Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-30 @ 9:53 AM
Study NCT ID:
NCT00916058
Status:
COMPLETED
Last Update Posted:
2019-06-04
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tbs2001@med.cornell.edu', 'phone': '646-962-7950', 'title': 'Tsiporah Shore', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.', 'description': 'All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Level 1', 'description': 'Dose Level 1; Bendamustine 30 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 30 mg/m\\^2 given on day 2 of melphalan\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose Level 2', 'description': 'Dose Level 2; Bendamustine 60 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m\\^2 given on the 2nd day of melphalan', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Dose Level 3', 'description': 'Dose Level 3; Bendamustine 90 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m\\^2 given on the 2nd day of melphalan', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose Level 4', 'description': 'Dose Level 4; Bendamustine 120 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m\\^2 given on the 1st and 2nd day of melphalan', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose Level 5', 'description': 'Dose Level 5; Bendamustine 150 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m\\^2 given on the 1st day of melphalan and 60 mg/m\\^2 given on the 2nd day of melphalan', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Dose Level 6', 'description': 'Dose Level 6; Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 125 mg/m\\^2 given on the 1st day of melphalan and 100mg/m\\^2 given on the 2nd day of melphalan', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Phase 2', 'description': 'Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 125 mg/m\\^2 given on the 1st day of melphalan and 100mg/m\\^2 given on the 2nd day of melphalan', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'deathsNumAffected': 6, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Mucositis Oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Rectal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Catheter-Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Oral Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Alkaline Phopshatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypophospohatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tumor Lysis Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Chest Wall Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Generalized Muscle Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Peripheral Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dry Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Maculopapular Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blurred Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and infestations - Rotavirus Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Tinea cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Streptococcus mitis Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Tinea pedia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Escherichia coli Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Clostridium difficile Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Microsporidia Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Eye Disorders - Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Reproductive system and breast disorders - Nipple Sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Infections and Infestations - Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Level 1', 'description': 'Dose Level 1; Bendamustine 30 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 30 mg/m\\^2 given on day 2 of melphalan\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'OG001', 'title': 'Dose Level 2', 'description': 'Dose Level 2; Bendamustine 60 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m\\^2 given on the 2nd day of melphalan'}, {'id': 'OG002', 'title': 'Dose Level 3', 'description': 'Dose Level 3; Bendamustine 90 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m\\^2 given on the 2nd day of melphalan'}, {'id': 'OG003', 'title': 'Dose Level 4', 'description': 'Dose Level 4; Bendamustine 120 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m\\^2 given on the 1st and 2nd day of melphalan'}, {'id': 'OG004', 'title': 'Dose Level 5', 'description': 'Dose Level 5; Bendamustine 150 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m\\^2 given on the 1st day of melphalan and 60 mg/m\\^2 given on the 2nd day of melphalan'}, {'id': 'OG005', 'title': 'Dose Level 6', 'description': 'Dose Level 6; Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 125 mg/m\\^2 given on the 1st day of melphalan and 100mg/m\\^2 given on the 2nd day of melphalan'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '35 days post-transplant', 'description': 'The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\\^3 and platelet count of 20,000/mm\\^3 untransfused by Day 35 post-transplant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 includes all patients enrolled and treated on Phase 1 of the study (Dose Levels 1 through 6).'