Table 3 Overall safety profile and most common AEs with IRd induction and single-agent ixazomib maintenance
All patients (N = 65) | Patients who did not proceed to SCT (N = 42) | Patients who received maintenance (N = 25)a | ||
|---|---|---|---|---|
n (%) | AE onset in cycles 1–12 (IRd) | AE onset in cycle 13+ (single-agent ixazomib) | ||
Any grade ≥3 AE | 51 (78) | 36 (86) | 17 (68) | 12 (48) |
Any serious AE | 30 (46) | 22 (52) | 9 (36) | 7 (28) |
AE leading to any study drug dose reduction | 37 (57) | 27 (64) | 19 (76) | 2 (8) |
AE leading to discontinuation of any of the study drugs | 10 (15) | 9 (21) | 0 | 0 |
On-study deaths | 2 (3) | 2 (5) | 0 | 0 |
Most common AEs (in >25% of the overall study population) | ||||
Diarrhea | 39 (60) | 28 (67) | 14 (56) | 13 (52) |
Fatigue | 39 (60) | 27 (64) | 18 (72) | 2 (8) |
Nausea | 36 (55) | 24 (57) | 12 (48) | 8 (32) |
PN NECb | 28 (43) | 19 (45) | 13 (52) | 3 (12) |
Upper respiratory tract infection | 28 (43) | 19 (45) | 9 (36) | 9 (36) |
Constipation | 26 (40) | 17 (40) | 13 (52) | 2 (8) |
Vomiting | 26 (40) | 16 (38) | 9 (36) | 2 (8) |
Rashes eruptions and exanthemsb | 23 (35) | 15 (36) | 11 (44) | 3 (12) |
Back pain | 22 (34) | 14 (33) | 7 (28) | 5 (20) |
Peripheral edema | 22 (34) | 14 (33) | 10 (40) | 3 (12) |
Thrombocytopeniac | 23 (35) | 16 (38) | 4 (16) | 4 (16) |
Insomnia | 21 (32) | 14 (33) | 8 (32) | 1 (4) |
Cough | 21 (32) | 17 (40) | 8 (32) | 3 (12) |
Pain in extremity | 20 (31) | 15 (36) | 5 (20) | 9 (36) |
Dizziness | 19 (29) | 15 (36) | 6 (24) | 3 (12) |
Neutropeniac | 20 (31) | 12 (29) | 5 (20) | 0 |
Pyrexia | 18 (28) | 13 (31) | 6 (24) | 2 (8) |
