared with the 8 weeks prior to pretreatment. HI-P (in participants with pretreatment platelet count \\< 100 × 10⁹/L): Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value \\> 20 × 10⁹/L or increase from \\< 20 × 10⁹/L to \\> 20 × 10⁹/L and by at least 100%. HI-N (in participants with pretreatment neutrophils \\< 1.0 × 10⁹/L): At least 100% increase in neutrophils and an absolute increase of \\> 0.5 × 10⁹/L. Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants randomized in the AML cohort (the percentage of participants with hematologic improvement was a pre-specified secondary endpoint for the AML cohort only).'}, {'type': 'SECONDARY', 'title': 'AML Cohort: Kaplan-Meier Estimate of Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '48.0'}, {'value': '52.0', 'groupId': 'OG001', 'lowerLimit': '15.1', 'upperLimit': '84.0'}]}]}], 'analyses': [{'pValue': '0.0381', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until relapse, PD, or death (up to approximately 34 months)', 'description': 'Duration of response is defined as the time from the first response morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) was observed until relapse, PD, or death based on the IWG 2003 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized in the AML cohort with an objective response (CR or CRi)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'title': 'Any treatment-emergent adverse event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}]}, {'title': 'TEAE related to DUR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'TEAE related to AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'TEAE related to DUR or AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 TEAE related to DUR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 TEAE related to AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 TEAE related to DUR or AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4 TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4 TEAE related to DUR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4 TEAE related to AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Grade 4 TEAE related to DUR or AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 TEAE related to DUR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5 TEAE related to AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Grade 5 TEAE related to DUR or AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAE related to DUR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Serious TEAE related to AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Serious TEAE related to DUR or AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'TEAE leading to discontinuation of DUR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to discontinuation of AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TEAE leading to discontinuation of DUR or AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TEAE leading to dose reduction of AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'TEAE leading to dose interruption of DUR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'TEAE leading to dose interruption of AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'TEAE leading to dose interruption of DUR or AZA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'TEAE leading to ongoing DUR infusion interruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine proir to the extension study (up to approximately 34 months)', 'description': 'Treatment emergent adverse events are adverse events (AEs) that occurred or worsened on or after the first dose of study drug (durvalumab or azacitidine) and within 90 days after last dose of durvalumab or 28 days after last dose of azacitidine. A treatment-related TEAE is a TEAE where the causal relationship was assessed by the investigator as "Suspected". The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death due to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of any study drug.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'comment': 'Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': 'NA'}, {'value': '16.3', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '22.6'}, {'value': '13.0', 'groupId': 'OG002', 'lowerLimit': '10.3', 'upperLimit': '17.3'}, {'value': '14.4', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '16.6'}]}]}], 'analyses': [{'pValue': '0.8973', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (very good, good and intermediate vs poor and very poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}, {'pValue': '0.0691', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Log-rank test stratified according to the cytogenetic risk at time of randomization (intermediate vs poor).', 'nonInferiorityComment': 'P-values were not part of the formal testing.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization to date of death or last known alive date (up to approximately 34 months)', 'description': 'Overall survival is defined as the time between randomization and death/censored date. Participants who were alive at the time of the clinical data cut-off were censored at the last known alive date.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'One-year Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months after randomization', 'description': 'One-year survival is defined as the probability of survival at 1 year from randomization and is represented by the Kaplan-Meier estimate of the percentage of participants alive after 1 year.