}, {'type': 'PRIMARY', 'title': 'Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2', 'description': 'Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 125 mg/m\\^2 given on the 1st day of melphalan and 100mg/m\\^2 given on the 2nd day of melphalan'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '100 days post-transplant', 'description': 'Number of patients achieving at least a partial response or better in disease status at Day 100 post-transplant, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Partial response in disease status is defined by the IMWG as ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \\<200 mg per 24 hours; If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1', 'description': 'Patients treated on Dose Level 1 through Dose Level 6. All patients received Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min).\n\nDose Level 1; Bendamustine 30 mg/m\\^2 total Dose Level 2; Bendamustine 60 mg/m\\^2 total Dose Level 3; Bendamustine 90 mg/m\\^2 total Dose Level 4; Bendamustine 120 mg/m\\^2 total Dose Level 5; Bendamustine 150 mg/m\\^2 total Dose Level 6; Bendamustine 225 mg/m\\^2 total'}], 'classes': [{'categories': [{'measurements': [{'value': '791', 'comment': 'Upper limit not estimable', 'groupId': 'OG000', 'lowerLimit': '351', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 0 to first incidence of disease progression, up to 1,128 days', 'description': 'Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \\>25% from lowest response value in any one or more of the following:\n\n* Serum M-component and/or (the absolute increase must be \\> 0.5 g/dL)\n* Urine M-component and/or (the absolute increase must be \\> 200 mg/24 h)\n* Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \\> 10 mg/dL\n* Bone marrow plasma cell percentage; the absolute percentage must be \\> 10%\n* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\n* Development of hypercalcaemia (corrected serum calcium \\> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of progression-free survival (PFS), as PFS is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2', 'description': 'Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'comment': 'Upper limit was not estimable', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 0 to first incidence of disease progression, up to 86 months', 'description': 'Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \\>25% from lowest response value in any one or more of the following:\n\n* Serum M-component and/or (the absolute increase must be \\> 0.5 g/dL)\n* Urine M-component and/or (the absolute increase must be \\> 200 mg/24 h)\n* Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \\> 10 mg/dL\n* Bone marrow plasma cell percentage; the absolute percentage must be \\> 10%\n* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\n* Development of hypercalcaemia (corrected serum calcium \\> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.'}, {'type': 'SECONDARY', 'title': 'Overall Survival at 2 Years (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1', 'description': 'Patients treated on Dose Level 1 through Dose Level 6. All patients received Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min).\n\nDose Level 1; Bendamustine 30 mg/m\\^2 total Dose Level 2; Bendamustine 60 mg/m\\^2 total Dose Level 3; Bendamustine 90 mg/m\\^2 total Dose Level 4; Bendamustine 120 mg/m\\^2 total Dose Level 5; Bendamustine 150 mg/m\\^2 total Dose Level 6; Bendamustine 225 mg/m\\^2 total'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '85.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 0 until time of death, assessed up to 2 years.', 'description': 'Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years.', 'unitOfMeasure': 'Percentage of participants alive', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of overall survival, as overall survival is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.'}, {'type': 'SECONDARY', 'title': 'Overall Survival at 3 Years (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2', 'description': 'Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 0 until time of death, assessed up to 3 years.', 'description': 'Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years.', 'unitOfMeasure': 'Percentage of participants alive', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Level 1', 'description': 'Dose Level 1; Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 30 mg/m2 given on day 2 of melphalan\n\nMelphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'FG001', 'title': 'Dose Level 2', 'description': 'Dose Level 2; Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m2 given on the 2nd day of melphalan'}, {'id': 'FG002', 'title': 'Dose Level 3', 'description': 'Dose Level 3; Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m2 given on the 2nd day of melphalan'}, {'id': 'FG003', 'title': 'Dose Level 4', 'description': 'Dose Level 4; Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 60 mg/m2 given on the 1st and 2nd day of melphalan'}, {'id': 'FG004', 'title': 'Dose Level 5', 'description': 'Dose Level 5; Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 90 mg/m2 given on the 1st day of melphalan and 60 mg/m2 given on the 2nd day of melphalan'}, {'id': 'FG005', 'title': 'Dose Level 6', 'description': 'Dose Level 6; Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan'}, {'id': 'FG006', 'title': 'Phase 2', 'description': 'Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)\n\nMelphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \\<70 ml/min)\n\nBendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Four subjects were ineligible and therefore never started treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}, {'value': '53', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Level 1', 'description': 'Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'BG001', 'title': 'Dose Level 2', 'description': 'Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'BG002', 'title': 'Dose Level 3', 'description': 'Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'BG003', 'title': 'Dose Level 4', 'description': 'Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'BG004', 'title': 'Dose Level 5', 'description': 'Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'BG005', 'title': 'Dose Level 6', 'description': 'Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'BG006', 'title': 'Phase 2', 'description': 'Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \\<70 ml/min)'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '65'}, {'value': '54.5', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '62'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '61'}, {'value': '62', 'groupId': 'BG003', 'lowerLimit': '62', 'upperLimit': '65'}, {'value': '53', 'groupId': 'BG004', 'lowerLimit': '51', 'upperLimit': '60'}, {'value': '55', 'groupId': 'BG005', 'lowerLimit': '48', 'upperLimit': '66'}, {'value': '61', 'groupId': 'BG006', 'lowerLimit': '41', 'upperLimit': '71'}, {'value': '59', 'groupId': 'BG007', 'lowerLimit': '37', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}, {'value': '26', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '13', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}, {'value': '43', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2009-06-05', 'resultsFirstSubmitDate': '2019-03-04', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-14', 'studyFirstPostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (Phase 1)', 'timeFrame': '35 days post-transplant', 'description': 'The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\\^3 and platelet count of 20,000/mm\\^3 untransfused by Day 35 post-transplant.'}, {'measure': 'Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant', 'timeFrame': '100 days post-transplant', 'description': 'Number of patients achieving at least a partial response or better in disease status at Day 100 post-transplant, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Partial response in disease status is defined by the IMWG as ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \\<200 mg per 24 hours; If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (Phase 1)', 'timeFrame': 'From Day 0 to first incidence of disease progression, up to 1,128 days', 'description': 'Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \\>25% from lowest response value in any one or more of the following:\n\n* Serum M-component and/or (the absolute increase must be \\> 0.5 g/dL)\n* Urine M-component and/or (the absolute increase must be \\> 200 mg/24 h)\n* Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \\> 10 mg/dL\n* Bone marrow plasma cell percentage; the absolute percentage must be \\> 10%\n* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\n* Development of hypercalcaemia (corrected serum calcium \\> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder'}, {'measure': 'Progression-Free Survival (Phase 2)', 'timeFrame': 'From Day 0 to first incidence of disease progression, up to 86 months', 'description': 'Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \\>25% from lowest response value in any one or more of the following:\n\n* Serum M-component and/or (the absolute increase must be \\> 0.5 g/dL)\n* Urine M-component and/or (the absolute increase must be \\> 200 mg/24 h)\n* Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \\> 10 mg/dL\n* Bone marrow plasma cell percentage; the absolute percentage must be \\> 10%\n* Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\n* Development of hypercalcaemia (corrected serum calcium \\> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder'}, {'measure': 'Overall Survival at 2 Years (Phase 1)', 'timeFrame': 'From Day 0 until time of death, assessed up to 2 years.', 'description': 'Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years.'}, {'measure': 'Overall Survival at 3 Years (Phase 2)', 'timeFrame': 'From Day 0 until time of death, assessed up to 3 years.', 'description': 'Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Autologous Stem Cell Transplant', 'ASCT', 'MM'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '31190006', 'type': 'DERIVED', 'citation': 'Gomez-Arteaga A, Mark TM, Guarneri D, Christos PJ, Gergis U, Greenberg JD, Hsu J, Mayer SA, Niesvizky R, Pearse RN, Phillips AA, Rossi A, Coleman M, van Besien K, Shore TB. High-dose bendamustine and melphalan conditioning for autologous stem cell transplantation for patients with multiple myeloma. Bone Marrow Transplant. 2019 Dec;54(12):2027-2038. doi: 10.1038/s41409-019-0587-0. Epub 2019 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.', 'detailedDescription': 'Bendamustine (TREANDA™) has been used in clinical trials to treat multiple myeloma. The results from these trials suggest that it may be beneficial in the treatment of multiple myeloma in a different treatment context. Researchers aim to determine if there may be an improved benefit in the context of bone marrow transplant. This initial clinical trial is intended to help determine how safe it is to use bendamustine as a conditioning regimen for bone marrow transplant, and to look for any initial evidence of benefit.