Overall safety profile with IRd and placebo-Rd among high-risk and standard-risk patients
| . | High risk . | Standard risk . | ||
|---|---|---|---|---|
| IRd, n = 74 . | Placebo-Rd, n = 62 . | IRd, n = 200 . | Placebo-Rd, n = 214 . | |
| Median treatment duration, mo | 16.3 | 9.9 | 16.1 | 14.7 |
| Any adverse event | 73 (99) | 61 (98) | 197 (99) | 214 (100) |
| Any grade ≥3 adverse event | 49 (66) | 45 (73) | 149 (75) | 140 (65) |
| Any serious adverse event | 31 (42) | 32 (52) | 90 (45) | 101 (47) |
| Adverse event resulting in dose reduction of any drug | 30 (41) | 26 (42) | 119 (60) | 110 (51) |
| Adverse event resulting in discontinuation of any drug | 13 (18) | 16 (26) | 55 (28) | 42 (20) |
| Adverse event resulting in discontinuation of regimen | 6 (8) | 8 (13) | 42 (21) | 31 (14) |
| On-study death | 0 | 6 (10) | 9 (5) | 13 (6) |
| . | High risk . | Standard risk . | ||
|---|---|---|---|---|
| IRd, n = 74 . | Placebo-Rd, n = 62 . | IRd, n = 200 . | Placebo-Rd, n = 214 . | |
| Median treatment duration, mo | 16.3 | 9.9 | 16.1 | 14.7 |
| Any adverse event | 73 (99) | 61 (98) | 197 (99) | 214 (100) |
| Any grade ≥3 adverse event | 49 (66) | 45 (73) | 149 (75) | 140 (65) |
| Any serious adverse event | 31 (42) | 32 (52) | 90 (45) | 101 (47) |
| Adverse event resulting in dose reduction of any drug | 30 (41) | 26 (42) | 119 (60) | 110 (51) |
| Adverse event resulting in discontinuation of any drug | 13 (18) | 16 (26) | 55 (28) | 42 (20) |
| Adverse event resulting in discontinuation of regimen | 6 (8) | 8 (13) | 42 (21) | 31 (14) |
| On-study death | 0 | 6 (10) | 9 (5) | 13 (6) |
Per the primary report from the study, exposure and safety data are reported from a prespecified analysis at a median follow up of ∼23 months. One patient with high-risk cytogenetics who was randomized to the ixazomib arm did not receive ixazomib and was not included in the ixazomib group safety population. Among patients with standard-risk cytogenetics, 1 patient randomized to the ixazomib arm did not receive ixazomib, and 2 patients randomized to the placebo arm accidentally received ixazomib and were conservatively included in the ixazomib group for analyses of exposure and safety.