Treatment exposure and overall safety profile in the safety population
| . | Ixazomib-Rd (N = 354) . | Placebo-Rd (N = 349) . |
|---|---|---|
| Median number of treatment cycles received, n (range) | 20 (1-80) | 20 (1-81) |
| Completed protocol-specified initial 18 cycles, n (%) | 196 (55.4) | 192 (55.0) |
| Median number of treatment cycles received in patients continuing treatment beyond cycle 18, n (range) | 44.0 (18-80) | 39.0 (19-81) |
| Mean (SD) relative dose intensity,* % | ||
| Ixazomib/placebo | 91.7 (12.5) | 94.8 (9.7) |
| Cycles 1 to 18 | 91.5 (12.9) | 94.9 (10.0) |
| Cycles >18 | 94.6 (7.7) | 96.9 (6.3) |
| Lenalidomide | 80.4 (24.7) | 84.6 (22.9) |
| Cycles 1 to 18 | 81.0 (28.1) | 85.3 (26.2) |
| Cycles >18 | 84.0 (20.2) | 88.0 (20.3) |
| Dexamethasone | 83.2 (20.9) | 86.4 (18.9) |
| Any TEAE, n (%) | 354 (100) | 349 (100) |
| Any drug-related TEAE, n (%) | 342 (96.6) | 323 (92.6) |
| Any grade ≥3 TEAE, n (%) | 312 (88.1) | 284 (81.4) |
| Any drug-related grade ≥3 TEAE, n (%) | 251 (70.9) | 199 (57.0) |
| Any serious TEAE, n (%) | 233 (65.8) | 218 (62.5) |
| Any drug-related serious TEAE, n (%) | 136 (38.4) | 106 (30.4) |
| TEAE resulting in dose reduction of ≥1 of the 3 agents in the study drug regimen, n (%) | 211 (59.6) | 189 (54.2) |
| TEAE resulting in discontinuation of ≥1 of the 3 agents in the study drug regimen, n (%) | 160 (45.2) | 108 (30.9) |
| TEAE resulting in dose discontinuation of the full study drug regimen, n (%) | 124 (35.0) | 94 (26.9) |
| On-study deaths, n (%) | 27 (7.6) | 22 (6.3) |
| . | Ixazomib-Rd (N = 354) . | Placebo-Rd (N = 349) . |
|---|---|---|
| Median number of treatment cycles received, n (range) | 20 (1-80) | 20 (1-81) |
| Completed protocol-specified initial 18 cycles, n (%) | 196 (55.4) | 192 (55.0) |
| Median number of treatment cycles received in patients continuing treatment beyond cycle 18, n (range) | 44.0 (18-80) | 39.0 (19-81) |
| Mean (SD) relative dose intensity,* % | ||
| Ixazomib/placebo | 91.7 (12.5) | 94.8 (9.7) |
| Cycles 1 to 18 | 91.5 (12.9) | 94.9 (10.0) |
| Cycles >18 | 94.6 (7.7) | 96.9 (6.3) |
| Lenalidomide | 80.4 (24.7) | 84.6 (22.9) |
| Cycles 1 to 18 | 81.0 (28.1) | 85.3 (26.2) |
| Cycles >18 | 84.0 (20.2) | 88.0 (20.3) |
| Dexamethasone | 83.2 (20.9) | 86.4 (18.9) |
| Any TEAE, n (%) | 354 (100) | 349 (100) |
| Any drug-related TEAE, n (%) | 342 (96.6) | 323 (92.6) |
| Any grade ≥3 TEAE, n (%) | 312 (88.1) | 284 (81.4) |
| Any drug-related grade ≥3 TEAE, n (%) | 251 (70.9) | 199 (57.0) |
| Any serious TEAE, n (%) | 233 (65.8) | 218 (62.5) |
| Any drug-related serious TEAE, n (%) | 136 (38.4) | 106 (30.4) |
| TEAE resulting in dose reduction of ≥1 of the 3 agents in the study drug regimen, n (%) | 211 (59.6) | 189 (54.2) |
| TEAE resulting in discontinuation of ≥1 of the 3 agents in the study drug regimen, n (%) | 160 (45.2) | 108 (30.9) |
| TEAE resulting in dose discontinuation of the full study drug regimen, n (%) | 124 (35.0) | 94 (26.9) |
| On-study deaths, n (%) | 27 (7.6) | 22 (6.3) |
SD, standard deviation.
Relative dose intensity defined as: 100 × (total dose received in mg)/(sum of prescribed dose of all treated cycles) for the specified period, for which total prescribed dose equals (dose prescribed × number of prescribed doses per cycle × the number of treated cycles).
For ixazomib/placebo: dose prescribed is 4 mg for the first 18 cycles and 3 mg after cycle 18; number of prescribed doses per cycle is 3.
For lenalidomide: dose prescribed is 25 mg for the first 18 cycles and 10 mg after cycle 18; for patients with baseline CrCl ≤60 mL/min, dose prescribed is 10 mg throughout the study; number of prescribed doses per cycle is 21.
For dexamethasone: dose prescribed is 20 mg for patients >75 y old and 40 mg for all other patients; number of prescribed doses per cycle is 4.