Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00788892
Status:
COMPLETED
Last Update Posted:
2018-01-12
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
Sponsor:
Organization:
Raw JSON
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'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '215-832-3750', 'title': 'Associate Director, Clinical Trial Disclosure & Transparency', 'organization': 'Jazz Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Assessed during treatment period and recorded and reported any new serious adverse events (up to 30 days after completion of Treatment Period)', 'description': 'The Safety Analysis Set included subjects receiving at least 1 dose of study drug and consisted of 126 subjects.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3', 'otherNumAtRisk': 85, 'otherNumAffected': 85, 'seriousNumAtRisk': 85, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice", 'otherNumAtRisk': 41, 'otherNumAffected': 41, 'seriousNumAtRisk': 41, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Cardiac disorders'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Cardiac disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mouth Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Oral Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Oral Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'General disorders'}, {'term': 'Catheter SIte Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Catheter Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 13}], 'organSystem': 'General disorders'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 12}], 'organSystem': 'General disorders'}, {'term': 'Gait Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 18}], 'organSystem': 'General disorders'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 14}], 'organSystem': 'General disorders'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Catheter Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Infections and infestations'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Infections and infestations'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 12}], 'organSystem': 'Infections and infestations'}, {'term': 'Transfusion Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Blood Alkaline Phosphate Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Investigations'}, {'term': 'Breath Sounds Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Cardiac Murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Investigations'}, {'term': 'Weight Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Investigations'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 12}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Mental Status Change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Night Sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue 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{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Restrictive Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Blindness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 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'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Graft Versus Host Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Catheter Site Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Catheter Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Clostridium Difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Device Related Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Fungal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Fungal Retinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Fungal Skin 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'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Brain Herniation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Acute Myeloid Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Leukaemia Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Malignant Melanoma In Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Haemorrhage Intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Subarachnoid Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Mental Status Changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Nephrogenic Diabetes Insipidus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Non-Cardiogenic Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Respiratory Tract Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Stevens-Johnson Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complete Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'OG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a 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One subject who developed Philadelphia chromosome positive disease prior to any efficacy assessment was excluded from the Efficacy Analysis Set.'}, {'type': 'SECONDARY', 'title': 'Remission Duration/Time to Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'OG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice"}], 'classes': [{'title': 'Remission Duration', 'categories': [{'measurements': [{'value': '275', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '730'}, {'value': '235', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '703'}]}]}, {'title': 'Time to Remission', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '32', 'upperLimit': '163'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Following achievement of CR over the study period', 'description': 'Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.\n\nTime to remission was measured from the date of randomization to the time measurement criteria for CR were first met.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Analysis Set'}, {'type': 'SECONDARY', 'title': 'Event Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'OG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice"}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000', 'lowerLimit': '116', 'upperLimit': '226'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '205'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 1 year from randomization', 'description': 'Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Analysis Set'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rate at 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'OG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice"}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Survival defined as the time from randomization to death.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Analysis Set'}, {'type': 'SECONDARY', 'title': 'Rate of Stem Cell Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'OG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice"}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'description': 'The rate of patients who underwent stem cell transplant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Analysis Set'}, {'type': 'SECONDARY', 'title': 'Aplasia Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'OG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice"}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14 (1st Induction)', 'description': 'Bone marrow aplasia was defined as \\<20% cellularity and 5% blasts in the bone marrow aspiration evaluation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Evaluable Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'FG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '23'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3'}, {'id': 'BG001', 'title': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '4.63', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '4.88', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '4.