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants'}, {'type': 'SECONDARY', 'title': 'Durvalumab Serum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'title': 'Cycle 1 Day 1 end of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '375548.511', 'spread': '140777.0558', 'groupId': 'OG000'}, {'value': '378598.369', 'spread': '201902.4363', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1 pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84380.032', 'spread': '92174.3455', 'groupId': 'OG000'}, {'value': '54216.956', 'spread': '28336.3692', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132266.794', 'spread': '126971.6223', 'groupId': 'OG000'}, {'value': '78622.429', 'spread': '41708.9956', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1 end of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '433942.600', 'spread': '233241.0329', 'groupId': 'OG000'}, {'value': '391523.395', 'spread': '147928.1261', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1 pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114448.977', 'spread': '64608.9007', 'groupId': 'OG000'}, {'value': '142517.871', 'spread': '248212.8037', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1 end of infusion (EOI), Cycle 2 Day 1 pre-infusion, Cycle 4 Day 1 pre-infusion and EOI, and Cycle 6 Day 1 pre-infusion', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of durvalumab and who had at least 1 measurable durvalumab concentration value and with available data at each time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Hematology Parameters I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'title': 'Leukocytes (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.330', 'spread': '2.8158', 'groupId': 'OG000'}, {'value': '-0.497', 'spread': '1.1452', 'groupId': 'OG001'}, {'value': '-2.050', 'spread': '9.0236', 'groupId': 'OG002'}, {'value': '-0.941', 'spread': '2.7708', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.242', 'spread': '0.5314', 'groupId': 'OG000'}, {'value': '-0.085', 'spread': '0.3904', 'groupId': 'OG001'}, {'value': '-0.394', 'spread': '1.6995', 'groupId': 'OG002'}, {'value': '-0.262', 'spread': '0.9024', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils, Segmented (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.665', 'spread': '1.6364', 'groupId': 'OG000'}, {'value': '-0.266', 'spread': '0.7576', 'groupId': 'OG001'}, {'value': '0.646', 'spread': '0.7870', 'groupId': 'OG002'}, {'value': '-0.102', 'spread': '0.7346', 'groupId': 'OG003'}]}]}, {'title': 'Platelets (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.7', 'spread': '112.92', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '82.05', 'groupId': 'OG001'}, {'value': '25.9', 'spread': '92.86', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '167.88', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with both non-missing baseline and postbaseline values'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Hematology Parameters II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '15.66', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '18.94', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '13.67', 'groupId': 'OG002'}, {'value': '-3.0', 'spread': '13.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with both non-missing baseline and postbaseline values'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Chemistry Parameters I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '2.93', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '5.00', 'groupId': 'OG002'}, {'value': '-3.8', 'spread': '4.78', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with both non-missing baseline and postbaseline values'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Chemistry Parameters II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'title': 'Alkaline Phosphatase (U/L)', 'categories': [{'measurements': [{'value': '8.7', 'spread': '15.71', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '13.90', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '55.70', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '68.53', 'groupId': 'OG003'}]}]}, {'title': 'Alanine Aminotransferase (U/L)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '16.96', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '9.40', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '21.05', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '19.41', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase (U/L)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '10.52', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '5.73', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '16.83', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '14.22', 'groupId': 'OG003'}]}]}, {'title': 'Lipase (U/L)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '18.23', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '25.80', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '10.28', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '42.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with both non-missing baseline and postbaseline values'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Chemistry Parameters III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'title': 'Calcium (mmol/L)', 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.1013', 'groupId': 'OG000'}, {'value': '0.016', 'spread': '0.1008', 'groupId': 'OG001'}, {'value': '-0.003', 'spread': '0.1523', 'groupId': 'OG002'}, {'value': '-0.039', 'spread': '0.1189', 'groupId': 'OG003'}]}]}, {'title': 'Glucose (mmol/L)', 'categories': [{'measurements': [{'value': '-0.40', 'spread': '2.210', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '1.265', 'groupId': 'OG001'}, {'value': '-0.38', 'spread': '2.513', 'groupId': 'OG002'}, {'value': '-0.02', 'spread': '2.365', 'groupId': 'OG003'}]}]}, {'title': 'Potassium (mmol/L)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.416', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.451', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.411', 'groupId': 'OG002'}, {'value': '0.04', 'spread': '0.622', 'groupId': 'OG003'}]}]}, {'title': 'Sodium (mmol/L)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.26', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '4.49', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '3.73', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with both non-missing baseline and postbaseline values'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Selected