Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT02312258
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2014-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'First dose of study drug through 30 days after last dose of study drug (up to 88 months)', 'description': 'All-cause mortality= ITT Population included all participants who were randomized and had post-randomization data. Serious and Other Adverse Events: Safety population included all participants who received at least 1 dose of ixazomib or placebo. Three participants assigned to placebo arm each received a single 3 mg dose of ixazomib. These participants were excluded from the placebo arm and included in the ixazomib arm in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.', 'otherNumAtRisk': 276, 'deathsNumAtRisk': 281, 'otherNumAffected': 188, 'seriousNumAtRisk': 276, 'deathsNumAffected': 115, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.', 'otherNumAtRisk': 426, 'deathsNumAtRisk': 425, 'otherNumAffected': 340, 'seriousNumAtRisk': 426, 'deathsNumAffected': 184, 'seriousNumAffected': 101}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 61}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 62}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 119}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 66}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 69}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Carcinoma in situ of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': "Chilaiditi's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Gastroenteritis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Transitional cell cancer of the renal pelvis and ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 276, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 426, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '8.51', 'upperLimit': '11.47'}, {'value': '17.4', 'groupId': 'OG001', 'lowerLimit': '14.78', 'upperLimit': '20.30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Per IMWG criteria, PD is defined as, increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/ deciliter (dL)); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved free light chains (FLC) levels (absolute increase \\>10 mg/dL); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia (corrected serum calcium \\>11.5mg/dL).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '69.5', 'groupId': 'OG000', 'lowerLimit': '56.67', 'upperLimit': '75.17'}, {'value': '64.8', 'groupId': 'OG001', 'lowerLimit': '54.87', 'upperLimit': '74.84'}]}]}], 'analyses': [{'pValue': '=0.473', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.090', 'ciLowerLimit': '0.861', 'ciUpperLimit': '1.381', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), International Staging System (ISS) stage before initial therapy (stage I or II vs stage III), age (\\<75 versus \\[vs\\] \\>=75 years) at randomization, and best response to initial therapy (complete response (CR) or very good partial response (VGPR) vs partial response (PR)).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 versus\\[vs\\] \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)', 'description': 'OS was measured as the time from the date of randomization to the date of death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'title': 'PR', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'VGPR', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'CR', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 27 months', 'description': 'Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= \\>=50% reduction of serum M protein and \\>=90% or \\<200 mg reduction urinary M protein in 24-hour, or \\>50% decrease in difference between involved and uninvolved FLC levels, or \\>50% reduction in bone marrow plasma cells, if bone marrow plasma cells \\>30% and \\>50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= \\>90% reduction (\\<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= \\>5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. The percentages are rounded off to the single nearest decimal point.'}, {'type': 'SECONDARY', 'title': 'Time to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '8.67', 'upperLimit': '11.99'}, {'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '15.67', 'upperLimit': '20.63'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.655', 'ciLowerLimit': '0.537', 'ciUpperLimit': '0.799', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing TTP between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival 2 (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'groupId': 'OG000', 'lowerLimit': '40.05', 'upperLimit': '62.46'}, {'value': '51.3', 'groupId': 'OG001', 'lowerLimit': '44.91', 'upperLimit': '63.41'}]}]}], 'analyses': [{'pValue': '=0.893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.984', 'ciLowerLimit': '0.777', 'ciUpperLimit': '1.246', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing PFS2 between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to every 12 weeks until second PD or death (up to 88 months)', 'description': 'PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Time to Next Line Therapy (TTNT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '13.54', 'upperLimit': '19.35'}, {'value': '22.1', 'groupId': 'OG001', 'lowerLimit': '19.55', 'upperLimit': '25.89'}]}]}], 'analyses': [{'pValue': '=0.018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.777', 'ciLowerLimit': '0.631', 'ciUpperLimit': '0.957', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing TTNT between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data.'