Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT01810705
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2013-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GRASPA Treatment for Patients With Acute Myeloblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708079', 'term': 'eryaspase'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anne-sophie.clermont@erytech.com', 'phone': '+33 4 78 78 15 70', 'title': 'Anne-Sophie Clermont', 'organization': 'Erytech Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from signature of the informed consent from first patient and until 4 months after last GRASPA/ low-dose cytarabine administration of last patient i.e. up to 28 months for the longuest study drug exposure and on a total of 46 months of AE collection period throughout the study.', 'eventGroups': [{'id': 'EG000', 'title': 'GRASPA', 'description': 'Patients having received at least one injection of GRASPA (100 IU/kg) i.e. 81 in GRASPA arm', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 80, 'seriousNumAtRisk': 81, 'deathsNumAffected': 70, 'seriousNumAffected': 74}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients having received at least one dose of study treatment i.e. 39 in control arm', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 39, 'seriousNumAtRisk': 39, 'deathsNumAffected': 34, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Alloimmunisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Alloimmunisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 50, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 27, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 29, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pancreatic enzymes abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 31, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 40, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Antithrombin III decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood chloride increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood chloride decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Prothrombin time ratio decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 149, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 84, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 87, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 31, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 98, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 34, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 170, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 74, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hemorrhagic Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 57, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 27, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 14, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 25, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hepatocellular injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Febrile bone marrow aplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hemorrhagic Events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GRASPA', 'description': 'patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm "Control")\n\nGRASPA: Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum'}, {'id': 'OG001', 'title': 'Control', 'description': 'patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '7.0'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '10.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'OS is defined as the time elapsed between randomization and death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'OS was to be assessed by measuring time elapsed between randomisation and death for any cause. Any patient not known to have died at the time of analysis is censored based on the last recorded date on which the patient was known to be alive'}, {'type': 'SECONDARY', 'title': 'Response to Treatment', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Percentage of patients with Complete remission (CR), Complete remission with incomplete recovery (neutrophil or platelet regeneration, CRi), Partial remission (PR)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Defined as the time elapsed between randomization and resistant disease or relapse or death from any cause', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient Quality of Life', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Collecting survey about patients quality of life', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Safety of GRASPA Adverse Events and Serious Adverse Events', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Number of incidences, type, severity and causality of adverse events / serious adverse events', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Relapse Free Survival', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Defined only for patients who achieve CR or CRi as the time elapsed between date of CR/CRi and date of disease relapse or death from any cause', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Hospitalizations (except schedule protocol visit during the study)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Need Transfusions', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Number of transfusions per patient (red blood cells and or platelets)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Pharmacodynamic and Pharmacokinetic Parameters of GRASPA', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Plasma concentrations of asparagine, aspartate, glutamine, glutamate, whole blood L- asparaginase activity', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Immunogenicity', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Titer of anti L-asparaginase antibodies', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Asparagine Synthetase (Optional)', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Asparagine synthetase and in vitro sensitivity to aspariginase on the harvested bone marrow cells', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Biomarker Cytogenetic Testing (Optional)', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Defined as cytogenetic biomarker testing', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GRASPA', 'description': 'patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm "Control")\n\nGRASPA: Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum'}, {'id': 'FG001', 'title': 'Control', 'description': 'patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GRASPA', 'description': 'In the experimental group, the