Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-20 @ 8:15 PM
Study NCT ID:
NCT01757535
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2012-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D000095384', 'term': 'Pathologic Complete Response'}], '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': 'D018450', 'term': 'Disease Progression'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C000709231', 'term': 'cc-486'}], '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': 'Clinica.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}}, 'adverseEventsModule': {'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 238, 'otherNumAffected': 235, 'seriousNumAtRisk': 236, 'deathsNumAffected': 172, 'seriousNumAffected': 110}, {'id': 'EG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 234, 'otherNumAffected': 224, 'seriousNumAtRisk': 233, 'deathsNumAffected': 176, 'seriousNumAffected': 109}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 104}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 61}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 56}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 142}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute myeloid leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 126}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastroenteritis eosinophilic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutropenic colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Allergy to vaccine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastroenteritis Escherichia coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Superinfection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cataract traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Chemical peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Post-traumatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Traumatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'General physical condition abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute myeloid leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 58}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Central nervous system leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Chloroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Gliomatosis cerebri', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Central nervous system inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Acute febrile neutrophilic dermatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 233, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Kaplan-Meier (K-M) Estimate for Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '30.5'}, {'value': '14.8', 'groupId': 'OG001', 'lowerLimit': '11.7', 'upperLimit': '17.6'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.55', 'ciUpperLimit': '0.86', 'pValueComment': 'The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.', 'estimateComment': 'The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "The confidence interval (CI) for the difference was derived using Kosorok's method."}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants.', 'description': 'Overall survival was defined as time from randomization to death from any cause; participants surviving at the end of the follow-up period, or who withdraw consent, or who were lost to follow up were censored at the date last known alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat (ITT) population includes participants who were randomized, regardless of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Relapse Free Survival (RFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '12.9'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '6.4'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.80', 'pValueComment': 'The p-value is 2-sided from a log-rank test stratified by age, cytogenetic risk category, and received consolidation therapy or not.', 'estimateComment': 'The hazard ratio is from a Cox proportional hazards model stratified by age, cytogenetic risk category, and received consolidation therapy or not.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'RFS was defined as the time from the date of randomization to the date of documented relapse or death from any cause, whichever occurred first. Participants who were still alive without documented relapse, or who were lost to follow-up or withdrew consent without documented relapse, were censored at the date of their last bone marrow assessment, prior to receiving any other therapy for AML. Documented relapse was defined as the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \\> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \\[myeloblasts\\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat population includes participants who were randomized, regardless of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of Time to Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '13.4'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'Time to relapse was defined as the interval (in months) from the date of randomization to the date of documented relapse. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from complete remission (CR)/ complete remission with incomplete blood count recovery (CRi). Documented relapse was defined as, the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \\> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \\[myeloblasts\\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat population includes participants who were randomized, regardless of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimates of Time to Discontinuation From Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '20.1'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '7.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'Time to discontinuation from treatment was assessed and defined as the interval from the date of randomization to the date of discontinuation from study drug. Participants who were receiving treatment at the time of study closure were censored at the date of last visit. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from CR/ CRi.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent to treat population includes participants who were randomized, regardless of whether they received treatment or not.