Treatment administration, tolerability, and adverse events
| . | Arm B (4 mg) . | Arm C (5.5 mg) . |
|---|---|---|
| Ixazomib | ||
| Number of cycles | 347 | 341 |
| Median cycle total dose (range) | 12 (2-12) | 16.5 (4-16.5) |
| Number of patients with dose reductions, N (%) | 6 (17) | 15 (43) |
| Total number of dose reductions | 7 | 21 |
| Dexamethasone | ||
| Number of cycles | 345 | 325 |
| Median cycle total dose (range) | 120 (0-240) | 120 (0-160) |
| Number of patients with dose reductions, N (%) | 8 (23) | 12 (34) |
| Total number of dose reductions | 10 | 16 |
| Treatment delays | ||
| Number of patients, N (%) | 9 (26) | 10 (29) |
| Total number of delays | 12 | 12 |
| . | Arm B (4 mg) . | Arm C (5.5 mg) . |
|---|---|---|
| Ixazomib | ||
| Number of cycles | 347 | 341 |
| Median cycle total dose (range) | 12 (2-12) | 16.5 (4-16.5) |
| Number of patients with dose reductions, N (%) | 6 (17) | 15 (43) |
| Total number of dose reductions | 7 | 21 |
| Dexamethasone | ||
| Number of cycles | 345 | 325 |
| Median cycle total dose (range) | 120 (0-240) | 120 (0-160) |
| Number of patients with dose reductions, N (%) | 8 (23) | 12 (34) |
| Total number of dose reductions | 10 | 16 |
| Treatment delays | ||
| Number of patients, N (%) | 9 (26) | 10 (29) |
| Total number of delays | 12 | 12 |
| Frequency of AEs . | Regardless of attribution . | At least possibly related . | Regardless of attribution . | At least possibly related . |
|---|---|---|---|---|
| Evaluable, N (%) | 35 (100) | 35 (100) | 35 (100) | 35 (100) |
| Grade 3+, N (%) | 15 (43) | 9 (26) | 26 (74) | 19 (54) |
| Grade 4+, N (%) | 2 (6) | 2 (6) | 3 (9) | 2 (6) |
| Grade 3+ hematologic, N (%) | 6 (17) | 5 (14) | 15 (43) | 13 (37) |
| Grade 4+ hematologic, N (%) | 0 (0) | 0 (0) | 2 (6) | 2 (6) |
| Grade 3+ nonhematologic, N (%) | 10 (29) | 4 (11) | 18 (51) | 10 (29) |
| Grade 4+ Nonhematologic, N (%) | 2 (6) | 2 (6) | 1 (3) | 0 (0) |
| Frequency of AEs . | Regardless of attribution . | At least possibly related . | Regardless of attribution . | At least possibly related . |
|---|---|---|---|---|
| Evaluable, N (%) | 35 (100) | 35 (100) | 35 (100) | 35 (100) |
| Grade 3+, N (%) | 15 (43) | 9 (26) | 26 (74) | 19 (54) |
| Grade 4+, N (%) | 2 (6) | 2 (6) | 3 (9) | 2 (6) |
| Grade 3+ hematologic, N (%) | 6 (17) | 5 (14) | 15 (43) | 13 (37) |
| Grade 4+ hematologic, N (%) | 0 (0) | 0 (0) | 2 (6) | 2 (6) |
| Grade 3+ nonhematologic, N (%) | 10 (29) | 4 (11) | 18 (51) | 10 (29) |
| Grade 4+ Nonhematologic, N (%) | 2 (6) | 2 (6) | 1 (3) | 0 (0) |
There were no on-study deaths.