Adverse events occurring during treatment (CTCAE grade ≥3)
| . | Standard treatment (arm A) . | CLO + standard treatment (arm B) . | ||
|---|---|---|---|---|
| ≤40 y, n = 79 . | >40 y, n = 87 . | ≤40 y, n = 80 . | >40 y, n = 88 . | |
| Any AE grade ≥3, n (%) | 73 (92) | 75 (86) | 74 (93) | 81 (92) |
| Infection | 42 (53) | 32 (37) | 52 (65) | 59 (67) |
| Gastro-intestinal | 29 (37) | 25 (29) | 29 (36) | 29 (33) |
| Neurological event | 12 (15) | 10 (11) | 15 (19) | 13 (15) |
| Thrombo-embolic events (CTCAE grade ≥2) | 27 (34) | 23 (26) | 20 (25) | 22 (25) |
| Any serious adverse event, n (%) | 55 (70) | 45 (52) | 66 (82) | 66 (75) |
| Fatal serious adverse event, n (%) | 2 (3) | 11 (13) | 6 (8) | 12 (14) |
| . | Standard treatment (arm A) . | CLO + standard treatment (arm B) . | ||
|---|---|---|---|---|
| ≤40 y, n = 79 . | >40 y, n = 87 . | ≤40 y, n = 80 . | >40 y, n = 88 . | |
| Any AE grade ≥3, n (%) | 73 (92) | 75 (86) | 74 (93) | 81 (92) |
| Infection | 42 (53) | 32 (37) | 52 (65) | 59 (67) |
| Gastro-intestinal | 29 (37) | 25 (29) | 29 (36) | 29 (33) |
| Neurological event | 12 (15) | 10 (11) | 15 (19) | 13 (15) |
| Thrombo-embolic events (CTCAE grade ≥2) | 27 (34) | 23 (26) | 20 (25) | 22 (25) |
| Any serious adverse event, n (%) | 55 (70) | 45 (52) | 66 (82) | 66 (75) |
| Fatal serious adverse event, n (%) | 2 (3) | 11 (13) | 6 (8) | 12 (14) |
Toxicity is graded according to National Cancer Insitute Common Terminology Criteria for Adverse Events (CTCAE, version 3).
CLO, clofarabine; N, number of patients.