}, {'type': 'SECONDARY', 'title': 'Time to End of the Next-line of Therapy After Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '22.70', 'upperLimit': '28.48'}, {'value': '23.1', 'groupId': 'OG001', 'lowerLimit': '20.93', 'upperLimit': '26.05'}]}]}], 'analyses': [{'pValue': '=0.462', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.111', 'ciLowerLimit': '0.839', 'ciUpperLimit': '1.470', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing Time to End of Next Line Therapy between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Duration of Next-line Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '10.41', 'upperLimit': '16.82'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '7.85', 'upperLimit': '10.87'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.293', 'ciLowerLimit': '0.968', 'ciUpperLimit': '1.727', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Develop a New Primary Malignancy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. The percentages are rounded off to the single nearest decimal point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 months', 'description': 'Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry. MRD negativity was defined as absence of MRD and MRD positivity was defined as presence of MRD. MRD was assessed by 8-color flow cytometry with the IMWG recommended sensitivity of 10\\^-5.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. The percentages are rounded off to the nearest single decimal point.'}, {'type': 'SECONDARY', 'title': 'Correlation of MRD Status With PFS and OS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'title': 'PFS for Participants with Known MRD+ at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.75', 'upperLimit': '11.99'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '13.47', 'upperLimit': '21.29'}]}]}, {'title': 'PFS for Participants with Known MRD- at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of confidence interval (CI) were not estimable due to censoring.', 'groupId': 'OG000', 'lowerLimit': '23.69', 'upperLimit': 'NA'}, {'value': '40.5', 'comment': 'Upper limit of CI was not estimable due to censoring.', 'groupId': 'OG001', 'lowerLimit': '26.94', 'upperLimit': 'NA'}]}]}, {'title': 'OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, upper, and lower limit of CI were not estimable due to censoring.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, upper, and lower limit of CI were not estimable due to censoring.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '=0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.582', 'ciLowerLimit': '0.425', 'ciUpperLimit': '0.796', 'groupDescription': 'PFS for Participants with Known MRD+ at Study Entry', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}, {'pValue': '=0.398', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.537', 'ciLowerLimit': '0.563', 'ciUpperLimit': '4.194', 'groupDescription': 'PFS for Participants with Known MRD- at Study Entry', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}, {'pValue': '=0.012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.173', 'ciLowerLimit': '1.194', 'ciUpperLimit': '86.649', 'groupDescription': 'OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization up to 52 months', 'description': 'PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category.'}, {'type': 'SECONDARY', 'title': 'OS in a High-risk Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '29.70', 'upperLimit': '74.48'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '26.05', 'upperLimit': '47.44'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)', 'description': 'High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation \\[t\\](4;14), t(14;16). OS was measured as the time from the date of randomization to the date of death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number of participants analyzed is the number of participants present in the high-risk group.'}, {'type': 'SECONDARY', 'title': 'PFS in a High-risk Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '5.62', 'upperLimit': '13.90'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '6.01', 'upperLimit': '17.02'}]}]}], 'analyses': [{'pValue': '=0.963', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.011', 'ciLowerLimit': '0.631', 'ciUpperLimit': '1.621', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'High-risk population included but not be limited to participants carrying del17, t(4;14), t(14;16). PFS was defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number of participants analyzed is the number of participants present in the high-risk group.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '355', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '332', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.49', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.47', 'groupId': 'OG001'}]}]}, {'title': 'PFSFU- Visit 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable for a single participant.', 'groupId': 'OG001'}]}]}, {'title': 'PDFU- Visit 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable for a single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)', 'description': "ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \\>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower grades indicate improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'TEAE', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose of study drug through 30 days after last dose of study drug (up to 88 months)', '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 (e.g., 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. TEAEs were defined as events that occurred after administration of the first dose of ixazomib or placebo through 30 days after the last dose of ixazomib or placebo. A SAE means any untoward medical occurrence that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was considered medically significant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. The percentages were rounded off to the nearest single decimal