Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-22 @ 9:41 AM
Study NCT ID:
NCT01751867
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1 908 704-5197', 'title': 'SR DIR COMPD DEV TM LDR', 'organization': 'Janssen R&D US'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the date of informed consent signed until 30 days after last dose of study medication', 'description': 'Safety analysis set included all participants who received at least 1 dose of study medication. Participants were analyzed according to the actual treatment received.', 'eventGroups': [{'id': 'EG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.', 'otherNumAtRisk': 34, 'otherNumAffected': 33, 'seriousNumAtRisk': 34, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.', 'otherNumAtRisk': 98, 'otherNumAffected': 97, 'seriousNumAtRisk': 98, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 69}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 60}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 52}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 48}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 54}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Gingival infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Anal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Oral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 1.4'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Oesophageal carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hepatosplenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Malignant tumour excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Anal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Respiratory tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'OG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '44.4'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '31.2'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'paramType': 'ORR %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.4', 'ciLowerLimit': '15.1', 'ciUpperLimit': '47.5', 'estimateComment': 'ORR % = Number of participants who achieved response divided by total ITT participants', 'groupDescription': 'Null Hypothesis: threshold for statistical significance = 10%', 'statisticalMethod': 'Exact binomial proportion test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001'], 'paramType': 'ORR %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '17.2', 'ciUpperLimit': '35.3', 'groupDescription': 'Null Hypothesis: threshold for statistical significance = 10%', 'statisticalMethod': 'Exact binomial proportion test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation', 'description': 'IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \\>= 11 gram per deciliter (g/dL), neutrophils \\>= 1000/mL, platelets \\>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \\>=50%, still greater than 5% in bone marrow.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: Participants who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'OG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation', 'description': 'IWG 2006 response criteria - CR: bone marrow evaluation shows \\<= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \\>= 11 g/dL, neutrophils \\>= 1000/mL, platelets \\>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \\>= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of \\>= 1.5 g/dL, platelet increase of \\>= 30,000/mL (starting with \\> 20,000/mL), neutrophils increase of \\>= 100% and \\> 500/μL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'OG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'classes': [{'title': 'Overall (n=6, 24)', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'CR+mCR+PR (n=3, 13)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}]}]}, {'title': 'CR (n=2, 3)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'mCR (n=1, 10)', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation', 'description': 'As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had baseline cytogenetic abnormality and had at least one post baseline cytogenetic assessments during study.'}, {'type': 'SECONDARY', 'title': 'Transfusion Independence: Number of Participants Who Were Transfusion Independent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'OG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'classes': [{'title': 'Baseline (Before First Dose) (n=34, 98)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Phase (n=34, 97)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; up to 2 years', 'description': 'A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) population: Participants who received at least one dose of study drug. Here, 'n' is the number of participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'OG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.6', 'spread': '34.20', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '34.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 years', 'description': 'Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration', 'unitOfMeasure': 'Percentage of total days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: Participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'OG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'classes': [{'title': '6-month survival rate', 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '74.8', 'upperLimit': '97.0'}, {'value': '84.7', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '90.5'}]}]}, {'title': '12-month survival rate', 'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000', 'lowerLimit': '57.5', 'upperLimit': '87.2'}, {'value': '65.9', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '74.