Most common any-grade (reported in ≥30% of patients on ixazomib-Rd arm) and grade ≥3 TEAEs (reported in ≥10% of patients on ixazomib-Rd arm) plus rates of additional TEAEs of clinical importance, reported with ixazomib-Rd and placebo-Rd in the safety population
| MedDRA preferred term, n (%) . | Ixazomib-Rd (N = 354) . | Placebo-Rd (N = 349) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Diarrhea | 216 (61.0) | 35 (9.9) | 161 (46.1) | 7 (2.0) |
| Rash* | 199 (56.2) | 59 (16.7) | 130 (37.2) | 26 (7.4) |
| Peripheral edema | 172 (48.6) | 4 (1.1) | 117 (33.5) | 4 (1.1) |
| Constipation | 151 (42.7) | 4 (1.1) | 144 (41.3) | 3 (0.9) |
| Nausea | 131 (37.0) | 5 (1.4) | 97 (27.8) | 1 (0.3) |
| Peripheral neuropathy* | 120 (33.9) | 8 (2.3) | 96 (27.5) | 4 (1.1) |
| Fatigue | 109 (30.8) | 14 (4.0) | 106 (30.4) | 14 (4.0) |
| Anemia | 108 (30.5) | 56 (15.8) | 108 (30.9) | 62 (17.8) |
| Vomiting | 105 (29.7) | 4 (1.1) | 46 (13.2) | 2 (0.6) |
| Cardiac arrhythmias*,† | 81 (22.9) | 37 (10.5) | 74 (21.2) | 26 (7.4) |
| Thrombocytopenia* | 73 (20.6) | 47 (13.3) | 33 (9.5) | 16 (4.6) |
| Neutropenia* | 71 (20.1) | 60 (16.9) | 104 (29.8) | 94 (26.9) |
| Pneumonia | 62 (17.5) | 36 (10.2) | 46 (13.2) | 26 (7.4) |
| Acute renal failure* | 58 (16.4) | 23 (6.5) | 65 (18.6) | 26 (7.4) |
| Hypotension* | 41 (11.6) | 8 (2.3) | 29 (8.3) | 7 (2.0) |
| Heart failure*,‡ | 32 (9.0) | 15 (4.2) | 21 (6.0) | 10 (2.9) |
| Liver impairment*,§ | 31 (8.8) | 9 (2.5) | 27 (7.7) | 9 (2.6) |
| Myocardial infarction*,‖ | 11 (3.1) | 6 (1.7) | 9 (2.6) | 8 (2.3) |
| Encephalopathy*,§ | 8 (2.3) | 3 (0.8) | 7 (2.0) | 4 (1.1) |
| New primary malignancies | 43 (12.1) | 40 (11.5) | ||
| MedDRA preferred term, n (%) . | Ixazomib-Rd (N = 354) . | Placebo-Rd (N = 349) . | ||
|---|---|---|---|---|
| Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
| Diarrhea | 216 (61.0) | 35 (9.9) | 161 (46.1) | 7 (2.0) |
| Rash* | 199 (56.2) | 59 (16.7) | 130 (37.2) | 26 (7.4) |
| Peripheral edema | 172 (48.6) | 4 (1.1) | 117 (33.5) | 4 (1.1) |
| Constipation | 151 (42.7) | 4 (1.1) | 144 (41.3) | 3 (0.9) |
| Nausea | 131 (37.0) | 5 (1.4) | 97 (27.8) | 1 (0.3) |
| Peripheral neuropathy* | 120 (33.9) | 8 (2.3) | 96 (27.5) | 4 (1.1) |
| Fatigue | 109 (30.8) | 14 (4.0) | 106 (30.4) | 14 (4.0) |
| Anemia | 108 (30.5) | 56 (15.8) | 108 (30.9) | 62 (17.8) |
| Vomiting | 105 (29.7) | 4 (1.1) | 46 (13.2) | 2 (0.6) |
| Cardiac arrhythmias*,† | 81 (22.9) | 37 (10.5) | 74 (21.2) | 26 (7.4) |
| Thrombocytopenia* | 73 (20.6) | 47 (13.3) | 33 (9.5) | 16 (4.6) |
| Neutropenia* | 71 (20.1) | 60 (16.9) | 104 (29.8) | 94 (26.9) |
| Pneumonia | 62 (17.5) | 36 (10.2) | 46 (13.2) | 26 (7.4) |
| Acute renal failure* | 58 (16.4) | 23 (6.5) | 65 (18.6) | 26 (7.4) |
| Hypotension* | 41 (11.6) | 8 (2.3) | 29 (8.3) | 7 (2.0) |
| Heart failure*,‡ | 32 (9.0) | 15 (4.2) | 21 (6.0) | 10 (2.9) |
| Liver impairment*,§ | 31 (8.8) | 9 (2.5) | 27 (7.7) | 9 (2.6) |
| Myocardial infarction*,‖ | 11 (3.1) | 6 (1.7) | 9 (2.6) | 8 (2.3) |
| Encephalopathy*,§ | 8 (2.3) | 3 (0.8) | 7 (2.0) | 4 (1.1) |
| New primary malignancies | 43 (12.1) | 40 (11.5) | ||
MedDRA, Medical Dictionary for Regulatory Activities; SMQ, standardized MedDRA query.