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'title': '≥ 1 TEAE', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 TEAE Related to Study Treatment', 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 Serious TEAE', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 Treatment Related Serious TEAE', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 Grade 3/4 TEAE', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 Treatment Related Grade 3/4 TEAE', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 TEAE Leading to Death', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 TEAE Leading to Dose Reduction (Red)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 TEAE Leading to Dose Interruption', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 TEAE Leading to Dose Red and Interruption', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '≥ 1 TEAE Leading to Study Drug Discontinuation', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'TEAEs include AEs that started between first dose date and 28 days after the last dose of study drug. A serious adverse event (SAE) is: • Death • Life-threatening event • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly or birth defect • Other important medical event The severity of AEs were assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0: Grade 1 (Mild): asymptomatic/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; urgent intervention indicated. Grade 5: Death due to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0) Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '10.92', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '9.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'The functional assessment of chronic illness therapy (FACIT-Fatigue Scale V 4.0) is a subscale of the FACIT-F and has been validated in the oncology setting. The FACIT-Fatigue Scale is a short, 13-item, self-administered tool that measures the level of fatigue in an individual during usually daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all; 4 = very much. The scores range from 0 to 52, with higher scores indicating less fatigue. If there were missing items, but the participant answered at least 50% of the items, then subscores were prorated.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with FACIT-Fatigue measurement by EOT'}, {'type': 'SECONDARY', 'title': 'Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0416', 'spread': '0.15467', 'groupId': 'OG000'}, {'value': '-0.0152', 'spread': '0.14799', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': "The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The instrument is scored using the United Kingdom (UK) index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with a EQ-5D-3L measurement at the end of treatment'}, {'type': 'SECONDARY', 'title': 'Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period', 'groupId': 'OG000', 'lowerLimit': '135.1', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable because the survival curve does not drop to or below 0.5, i.e. the cumulative probability of developing clinically meaningful deterioration does not reach or exceed 50%, during the observation period', 'groupId': 'OG001', 'lowerLimit': '122.9', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.7522', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9345', 'ciLowerLimit': '0.6136', 'ciUpperLimit': '1.4231', 'pValueComment': 'Stratification factors: • Age (at induction therapy): 55 to 64 years and ≥ 65 years • Prior history of MDS: yes/no • Cytogenetic risk (at induction therapy): intermediate-risk/poor-risk • Received consolidation therapy following induction: yes/no', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months', 'description': "Clinically meaningful deterioration was defined at least 0.10 point of deterioration from baseline for at least 2 consecutive visits for the EQ-5D Health Utility Index. The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The EQ-5D-3L is scored using the UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'.", 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Health Related Quality of Life (HRQoL) evaluable population was defined as the ITT participants with a non-missing EQ-5D-3L score at baseline (C1D1) and at least one post-baseline visit. Results are presented for each post-baseline visit with sample size ≥ 25 in both arms. Death was censored at the date of the last HRQoL assessment visit.'}, {'type': 'SECONDARY', 'title': 'Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.36', 'groupId': 'OG000', 'lowerLimit': '0.31', 'upperLimit': '0.42'}, {'value': '0.63', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '0.74'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.', 'unitOfMeasure': 'Hospitalizations per person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Healthcare Resource Utilization (HRU): Number of Days Hospitalized Per Person-Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'OG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '5.78', 'upperLimit': '6.22'}, {'value': '13.13', 'groupId': 'OG001', 'lowerLimit': '12.68', 'upperLimit': '13.60'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.', 'unitOfMeasure': 'Days per person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population includes all participants who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'FG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Treatment Phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '233'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '234'}]}], 'dropWithdraws': [{'type': 'Disease Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': '472 Participants Randomized, 469 participants treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '472', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Azacitidine Plus Best Supportive Care', 'description': 'Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'BG001', 'title': 'Placebo Plus Best Supportive Care', 'description': 'Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '5.72', 'groupId': 'BG000'}, {'value': '68.0', 'spread': '5.62', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '5.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 to 64 Years', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '65 to 84 Years', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}, {'title': '≥ 85 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}, {'title': 'Black or African-American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Initial Acute Myeloid Leukemia (AML) Classification', 'classes': [{'categories': [{'title': 'AML with Recurrent Genetic Abnormalities', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'AML with Myelodysplasia - Related Changes', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Therapy-related Myeloid Neoplasms', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'AML not Otherwise Specified', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '293', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'AML is classified using the WHO classification system based upon a combination of morphology, immunophenotype, genetics, and clinical features. There are several broad groups and include: 1. AML with genetic abnormalities; 2. AML with multilineage dysplasia 3. AML related to previous chemotherapy or radiation 4. Unspecified AML - do not fall into the above groups', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Acute Myeloid Leukemia (AML)', 'classes': [{'categories': [{'title': 'Primary (de novo)', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}, {'title': 