Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 6:18 PM
Study NCT ID:
NCT01217957
Status:
COMPLETED
Last Update Posted:
2018-03-14
First Post:
2010-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed 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': 'C548400', 'term': 'ixazomib'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 787 days', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: Ixazomib + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.', 'otherNumAtRisk': 15, 'otherNumAffected': 15, 'seriousNumAtRisk': 15, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.', 'otherNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasal vestibulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Joint stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Lower urinary tract symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Breast tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Macule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Skin hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bone abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pneumonia respiratory syncytial viral', 'notes': 'One treatment-emergent death occurred in the Phase 2: Ixazomib 4 mg treatment arm and is related to the full regimen (lenalidomide, dexamethasone, and ixazomib).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cardio-respiratory arrest', 'notes': 'One treatment-emergent death occurred in the Phase 2: Ixazomib 4 mg treatment arm and is not related to study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Limb traumatic amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23. mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '73'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '75'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)', 'description': 'ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \\< 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or; 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.'}, {'type': 'PRIMARY', 'title': 'Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)', 'description': 'RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'All Phase 1 participants.'}, {'type': 'PRIMARY', 'title': 'Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)', 'description': 'MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'All Phase 1 participants.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2 :Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'title': 'Grade 3 or Higher AEs', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'AEs Resulting in Treatment Discontinuation', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined as all patients who received at least one dose of any of the 3 study drugs.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Day 1 (n=1, 3, 4, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '22.303', 'spread': '13.0184', 'groupId': 'OG001'}, {'value': '94.779', 'spread': '34.5442', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 (n=2, 3, 4, 1)', 'categories': [{'measurements': [{'value': '11.999', 'spread': 'NA', 'comment': 'Not calculated for 2 participants.', 'groupId': 'OG000'}, {'value': '31.368', 'spread': '31.9963', 'groupId': 'OG001'}, {'value': '53.517', 'spread': '22.1412', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 and 15', 'description': 'Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Day 1 (n=1, 3, 4, 1)', 'categories': [{'measurements': [{'value': '1.020', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.520', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '8.00'}, {'value': '1.060', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '1.08'}, {'value': '0.250', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Day 15 (n=2, 3, 4, 1)', 'categories': [{'measurements': [{'value': '4.165', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '7.28'}, {'value': '1.000', 'groupId': 'OG001', 'lowerLimit': '0.98', 'upperLimit': '2.03'}, {'value': '1.015', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '2.02'}, {'value': '2.000', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, Days 1 and 15', 'description': 'Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with data available.'}, {'type': 'SECONDARY', 'title': 'Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Day 1 (n=1, 3, 4, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '587.667', 'spread': '350.1861', 'groupId': 'OG001'}, {'value': '923.484', 'spread': '156.2679', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 (n=2, 3, 3, 1)', 'categories': [{'measurements': [{'value': '834.608', 'spread': 'NA', 'comment': 'Not calculated for 2 participants.', 'groupId': 'OG000'}, {'value': '1083.998', 'spread': '104.0256', 'groupId': 'OG001'}, {'value': '1831.324', 'spread': '262.7420', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated for 1 participant.', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Days 1 and 15', 'description': 'AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Rac: Accumulation Ratio of Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated for 1 participant', 'groupId': 'OG000'}, {'value': '1.849', 'spread': '0.8359', 'groupId': 'OG001'}, {'value': '2.051', 'spread': '0.6469', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1, Day 15', 'description': 'The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) analysis population, defined as all patients enrolled in the phase 1 portion of the study who had sufficient dosing data and ixazomib concentration-time data to permit calculation of ixazomib pharmacokinetic parameters, with available data.'