Table 4 Secondary safety parameters by treatment group
NECT (n = 55) | Eflornithine (n = 54) | All (n = 109) | P-value | |
|---|---|---|---|---|
n (%) | n (%) | n (%) | ||
No. of deaths during 30 days | 1 (1.8) | 1 (1.9) | 2 (1.8) | 1.00 |
No. of deaths during follow-up | 3 (5.5) | 0 | 3 (2.8) | 0.24 |
At least one severe adverse event | 7 (12.7) | 15 (27.8) | 22 (20.2) | 0.16 |
No. of patients with permanent treatment interruption | 0 | 1 (1.9) | 1 (0.9) | 0.50 |
No. of patients with temporary treatment interruption | 0 | 1 (1.9) | 1 (0.9) | 0.50 |
At least one severe adverse event (intensity grade 3 & 4) (clinical & laboratory) | 14 (25.5) | 15 (27.8) | 29 (26.6) | 0.78 |
At least one severe adverse event (intensity grade 3 & 4) (clinical) | 9 (16.4) | 13 (24.1) | 22 (20.2) | 0.32 |
At least one severe adverse event (intensity grade 3 & 4) (laboratory) | 9 (16.4) | 8 (14.8) | 17 (15.6) | 0.82 |
At least one adverse event (clinical & laboratory) | 49 (89.1) | 49 (90.7) | 98 (89.9) | 0.78 |
At least one adverse event (clinical) | 44 (80.0) | 46 (85.2) | 90 (82.6) | 0.48 |
At least one adverse event (laboratory) | 30 (54.6) | 41 (75.9) | 71 (65.1) | 0.02a |
At least one adverse event (possibly) related to treatment | 37 (67.3) | 39 (72.2) | 76 (69.7) | 0.57 |