Chemistry Parameters IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'OG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'classes': [{'title': 'Bilirubin (umol/L)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '5.13', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '4.21', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '6.23', 'groupId': 'OG002'}, {'value': '-0.0', 'spread': '5.31', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine (umol/L)', 'categories': [{'measurements': [{'value': '-4.0', 'spread': '14.77', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '10.19', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '16.39', 'groupId': 'OG002'}, {'value': '-0.6', 'spread': '15.93', 'groupId': 'OG003'}]}]}, {'title': 'Urate (umol/L)', 'categories': [{'measurements': [{'value': '6.8', 'spread': '65.85', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '67.06', 'groupId': 'OG001'}, {'value': '-15.1', 'spread': '75.69', 'groupId': 'OG002'}, {'value': '-29.1', 'spread': '80.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with both non-missing baseline and postbaseline values'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'FG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'FG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'FG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '64'}, {'groupId': 'FG003', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '60'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'This study consisted of 2 cohorts: • Adults with previously untreated intermediate, high or very high risk myelodysplastic syndromes (MDS) not eligible for hematopoietic stem cell transplantation (HSCT). • Adults with previously untreated acute myeloid leukemia (AML) ≥ 65 years and not eligible for HSCT with intermediate or poor cytogenetic risk.', 'preAssignmentDetails': 'Within each cohort participants were randomized in a 1:1 ratio to receive either azacitidine plus durvalumab or azacitidine alone. Randomization was stratified according to cytogenetic risk: • Very good, good and intermediate versus poor and very poor for MDS • Intermediate versus poor for AML .'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '213', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MDS: Azacitidine + Durvalumab', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'BG001', 'title': 'MDS: Azacitidine Alone', 'description': 'Participants with MDS received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'BG002', 'title': 'AML: Azacitidine + Durvalumab', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'BG003', 'title': 'AML: Azacitidine Alone', 'description': 'Participants with AML received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'MDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '72.5', 'spread': '6.53', 'groupId': 'BG000'}, {'value': '73.2', 'spread': '8.83', 'groupId': 'BG001'}, {'value': '72.8', 'spread': '7.72', 'groupId': 'BG004'}]}]}, {'title': 'AML', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '76.2', 'spread': '5.97', 'groupId': 'BG002'}, {'value': '75.3', 'spread': '5.36', 'groupId': 'BG003'}, {'value': '75.8', 'spread': '5.67', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data were collected and reported separately for each cohort.'}, {'title': 'Age, Customized', 'classes': [{'title': 'MDS Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'categories': [{'title': '< 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': '≥ 65 to < 75 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': '≥ 75 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG004'}]}]}, {'title': 'AML Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'categories': [{'title': '< 65 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '≥ 65 to < 75 years', 'measurements': [{'value': '24', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': '≥ 75 years', 'measurements': [{'value': '40', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '77', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were collected and reported separately for each cohort.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'MDS Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG004'}]}]}, {'title': 'AML Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were collected and reported separately for each cohort.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'MDS Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'AML Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were collected and reported separately for each cohort.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'MDS Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'Not Collected or Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'AML Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}]}, {'title': 'Not Collected or Reported', 'measurements': [{'value': '18', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were collected and reported separately for each cohort.'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'title': 'MDS Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'categories': [{'title': '0 - Fully active', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG004'}]}, {'title': '1 - Restricted but ambulatory', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': '2 - Ambulatory but unable to work', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': '3 - Limited self-care', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '4 - Completely Disabled', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'AML Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'categories': [{'title': '0 - Fully active', 'measurements': [{'value': '19', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}, {'title': '1 - Restricted but ambulatory', 'measurements': [{'value': '40', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'title': '2 - Ambulatory but unable to work', 'measurements': [{'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': '3 - Limited self-care', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '4 - Completely Disabled', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: - 0 = Fully active, no restrictions; - 1 = Restricted activity but ambulatory, able to carry out work of a light nature; - 2 = Ambulatory and capable of all self-care but unable to carry out work activities; - 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; - 4 = Completely disabled, no selfcare, confined to bed or chair; - 5 = Dead", 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were collected and reported separately for each cohort.'