patients will receive one administration of GRASPA (100 IU/kg) at Day 11 in combination with subcutaneous low-dose cytarabine as 40 mg daily (either one single dose of 40 mg or 20 mg twice daily according to local practice) for 10 consecutive days, every 28 days, for duration up to 24 months'}, {'id': 'BG001', 'title': 'Control', 'description': 'In the control arm, patients will be treated with subcutaneous low-dose cytarabine as 40 mg daily (either one single dose of 40 mg or 20 mg twice daily according to local practice) for 10 consecutive days, every 28 days, for duration up to 24 months. Each period of 28 days constitute a cycle of chemotherapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-05', 'size': 1955649, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-30T03:01', 'hasProtocol': True}, {'date': '2017-10-26', 'size': 1154764, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-30T03:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-18', 'studyFirstSubmitDate': '2013-03-07', 'resultsFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2013-03-12', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-18', 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'OS is defined as the time elapsed between randomization and death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Response to Treatment', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Percentage of patients with Complete remission (CR), Complete remission with incomplete recovery (neutrophil or platelet regeneration, CRi), Partial remission (PR)'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Defined as the time elapsed between randomization and resistant disease or relapse or death from any cause'}, {'measure': 'Patient Quality of Life', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Collecting survey about patients quality of life'}, {'measure': 'Safety of GRASPA Adverse Events and Serious Adverse Events', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Number of incidences, type, severity and causality of adverse events / serious adverse events'}, {'measure': 'Relapse Free Survival', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Defined only for patients who achieve CR or CRi as the time elapsed between date of CR/CRi and date of disease relapse or death from any cause'}, {'measure': 'Number of Hospitalizations', 'timeFrame': 'Each patient will be followed for a duration of 24 months.', 'description': 'Hospitalizations (except schedule protocol visit during the study)'}, {'measure': 'Percentage of Patients Who Need Transfusions', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Number of transfusions per patient (red blood cells and or platelets)'}, {'measure': 'Pharmacodynamic and Pharmacokinetic Parameters of GRASPA', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Plasma concentrations of asparagine, aspartate, glutamine, glutamate, whole blood L- asparaginase activity'}, {'measure': 'Immunogenicity', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Titer of anti L-asparaginase antibodies'}, {'measure': 'Asparagine Synthetase (Optional)', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Asparagine synthetase and in vitro sensitivity to aspariginase on the harvested bone marrow cells'}, {'measure': 'Biomarker Cytogenetic Testing (Optional)', 'timeFrame': 'Until patient stops treatment (expected average of 8 months)', 'description': 'Defined as cytogenetic biomarker testing'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myeloid', 'leukemia'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive chemotherapy.', 'detailedDescription': 'L-asparaginase (ASNase) holds a key role in chemotherapy for Acute Lymphoblastic Leukemia (ALL) in children and young adults. In elderly patients, its efficacy is counterbalanced by its toxicity, which impairs its use. However, a study conducted with GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) in elderly ALL (study reference "GRASPALL-GRAAL SA2 2008") showed that efficacy/safety profile was positive, paving the way for introducing ASNase benefit into chemotherapy for elderly patients.\n\nIn adults, Capizzi (1988) reported a significant benefit of ASNase associated with high-dose cytarabine treatment (HiDAC) in Acute Myeloid Leukemia (AML). Indeed, there was an overall statistically superior complete remission rate for HiDAC/ASNase (40%) vs HiDAC (24%) and an overall survival benefit for patients treated with HiDAC/ASNase (19.6 weeks vs 15.9 weeks).\n\nAnother study in elderly patients also displayed positive results for ASNase treatment (Petti, 1989), as well as recent single case reports that point out the potential benefit of ASNase in different AML or mixed lineage leukemia (Horikoshi, 2009; Rubnitz, 2009).\n\nOur preclinical results also showed that an AML cell line and blast cells from the bone marrow of AML patients were sensitive to ASNase in vitro.\n\nHowever, up to now, the toxicity of ASNase for elderly had prevented its use in this population that represents the majority of AML patients.\n\nConsidering the promising results of ASNase for AML treatment and the better safety profile offered by GRASPA (L-aspariginase encapsulated in red blood cells, erysapase), a multicenter, randomized, controlled IIb trial is open for recruitment. Efficacy and tolerability of GRASPA plus low-dose cytarabine will be evaluated versus low-dose cytarabine alone in treatment of AML patients over 65 year-old, unfit for intensive chemotherapy.\n\nOne hundred and twenty-three patients (65-85 year-old) newly diagnosed for AML are planned for inclusion in the study.\n\nA 2:1 randomization will be respected (82 patients treated with GRASPA® plus low-dose cytarabine and 41 patients treated with low-dose cytarabine alone). Each patient will be followed for 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patient \\> 65 years old and \\< 85 years old\n* Newly diagnosed Acute Myeloid Leukemia (AML) or post myelodysplastic syndrome diagnosed within 6 months prior to study enrollment\n* Unfit for intensive chemotherapy (at risk to suffer treatment related pejorative toxicities /early death) due to the presence of one or more of the following criteria: Dependence in activities of daily living owing to the presence of comorbidities other than those resulting from the deterioration caused by the neoplastic disease. Presence in the patient's medical history of three or more of the following comorbidities, even if they are under control with proper treatment: Congestive heart failure, other chronic cardiovascular diseases, chronic obstructive pulmonary disease, cerebrovascular disease, peripheral neuropathy, chronic kidney failure, hypertension, diabetes mellitus, systemic vasculitis, severe arthritis\n* Presence of geriatric syndromes such as fecal or urinary incontinence, spontaneous bone fractures, mild and moderate dementia, or patients who fall repeatedly, or, patient unwilling to receive intensive chemotherapy\n* Eligible to receive low-dose cytarabine treatment\n* ECOG performance status ≤ 2\n* Female patients of childbearing potential and males must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and for 6 months after the last dose of Cytarabine or 3 months after last dose of GRASPA (whichever is the longest).