'Secondary', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Primary AML is a cancer that originates in the blood and bone marrow. AML affects a group of white blood cells called myeloid cells, which normally develop into the various types of mature blood cells, such as red blood cells, white blood cells and platelets. Secondary acute myeloid leukemia (s-AML) refers to a leukemic process: (1) evolving from prior myelodysplasia (MDS), myeloproliferative disorder (MPN), or aplastic anemia (AA) with or without treatment or (2) as a product of previous exposure to a proven leukemogenic chemotherapeutic agent (therapy-related AML \\[t-AML\\]).', 'unitOfMeasure': 'Participants'}, {'title': 'Cytogenetic Risk Category at Diagnosis', 'classes': [{'categories': [{'title': 'Intermediate', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}, {'title': 'Poor', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cytogenetic Risk - Intermediate -I is of a normal karyotype; Poor Risk - includes complex karyotypes having 3 or more cytogenetic abnormalities.', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status', 'classes': [{'categories': [{'title': 'Grade 0', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}, {'title': 'Grade 1', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Grade 2', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Grade 3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], '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 = Capable to only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead.", 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent to treat (ITT) population includes participants who were randomized, regardless of whether they received treatment or not.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-08', 'size': 2357911, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-29T16:35', 'hasProtocol': True}, {'date': '2019-07-25', 'size': 474111, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-29T16:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 472}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'dispFirstSubmitDate': '2019-10-16', 'completionDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2012-11-21', 'dispFirstSubmitQcDate': '2019-10-16', 'resultsFirstSubmitDate': '2020-09-29', 'studyFirstSubmitQcDate': '2012-12-21', 'dispFirstPostDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-04', 'studyFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kaplan-Meier (K-M) Estimate for Overall Survival (OS)', 'timeFrame': 'Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants.', 'description': 'Overall survival was defined as time from randomization to death from any cause; participants surviving at the end of the follow-up period, or who withdraw consent, or who were lost to follow up were censored at the date last known alive.'}], 'secondaryOutcomes': [{'measure': 'Kaplan-Meier Estimate of Relapse Free Survival (RFS)', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'RFS was defined as the time from the date of randomization to the date of documented relapse or death from any cause, whichever occurred first. Participants who were still alive without documented relapse, or who were lost to follow-up or withdrew consent without documented relapse, were censored at the date of their last bone marrow assessment, prior to receiving any other therapy for AML. Documented relapse was defined as the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \\> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \\[myeloblasts\\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.'}, {'measure': 'Kaplan-Meier Estimate of Time to Relapse', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'Time to relapse was defined as the interval (in months) from the date of randomization to the date of documented relapse. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from complete remission (CR)/ complete remission with incomplete blood count recovery (CRi). Documented relapse was defined as, the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \\> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \\[myeloblasts\\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.'}, {'measure': 'Kaplan-Meier Estimates of Time to Discontinuation From Treatment', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'Time to discontinuation from treatment was assessed and defined as the interval from the date of randomization to the date of discontinuation from study drug. Participants who were receiving treatment at the time of study closure were censored at the date of last visit. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from CR/ CRi.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'TEAEs include AEs that started between first dose date and 28 days after the last dose of study drug. A serious adverse event (SAE) is: • Death • Life-threatening event • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly or birth defect • Other important medical event The severity of AEs were assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0: Grade 1 (Mild): asymptomatic/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; urgent intervention indicated. Grade 5: Death due to AE.'}, {'measure': 'Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0) Score From Baseline', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'The functional assessment of chronic illness therapy (FACIT-Fatigue Scale V 4.0) is a subscale of the FACIT-F and has been validated in the oncology setting. The FACIT-Fatigue Scale is a short, 13-item, self-administered tool that measures the level of fatigue in an individual during usually daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all; 4 = very much. The scores range from 0 to 52, with higher scores indicating less fatigue. If there were missing items, but the participant answered at least 50% of the items, then subscores were prorated.'}, {'measure': 'Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': "The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The instrument is scored using the United Kingdom (UK) index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'."}, {'measure': 'Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months', 'description': "Clinically meaningful deterioration was defined at least 0.10 point of deterioration from baseline for at least 2 consecutive visits for the EQ-5D Health Utility Index. The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The EQ-5D-3L is scored using the UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'."}, {'measure': 'Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.'}, {'measure': 'Healthcare Resource Utilization (HRU): Number of Days Hospitalized Per Person-Year', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Maintenance therapy', 'AML', 'Acute Myeloid Leukemia', 'Oral Azacitidine', 'Best supportive care', 'Complete remission'], 'conditions': ['Leukemia, Myeloid, Acute']}, 'referencesModule': {'references': [{'pmid': '26785287', 'type': 'BACKGROUND', 'citation': 'Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.'