point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '16.63', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '16.77', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '15.74', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '17.14', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '16.80', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '16.53', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '15.79', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '16.33', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '18.33', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '16.56', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '16.32', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '17.28', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '18.07', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '17.44', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '16.67', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '16.57', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '16.38', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '17.82', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '17.37', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '17.75', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '16.26', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '16.13', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '16.85', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '16.99', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '17.45', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '16.74', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '17.65', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '15.57', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '17.03', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '15.09', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '18.09', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '18.40', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '16.87', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '18.07', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '17.24', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '17.95', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '16.13', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '16.39', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '16.19', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '15.55', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '17.13', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '19.01', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '16.96', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '20.46', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '15.65', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '18.80', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '17.52', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '17.49', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '17.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Correlation Between Frailty Status and PFS and OS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'title': 'PFS Based on Frailty Status of Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '7.39', 'upperLimit': '10.41'}, {'value': '18.6', 'groupId': 'OG001', 'lowerLimit': '12.75', 'upperLimit': '25.63'}]}]}, {'title': 'PFS Based on Frailty Status of Unfit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '7.39', 'upperLimit': '14.23'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '13.17', 'upperLimit': '21.78'}]}]}, {'title': 'PFS Based on Frailty Status of Frail', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '8.44', 'upperLimit': '15.67'}, {'value': '15.4', 'groupId': 'OG001', 'lowerLimit': '11.10', 'upperLimit': '23.75'}]}]}, {'title': 'OS Based on Frailty Status of Fit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, upper, and lower limit of CI were not estimable due to censoring.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median, upper, and lower limit of CI were not estimable due to censoring.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'OS Based on Frailty Status of Unfit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median, upper, and lower limit of CI were not estimable due to censoring.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and lower limit of CI were not estimable due to censoring.', 'groupId': 'OG001', 'lowerLimit': '39.59', 'upperLimit': 'NA'}]}]}, {'title': 'OS Based on Frailty Status of Frail', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.5', 'comment': 'Upper limit of CI was not estimable due to censoring.', 'groupId': 'OG000', 'lowerLimit': '29.93', 'upperLimit': 'NA'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '34.30', 'upperLimit': '46.52'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.530', 'ciLowerLimit': '0.387', 'ciUpperLimit': '0.727', 'groupDescription': 'PFS Based on Frailty Status of Fit', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\\<75 vs \\>=75 years) at randomization.\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\\<75 vs \\>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}, {'pValue': '=0.098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.746', 'ciLowerLimit': '0.526', 'ciUpperLimit': '1.058', 'groupDescription': 'PFS Based on Frailty Status of Unfit', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\\<75 vs \\>=75 years) at randomization.\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\\<75 vs \\>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}, {'pValue': '=0.147', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.733', 'ciLowerLimit': '0.481', 'ciUpperLimit': '1.117', 'groupDescription': 'PFS Based on Frailty Status of Frail', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing PFS between treatment groups was based on Log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\\<75 vs \\>=75 years) at randomization.\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), and age (\\<75 vs \\>=75 years) at randomization, comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}, {'pValue': '=0.714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.897', 'ciLowerLimit': '0.502', 'ciUpperLimit': '1.602', 'groupDescription': 'OS Based on Frailty Status of Fit', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}, {'pValue': '=0.124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.750', 'ciLowerLimit': '0.850', 'ciUpperLimit': '3.601', 'groupDescription': 'OS Based on Frailty Status of Unfit', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}, {'pValue': '=0.630', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.854', 'ciLowerLimit': '0.448', 'ciUpperLimit': '1.627', 'groupDescription': 'OS Based on Frailty Status of Frail', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR).\n\nHazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\\<75 vs \\>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant."}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization up to 52 months', 'description': "Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first, assessed for up to 52 months in this outcome measure. OS will be measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure.", 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis for the specified category.