Higher-level term, SMQ, or pooled term incorporating multiple preferred terms. “Rash” included the preferred terms of rash maculopapular, rash macular, pruritus, rash, rash erythematous, rash popular, pruritus generalized, urticaria, drug eruption, rash pruritic, dermatitis acneiform, purpura, dermatitis allergic, rash generalized, erythema multiforme, rash vesicular, rash morbilliform, Stevens-Johnson syndrome, exfoliative rash, rash follicular, toxic epidermal necrolysis, rash pustular. “Peripheral neuropathy” included the preferred terms of peripheral sensory neuropathy, neuropathy peripheral, peripheral sensorimotor neuropathy, peripheral motor neuropathy. “Cardiac arrhythmias” included the preferred terms of syncope, atrial fibrillation, palpitations, sinus tachycardia, bradycardia, tachycardia, atrioventricular block complete, cardiac arrest, atrial flutter, supraventricular tachycardia, loss of consciousness, sudden death, sinus bradycardia, ventricular extrasystoles, atrioventricular block, arrhythmia, heart rate irregular, bundle branch block right, supraventricular extrasystoles, atrioventricular block first degree, extrasystoles, heart rate increased, sinus node dysfunction, bundle branch block left, electrocardiogram QT prolonged, ventricular tachycardia, cardiorespiratory arrest, heart rate decreased. “Thrombocytopenia” included the preferred terms of thrombocytopenia, platelet count decreased. “Neutropenia” included the preferred terms of neutropenia, neutrophil count decreased. “Acute renal failure” included the preferred terms of blood creatinine increased, acute kidney injury, renal failure, renal impairment, creatinine renal clearance decreased, oliguria, azotemia, nephritis, glomerular filtration rate decreased, proteinuria, renal tubular disorder. “Hypotension” included the preferred terms of hypotension, orthostatic hypotension, anaphylactic reaction. “Heart failure” included the preferred terms of cardiac failure, pulmonary edema, cardiac failure congestive, cardiomegaly, diastolic dysfunction, orthopnea, acute pulmonary edema, pulmonary congestion, right ventricular failure, left ventricular failure. “Liver impairment” included the preferred terms of alanine aminotransferase increased, hypoalbuminemia, aspartate aminotransferase increased, hepatocellular injury, blood alkaline phosphatase increased, γ-glutamyltransferase increased, hyperbilirubinemia, hepatic steatosis, liver function test increased, drug-induced liver injury, hepatic cirrhosis, hepatic function abnormal, cholestasis, hepatic encephalopathy, hepatic enzyme increased, blood bilirubin increased, ascites, hepatitis cholestatic, liver disorder. “Myocardial infarction” included the preferred terms of acute coronary syndrome, angina unstable, acute myocardial infarction, blood creatine phosphokinase increased, coronary artery occlusion, electrocardiogram ST segment elevation, myocardial infarction, troponin increased. “Encephalopathy” included the preferred terms of delirium, hepatic encephalopathy, leukoencephalopathy, encephalopathy, hypoxic-ischemic encephalopathy, posterior reversible encephalopathy syndrome.
Includes 7 (2.0%) and 1 (0.3%) patients with grade 5 events in the ixazomib-Rd and placebo-Rd arms, respectively.
Includes 0 and 1 (0.3%) patients with grade 5 events in the ixazomib-Rd and placebo-Rd arms, respectively.
Includes 1 (0.3%) and 0 patients with grade 5 events in the ixazomib-Rd and placebo-Rd arms, respectively.
Includes 1 (0.3%) and 1 (0.3%) patients with grade 5 events in the ixazomib-Rd and placebo-Rd arms, respectively.