}, {'pmid': '37952982', 'type': 'DERIVED', 'citation': 'Ravandi F, Dohner H, Wei AH, Montesinos P, Pfeilstocker M, Papayannidis C, Lai Y, Wang K, See WL, de Menezes DL, Petrlik E, Prebet T, Roboz GJ. Survival outcomes in patients with acute myeloid leukaemia who received subsequent therapy for relapse in QUAZAR AML-001. Br J Haematol. 2024 Mar;204(3):877-886. doi: 10.1111/bjh.19202. Epub 2023 Nov 12.'}, {'pmid': '36951156', 'type': 'DERIVED', 'citation': 'Wei AH, Roboz GJ, Dombret H, Dohner H, Schuh AC, Montesinos P, Selleslag D, Bondarenko SN, Prebet T, Lai Y, Skikne B, Beach CL, Ravandi F. Survival outcomes with oral azacitidine maintenance in patients with acute myeloid leukemia in remission by receipt of initial chemotherapy: subgroup analyses from the phase III QUAZAR AML-001 trial. Haematologica. 2023 Oct 1;108(10):2820-2825. doi: 10.3324/haematol.2022.282296. No abstract available.'}, {'pmid': '35960871', 'type': 'DERIVED', 'citation': 'Dohner H, Wei AH, Roboz GJ, Montesinos P, Thol FR, Ravandi F, Dombret H, Porkka K, Sandhu I, Skikne B, See WL, Ugidos M, Risueno A, Chan ET, Thakurta A, Beach CL, Lopes de Menezes D. Prognostic impact of NPM1 and FLT3 mutations in patients with AML in first remission treated with oral azacitidine. Blood. 2022 Oct 13;140(15):1674-1685. doi: 10.1182/blood.2022016293.'}, {'pmid': '35437111', 'type': 'DERIVED', 'citation': 'Zhu J, Wu Q, Wang J, Niu T. Cost-effectiveness analysis of azacitidine maintenance therapy in patients with acute myeloid leukemia. Expert Rev Hematol. 2022 Apr;15(4):375-382. doi: 10.1080/17474086.2022.2061456. Epub 2022 May 11.'}, {'pmid': '34995344', 'type': 'DERIVED', 'citation': 'Roboz GJ, Ravandi F, Wei AH, Dombret H, Thol F, Voso MT, Schuh AC, Porkka K, La Torre I, Skikne B, Zhong J, Beach CL, Risueno A, Menezes DL, Ossenkoppele G, Dohner H. Oral azacitidine prolongs survival of patients with AML in remission independently of measurable residual disease status. Blood. 2022 Apr 7;139(14):2145-2155. doi: 10.1182/blood.2021013404.'}, {'pmid': '34454540', 'type': 'DERIVED', 'citation': 'Ravandi F, Roboz GJ, Wei AH, Dohner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021 Aug 28;14(1):133. doi: 10.1186/s13045-021-01142-x.'}, {'pmid': '33369355', 'type': 'DERIVED', 'citation': 'Wei AH, Dohner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Cakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Cermak J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy.\n\nThe study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.', 'detailedDescription': 'This is an international, multicenter, placebo-controlled, Phase 3 study with a double-blind, randomized, parallel-group design in subjects with de novo AML or AML secondary to prior diagnosis of myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) aged ≥ 55 years, who are in first CR/CRi following induction therapy with or without consolidation chemotherapy. The study consists of 3 phases; the pre-randomization phase (screening phase), the treatment phase, and the follow-up phase.\n\nThe study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine after unblinding by sponsor until they meet the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Male or female participants ≥ 55 years of age\n2. Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)\n3. First complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) with induction therapy with intensive chemotherapy with or without consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi)\n4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3\n\nKey Inclusion Criteria in the Extended Phase of the study:\n\nAt the Investigator's discretion and with approval of the sponsor, participants meeting all of the following eligibility criteria are eligible to enter the extension phase:\n\n1. All participants randomized into the oral azacitidine or placebo arm and are continuing in either the treatment phase or follow-up phase of the CC-486-AML-001 study;\n\n * Participants randomized to oral azacitidine treatment arm and continuing in the treatment phase demonstrating clinical benefit as assessed by the investigator are eligible to receive oral azacitidine in the extension phase (EP);\n * Participants randomized into placebo arm of the study will not receive oral azacitidine in the EP, but will be followed for survival in the EP;\n * Participants currently in the follow-up phase will continue to be followed for survival in the EP;\n2. Participants who have signed the informed consent for the EP of the study;\n3. Participants who do not meet any of the criteria for study discontinuation\n\nKey Exclusion Criteria:\n\n1. AML with inversion (inv)(16), translocation = t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations\n2. Prior bone marrow or stem cell transplantation\n3. Have achieved CR/CRi following therapy with hypomethylating agents\n4. Diagnosis of malignant disease within the previous 12 months\n5. Proven central nervous system (CNS) leukemia"}, 'identificationModule': {'nctId': 'NCT01757535', 'acronym': 'QUAZAR AML-001', 'briefTitle': 'Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission', 'orgStudyIdInfo': {'id': 'CC-486-AML-001'}, 'secondaryIdInfos': [{'id': '2012-003457-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Azacitidine', 'description': '300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.', 'interventionNames': ['Drug: Oral Azacitidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oral Azacitidine', 'type': 'DRUG', 'otherNames': ['CC-486; Onureg®'], 'description': '300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.', 'armGroupLabels': ['Oral Azacitidine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates, P.C.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence St Joseph Medical Center Cancer Center', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '91010-301', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City Of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Fresno Campus', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California Norris Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-6956', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 006', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 050', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '80218-1210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06489', 'city': 'Southington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Local Institution - 010', 'geoPoint': {'lat': 41.59649, 'lon': -72.8776}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington University Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 046', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mount Sinai Comprehensive Cancer Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution - 044', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '60714', 