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetic Parameter: Plasma Concentration of Ixazomib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'title': 'Cycle 1 Day 1 - 1 Hour Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '413', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.353', 'spread': '89.2568', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 1 - 4 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.698', 'spread': '67.8350', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 8 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.683', 'spread': '162.3947', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 15 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.828', 'spread': '86.7699', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.958', 'spread': '170.8938', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 8 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '394', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.217', 'spread': '188.6379', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.252', 'spread': '56.2869', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.363', 'spread': '52.9781', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.328', 'spread': '53.0909', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5 Day 8 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.547', 'spread': '224.4312', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.503', 'spread': '52.9349', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 7 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.585', 'spread': '57.9514', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.606', 'spread': '58.5109', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 9 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.566', 'spread': '58.1094', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 10 Day 1 - Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.686', 'spread': '50.2494', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (cycle length=28 days)', 'description': 'Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) assay.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Population included all participants with at least one pharmacokinetic (PK) sample that was collected and analyzed. Number analyzed is the number of participants with data available for analysis at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Peripheral Neuropathy (PN) Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '196.0', 'groupId': 'OG000', 'lowerLimit': '43.0', 'upperLimit': '331.0'}, {'value': '451.0', 'comment': 'Upper limit of CI was not estimable due to censoring.', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 52 months', 'description': 'PN is defined as the event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the medical dictionary for regulatory activities (MedDRA). A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Overall number of participants analyzed are the number of participants with events.'}, {'type': 'SECONDARY', 'title': 'Time to Improvement of PN Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'OG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '280.0'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '29.0', 'upperLimit': '393.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 52 months', 'description': 'PN is defined as the event in the high-level term of peripheral neuropathies NEC according to the MedDRA. A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the improvement date or the day before and after. Time to improvement was defined as the time from the initial onset date (inclusive) to the improvement of event.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Overall number of participants analyzed are the number of participants with events.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'FG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '425'}]}, {'type': 'Safety Population', 'comment': 'The safety population was defined as all participants who received at least 1 dose of ixazomib or placebo.\n\nThree placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '426'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '281'}, {'groupId': 'FG001', 'numSubjects': '425'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '115'}, {'groupId': 'FG001', 'numSubjects': '181'}]}]}], 'recruitmentDetails': 'Participants took part in the study from 09 April 2015 to 26 August 2022.', 'preAssignmentDetails': 'Participants with newly diagnosed multiple myeloma not treated with stem cell transplantation (SCT) were enrolled and randomized in a 3:2 ratio to receive ixazomib or placebo respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '706', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.'}, {'id': 'BG001', 'title': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '6.77', 'groupId': 'BG000'}, {'value': '72.3', 'spread': '6.87', 'groupId': 'BG001'}, {'value': '72.5', 'spread': '6.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '222', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '366', 'groupId': 'BG001'}, {'value': '603', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '557', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'China', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic Of', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan, Province Of China', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) Population included all participants who were randomized and had post-randomization data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-18', 'size': 3103956, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-23T05:28', 'hasProtocol': True}, {'date': '2019-09-20', 'size': 3057090, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-08-06T10:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 706}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-23', 'studyFirstSubmitDate': '2014-12-05', 'resultsFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-19', 'studyFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Per IMWG criteria, PD is defined as, increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/ deciliter (dL)); or urine M-component (absolute increase ≥200 mg/24-hour); difference between involved and uninvolved free light chains (FLC) levels (absolute increase \\>10 mg/dL); or bone marrow plasma cell percentage (absolute plasma cell percentage ≥10%); development of new/ increase in size of existing bone lesions or soft tissue plasmacytoma; or development of hypercalcemia (corrected serum calcium \\>11.5mg/dL).'