}, {'title': 'Revised International Prognostic Scoring System (IPSS-R) Cytogenetic Risk Groups (MDS Cohort)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Very good', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Good', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG004'}]}, {'title': 'Intermediate', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Poor', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG004'}]}, {'title': 'Very Poor', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The IPSS-R cytogenetic risk score is based on cytogenetic (chromosomal) abnormalities observed in the bone marrow cells. A good cytogenetic prognosis predicts longer survival and lower transformation to leukemia.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants in the MDS cohort only'}, {'title': 'Cytogenetic Risk Classifications (AML Cohort)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Better risk', 'measurements': [{'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Intermediate risk', 'measurements': [{'value': '25', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}]}, {'title': 'Poor risk', 'measurements': [{'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}, {'title': 'Missing', 'measurements': [{'value': '23', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cytogenetic risk classification according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Myeloid Leukemia. Risk categories are based on analysis of cytogenetics (the study of chromosomes), including chromosomal deletions, duplications, or substitutions and analysis of molecular abnormalities such as specific mutations. Better risk indicates disease more likely to respond to initial treatment and less likely to relapse whereas poor-risk is characterized by poor response to induction chemotherapy and higher relapse rates.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants in the AML cohort only'}], 'populationDescription': 'All randomized participants (intent-to-treat population)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-05', 'size': 8103632, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-17T15:51', 'hasProtocol': True}, {'date': '2017-10-23', 'size': 2510951, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-17T15:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-01', 'studyFirstSubmitDate': '2016-05-16', 'resultsFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2016-05-16', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-22', 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MDS Cohort: Overall Response Rate', 'timeFrame': 'Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 239 days (AZA) and 215 days (DUR) in the AZA + DUR group and 210 days in the AZA alone group.', 'description': 'Overall response rate (ORR) is defined as the percentage of participants achieving a complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI) based on International Working Group (IWG) 2006 response criteria for MDS and central review. CR: ≤ 5% myeloblasts in bone marrow (BM), and peripheral blood: hemoglobin ≥ 11 g/dL; platelets ≥ 100 × 10⁹/L; neutrophils ≥ 1.0 × 10⁹/L; blasts 0% PR: BM blasts decreased by ≥ 50% but still \\> 5%; peripheral blood as for CR mCR: BM ≤ 5% myeloblasts and decrease by ≥ 50% HI: Any of the following: •Hemoglobin increase by ≥ 1.5 g/dL or reduction of units of red blood cell (RBC) transfusions of at least 4 RBC transfusions/8 weeks compared with pretreatment •Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value \\> 20 × 10⁹/L or increase from \\< 20 × 10⁹/L to \\> 20 × 10⁹/L and by at least 100% •At least 100% increase in neutrophils and an absolute increase of \\> 0.5 × 10⁹/L'}, {'measure': 'AML Cohort: Overall Response Rate', 'timeFrame': 'Response was assessed following every 3 treatment cycles until treatment discontinuation; median duration of treatment was 198 days (AZA) and 171 days (DUR) in the AZA + DUR group and 203 days in the AZA alone group.', 'description': 'Overall response rate for AML is defined as the percentage of participants achieving an overall response of morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) based on modified IWG 2003 response criteria for AML and central review. CR: The following conditions must be met: •Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L •Platelet count ≥ 100 x10⁹/L •The bone marrow should contain less than 5% blast cells; •Auer rods should not be detectable; •No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. CRi: Defined as a morphologic complete remission but the ANC count may be \\< 1.0 x10⁹/L and/or the platelet count may be \\< 100 x10⁹/L.'}], 'secondaryOutcomes': [{'measure': 'MDS Cohort: Kaplan Meier Estimate of Time to First Response', 'timeFrame': 'From randomization to the earliest date any response (up to approximately 34 months)', 'description': 'Time to first response is defined as the time from randomization to the earliest date any response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) based on International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'MDS Cohort: Kaplan Meier Estimate of Relapse-free Survival', 'timeFrame': 'From randomization to to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months)', 'description': 'Relapse-free survival is defined as the time from the date of first documented response (complete remission (CR), partial remission (PR)) to the date of disease relapse or death from any cause, whichever occurred first according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy. Relapse after CR or PR is defined as at least one of the following: •Return to pretreatment bone marrow blast % •Decrement of ≥ 50% from maximum remission/response levels in granulocytes or platelets •Reduction in hemoglobin concentration by ≥ 1.5 g/dL or transfusion dependence. Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'MDS Cohort: Percentage of Participants Who Achieved a Cytogenetic Response', 'timeFrame': 'From randomization up to approximately 34 months', 'description': 'Cytogenetic response is defined as the percentage of participants who achieved a complete cytogenetic response or partial cytogenetic response according to the International Working Group (IWG) 2006 response criteria and central review. Complete cytogenetic response: Disappearance of the baseline chromosomal abnormality without appearance of new abnormalities. Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'MDS Cohort: Kaplan-Meier Estimate of Progression-free Survival (PFS)', 'timeFrame': 'From randomization to the first documented progressive disease (PD), relapse, or death due to any cause (up to approximately 34 months)', 'description': 'Progression-free survival is defined as the time from randomization to the first documented progressive disease (PD), relapse, or death due to any cause during or after the treatment period, whichever occurred first, according to the International Working Group (IWG) 2006 response criteria for MDS and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Progressive disease is defined as follows: - an increase in BM blasts relative to nadir: •If nadir less than 5% blasts: ≥ 50% increase in blasts to \\> 5% blasts •If nadir 5% - 10% blasts: ≥ 50% increase in blasts to \\> 10% blasts •If nadir 10% - 20% blasts: ≥ 50% increase in blasts to \\> 20% blasts •If nadir 20% - 30% blasts: ≥ 50% increase in blasts to \\> 30% blasts And any of the following: •At least 50% decrement from maximum remission/response levels in granulocytes or platelets •Reduction in Hgb concentration by ≥ 2 g/dL •Transfusion dependence'}, {'measure': 'MDS Cohort: Kaplan-Meier Estimate of Duration of Response', 'timeFrame': 'From randomization to the first overall response, or death (up to approximately 34 months)', 'description': 'Duration of response is defined as the time from when the first overall response (complete remission (CR), partial remission (PR), marrow complete remission (mCR), and/or hematological improvement (HI)) was observed until relapse, progressive disease (PD), or death, as defined by the International Working Group (IWG) 2006 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'MDS Cohort: Kaplan-Meier Estimate of Time to AML Transformation', 'timeFrame': 'From randomization to the date the participant had documented transformation to AML (up to approximately 34 months)', 'description': 'Participants were monitored for transformation to acute myeloid leukemia (AML) until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Time to transformation to AML is defined as the time from the date of randomization until the date the participant had documented transformation to AML (defined as at least 30% of myeloblasts in the bone marrow). Participants with no transformation to AML were censored at the date of their last disease assessment.'}, {'measure': 'MDS Cohort: Percentage of Participants With Disease Transformation to AML', 'timeFrame': 'From randomization until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial (up to approximately 34 months)', 'description': 'Disease transformation to acute myeloid leukemia (AML) is defined as at least 30% myeloblasts in the bone marrow. Participants were monitored for transformation to AML until death, lost to follow-up, withdrawal of consent for further data collection, or the end of the trial. Participants with no transformation to AML were censored at the date of their last disease assessment.'}, {'measure': 'AML Cohort: Kaplan Meier Estimate of Time to First Response', 'timeFrame': 'From randomization and the earliest date any response (up to approximately 34 months)', 'description': 'Time to first response is defined as the time between the date of randomization and the earliest date any response (CR or CRi) was observed based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who did not achieve any defined response were censored at the date of last adequate response assessment, disease progression, or death, whichever occurred first. Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'AML Cohort: Kaplan Meier Estimate of Relapse-free Survival', 'timeFrame': 'From randomization to the date of disease relapse or death from any cause, whichever occurred first (up to approximately 34 months)', 'description': 'Relapse-free survival is defined as time from the date of first documented response (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) to the date of disease relapse or death from any cause, whichever occurred first based on the modified International Working Group (IWG) 2003 response criteria for AML and central review. Participants who were still alive and progression-free were censored at the date of their last response assessment. Participants who received a subsequent therapy before the date of disease relapse or death were censored at the time of subsequent therapy.'}, {'measure': 'AML Cohort: Percentage of Participants Who Achieved a Complete Cytogenetic Response', 'timeFrame': 'From randomization up to approximately 34 months)', 'description': 'Complete cytogenetic response (CyCR) based on the modified International Working Group (IWG) 2003 response criteria is defined as morphologic complete remission with a reversion to a normal karyotype. The following conditions must be met: • Absolute neutrophil count (ANC) ≥ 1.0 x10⁹/L • Platelet count ≥ 100 x10⁹/L • The bone marrow should contain less than 5% blast cells; • Auer rods should not be detectable; • No platelet, or whole blood transfusions for 7days prior to the date of the hematology assessment. AND • Reversion to normal karyotype at time of CR (based on ≥ 10 metaphases). Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'AML Cohort: Percentage of Participants With Hematologic Improvement', 'timeFrame': 'From randomization up to approximately 34 months', 'description': 'Hematological improvement was defined as participants with a erythroid response (HI-E), platelet response (HI-P) or neutrophil response (HI-NE) for at least 8 weeks, according to the IWG 2006 response criteria: Hi-E (in participants with pretreatment hemoglobin \\< 11 g/dL or red blood cell (RBC)-transfusion dependent): Hemoglobin increase of ≥ 1.5 g/dL, or reduction in units of RBC transfusions of at least 4 RBC transfusions/8 weeks compared with the 8 weeks prior to pretreatment. HI-P (in participants with pretreatment platelet count \\< 100 × 10⁹/L): Absolute increase in platelets of ≥ 30 × 10⁹/L if pretreatment value \\> 20 × 10⁹/L or increase from \\< 20 × 10⁹/L to \\> 20 × 10⁹/L and by at least 100%. HI-N (in participants with pretreatment neutrophils \\< 1.0 × 10⁹/L): At least 100% increase in neutrophils and an absolute increase of \\> 0.5 × 10⁹/L. Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'AML Cohort: Kaplan-Meier Estimate of Duration of Response', 'timeFrame': 'From randomization until relapse, PD, or death (up to approximately 34 months)', 'description': 'Duration of response is defined as the time from the first response morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi)) was observed until relapse, PD, or death based on the IWG 2003 response criteria and central review. If no relapse, PD, or death was observed, the duration of response was censored at the last response assessment date that the participant was known to be progression-free. Response was assessed following every 3 treatment cycles until treatment discontinuation.'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose to 90 days after last dose of durvalumab or 28 days after last dose of azacitidine proir to the extension study (up to approximately 34 months)', 'description': 'Treatment emergent adverse events are adverse events (AEs) that occurred or worsened on or after the first dose of study drug (durvalumab or azacitidine) and within 90 days after last dose of durvalumab or 28 days after last dose of azacitidine. A treatment-related TEAE is a TEAE where the causal relationship was assessed by the investigator as "Suspected". The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03: Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death due to AE.'}, {'measure': 'Kaplan-Meier Estimate of Overall Survival', 'timeFrame': 'From randomization to date of death or last known alive date (up to approximately 34 months)', 'description': 'Overall survival is defined as the time between randomization and death/censored date. Participants who were alive at the time of the clinical data cut-off were censored at the last known alive date.'}, {'measure': 'One-year Survival', 'timeFrame': 'At 12 months after randomization', 'description': 'One-year survival is defined as the probability of survival at 1 year from randomization and is represented by the Kaplan-Meier estimate of the percentage of participants alive after 1 year.'}, {'measure': 'Durvalumab Serum Concentration', 'timeFrame': 'Cycle 1 Day 1 end of infusion (EOI), Cycle 2 Day 1 pre-infusion, Cycle 4 Day 1 pre-infusion and EOI, and Cycle 6 Day 1 pre-infusion'}, {'measure': 'Change From Baseline in Selected Hematology Parameters I', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.'}, {'measure': 'Change From Baseline in Selected Hematology Parameters II', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.'}, {'measure': 'Change From Baseline in Selected Chemistry Parameters I', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.'}, {'measure': 'Change From Baseline in Selected Chemistry Parameters II', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.'}, {'measure': 'Change From Baseline in Selected Chemistry Parameters III', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.'}, {'measure': 'Change From Baseline in Selected Chemistry Parameters IV', 'timeFrame': 'Baseline and last lab measurement collected in Cycle 2 (Last measurement could be taken either on Day 1, 8, 15 or 22)', 'description': 'Baseline values are defined as the last assessment of a particular parameter prior to administration of the participants first dose.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MEDI4736', 'Durvalumab', 'Myelodysplastic Syndromes', 'Acute Myeloid Leukemia', 'Hematopoietic Stem Cell Transplantation', 'Azacitidine', 'Safety', 'Efficacy', 'PD-L1'], 'conditions': ['Leukemia, Myeloid, Acute', 'Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'pmid': '40546817', 'type': 'DERIVED', 'citation': 'Bewersdorf JP, Hasle V, Shallis RM, Thompson E, Lopes de Menezes D, Rose S, Boss I, Mendez L, Podoltsev N, Stahl M, Kewan T, Halene S, Haferlach T, Fox BA, Zeidan AM. Integrated Immune Landscape Analysis of RNA Splicing Factor-Mutant AML and Higher risk MDS Treated with Azacitidine +/- Durvalumab. Ther Adv Hematol. 2025 Jun 21;16:20406207251347344. doi: 10.1177/20406207251347344. eCollection 2025.'}, {'pmid': '38883163', 'type': 'DERIVED', 'citation': 'Zeidan AM, Bewersdorf JP, Hasle V, Shallis RM, Thompson E, de Menezes DL, Rose S, Boss I, Halene S, Haferlach T, Fox BA. Integrated genetic, epigenetic, and immune landscape of TP53 mutant AML and higher risk MDS treated with azacitidine. Ther Adv Hematol. 2024 Jun 15;15:20406207241257904. doi: 10.1177/20406207241257904. eCollection 2024.'}, {'pmid': '34972214', 'type': 'DERIVED', 'citation': "Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Ogasawara K, Cavenagh J, Silverman LR, Voso MT, Hellmann A, Tormo M, O'Connor T, Previtali A, Rose S, Garcia-Manero G. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes. Blood Adv. 2022 Apr 12;6(7):2207-2218. doi: 10.1182/bloodadvances.2021005487."}, {'pmid': '34933333', 'type': 'DERIVED', 'citation': "Zeidan AM, Boss I, Beach CL, Copeland WB, Thompson E, Fox BA, Hasle VE, Hellmann A, Taussig DC, Tormo M, Voso MT, Cavenagh J, O'Connor T, Previtali A, Rose S, Silverman LR. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for older patients with AML. Blood Adv. 2022 Apr 12;6(7):2219-2229. doi: 10.1182/bloodadvances.2021006138."}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in adults with previously untreated, higher risk MDS who are not eligible for HSCT or in adults ≥ 65 years old with previously untreated AML who are not eligible for HSCT, with intermediate or poor cytogenetic risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor both cohorts:\n\n1. Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.\n2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n3. Female subjects of childbearing potential may participate, providing they meet the following conditions:\n\n 1. Have 2 negative pregnancy tests as verified by the Investigator prior to starting any investigational product (IP) therapy: serum pregnancy test at screening and negative serum or urine pregnancy test (Investigator's discretion) within 72 hours prior to starting treatment with IP (Cycle 1, Day 1). They must agree to ongoing pregnancy testing during the course of the study (before beginning each subsequent cycle of treatment), and after the last dose of any IP. This applies even if the subject practices complete abstinence from heterosexual contact.\n 2. Agree to practice true abstinence (which must be reviewed on a monthly basis and source documented) or agree to the use of a highly effective method of contraception use from 28 days prior to starting durvalumab or azacitidine, and must agree to continue using such precautions while taking durvalumab or azacitidine (including dose interruptions) and up to 90 days after the last dose of durvalumab or azacitidine. Cessation of contraception after this point should be discussed with a responsible physician.\n 3. Agree to abstain from breastfeeding during study participation and for at least 90 days after the last dose of IP.\n 4. Refrain from egg cell donation while taking durvalumab and for at least 90 days after the last dose of durvalumab.\n4. Male subject must:\n\n 1. Either practice true abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to avoid fathering a child, to use highly effective methods of contraception, male condom plus spermicide during sexual contact with a pregnant female or a female of childbearing potential (even if he has undergone a successful vasectomy) from starting dose of IP (Cycle 1 Day 1), including dose interruptions through 90 days after receipt of the last dose of durvalumab or azacitidine.\n 2. Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP.\n5. Understand and voluntarily sign a biomarker-specific component of the informed consent form prior to any study-related procedures conducted.\n6. Willing and able to adhere to the study visit schedule and other protocol requirements.\n\n MDS Cohort:\n7. Age ≥ 18 years at the time of signing the informed consent form.\n8. Central confirmation of diagnosis of previously untreated primary or secondary myelodysplastic syndromes (MDS) as per World Health Organization (WHO) classification. Results of central pathology review are required prior to receiving the first dose of IP.\n9. Central confirmation of the categorization of the MDS risk classification, as per the Revised - International prognostic scoring system (IPSS-R) Intermediate risk with \\>10% blasts or poor or very poor cytogenetics, or IPSS-R High or Very High risk (results of central pathology review required prior to receiving the first dose of IP).\n\n Acute myeloid leukemia (AML) Cohort:\n10. Age ≥ 65 years at the time of signing the informed consent form (ICF).\n11. Central confirmation of diagnosis of one of the following untreated AML as per WHO classification:\n\n * Newly diagnosed, histologically confirmed de novo AML (bone marrow blasts ≥ 20%), or\n * AML secondary to prior MDS, or\n * AML secondary to exposure to potentially leukemogenic therapies or agents (eg, radiation therapy, alkylating agents, topoisomerase II inhibitors) with the primary malignancy in remission for at least 2 years.\n12. Central confirmation of intermediate or poor risk status, based on Cytogenetics for acute myeloid leukemia.\n\nExclusion Criteria:\n\nFor both cohorts:\n\n1. Prior hematopoietic stem cell transplant.\n2. Considered eligible for hematopoietic stem cell transplant (allogeneic or autologous) at the time of signing the ICF.\n3. Prior exposure to azacitidine, decitabine or prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative.\n4. Inaspirable bone marrow.\n5. Use of any of the following within 28 days prior to the first dose of IP:\n\n * Thrombopoiesis-stimulating agents (eg, romiplostim, eltrombopag, Interleukin-11)\n * Any hematopoietic growth factors (erythropoietin-stimulating agents \\[ESAs\\], granulocyte colony-stimulating factor (G-CSF) and other red blood cell (RBC) hematopoietic growth factors (eg, Interleukin-3)\n * Any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment\n6. Prior history of malignancies (except MDS for AML subjects), unless the subject has been free of the disease for ≥ 2 years. However, subjects with the following history/concurrent conditions are allowed:\n\n * Basal or squamous cell carcinoma of the skin\n * Carcinoma in situ of the cervix\n * Carcinoma in situ of the breast\n * Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[tumor, node, metastases (TNM)\\] clinical staging system).\n7. Pregnant or breast-feeding females or females who intend to become pregnant during study participation.