'city': 'Niles', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL', 'geoPoint': {'lat': 42.01892, 'lon': -87.80284}}, {'zip': '46202-528', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Local Institution - 013', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Franciscan St. Francis Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Local Institution - 003', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Local Institution - 049', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Local Institution - 058', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Local Institution - 047', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70121-2483', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center - Jefferson Highway', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Local Institution - 015', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Local Institution - 037', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Local Institution - 023', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School Of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Local Institution - 057', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '11501-3893', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution - 009', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution - 002', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution - 004', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution - 014', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution - 025', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution - 016', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Peggy and Charles Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Kaiser Permanente Northwest Oncology Hematology', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lancaster General Hospital', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Pavillion', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Local Institution - 011', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-5505', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Local Institution - 007', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390-9068', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 041', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 034', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 001', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Care Centers of South Texas - Loop', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 039', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23298-0037', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Local Institution - 035', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Inst', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'Yakima Valley Memorial Hospital/ North Star Lodge', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}, {'zip': '53226-3522', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital BMT Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Local Institution - 510', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '4101', 'city': 'South Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Local Institution - 509', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'zip': 'SA 5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Local Institution - 508', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Local Institution - 511', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '5011', 'city': 'Woodville South', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Local Institution - 504', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': '3084', 'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Local Institution - 503', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '7000', 'city': 'Hobart', 'country': 'Australia', 'facility': 'Local Institution - 502', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '2170', 'city': 'Liverpool', 'country': 'Australia', 'facility': 'Local Institution - 507', 'geoPoint': {'lat': -33.91938, 'lon': 150.92588}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'Local Institution - 500', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6000', 'city': 'Perth', 'country': 'Australia', 'facility': 'Local Institution - 505', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '6000', 'city': 'Perth', 'country': 'Australia', 'facility': 'Local Institution - 512', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '2065', 'city': 'St Leonards', 'country': 'Australia', 'facility': 'Local Institution - 506', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '4102', 'city': 'Woolloongabba', 'country': 'Australia', 'facility': 'Local Institution - 501', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '73013', 'city': 'Graz', 'country': 'Austria', 'facility': 'Local Institution - 271', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Local Institution - 270', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Local Institution - 274', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Local Institution - 272', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1190', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Local Institution - 273', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Local Institution - 300', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '6000', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Local Institution - 301', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'Local Institution - 302', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '81520-060', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Local Institution - 233', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Local Institution - 231', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '20230-130', 'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Local Institution - 232', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': '01308-050', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Local Institution - 234', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '05651-901', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Local Institution - 230', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution - 605', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'R3E OV9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Local Institution - 600', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Local Institution - 601', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Local Institution - 603', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Local Institution - 604', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution - 607', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution - 608', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Local Institution - 602', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '625 00', 'city': 'Brno', 'state': 'South Moravian', 'country': 'Czechia', 'facility': 'Local