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)', 'description': 'OS was measured as the time from the date of randomization to the date of death.'}, {'measure': 'Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period', 'timeFrame': 'Up to 27 months', 'description': 'Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= \\>=50% reduction of serum M protein and \\>=90% or \\<200 mg reduction urinary M protein in 24-hour, or \\>50% decrease in difference between involved and uninvolved FLC levels, or \\>50% reduction in bone marrow plasma cells, if bone marrow plasma cells \\>30% and \\>50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= \\>90% reduction (\\<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= \\>5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.'}, {'measure': 'Time to Progression (TTP)', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'TTP is defined as the time from the date of randomization to the date of first documentation of PD, using IMWG criteria.'}, {'measure': 'Progression Free Survival 2 (PFS2)', 'timeFrame': 'From the date of randomization to every 12 weeks until second PD or death (up to 88 months)', 'description': 'PFS2 is defined as the time from the date of randomization to objective PD on next-line treatment using IMWG criteria, or death due to any cause, whichever occurred first.'}, {'measure': 'Time to Next Line Therapy (TTNT)', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'TTNT is defined as the time from the date of randomization to the date of the first dose of next-line antineoplastic therapy.'}, {'measure': 'Time to End of the Next-line of Therapy After Study Treatment', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'Time to end of the next line of therapy is defined as the time from the date of randomization to the date of last dose of the next line of antineoplastic therapy following study treatment.'}, {'measure': 'Duration of Next-line Therapy', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.'}, {'measure': 'Percentage of Participants Who Develop a New Primary Malignancy', 'timeFrame': 'From randomization until PD or death (up to 52 months)'}, {'measure': 'Percentage of Participants With Conversion From Minimal Residual Disease (MRD) Positive to MRD Negative', 'timeFrame': 'Up to 52 months', 'description': 'Bone marrow aspirates and blood samples were sent to a central laboratory and were assessed for MRD using flow cytometry. MRD negativity was defined as absence of MRD and MRD positivity was defined as presence of MRD. MRD was assessed by 8-color flow cytometry with the IMWG recommended sensitivity of 10\\^-5.'}, {'measure': 'Correlation of MRD Status With PFS and OS', 'timeFrame': 'From randomization up to 52 months', 'description': 'PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.'}, {'measure': 'OS in a High-risk Population', 'timeFrame': 'From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)', 'description': 'High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation \\[t\\](4;14), t(14;16). OS was measured as the time from the date of randomization to the date of death.'}, {'measure': 'PFS in a High-risk Population', 'timeFrame': 'From randomization until PD or death (up to 52 months)', 'description': 'High-risk population included but not be limited to participants carrying del17, t(4;14), t(14;16). PFS was defined as the time from the date of randomization to the date of first documentation of PD or death from any cause.'}, {'measure': 'Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status', 'timeFrame': 'Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)', 'description': "ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \\>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower grades indicate improvement."}, {'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'First dose of study drug through 30 days after last dose of study drug (up to 88 months)', '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 (e.g., 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. TEAEs were defined as events that occurred after administration of the first dose of ixazomib or placebo through 30 days after the last dose of ixazomib or placebo. A SAE means any untoward medical occurrence that resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was considered medically significant.'}, {'measure': 'Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) as Measured by the Global Health Status (GHS)', 'timeFrame': 'Baseline, Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26 (cycle length=28 days)', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The change from baseline in GHS (EORTC QLQ-C30) score is presented. Participant responses to the question "How would you rate your overall health during the past week?" are scored on a 7-point scale (1=very poor to 7=excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall GHS.'}, {'measure': 'Correlation Between Frailty Status and PFS and OS', 'timeFrame': 'From randomization up to 52 months', 'description': "Participant's frailty status is classified as fit, unfit or frail on the bases of 4 components: age, the Charlson comorbidity scoring system without age weighting, the Katz index of independence in activities of daily living, and the Lawton instrumental activities of daily living scale. The sum of the 4 frailty scores equals the total frailty score. A total frailty score of 0 corresponds to a frailty status of fit; a total score of 1, to unfit; and a total score of 2 or more, to frail. PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurs first, assessed for up to 52 months in this outcome measure. OS will be measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure."}, {'measure': 'Pharmacokinetic Parameter: Plasma Concentration of Ixazomib', 'timeFrame': 'Cycle 1 (1 and 4 hours post-dose Day 1, Days 8 and 15 pre-dose); Cycle 2 and 5 (Days 1 and 8 pre-dose) and Cycles 3, 4, 6 to 10 (Day 1 pre-dose) (cycle length=28 days)', 'description': 'Plasma concentrations of the complete hydrolysis product of ixazomib citrate (ixazomib) were measured using a validated liquid chromatography-tandem mass spectrometry (LC/MS/MS) assay.'}, {'measure': 'Time to Resolution of Peripheral Neuropathy (PN) Events', 'timeFrame': 'Up to 52 months', 'description': 'PN is defined as the event in the high-level term of peripheral neuropathies not elsewhere classified (NEC) according to the medical dictionary for regulatory activities (MedDRA). A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the resolution date or the day before and after. Time to resolution was defined as the time from the initial onset date (inclusive) to the resolution date for resolved events.'}, {'measure': 'Time to Improvement of PN Events', 'timeFrame': 'Up to 52 months', 'description': 'PN is defined as the event in the high-level term of peripheral neuropathies NEC according to the MedDRA. A PN event was considered as resolved if its final outcome was resolved with no subsequent PN event of the same preferred term occurring on the improvement date or the day before and after. Time to improvement was defined as the time from the initial onset date (inclusive) to the improvement of event.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '36130300', 'type': 'DERIVED', 'citation': 'Paiva B, Manrique I, Dimopoulos MA, Gay F, Min CK, Zweegman S, Spicka I, Teipel R, Mateos MV, Giuliani N, Cavo M, Hopkins CR, Fu W, Suryanarayan K, Vorog A, Li C, Wang B, Estevam J, Labotka R, Dash AB. MRD dynamics during maintenance for improved prognostication of 1280 patients with myeloma in the TOURMALINE-MM3 and -MM4 trials. Blood. 2023 Feb 9;141(6):579-591. doi: 10.1182/blood.2022016782.'}, {'pmid': '33021870', 'type': 'DERIVED', 'citation': 'Dimopoulos MA, Spicka I, Quach H, Oriol A, Hajek R, Garg M, Beksac M, Bringhen S, Katodritou E, Chng WJ, Leleu X, Iida S, Mateos MV, Morgan G, Vorog A, Labotka R, Wang B, Palumbo A, Lonial S; TOURMALINE-MM4 study group. Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial. J Clin Oncol. 2020 Dec 1;38(34):4030-4041. doi: 10.1200/JCO.20.02060. Epub 2020 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response \\[CR\\], very good partial response \\[VGPR\\], or partial response \\[PR\\]) to initial therapy and who have not undergone SCT.', 'detailedDescription': 'The drug being tested in this study is called ixazomib citrate. Ixazomib citrate is being tested to slow progressive disease (PD) and improve overall survival in people who have NDMM who have had a major positive response to initial therapy and have not undergone SCT. This study will look at the effect of ixazomib citrate has on the length of time that participants are free of PD and their overall survival.\n\nThe study will enrol approximately 700 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 3:2 ratio to Ixazomib or matching placebo groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):\n\n* Ixazomib citrate initiates at 3 mg which will be escalated to 4 mg with cycle 5 day 1\n* Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient\n\nAll participants will be asked to take one capsule on Days 1, 8 and 15 of each 28-day cycle. The treatment period will be approximately 24 months (equivalent to 26 cycles) or until patients experience PD or unacceptable toxicities, whichever occurs first.\n\nThis multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 78 to 106 months. Participants will make 28 visits to the clinic during the treatment period and will continue to make follow-up visits every 4 weeks until the next line of therapy begins. Participants will also be contacted by telephone every 12 weeks after last treatment visit for a follow-up assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult male or female participants 18 years or older with a confirmed diagnosis of symptomatic newly diagnosed multiple myeloma (NDMM) according to standard criteria.\n2. Completed 6 to 12 months (± 2 weeks) of initial therapy, during which the participant was treated to best response, defined as the best response maintained for 2 cycles after the M-protein nadir is reached.\n3. Documented major response (PR, VGPR, CR) according to the International Myeloma Working Group (IMWG) uniform response criteria, version 2011, after this initial therapy.\n4. Female participants who:\n\n * Are postmenopausal for at least 1 year before the screening visit, OR\n * Are surgically sterile, OR\n * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, OR\n * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[eg, calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n\n Male participants, even if surgically sterilized (that is, status postvasectomy), who:\n * Agree to practice effective barrier contraception during the entire study Treatment period and through 90 days after the last dose of study drug, OR\n * Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[example, calendar, ovulation, symptothermal, postovulation methods for the female partner\\] and withdrawal are not acceptable methods of contraception.)\n5. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.\n6. Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.\n7. Eastern Cooperative Oncology Group Performance Status of 0 to 2.\n8. Suitable venous access for the study-required blood sampling and consent for the specific amounts that will be taken.\n9. Is willing and able to adhere to the study visit schedule and other protocol requirements including blood sampling and bone marrow aspiration.\n10. Must meet the following clinical laboratory criteria at study entry:\n\n * Absolute neutrophil count (ANC) greater than or equal to (≥) 1,000 per cubic millimeter (/mm\\^3) without growth factor support and platelet count ≥75,000/mm\\^3. Platelet transfusions to help participants meet eligibility criteria are not allowed within 3 days before randomization.\n * Total bilirubin less than or equal to (≤) 1.5\\*the upper limit of the normal range (ULN).\n * Alanine aminotransferase and aspartate aminotransferase ≤ 3\\*ULN.\n * Calculated creatinine clearance ≥ 30 milliliter per minute (mL/min) (using the Cockcroft-Gault equation).\n\nExclusion Criteria:\n\n1. Multiple myeloma that has relapsed after, or was not responsive to, initial therapy.