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: All randomized participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2012-05-16', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2008-11-10', 'dispFirstSubmitQcDate': '2012-05-16', 'resultsFirstSubmitDate': '2017-09-03', 'studyFirstSubmitQcDate': '2008-11-10', 'dispFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-15', 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Complete Remission', 'timeFrame': 'Within 6 weeks of the last induction treatment', 'description': 'Response was defined according to International Working Group Criteria (Cheson, et al. 2003) which requires peripheral blood neutrophils of \\>1000/µL and peripheral blood platelets of \\>100,000/µL in the absence of bone marrow blasts.'}], 'secondaryOutcomes': [{'measure': 'Remission Duration/Time to Remission', 'timeFrame': 'Following achievement of CR over the study period', 'description': 'Remission Duration was assessed from the time measurement criteria for CR were met until the first date that disease relapse was objectively documented or the subject died.\n\nTime to remission was measured from the date of randomization to the time measurement criteria for CR were first met.'}, {'measure': 'Event Free Survival', 'timeFrame': 'Up to 1 year from randomization', 'description': 'Event-free survival begins from randomization to the date persistent disease is documented or date of relapse after CR, or death, whichever comes first.'}, {'measure': 'Overall Survival Rate at 1 Year', 'timeFrame': '1 year', 'description': 'Survival defined as the time from randomization to death.'}, {'measure': 'Rate of Stem Cell Transplant', 'timeFrame': 'Up to 1 year', 'description': 'The rate of patients who underwent stem cell transplant.'}, {'measure': 'Aplasia Rate', 'timeFrame': 'Day 14 (1st Induction)', 'description': 'Bone marrow aplasia was defined as \\<20% cellularity and 5% blasts in the bone marrow aspiration evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute', 'Myeloid', 'Leukemia', 'elderly', 'Newly', 'Diagnosed'], 'conditions': ['Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '24687088', 'type': 'DERIVED', 'citation': 'Lancet JE, Cortes JE, Hogge DE, Tallman MS, Kovacsovics TJ, Damon LE, Komrokji R, Solomon SR, Kolitz JE, Cooper M, Yeager AM, Louie AC, Feldman EJ. Phase 2 trial of CPX-351, a fixed 5:1 molar ratio of cytarabine/daunorubicin, vs cytarabine/daunorubicin in older adults with untreated AML. Blood. 2014 May 22;123(21):3239-46. doi: 10.1182/blood-2013-12-540971. Epub 2014 Mar 31.'}]}, 'descriptionModule': {'briefSummary': 'The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens.\n\nThe study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.', 'detailedDescription': 'This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).\n\nPatients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥60 and \\<76 years at the time of diagnosis of AML\n* Pathological confirmation of AML\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Able to adhere to the study visit schedule and other protocol requirements\n* Laboratory values fulfilling the following:\n\nSerum creatinine \\< 2.0 mg/dL Serum total bilirubin \\< 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase \\< 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.\n\n* Cardiac ejection fraction \\> 50% by echocardiography or MUGA scan\n\nExclusion Criteria:\n\n* Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors \\>5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for \\>2 years before randomization are eligible)\n* Prior treatment for AML; only hydroxyurea is permitted (see below)\n* Acute promyelocytic leukemia \\[t(15;17)\\] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization\n* Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)\n* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent\n* Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment\n* Clinical evidence of active CNS leukemia\n* Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging\n* Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.\n* Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection\n* Hypersensitivity to cytarabine, daunorubicin or liposomal products\n* History of Wilson's disease or other copper-related disorder"}, 'identificationModule': {'nctId': 'NCT00788892', 'briefTitle': 'Trial of CPX-351 in Newly Diagnosed Elderly AML Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jazz Pharmaceuticals'}, 'officialTitle': 'Phase IIB, Multicenter, Randomized, Open Label Trial of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients With Untreated AML 60-75 Years of Age.', 'orgStudyIdInfo': {'id': 'CLTR0308-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: CPX-351', 'description': 'First induction: CPX-351 at 100u/m2 administered on days 1, 3 and 5 Second induction: CPX-351 at 100u/m2 administered on days 1 and 3 Consolidation: CPX-351 at 100u/m2 administered on days 1 and 3', 'interventionNames': ['Drug: CPX-351']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Cytarabine + Daunorubicin', 'description': "First induction: Cytarabine at a dose of 100mg/m2/day on days 1-7, Daunorubicin at dose of 45 or 60mg/m2 on days 1-3 Second induction: Cytarabine at a dose of 100mg/m2/day on days 1-5, Daunorubicin at a dose of 45 or 60 mg/m2/day on days 1 and 2 Consolidation: Investigator's Choice", 'interventionNames': ['Drug: Cytarabine', 'Drug: Daunorubicin']}], 'interventions': [{'name': 'CPX-351', 'type': 'DRUG', 'armGroupLabels': ['Arm A: CPX-351']}, {'name': 'Cytarabine', 'type': 'DRUG', 'armGroupLabels': ['Arm B: Cytarabine + Daunorubicin']}, {'name': 'Daunorubicin', 'type': 'DRUG', 'armGroupLabels': ['Arm B: Cytarabine + Daunorubicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 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'geoPoint': {'lat': 39.72199, 'lon': -86.08998}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Northern New Jersey Cancer Associates', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '11020', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weil Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College, Division of Oncology', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Blumenthal Cancer Center/Mecklenburg Medical Group', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Jewish Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburg Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Joe Arrington Cancer Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '79415', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy and Research Center at the University of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedlert Hospital/Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'V5Z 1L3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Research Center', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elisabeth II Health Sciences Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Department of Oncology', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jeffrey E Lancet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jazz Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}