| Induction period | Consolidation period | Overall treatment period | |||||
|---|---|---|---|---|---|---|---|
| n (%) | 100 units/m2 CPX-351 (n=375) | All controls (n=236) | 65 units/m2 CPX-351 (n=52) | 100 units/m2 CPX-351 (n=63) | All controls (n=55) | CPX-351 (n=375) | All controls (n=236) |
| Any TEAE | 375 (100) | 236 (100) | 44 (85) | 61 (97) | 49 (89) | 375 (100) | 236 (100) |
| Grade ≥3 TEAE | 342 (91) | 211 (89) | 28 (54) | 46 (73) | 30 (55) | 346 (92) | 212 (90) |
| Serious TEAE | 145 (39) | 76 (32) | 25 (48) | 33 (52) | 24 (44) | 189 (50) | 91 (39) |
| Treatment-related TEAE | 362 (97) | 220 (93) | 36 (69) | 49 (78) | 39 (71) | 363 (97) | 220 (93) |
| TEAE leading to discontinuation | 7 (2) | 3 (1) | 0 | 0 | 0 | 7 (2) | 3 (1) |
| TEAE leading to death | 28 (7) | 25 (11) | 1 (2) | 5 (8) | 4 (7) | 34 (9) | 29 (12) |
| 30-day mortality | 14 (4) | 15 (8) | 1 (2) | 2 (3) | 2 (6) | 21 (6) | 19 (10) |
| 60-day mortality | 23 (6) | 17 (9) | 1 (2) | 2 (3) | 2 (6) | 47 (13) | 38 (20) |
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