\n\nBendamustine (TREANDA™) is approved by the Food and Drug Administration (FDA) for the treatment of Chronic Lymphocytic Leukemia and Melphalan is a type of chemotherapy drug.\n\nThe use of Melphalan alone as a conditioning regimen for Autologous Stem Cell Transplant is considered "Standard of Care," that is, the treatment or process that your doctor would normally follow to treat your disease. Although Bendamustine (TREANDA™) has been used in multiple myeloma research studies, the combination of Bendamustine (TREANDA™) and Melphalan as treatment for Multiple Myeloma is not approved by the FDA, thus the combination therapy used in this research study is considered "investigational."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with multiple myeloma who have received induction therapy and have had stem cells mobilized in preparation for autologous transplantation will be eligible for this study. Patients are also eligible with relapsed or refractory disease, after attempts at more standard approaches, and with the availability of stem cells.\n* Patients must be age 18 or older.\n* Patients must have a life expectancy of at least 12 weeks.\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n* Patients must provide written informed consent.\n\nExclusion Criteria:\n\n* Impaired renal function with a measured or calculated creatinine clearance of less than 25 ml/min.\n* Impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 x ULN.\n* Serious active or uncontrolled infection or medical condition.\n* Women who are pregnant or breast feeding. Women of childbearing age must use adequate contraception and have a negative pregnancy test.\n* Impaired pulmonary function with a diffusing capacity of the lung for carbon monoxide (DLCO) less than 45% predicted.\n* Impaired cardiac function with an ejection fraction less than 40% of predicted.\n* Other systemic anticancer therapy or ongoing toxicities from such therapy.'}, 'identificationModule': {'nctId': 'NCT00916058', 'briefTitle': 'Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Phase 1-2 Study of a Novel Conditioning Regimen of Bendamustine and Melphalan Followed by Autologous Stem Cell Transplant for Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': '0812010147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1', 'description': 'Dose Level 1; Bendamustine 30 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)', 'interventionNames': ['Drug: Bendamustine', 'Drug: Melphalan']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 2', 'description': 'Dose Level 2; Bendamustine 60 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)', 'interventionNames': ['Drug: Melphalan', 'Drug: Bendamustine']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3', 'description': 'Dose Level 3; Bendamustine 90 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)', 'interventionNames': ['Drug: Melphalan', 'Drug: Bendamustine']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 4', 'description': 'Dose Level 4; Bendamustine 120 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)', 'interventionNames': ['Drug: Melphalan', 'Drug: Bendamustine']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 5', 'description': 'Dose Level 5; Bendamustine 150 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)', 'interventionNames': ['Drug: Melphalan', 'Drug: Bendamustine']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 6', 'description': 'Dose Level 6; Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)', 'interventionNames': ['Drug: Melphalan', 'Drug: Bendamustine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2', 'description': 'Bendamustine 225 mg/m\\^2 total, Melphalan 200 mg/m\\^2 total (140 mg/m\\^2 total for patients with Creatinine Clearance \\<70 ml/min)', 'interventionNames': ['Drug: Melphalan', 'Drug: Bendamustine']}], 'interventions': [{'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda'], 'description': '30 mg/m\\^2 given on day 2 of melphalan', 'armGroupLabels': ['Dose Level 1']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Alkeran'], 'description': '100 mg/m\\^2 for 2 days (70 mg/m\\^2 for patients with Creatinine Clearance \\<70 ml/min)', 'armGroupLabels': ['Dose Level 1', 'Dose Level 2', 'Dose Level 3', 'Dose Level 4', 'Dose Level 5', 'Dose Level 6', 'Phase 2']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda'], 'description': '60 mg/m\\^2 given on the 2nd day of melphalan', 'armGroupLabels': ['Dose Level 2']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda'], 'description': '90 mg/m\\^2 given on the 2nd day of melphalan', 'armGroupLabels': ['Dose Level 3']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda'], 'description': '60 mg/m\\^2 given on the 1st and 2nd day of melphalan', 'armGroupLabels': ['Dose Level 4']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda'], 'description': '90 mg/m\\^2 given on the 1st day of melphalan and 60 mg/m\\^2 given on the 2nd day of melphalan', 'armGroupLabels': ['Dose Level 5']}, {'name': 'Bendamustine', 'type': 'DRUG', 'otherNames': ['Treanda'], 'description': '125 mg/m\\^2 given on the 1st day of melphalan and 100mg/m\\^2 given on the 2nd day of melphalan', 'armGroupLabels': ['Dose Level 6', 'Phase 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Tsiporah Shore, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}