{"description":"Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. This is not the same definition of SAE per protocol but parallels the publication. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv4. Maximum grade toxicity by type was then calculated. No further data is available to specify classification of other beyond the general term.","eventGroups":[{"deathsNumAffected":89,"deathsNumAtRisk":357,"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"EG000","otherNumAffected":343,"otherNumAtRisk":357,"seriousNumAffected":279,"seriousNumAtRisk":357,"title":"RVD Alone"},{"deathsNumAffected":88,"deathsNumAtRisk":365,"description":"All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (\\~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study.\n\nAfter finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant.\n\nRVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"EG001","otherNumAffected":345,"otherNumAtRisk":365,"seriousNumAffected":344,"seriousNumAtRisk":365,"title":"RVD Plus ASCT"},{"deathsNumAffected":1,"deathsNumAtRisk":7,"description":"RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1) on days 1, 2, 4, 5, 8, 9, 11, and 12","id":"EG002","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":4,"seriousNumAtRisk":7,"title":"RVD Cycle 1 Only"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abcess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abdominal crampy pains"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":357},{"groupId":"EG001","numAffected":20,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":357},{"groupId":"EG001","numAffected":24,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abdominal wall cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abnormal bowel sounds"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abnormal sensation in ear"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abnormal sensation of limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":357},{"groupId":"EG001","numAffected":2,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abnormal vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":2,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abrasions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":2,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abscess jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abscess limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Abscesses of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Absolute lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Absolute monocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Accidental death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":357},{"groupId":"EG001","numAffected":5,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Ache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Achilles tendon pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Achilles tendonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Aching joints"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":357},{"groupId":"EG001","numAffected":11,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acid reflux"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":4,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acne"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Actinic keratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":2,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":357},{"groupId":"EG001","numAffected":10,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute renal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute respiratory insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Acute vaginitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Adenocarcinoma of prostate"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Adverse drug reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":2,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Ageusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Aggressive reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":357},{"groupId":"EG001","numAffected":9,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Alanine aminotransferase decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 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(4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":357},{"groupId":"EG001","numAffected":1,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Cholecystostomy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":357},{"groupId":"EG001","numAffected":0,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":357},{"groupId":"EG001","numAffected":8,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":357},{"groupId":"EG001","numAffected":9,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":357},{"groupId":"EG001","numAffected":3,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Hypotension orthostatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":357},{"groupId":"EG001","numAffected":8,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":357},{"groupId":"EG001","numAffected":6,"numAtRisk":365},{"groupId":"EG002","numAffected":0,"numAtRisk":7}],"term":"Thromboembolic event"}],"timeFrame":"Assessed throughout the treatment period, from time of first dose and up to day 30 post-treatment. Maximum treatment duration was 133.5 months in this study cohort."}