Table 3.
Overview of Safety Profile of IRd (n = 84)
| TEAEa | Patients, n (%) |
|---|---|
| Any grade TEAE | 77 (92) |
| Any grade treatment-related TEAE | 59 (70) |
| Grade ≥ 3 TEAE | 40 (48) |
| Grade ≥ 3 treatment-related TEAE | 21 (25) |
| TEAE leading to drug modificationb | 42 (50) |
| TEAE leading to drug discontinuationb | 6 (7) |
| Serious TEAE | 30 (36) |
| Treatment-related serious TEAE | 9 (11) |
| Deaths during study | 2 (2) |
Abbreviations: IRd = ixazomib, lenalidomide, dexamethasone; TEAE = treatment-emergent adverse event.
TEAEs were defined as adverse events that occurred after administration of the first dose through 30 days after the last dose of the study drug regimen (IRd). TEAEs were considered serious if they resulted in death, were life-threatening, had required inpatient hospitalization or prolongation of an existing hospitalization (excluding planned hospital admissions and surgical procedures for a preexisting condition unless it had deteriorated unexpectedly during the study period), had resulted in persistent or significant disability or incapacity, or were a congenital anomaly/birth defect or a “medically important event”.
Modification or discontinuation of any of the 3 study drugs (ixazomib, lenalidomide, dexamethasone).