Table 3.
Treatment exposure and overall safety profile with ixa-dex and pom-dex in the safety population.
| Ixa-dex n = 72 | Pom-dex n = 47 | |
|---|---|---|
| Treatment exposure | ||
| Median number of treatment cycles received, n (range) | 6 (1–25) | 6 (1–27) |
| Median time on treatment at ixa 5.5 mg, months (range) | n = 46 1.8 (<1–17) | |
| Patients receiving ≥7 cycles, n (%) | 35 (49) | 21 (45) |
| Patients receiving ≥19 cycles, n (%) | 5 (7) | 7 (15) |
| Mean (StD) relative dose intensity, % | ||
| Ixazomib / Pomalidomide | 79.5 (15.02) | 89.9 (13.31) |
| Dexamethasone | 84.0 (16.62) | 87.8 (15.57) |
| Safety profile | ||
| Any TEAE, n (%) | 70 (97) | 47 (100) |
| Any drug-related TEAE, n (%) | 64 (89) | 39 (83) |
| Any Grade ≥3 TEAE, n (%) | 50 (69) | 38 (81) |
| Any drug-related Grade ≥3 TEAE, n (%) | 35 (49) | 31 (66) |
| Any serious TEAE, n (%) | 37 (51) | 25 (53) |
| Any drug-related serious TEAE, n (%) | 16 (22) | 13 (28) |
| TEAE resulting in dose reduction of ≥1 of the 2 agents in the study drug regimen, n (%) | 32 (44) | 15 (32) |
| TEAE resulting in discontinuation of ≥1 of the 2 agents in the study drug regimen, n (%) | 28 (39) | 17 (36) |
| On-study deaths, n (%) | 9 (13) | 6 (13) |
Dex dexamethasone, ixa ixazomib, pom pomalidomide, StD standard deviation, TEAE treatment-emergent adverse event.