}, {'type': 'SECONDARY', 'title': 'Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'timeFrame': 'Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose', 'description': "Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.", 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'timeFrame': 'Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose', 'description': "TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported.", 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)', 'description': 'TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-to-Treat (mITT) population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to the low number of participants who died.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to the low number of participants who died.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first dose of study treatment to the date of death (up to 787 days)', 'description': 'OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included al participants who received 1 of the 3 study drugs. Participants who did not die were censored at the last study visit.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '95'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '77', 'upperLimit': '96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 787 days', 'description': 'ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to \\< 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'title': 'After 3 cycles', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '50'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '51'}]}]}, {'title': 'After 6 cycles', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '62'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '62'}]}]}, {'title': 'After 9 cycles', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '42', 'upperLimit': '71'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '71'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After Cycles 3, 6 and 9 (Up to 787 days)', 'description': 'Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \\< 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '34'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '37'}]}]}, {'title': 'sCR', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '21'}]}]}, {'title': 'VGPR', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '54'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '53'}]}]}, {'title': 'nCR', 'categories': [{'measurements': [{'value': '2', 'comment': '95% CI lower limit is \\<1.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '11'}, {'value': '2', 'comment': '95% CI lower limit is \\<1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': '10'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '80'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '78'}]}]}, {'title': 'MR', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '17'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '16'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycles 3, 6, 9 and 12 (Up to 787 days)', 'description': 'Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\< 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The response-evaluable population was defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to Best Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '11.3'}, {'value': '3.01', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '12.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 787 days', 'description': 'Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants form the response-evaluable population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with available data.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to the low number of participants with events (progressive disease).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to the low number of participants with events (progressive disease).', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 787 days', 'description': 'DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Response Evaluable Population, defined as all patients who received at least one dose of ixazomib, had measurable disease at baseline, and at least one post-baseline disease assessment, with data available for analysis. Patients who did not experience PD were censored at the last response assessment that was SD or better.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.98', 'comment': 'Not estimable due to the low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '13.37', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to the low number of participants with events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 787 days', 'description': 'PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population was defined as all patients who received at least one dose of any study drug in phase 2 or who received at least one dose of any study drug and were treated at the phase 2 dose level during phase 1.'}, {'type': 'SECONDARY', 'title': 'Phase 2: 1 Year Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle. Includes 3 participants who received 2.23 mg/m\\^2 in Phase 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '97'}, {'value': '92', 'groupId': 'OG001', 'lowerLimit': '81', 'upperLimit': '97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year after first dose of study drug', 'description': '1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'FG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'FG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'FG004', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', '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': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Completed=Participants who are ongoing or who have died on study.', 'groupId': 'FG004', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled in the study at 10 investigative sites in the United States from 22 November 2010 to data cut-off 08 March 2013.', 'preAssignmentDetails': 'Participants with a diagnosis of multiple myeloma were enrolled in 1 of 4 dose-escalation cohorts ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m\\^2 in combination with lenalidomide, and dexamethasone to establish maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D) in Phase 2. 