Institution - 320', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Local Institution - 321', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 20', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Local Institution - 322', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Local Institution - 361', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Local Institution - 362', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Local Institution - 360', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Local Institution - 456', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'facility': 'Local Institution - 465', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '93009', 'city': 'Bobigny', 'country': 'France', 'facility': 'Local Institution - 457', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '62200', 'city': 'Boulognes Sur Mer', 'country': 'France', 'facility': 'Local Institution - 462'}, {'zip': '92141', 'city': 'Clamart', 'country': 'France', 'facility': 'Local Institution - 460', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Local Institution - 452', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '78157', 'city': 'Le Chesnay', 'country': 'France', 'facility': 'Local Institution - 458', 'geoPoint': {'lat': 48.8222, 'lon': 2.12213}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Local Institution - 453', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'Local Institution - 461', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Local Institution - 450', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution - 463', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution - 454', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Local Institution - 800', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '95301', 'city': 'Pontoise', 'country': 'France', 'facility': 'Local Institution - 464', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Local Institution - 455', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'Local Institution - 459', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Local Institution - 451', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Local Institution - 400', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Local Institution - 413', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Local Institution - 410', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Local Institution - 406', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Local Institution - 415', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '65929', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Local Institution - 404', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '47574', 'city': 'Goch', 'country': 'Germany', 'facility': 'Local Institution - 412', 'geoPoint': {'lat': 51.67873, 'lon': 6.15895}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Local Institution - 405', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '74078', 'city': 'Heilbronn', 'country': 'Germany', 'facility': 'Local Institution - 408', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Local Institution - 414', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '24105', 'city': 'Keil', 'country': 'Germany', 'facility': 'Local Institution - 403'}, {'zip': '68167', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Local Institution - 402', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80804', 'city': 'München', 'country': 'Germany', 'facility': 'Local Institution - 409', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Local Institution - 411', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '26133', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Local Institution - 407', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '52249', 'city': 'Schweiler', 'country': 'Germany', 'facility': 'Local Institution - 416', 'geoPoint': {'lat': 50.24617, 'lon': 6.26009}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Local Institution - 401', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '24', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Local Institution - 950', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'ST46QG', 'city': 'Galway', 'country': 'Ireland', 'facility': 'Local Institution - 951', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Local Institution - 381', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '35254', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Local Institution - 380', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Local Institution - 383', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Local Institution - 382', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '15121', 'city': 'Alessandria', 'country': 'Italy', 'facility': 'Local Institution - 701', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Local Institution - 721', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Local Institution - 720', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': 'O9126', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'Local Institution - 710', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '26100', 'city': 'Cremona', 'country': 'Italy', 'facility': 'Local Institution - 702', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'zip': '50129', 'city': 'Florence', 'country': 'Italy', 'facility': 'Local Institution - 708', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Local Institution - 712', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '73100', 'city': 'Lecce', 'country': 'Italy', 'facility': 'Local Institution - 716', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Local Institution - 706', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Local Institution - 726', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'Local Institution - 704', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Local Institution - 717', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Local Institution - 725', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'zip': '10043', 'city': 'Orbassano (TO)', 'country': 'Italy', 'facility': 'Local Institution - 705', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Local Institution - 703', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Local Institution - 719', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '31122', 'city': 'Pesaro', 'country': 'Italy', 'facility': 'Local Institution - 724', 'geoPoint': {'lat': 43.90921, 'lon': 12.9164}}, {'zip': '89100', 'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Local Institution - 700', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Local Institution - 709', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'facility': 'Local Institution - 714', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00189', 'city': 'Roma', 'country': 'Italy', 'facility': 'Local Institution - 723', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '133', 'city': 'Rome', 'country': 'Italy', 'facility': 'Local Institution - 722', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Local Institution - 715', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Local Institution - 718', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Local Institution - 711', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Local Institution - 707', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '5809', 'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'Local Institution - 750', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'zip': '52763', 'city': 'Huixquilucan de Degollado', 'country': 'Mexico', 'facility': 'Local Institution - 252', 'geoPoint': {'lat': 19.36028, 'lon': -99.3498}}, {'zip': '14080', 'city': 'México', 'country': 'Mexico', 'facility': 'Local Institution - 251', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Local Institution - 250', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '85-168', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Local Institution - 824', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Local Institution - 820', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '93-510', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Local Institution - 822', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '02-776', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Local Institution - 821', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-367', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Local Institution - 823', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '4200-072', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Local Institution - 841', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '1099-023', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Local Institution - 840', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1150-314', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Local Institution - 843', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-072', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Local Institution - 842', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4200', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Local Institution - 844', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '125101', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Local Institution - 971', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603005', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'Local Institution - 970', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '196022', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Local Institution - 972', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197341', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Local Institution - 973', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Local Institution - 535', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '700-721', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Local Institution - 533', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution - 536', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution - 530', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution - 531', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution - 532', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07198', 'city': 'Palma de Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Local Institution - 872', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Local Institution - 867', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '8916', 'city': 'Badalona (Barcelona)', 'country': 'Spain', 'facility': 'Local Institution - 869', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution - 871', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Local Institution - 870', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '10003', 'city': 'Cáceres', 'country': 'Spain', 'facility': 'Local Institution - 873', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Local Institution - 863', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution - 868', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution - 866', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Local Institution - 865', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '33006', 'city': 'Oviedo', 'country': 'Spain', 'facility': 'Local Institution - 864', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Local Institution - 861', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Local Institution - 862', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Local Institution - 860', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '11217', 'city': 'Beitou District, Taipei City', 'country': 'Taiwan', 'facility': 'Local Institution - 599', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '83301', 'city': 'Niaosong District Kaohsiung City', 'country': 'Taiwan', 'facility': 'Local Institution - 595'}, {'zip': '404', 'city': 'Taichung, Northern Dist.', 'country': 'Taiwan', 'facility': 'Local Institution - 596', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan, Taiana', 'country': 'Taiwan', 'facility': 'Local Institution - 597', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei, Zhongzheng Dist.', 'country': 'Taiwan', 'facility': 'Local Institution - 598', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Local Institution - 653', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06200', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Local Institution - 650', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '34662', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Local Institution - 651', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '55139', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Local Institution - 652', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Local Institution - 904', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'PE21 9QS', 'city': 'Boston', 'country': 'United Kingdom', 'facility': 'Local Institution - 907', 'geoPoint': {'lat': 52.97633, 'lon': -0.02664}}, {'zip': 'BN2 5BE', 'city': 'Brighton East Sussex', 'country': 'United Kingdom', 'facility': 'Local Institution - 903'}, {'zip': 'CT1 3NG', 'city': 'Canterbury Kent', 'country': 'United Kingdom', 'facility': 'Local Institution - 902'}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Local Institution - 905', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Local Institution - 901', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Local Institution - 908', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'country': 'United Kingdom', 'facility': 'Local Institution - 909', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Local Institution - 900', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'RM7 0AG', 'city': 'Romford, Essex', 'country': 'United Kingdom', 'facility': 'Local Institution - 906', 'geoPoint': {'lat': 51.57515, 'lon': 0.18582}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celgene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}