Table 4.
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) |
There were no on-study deaths.