Table 4 Treatment-emergent adverse events, discontinuations and deaths (safety population)
ASPIRE | ENDEAVOR | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Prior ASCT | 1R1T | No prior ASCT | Prior ASCT | 1R1T | No prior ASCT | |||||||
KRd (n=215) | Rd (n=224) | KRd (n=88) | Rd (n=78) | KRd (n=177) | Rd (n=165) | Kd (n=266) | Vd (n=268) | Kd (n=123) | Vd (n=139) | Kd(n=197) | Vd(n=188) | |
Patients with any-grade AE, % | 99 | 97 | 100 | 99 | 95 | 98 | 99 | 99 | 98 | 99 | 97 | 97 |
Grade⩾3 AE, % | 87 | 79 | 91 | 82 | 79 | 82 | 72 | 64 | 69 | 59 | 75 | 71 |
Patients discontinuing due to AEs, % | 23 | 23 | 23 | 25 | 19 | 20 | 19 | 19 | 15 | 20 | 21 | 23 |
AE leading to death, % | 6 | 4 | 1.1 | 3 | 11 | 12 | 6 | 3 | 4 | 3 | 5 | 6 |
Any-grade AEs of interest, % | ||||||||||||
Anemia | 46 | 40 | 49 | 44 | 38 | 40 | 42 | 24 | 38 | 20 | 36 | 31 |
Thrombocytopenia | 36 | 23 | 31 | 22 | 20 | 22 | 21 | 20 | 20 | 16 | 19 | 13 |
Neutropenia | 45 | 36 | 39 | 31 | 29 | 30 | 6 | 5 | 4 | 4 | 5 | 6 |
Hypertension | 15 | 8 | 15 | 5 | 14 | 5 | 23 | 10 | 26 | 9 | 27 | 7 |
Peripheral neuropathy (SMQN) | 19 | 16 | 24 | 14 | 15 | 19 | 20 | 53 | 20 | 50 | 17 | 49 |
Cardiac failure (SMQN) | 4 | 4 | 1.1 | 5 | 9 | 4 | 5 | 1.5 | 3 | 2 | 13 | 5 |
Acute renal failure (SMQN) | 8 | 5 | 9 | 3 | 8 | 10 | 9 | 4 | 11 | 5 | 7 | 6 |
Grade⩾3 AEs of interest, % | ||||||||||||
Anemia | 18 | 17 | 16 | 21 | 18 | 17 | 15 | 8 | 11 | 6 | 14 | 13 |
Thrombocytopenia | 20 | 13 | 17 | 16 | 12 | 11 | 9 | 11 | 3 | 10 | 8 | 7 |
Neutropenia | 34 | 29 | 31 | 25 | 24 | 22 | 3 | 3 | 1.6 | 1.4 | 1.0 | 1.6 |
Hypertension | 4 | 1.8 | 5 | 1.3 | 5 | 1.8 | 8 | 2 | 8 | 3 | 11 | 3 |
Peripheral neuropathy (SMQN) | 3 | 1.8 | 5 | 1.3 | 2 | 5 | 3 | 9 | 2 | 7 | 1.5 | 7 |
Cardiac failure (SMQN) | 2 | 1.3 | 0 | 1.3 | 6 | 2 | 3 | 0.7 | 3 | 1.4 | 7 | 3 |
Acute renal failure (SMQN) | 3 | 1.8 | 1.1 | 1.3 | 3 | 5 | 5 | 1.9 | 6 | 2 | 3 | 4 |