\n2. Prior SCT.\n3. Radiotherapy within 14 days before randomization.\n4. Diagnosed or treated for another malignancy within 5 years before randomization or previous diagnosis with another malignancy. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.\n5. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period.\n6. Major surgery within 14 days before randomization.\n7. Central nervous system involvement.\n8. Infection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.\n9. Diagnosis of Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome (POEMS), plasma cell leukemia, primary amyloidosis, myelodysplastic syndrome, or myeloproliferative syndrome.\n10. Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.\n11. Systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or St. John's wort within 14 days before randomization.\n12. Ongoing or active infection, known human immunodeficiency virus (HIV) positive, active hepatitis B or C infection.\n13. Comorbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens (example, PN that is Grade 1 with pain or Grade 2 or higher of any cause).\n14. Psychiatric illness or social situation that would limit compliance with study requirements.\n15. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n16. Inability to swallow oral medication, inability or unwillingness to comply with the drug administration requirements, or gastrointestinal (GI) procedure that could interfere with the oral absorption or tolerance of treatment.\n17. Treatment with any investigational products within 30 days before randomization."}, 'identificationModule': {'nctId': 'NCT02312258', 'briefTitle': 'A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'C16021'}, 'secondaryIdInfos': [{'id': 'U1111-1160-1702', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '2014-001394-13', 'type': 'EUDRACT_NUMBER'}, {'id': 'REec-2015-1414', 'type': 'REGISTRY', 'domain': 'REec'}, {'id': 'JapicCTI-152873', 'type': 'REGISTRY', 'domain': 'JapicCTI'}, {'id': '153300410A0048', 'type': 'REGISTRY', 'domain': 'RNEC'}, {'id': '1046003327', 'type': 'REGISTRY', 'domain': 'TCTIN'}, {'id': 'SNCTP000001745', 'type': 'REGISTRY', 'domain': 'SNCTP'}, {'id': '15/NE/0167', 'type': 'REGISTRY', 'domain': 'NRES'}, {'id': '182602', 'type': 'REGISTRY', 'domain': 'HC-CTD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ixazomib', 'description': 'Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.', 'interventionNames': ['Drug: Ixazomib']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Ixazomib placebo-matching capsules.', 'armGroupLabels': ['Placebo']}, {'name': 'Ixazomib', 'type': 'DRUG', 'description': 'Ixazomib capsules.', 'armGroupLabels': ['Ixazomib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Robert A Moss MD FACP Inc', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Hematology and Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'North County Oncology Medical Clinic Inc', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Ventura County Hematology Oncology Specialists', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '92373', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Emad Ibrahim, MD, Inc', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Global Cancer Research Institute (GCRI), Inc.', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Central Coast Medical Oncology Corporation', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute, Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H. Stroger Jr. Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology - Oncology Associates LLP', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '41701', 'city': 'Hazard', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Appalachian Regional Healthcare', 'geoPoint': {'lat': 37.24954, 'lon': -83.19323}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': 'New England Cancer Specialists', 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Saint Agnes Hospital - Baltimore - Hunt - PPDS', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'University Hospital of Wales -', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center - PPDS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48912', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Herbert-Herman Cancer Center', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Clinical Research Alliance Inc', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'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': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cancer Care of WNC PA', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Cancer Pavillion', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75701', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'HOPE Cancer Center of East Texas', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'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': 'B1629AHJ', 'city': 'Buenos Aires', 'state': 'Ciudad Autonoma de BuenosAires', 'country': 'Argentina', 'facility': 'Hospital Universitario Austral', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1181ACH', 'city': 'Buenos Aires', 'state': 'Ciudad Autonoma de BuenosAires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1431FWO', 'city': 'Buenos Aires', 'state': 'Ciudad Autonoma de BuenosAires', 'country': 'Argentina', 'facility': 'Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'X5000JHQ', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Sanatorio Allende S.A.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'S3000ADL', 'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Hospital Iturraspe', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'St Vincents Hospital Melbourne - PPDS', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Frankston Hospital', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Universitatsklinikum Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Paracelsus Medizinische Privatuniversitat', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitat Wien (Medical University of Vienna)', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Klinikum Wels-Grieskirchen GmbH', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '1090', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel - 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