Comparison of selected safety outcomes within CLL12 trial
| Parameter . | Placebo (n = 181) . | Ibrutinib (n = 182) . |
|---|---|---|
| D/C treatment due to AE, n (%) | 26 (14.3) | 53 (29.1) |
| Dose reductions (% cycles) | 2.5 | 16.6 |
| Any grade atrial fibrillation, n (%) | 2 (1.3) | 19 (12) |
| Any grade cardiac arrhythmias, n (%) | 12 (7.7) | 34 (21.5) |
| Grade 3+ cardiac arrhythmias, n (%) | 2 (1.3) | 13 (8.2) |
| Any grade hypertension, n (%) | 7 (4.5) | 16 (10.1) |
| Any grade bleeding, n (%) | 23 (14.8) | 53 (33.5) |
| Parameter . | Placebo (n = 181) . | Ibrutinib (n = 182) . |
|---|---|---|
| D/C treatment due to AE, n (%) | 26 (14.3) | 53 (29.1) |
| Dose reductions (% cycles) | 2.5 | 16.6 |
| Any grade atrial fibrillation, n (%) | 2 (1.3) | 19 (12) |
| Any grade cardiac arrhythmias, n (%) | 12 (7.7) | 34 (21.5) |
| Grade 3+ cardiac arrhythmias, n (%) | 2 (1.3) | 13 (8.2) |
| Any grade hypertension, n (%) | 7 (4.5) | 16 (10.1) |
| Any grade bleeding, n (%) | 23 (14.8) | 53 (33.5) |
D/C, discontinued.