65 participants were enrolled; 15 in phase 1 and 50 in phase 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'BG003', 'title': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'BG004', 'title': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '3.21', 'groupId': 'BG000'}, {'value': '72.3', 'spread': '4.51', 'groupId': 'BG001'}, {'value': '63.2', 'spread': '12.19', 'groupId': 'BG002'}, {'value': '64.7', 'spread': '9.29', 'groupId': 'BG003'}, {'value': '64.2', 'spread': '11.16', 'groupId': 'BG004'}, {'value': '64.4', 'spread': '10.67', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '52', 'groupId': 'BG005'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '50', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.9', 'spread': '12.90', 'groupId': 'BG000'}, {'value': '155.4', 'spread': '3.20', 'groupId': 'BG001'}, {'value': '165.9', 'spread': '10.21', 'groupId': 'BG002'}, {'value': '171.1', 'spread': '8.07', 'groupId': 'BG003'}, {'value': '169.4', 'spread': '11.57', 'groupId': 'BG004'}, {'value': '168.5', 'spread': '11.30', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Height data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '87.43', 'spread': '12.683', 'groupId': 'BG000'}, {'value': '64.93', 'spread': '16.045', 'groupId': 'BG001'}, {'value': '72.82', 'spread': '14.557', 'groupId': 'BG002'}, {'value': '116.63', 'spread': '25.480', 'groupId': 'BG003'}, {'value': '86.13', 'spread': '17.695', 'groupId': 'BG004'}, {'value': '85.39', 'spread': '19.247', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Surface Area', 'classes': [{'categories': [{'measurements': [{'value': '2.024', 'spread': '0.2180', 'groupId': 'BG000'}, {'value': '1.665', 'spread': '0.1923', 'groupId': 'BG001'}, {'value': '1.826', 'spread': '0.2272', 'groupId': 'BG002'}, {'value': '2.348', 'spread': '0.3050', 'groupId': 'BG003'}, {'value': '2.011', 'spread': '0.2343', 'groupId': 'BG004'}, {'value': '1.994', 'spread': '0.2565', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Body surface area is defined as \\[Height(cm) x Weight (kg)\\]/3600)\\^1/2. Body surface area data was available for 3, 3, 6, 3, 48 and 51 participants in each treatment arm, respectively.', 'unitOfMeasure': 'm^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety Analysis Population: all participants who received at least one dose of any of the 3 study drugs.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-12', 'studyFirstSubmitDate': '2010-09-24', 'resultsFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-19', 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.'}, {'measure': 'Phase 2: Objective Response Rate (ORR) Following Treatment With the Combination Of Oral Ixazomib, Lenalidomide And Low-Dose Dexamethasone', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)', 'description': 'ORR was defined as the percentage of participants with Complete (CR) + Very Good Partial Response (VGPR) assessed by the investigatory using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \\< 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or; 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.'}, {'measure': 'Phase 1: Recommended Phase 2 Dose of Ixazomib Given in Combination With Lenalidomide and Low-Dose Dexamethasone', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)', 'description': 'RP2D will be determined based on number and type of adverse event and serious adverse events, assessments of clinical laboratory values, neurotoxicity grading, and treatment discontinuation.'}, {'measure': 'Phase 1: Maximum Tolerated Dose (MTD) of Ixazomib Administered Weekly in Combination With Lenalidomide and Low-Dose Dexamethasone', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 336 days)', 'description': 'MTD of ixazomib will be determined by assessing adverse events and serious adverse events, clinical laboratory values, neurotoxicity grading, and vital sign measurements.'}, {'measure': 'Phase 2: Percentage of Participants With Grade 3 or Higher AEs, SAEs and Treatment Discontinuation', 'timeFrame': 'Until occurrence of progressive disease or unacceptable toxicity (Up to 787 days)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.'}], 'secondaryOutcomes': [{'measure': 'Phase 1: Cmax: Maximum Observed Plasma Concentration for Ixazomib', 'timeFrame': 'Cycle 1, Days 1 and 15', 'description': 'Cmax: Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of ixazomib obtained directly from the plasma concentration-time curve.'}, {'measure': 'Phase 1: Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for Ixazomib', 'timeFrame': 'Cycle 1, Days 1 and 15', 'description': 'Tmax: Time to reach the first maximum observed plasma concentration (Cmax), equal to time (hours) to Cmax, obtained directly from the plasma concentration-time curve.'}, {'measure': 'Phase 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for Ixazomib', 'timeFrame': 'Cycle 1, Days 1 and 15', 'description': 'AUC(0-168) is a measure of the area under the plasma concentration-time curve from time 0 to 168 hours postdose for Ixazomib.'