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population- Participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'OG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'spread': '29.48', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '26.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of treatment (approximately up to 2 years)', 'description': 'EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population- Participants who received at least one dose of study drug. The missing data was imputed by the Last Observation Carried Forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'FG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '99'}]}], 'dropWithdraws': [{'type': 'Completed treatment,dropped in follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Diease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Poor Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'Randomized but not treated.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted across 12 centers in China.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '3-Day Posology', 'description': 'Decitabine 15 milligram per meter\\^2 (mg/m\\^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.'}, {'id': 'BG001', 'title': '5-Day Posology', 'description': 'Decitabine 20 mg/m\\^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '16.04', 'groupId': 'BG000'}, {'value': '51.6', 'spread': '14.78', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '15.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-60 Years (Y) (including 18 Y, excluding 60 Y)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'Greater than or equal to (>=) 60 Y', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized analysis set included all randomized participants, regardless of whether having received any treatment, or whether having any post-baseline efficacy data.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-01', 'studyFirstSubmitDate': '2012-07-25', 'resultsFirstSubmitDate': '2013-06-24', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-23', 'studyFirstPostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR): Number of Participants Who Achieved Either Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) - International Working Group (IWG) 2006 Response Criteria', 'timeFrame': 'From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation', 'description': 'IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \\>= 11 gram per deciliter (g/dL), neutrophils \\>= 1000/mL, platelets \\>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \\>=50%, still greater than 5% in bone marrow.'}], 'secondaryOutcomes': [{'measure': 'Hematological Improvement Rate: Number of Participants Who Achieved Complete Remission (CR), Partial Remission (PR) and Hematologic Improvement (HI) - International Working Group (IWG) 2006 Response Criteria', 'timeFrame': 'From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation', 'description': 'IWG 2006 response criteria - CR: bone marrow evaluation shows \\<= 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \\>= 11 g/dL, neutrophils \\>= 1000/mL, platelets \\>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \\>= 50%, still greater than 5% in bone marrow; HI: hemoglobin increase of \\>= 1.5 g/dL, platelet increase of \\>= 30,000/mL (starting with \\> 20,000/mL), neutrophils increase of \\>= 100% and \\> 500/μL.'}, {'measure': 'Cytogenetic Response Rate: Percentage of Participants Who Achieved Cytogenetic Response (Complete+Partial) by Status of Clinical Overall Response - International Working Group (IWG) 2006 Response Criteria', 'timeFrame': 'From the date of first dose until 30 to 42 days after the last dose of the 2 years treatment period, or at time of discontinuation', 'description': 'As per IWG 2006 response criteria - Complete cytogenetic response: disappearance of the chromosomal abnormality without appearance of new ones; Partial cytogenetic response: At least 50% reduction of the chromosomal abnormality. Status of Clinical response - complete remission (CR); marrow CR (mCR); partial remission (PR).'}, {'measure': 'Transfusion Independence: Number of Participants Who Were Transfusion Independent', 'timeFrame': 'Baseline; up to 2 years', 'description': 'A participant was considered to be transfusion independent, if the participant had no transfusions of Red Blood Cells (RBCs) or platelets for 8 consecutive weeks or more.'}, {'measure': 'Mean Percentage of Duration of Hospitalization (Relative to Days on Study Treatment)', 'timeFrame': 'Up to 2 years', 'description': 'Duration of hospitalization was calculated as, total number of days a participant stayed in hospital during study treatment divided by the study treatment duration'}, {'measure': 'Overall Survival Rate: Percentage of Participants Who Survived During 6 Months and 12 Months of Treatment.', 'timeFrame': 'From the date of dosing until death or lost to follow-up for up to 2.5 years after last patient was enrolled'}, {'measure': 'Mean Change From Baseline to End of Treatment in Scores of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ C-30) Physical Functioning Scale', 'timeFrame': 'Baseline to end of treatment (approximately up to 2 years)', 'description': 'EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from "1 = not at all" to "4 = very much". Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from "1 = very poor" to "7 = excellent". Lower scores indicate worsening. Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndrome', 'Dacogen', 'Oncology', 'Decitabine', 'Bone marrow disorders'], 'conditions': ['Myelodysplastic Syndrome']}, 'referencesModule': {'references': [{'pmid': '26568466', 'type': 'DERIVED', 'citation': 'Wu D, Du X, Jin J, Xiao Z, Shen Z, Shao Z, Li X, Huang X, Liu T, Yu L, Li J, Chen B, He G, Cai Z, Liang H, Li J, Ruan C. Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study. Adv Ther. 2015 Nov;32(11):1140-59. doi: 10.1007/s12325-015-0263-8. Epub 2015 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.', 'detailedDescription': 'This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), open-label (all people involved in the study know the identity of the assigned drug), Phase IIIb study to evaluate the efficacy and safety of decitabine in the treatment of myelodysplastic syndrome (MDS). Patients are randomized (study drug assigned by chance) in 1:1 ratio to receive treatment with decitabine either 3-day or 5-day course of therapy. When a minimum of 30 patients are reached for 3-day course of therapy, the rest of the patients will all be enrolled into 5-day course of therapy. Each patient in the study treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles. The entire study duration for each patient will be approximately two years. Safety will be evaluated for each patient by monitoring of adverse events, physical examinations, vital signs measurements, electrocardiogram, hematology and clinical chemistry testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have diagnosed with Myelodysplastic Syndrome (MDS) denovo (previously not present) or secondary as per the classification of French-American-British (FAB) and International Prognostic Scoring System (IPSS) greater than or eaul to 0.5 as determined by complete blood count (CBC), bone marrow assessment and bone marrow cytogenetics\n* Must have an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2\n* Must have adequate hepatic and renal function as measured by the aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin and serum creatinine, respectively\n* Must have recovered from all toxic effects of prior therapy and not received any chemotherapy for a minimum of 4 weeks (6 weeks if the patient has been treated with a nitrosoureas) prior to the first dose of study drug - Woman must be postmenopausal, or surgically sterile, or abstinent, or, if sexually active, be practicing an effective method of birth control (eg, oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization)\n\nExclusion Criteria:\n\n* Must not have a diagnosis of acute myeloid leukemia (greater than 30% bone marrow blasts) - Must not have received radiotherapy within 14 days before the first dose of study drug - Must not have any other prior cancer, other than superficial bladder cancer, basal cell skin and cervical cancer - Must not have associated autoimmune hemolytic anemia or immune thrombocytopenia and inaspirable bone marrow - Must not have a mental illness or any other condition (eg, uncontrolled cardiac or pulmonary disease, diabetes), that could prevent full cooperation with the study requirements.'}, 'identificationModule': {'nctId': 'NCT01751867', 'briefTitle': 'An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xian-Janssen Pharmaceutical Ltd.'}, 'officialTitle': 'An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome (MDS)', 'orgStudyIdInfo': {'id': 'CR017443'}, 'secondaryIdInfos': [{'id': 'DACOGENMYE-3002', 'type': 'OTHER', 'domain': 'Xian-Janssen Pharmaceutical Ltd'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3-Day Dose schedule', 'description': 'Decitabine will be administered at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3 hour period, repeated every 8 hours for 3 consecutive days. Cycles will be repeated every 6 weeks.', 'interventionNames': ['Drug: Decitabine at 15 mg/m2']}, {'type': 'EXPERIMENTAL', 'label': '5-Day Dose schedule', 'description': 'Decitabine will be administered at a dose of 20 mg/m2 as a intravenous infusion within 1 hour, once daily for 5 consecutive days. Cycles will be repeated every 4 weeks.', 'interventionNames': ['Drug: Decitabine at 20 mg/m2']}], 'interventions': [{'name': 'Decitabine at 15 mg/m2', 'type': 'DRUG', 'description': 'Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks.', 'armGroupLabels': ['3-Day Dose schedule']}, {'name': 'Decitabine at 20 mg/m2', 'type': 'DRUG', 'description': 'Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.', 'armGroupLabels': ['5-Day Dose schedule']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chengdu', 'country': 'China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Guangdong', 'country': 'China', 'geoPoint': {'lat': 42.76832, 'lon': 129.33635}}, {'city': 'Hangzhou', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Nanjing', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Suzhou', 'country': 'China', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Tianjin', 'country': 'China', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Xian-Janssen Pharmaceutical Ltd Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Xian-Janssen Pharmaceutical Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xian-Janssen Pharmaceutical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}