\n* Negative serum pregnancy test at study entry for female subjects of childbearing potential\n* Subscription to social security insurance (if applicable, in accordance with local regulations)\n* Ability to understand, and willingness to sign, a written informed consent document and to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n\nExclusion criteria:\n\n* Patients with M3 AML of FAB classification (APL, acute promyelocytic leukemia)\n* Patients with AML involving chromosome 16 abnormalities or translocation (8:21) (CBF-AML)\n* Patient with secondary AML subsequent to prior malignant blood disorder such as: Myelodysplastic syndrome diagnosed more than 6 months before study entry or Myeloproliferative syndrome\n* Prior therapy to AML (standard therapy or investigational agents)\n* Inadequate organ function : Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis, Serum creatinine concentration \\> 2 x ULN (Upper Limit of Normal), AST or ALT levels \\> 3.5xULN or 5xULN if related to AML, Total bilirubin \\> 2 x ULN, INR \\> 1.5, unless patient under chronic treatment with anticoagulants (in this case, INR should be within expected ranges for the specific condition), Insulin-dependent or uncontrolled diabetes mellitus\n* Concurrent malignancies other than AML requiring chemotherapy\n* Severe active infection, HIV seropositivity, or known active type B or C viral hepatitis\n* Known or suspected hypersensitivity or intolerance to mannitol\n* Breastfeeding or lactating women"}, 'identificationModule': {'nctId': 'NCT01810705', 'acronym': 'ENFORCE', 'briefTitle': 'GRASPA Treatment for Patients With Acute Myeloblastic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'ERYtech Pharma'}, 'officialTitle': 'A Multicenter, Open, Randomized, Controlled Phase IIb Trial Evaluating Efficacy and Tolerability of GRASPA (L-asparaginase Encapsulated in Red Blood Cells, Eryaspase) Plus Low-dose Cytarabine vs Low-dose Cytarabine Alone, in Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Elderly Patients, Unfit for Intensive Chemotherapy', 'orgStudyIdInfo': {'id': 'GRASPA-AML2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GRASPA', 'description': 'patients will receive one injection of GRASPA (100 IU/kg) after each course of low-dose cytarabine (see Arm "Control")', 'interventionNames': ['Drug: GRASPA']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'patients will receive successive courses of low intensive chemotherapy, as subcutaneous low-dose cytarabine 20mg twice daily for 10 days per course (from day 1 to day 10), each course occurring every 28 days, for a duration up to 24 months'}], 'interventions': [{'name': 'GRASPA', 'type': 'DRUG', 'otherNames': ['L-asparaginase encapsulated in red blood cells'], 'description': 'Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum', 'armGroupLabels': ['GRASPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': "Hôpital l'Archet 1", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '69008', 'city': 'Lyon', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Centre hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '13000', 'city': 'Marseille', 'state': 'Bouche Du Rhone', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '25000', 'city': 'Besançon', 'state': 'Doubs', 'country': 'France', 'facility': 'Hôpital JEAN MINJOZ', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '29200', 'city': 'Brest', 'state': 'Finistere', 'country': 'France', 'facility': 'Hopital Morvan', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '33600', 'city': 'Pessac', 'state': 'Gironde', 'country': 'France', 'facility': 'Hôpital Haut-Lévèque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '30000', 'city': 'Nîmes', 'state': 'Guard', 'country': 'France', 'facility': 'CHRU de Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '67000', 'city': 'Strasbourg', 'state': 'Haut Rhin', 'country': 'France', 'facility': 'Hopital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31500', 'city': 'Toulouse', 'state': 'Haute Garonne', 'country': 'France', 'facility': 'Hopital De Purpan CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '74000', 'city': 'Pringy', 'state': 'Haute Savoie', 'country': 'France', 'facility': "Hopital Région d'Annecy", 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'zip': '34295', 'city': 'Montpellier', 'state': 'Hérault', 'country': 'France', 'facility': 'Hôpital Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44200', 'city': 'Nantes', 'state': 'Loire Atlantique', 'country': 'France', 'facility': 'Hôtel Dieu - CHU de NANTES', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '49000', 'city': 'Angers', 'state': 'Maine Et Loire', 'country': 'France', 'facility': "Chu D'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Meurthe Et Moselle', 'country': 'France', 'facility': 'Hopital de Brabois', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '59800', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'Hôpital Claude-Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '42270', 'city': 'Saint-priest-en-jarez', 'state': 'Pays de la Loire Region', 'country': 'France', 'facility': 'Institut de Cancérologie de la Loire'}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'state': 'Puy De Dome', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '66100', 'city': 'Perpignan', 'state': 'Pyrénées Orientales', 'country': 'France', 'facility': 'hopital de Perpignan', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}, {'zip': '76100', 'city': 'Rouen', 'state': 'Seine Maritime', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '80090', 'city': 'Amiens', 'state': 'Somme', 'country': 'France', 'facility': 'Groupe Hospitalier Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'overallOfficials': [{'name': 'X Thomas, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ERYtech Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}