Table 4 Most common any-grade (reported in ≥10% of patients in either arm) and grade ≥3 AEs, and AEs of clinical importance (safety population).
Preferred term | Ixazomib–dexamethasone (n = 85) | Physician’s choice (n = 81) | ||
|---|---|---|---|---|
Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | |
Fatigue | 38 (45) | 8 (9) | 35 (43) | 7 (9) |
Peripheral edema | 39 (46) | 4 (5) | 26 (32) | 4 (5) |
Diarrhea | 29 (34) | 2 (2) | 24 (30) | 2 (2) |
Insomnia | 32 (38) | 3 (4) | 14 (17) | 2 (2) |
Constipation | 18 (21) | 1 (1) | 21 (26) | 3 (4) |
Dyspnea | 20 (24) | 5 (6) | 15 (19) | 3 (4) |
Upper respiratory tract infection | 20 (24) | 1 (1) | 13 (16) | 0 |
Nausea | 20 (24) | 1 (1) | 11 (14) | 0 |
Peripheral sensory neuropathy | 16 (19) | 1 (1) | 10 (12) | 1 (1) |
Dizziness | 13 (15) | 0 | 11 (14) | 0 |
Vomiting | 13 (15) | 1 (1) | 11 (14) | 0 |
Anemia | 7 (8) | 2 (2) | 15 (19) | 9 (11) |
Decreased appetite | 10 (12) | 1 (1) | 9 (11) | 0 |
Back pain | 15 (13) | 1 (1) | 8 (10) | 1 (1) |
Muscle spasms | 9 (11) | 0 | 9 (11) | 0 |
Muscular weakness | 13 (15) | 0 | 5 (6) | 1 (1) |
Asthenia | 9 (11) | 3 (4) | 8 (10) | 2 (2) |
Cough | 10 (12) | 0 | 6 (7) | 0 |
Abdominal distension | 10 (12) | 0 | 4 (5) | 0 |
Epistaxis | 10 (12) | 0 | 4 (5) | 0 |
Headache | 10 (12) | 0 | 4 (5) | 0 |
Rash maculo-papular | 11 (13) | 3 (4) | 3 (4) | 2 (2) |
Arthralgia | 10 (12) | 0 | 3 (4) | 1 (1) |
Hypertension | 10 (12) | 1 (1) | 2 (2) | 1 (1) |
Bronchitis | 9 (11) | 0 | 1 (1) | 1 (1) |
Pain in extremity | 9 (11) | 0 | 1 (1) | 0 |
Other AEs of clinical importance | ||||
Rash | 28 (33) | 3 (4) | 16 (20) | 4 (5) |
Cardiac arrhythmias | 22 (26) | 8 (9) | 12 (15) | 5 (6) |
Atrial fibrillation | 7 (8) | 1 (1) | 1 (1) | 0 |
Pneumonia | 18 (21) | 4 (5) | 13 (16) | 8 (10) |
Peripheral neuropathy | 16 (19) | 1 (1) | 12 (15) | 1 (1) |