\n8. Subject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis, Crohn's disease\\], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease \\[exclude only if active within the last 6 months prior to signing the ICF\\], or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome \\[granulomatosis with polyangiitis\\]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:\n\n * Subjects with vitiligo or alopecia;\n * Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement for ≥ 3 months prior to signing the ICF; or\n * Subjects with psoriasis not requiring systemic treatment\n9. Significant active cardiac disease within the previous 6 months prior to signing the ICF, including:\n\n * New York Heart Association (NYHA) Class III or IV congestive heart failure;\n * Unstable angina or angina requiring surgical or medical intervention; and/or\n * Significant cardiac arrhythmia\n * Myocardial infarction\n10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment), uncontrolled hypertension, cardiac arrhythmia, pneumonitis, interstitial lung disease, active peptic ulcer disease or gastritis that would limit compliance with study requirement.\n11. Known human immunodeficiency virus (HIV) or hepatitis C (HCV) infection, or evidence of active hepatitis B virus (HBV) infection.\n12. Known or suspected hypersensitivity to azacitidine, mannitol, or durvalumab, its constituents, or to any other humanized monoclonal antibody.\n13. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.\n14. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.\n15. Prior anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), programmed death-1 (PD-1), or programmed death ligand-1 (PD-L1) or other immune checkpoint mAb exposure.\n16. Other investigational monoclonal antibodies (mAbs) within 6 months prior to first dose of IP.\n17. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:\n\n * Intranasal, inhaled, topical, or local steroid injections (eg, intra-articular injection)\n * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent\n * Steroids as premedication for hypersensitivity reactions (eg, computed tomography \\[CT\\] scan premedication)\n18. History of primary immunodeficiency.\n19. Receipt of live, attenuated vaccine within 30 days prior to the first dose of IP (NOTE: Subjects, if enrolled, should not receive live vaccine during the study and for 30 days after the last dose of durvalumab).\n20. Unwilling or unable to complete subject reported outcome assessments without assistance or with minimal assistance from trained site personnel and/or caregiver.\n21. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.\n22. Presence of advanced malignant hepatic tumors.\n23. Any of the following laboratory abnormalities:\n\n * Serum aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) \\> 2.5 × upper limit of normal (ULN)\n * Serum total bilirubin \\> 1.5 × ULN. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of \\> 2% with either a positive Coombs' test or over 50% of indirect bilirubin\n * Serum creatinine \\> 2.5 × ULN.\n\n MDS Cohort:\n24. Any previous cytotoxic, cytostatic, hormonal, biological or immunological treatment for MDS (ESA with or without G-CSF are allowed under certain conditions, see exclusion criterion # 5).\n25. Any investigational therapy within 28 days prior to the first dose of IP.\n26. Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.\n27. Absolute white blood cell (WBC) count ≥ 15 × 10\\^9/L.\n\n AML Cohort:\n28. Previous cytotoxic, cytostatic, hormonal, biological or immunological treatment (ESA with or without G-CSF and iron chelating therapy and hydroxyurea are allowed under certain conditions, see exclusion criterion #5) or biologic treatment for AML.\n29. Any investigational therapy within 28 days prior to the first dose of IP.\n30. Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.\n31. Prior use of targeted therapy agents (eg, FLT3 inhibitors, other kinase inhibitors).\n32. Suspected or proven acute promyelocytic leukemia (French-American-British (FAB) M3) based on morphology, immunophenotype, molecular assay, or karyotype; AML associated with t(9;22) karyotype, biphenotypic acute leukemia or AML with previous hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms.\n33. Acute myeloid leukemia associated with inv(16), t(8;21), t(16;16), t(15;17) karyotypes or molecular evidence of such translocations if not associated with a c-Kit mutation.\n34. Absolute WBC count ≥ 15 × 10\\^⁹/L (NOTE: Hydroxyurea is not allowed to attain a WBC count ≤ 15 x 10⁹/L).\n35. Known history or presence of Sweet Syndrome at screening"}, 'identificationModule': {'nctId': 'NCT02775903', 'briefTitle': 'An Efficacy and Safety Study of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Adults With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly Patients With Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Randomized, Multicenter, Open-label, Phase 2 Study Evaluating the Efficacy and Safety of Azacitidine Subcutaneous in Combination With Durvalumab (MEDI4736) in Previously Untreated Subjects With Higher-Risk Myelodysplastic Syndromes (MDS) or in Elderly (>= 65 Years) Acute Myeloid Leukemia (AML) Subjects Not Eligible for Hematopoietic Stem Cell Transplantation (HSCT)', 'orgStudyIdInfo': {'id': 'MEDI4736-MDS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Azacitidine + Durvalumab', 'description': 'Participants received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks (Q4W) in combination with 1500 mg intravenous durvalumab on Day 1 of every 4 week cycle for at least 6 cycles. Participants who benefited from treatment may have continued treatment until loss of that benefit, disease progression or other treatment discontinuation criterion were met.', 'interventionNames': ['Drug: Azacitidine', 'Biological: Durvalumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Azacitidine Alone', 'description': 'Participants received 75 mg/m² subcutaneous azacitidine for 7 days every 4 weeks for at least 6 cycles. 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