Variable | Ixazomib-Rd (n = 57) | Placebo-Rd (n = 58) |
---|---|---|
Median number of cycles, n (range) | 9 (1–25) | 6.5 (1–25) |
Patients receiving ≥10 cycles, n (%) | 28 (49) | 20 (34) |
Median treatment duration, days (range) | 272 (8–679) | 181 (16–712) |
Relative dose intensity, %, mean (standard deviation)/median (range)a | ||
 Ixazomib or placebo | 96.0 (8.13)/100 (67–100) | 98.7 (2.95)/100 (89–100) |
 Lenalidomide | 89.7 (15.96)/97.1 (38–100) | 94.5 (14.87)/99.8 (53–137) |
 Dexamethasone | 91.7 (13.52)/97.5 (50–100) | 95.2 (9.80)/98.2 (45–100) |
Rates of AEs, n (%) | ||
 Any AE | 57 (100) | 57 (98) |
  Any drug-related AE | 54 (95) | 57 (98) |
 Any grade ≥3 AE | 38 (67) | 43 (74) |
  Any drug-related grade ≥3 AE | 33 (58) | 37 (64) |
 Any serious AE (SAE) | 19 (33) | 18 (31) |
  Any drug-related SAE | 11 (19) | 7 (12) |
 AEs resulting in dose reduction of any study drug | 12 (21) | 11 (19) |
  Ixazomib/placebob | 1 (2) | 0 |
  Lenalidomidec | 7 (12) | 9 (16) |
  Dexamethasoned | 5 (9) | 3 (5) |
 AEs resulting in discontinuation of any study druge | 8 (14) | 8 (14) |
 AEs resulting in discontinuation of study regimen | 5 (9) | 6 (10) |
 On-study deathsf | 4 (7) | 5 (9) |