}, {'measure': 'Phase 1: Rac: Accumulation Ratio of Ixazomib', 'timeFrame': 'Cycle 1, Day 15', 'description': 'The accumulation ratio (Rac) was estimated as the ratio of AUC(0-168) on Day 15 to the AUC(0-168) on Day 1. AUC(0-168) is the area under the plasma concentration-time curve from time 0 to 168 hours postdose for ixazomib.'}, {'measure': 'Phase 1: Emax: Maximum Observed Inhibition of Whole Blood 20S Proteasome', 'timeFrame': 'Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose', 'description': "Emax is the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported."}, {'measure': 'Phase 1: TEmax: Time to the Maximum Observed Inhibition of Whole Blood 20S Proteasome', 'timeFrame': 'Day 1 predose and at multiple time points (up to 168 hours) postdose and Day 15 predose and at multiple time points (up to 336 hours) postdose', 'description': "TEmax is the time to the maximum observed inhibition of whole blood 20S proteasome. The pharmacodynamics 20S Proteasome samples were collected and the assays were performed; however, concerns about the third-party laboratory's performance of the blood 20S proteasome activity assay were identified that precluded the ability to confirm the accuracy of the data so no data is reported."}, {'measure': 'Phase 2: Time to Progression (TTP)', 'timeFrame': 'From the first dose of study treatment to the date of first documented progressive disease (Up to 787 days)', 'description': 'TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD).'}, {'measure': 'Phase 2: Overall Survival (OS)', 'timeFrame': 'From the first dose of study treatment to the date of death (up to 787 days)', 'description': 'OS was measured as the time in months from the first dose of study treatment to the date of death + 1 day.'}, {'measure': 'Phase 2: Overall Response Rate (ORR)', 'timeFrame': 'Up to 787 days', 'description': 'ORR was defined as the percentage of participants with CR, VGPR and Partial Response (PR) assessed by the investigator using IMWG criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. PR=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 90% or to \\< 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.'}, {'measure': 'Phase 2: Percentage of Participants With Complete Response (CR) and Very Good Partial Response (VGPR)', 'timeFrame': 'After Cycles 3, 6 and 9 (Up to 787 days)', 'description': 'Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; \\< 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.'}, {'measure': 'Phase 2: Percentage of Participants With Complete Response (CR), Stringent Complete Response (sCR), Very Good Partial Response (VGPR), Near Complete Response (nCR), Partial Response (PR) and Minimal Response (MR)', 'timeFrame': 'Cycles 3, 6, 9 and 12 (Up to 787 days)', 'description': 'Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=Negative immunofixation on the serum and urine + Disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. sCR= CR + Normal free light chain (FLC) ratio and Absence of clonal cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \\< 200 mg per 24 hours. VGPR= Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours. nCR=Positive immunofixation analysis of serum or urine as the only evidence of disease. Disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. MR=25% to 49% reduction in serum paraprotein and 50% to 89% reduction in urine light chain excretion for 6 weeks.'}, {'measure': 'Phase 2: Time to Best Response', 'timeFrame': 'Up to 787 days', 'description': 'Time to Best Response was measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.'}, {'measure': 'Phase 2: Duration of Response (DOR)', 'timeFrame': 'Up to 787 days', 'description': 'DOR was measured as the time in months from the date of first documentation of a confirmed response (CR + PR+ VGPR) to the date of the first documented disease progression (PD). Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. CR=negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \\< 5% plasma cells in bone marrow. VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \\< 100 mg per 24 hours.'}, {'measure': 'Phase 2: Progression Free Survival (PFS)', 'timeFrame': 'Up to 787 days', 'description': 'PFS was measured as the time in months from the first dose of study treatment to the date of the first documented PD or death.'}, {'measure': 'Phase 2: 1 Year Survival Rate', 'timeFrame': '1 year after first dose of study drug', 'description': '1-year survival rate is defined as the percentage of participants still alive at year after the first dose of stud drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '28803351', 'type': 'DERIVED', 'citation': 'Gupta N, Yang H, Hanley MJ, Zhang S, Liu R, Kumar S, Richardson PG, Skacel T, Venkatakrishnan K. Dose and Schedule Selection of the Oral Proteasome Inhibitor Ixazomib in Relapsed/Refractory Multiple Myeloma: Clinical and Model-Based Analyses. Target Oncol. 2017 Oct;12(5):643-654. doi: 10.1007/s11523-017-0524-3.'}, {'pmid': '25456369', 'type': 'DERIVED', 'citation': 'Kumar SK, Berdeja JG, Niesvizky R, Lonial S, Laubach JP, Hamadani M, Stewart AK, Hari P, Roy V, Vescio R, Kaufman JL, Berg D, Liao E, Di Bacco A, Estevam J, Gupta N, Hui AM, Rajkumar V, Richardson PG. Safety and tolerability of ixazomib, an oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma: an open-label phase 1/2 study. Lancet Oncol. 2014 Dec;15(13):1503-1512. doi: 10.1016/S1470-2045(14)71125-8. Epub 2014 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of Phase 1 of this study was to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral ixazomib administered in combination with lenalidomide and low-dose dexamethasone in participants with newly diagnosed multiple myeloma (NDMM). The purpose of Phase 2 of this study was to determine the overall response rate (ORR) and further evaluate the tolerability and toxicity of the combination of oral ixazomib, lenalidomide, and low-dose dexamethasone in patients with NDMM.', 'detailedDescription': 'The drug being tested in this study is called ixazomib. Ixazomib was being tested to treat people who had newly diagnosed multiple myeloma who had not previously received systemic treatment. This study was conducted in two Phases. Phase 1 looked at side effects and lab results in people who took ixazomib to determine the MTD and RP2D. Phase 2 looked at overall response rates and side effects in people who took ixazomib.\n\nThe study enrolled 15 patients in Phase 1 and 50 patients in Phase 2. Participants in Phase 1 were assigned to cohorts and received ixazomib 1.68, 2.23, 2.97, or 3.95 mg/m\\^2 in addition to dexamethasone 40 mg and lenalidomide 25 mg. Participants in Phase 2 received ixazomib 4.0 mg fixed dose in addition to dexamethasone 40 mg and lenalidomide 25 mg. In both Phases study treatment was administered in 28-day Cycles as follows: ixazomib Days 1, 8 and 15, dexamethasone Days 1, 8, 15 and 22, and lenalidomide 25 mg Days 1 through 21.\n\nThis multi-center trial was conducted in the United States. The overall time to participate in this study was 12, 28-day cycles with the option to continue into a maintenance portion in the absence of disease progression or unacceptable toxicity. Participants made multiple visits to the clinic and a final visit 30 days after last dose of study drug for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach patient must meet all of the following eligibility criteria to be enrolled in the study:\n\n* Male or female patients 18 years or older\n* Previously untreated multiple myeloma diagnosed according to standard criteria requiring systemic treatment\n* Patients must have measurable disease\n* Nonsecretory multiple myeloma based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is evaluated Patients must meet clinical laboratory criteria as specified in study protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Female and male patients MUST adhere to the guidelines of the lenalidomide pregnancy prevention program\n* Must be able to take concurrent aspirin 325 mg daily\n* Voluntary written consent\n\nExclusion Criteria\n\nPatients meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n* Peripheral neuropathy that is greater or equal to Grade 2\n* Female patients who are lactating or pregnant\n* Major surgery or radiotherapy within 14 days before the first dose of study drug\n* Serious infection requiring systemic antibiotic therapy within 14 days before the first dose of study drug\n* Diarrhea greater than Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events\n* Central nervous system involvement.\n* Evidence of current uncontrolled cardiovascular conditions within the past 6 months\n* Known human immunodeficiency virus (HIV) positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection\n* Serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol\n* Known gastrointestinal condition that could interfere with swallowing or the oral absorption or tolerance of ixazomib\n* No other prior malignancy within 2 years except nonmelanoma skin cancer or carcinoma in situ of any type if they have undergone complete resection"}, 'identificationModule': {'nctId': 'NCT01217957', 'briefTitle': 'A Study of Ixazomib Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment', 'orgStudyIdInfo': {'id': 'C16005'}, 'secondaryIdInfos': [{'id': 'U1111-1176-7340', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 1.68 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Ixazomib', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.23 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Ixazomib', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 2.97 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Ixazomib', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'description': 'In phase 1, ixazomib 3.95 mg/m\\^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m\\^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Ixazomib', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone', 'description': 'In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Ixazomib', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Ixazomib', 'type': 'DRUG', 'otherNames': ['MLN9708', 'NINLARO®'], 'description': 'Ixazomib capsules', 'armGroupLabels': ['Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Lenalidomide capsules', 'armGroupLabels': ['Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Dexamethasone tablets', 'armGroupLabels': ['Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone', 'Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Center Rose', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06489', 'city': 'Southington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Cancer Center of Central Connecticut', 'geoPoint': {'lat': 41.59649, 'lon': -72.8776}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Mt Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Harry and Jeannette Weinberg Cancer Center at Franklin Square Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital - Weill-Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'W VA University Mary Babb Randolph Cancer Center', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Medical College of Wisconsin, Inc.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Millennium Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Millennium Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}