Serious adverse events (safety cohort)
| . | Ibrutinib (n = 158) . | Placebo (n = 155) . | ||||
|---|---|---|---|---|---|---|
| . | Any grade . | Grade 1-2 . | Grade ≥3 . | Any grade . | Grade 1-2 . | Grade ≥3 . |
| Any serious AEs, n (%) | 62 (39.2) | 11 (6.9) | 51 (32.3) | 58* (37.4) | 4 (2.6) | 53 (34.2) |
| Total n of serious adverse events | 112 | 18 | 94 | 108* | 8 | 99 |
| Serious AEs with ≥2% incidence in either group, n (%)† | ||||||
| Atrial fibrillation | 9 (5.7) | 1 (0.6) | 8 (5.1) | 1 (0.6) | 1 (0.6) | |
| Acute myocardial infarction | 1 (0.6) | 1 (0.6) | 4 (2.6) | 4 (2.6) | ||
| Pneumonia | 7 (4.4) | 7 (4.4) | 6 (3.9) | 6 (3.9) | ||
| Basal cell carcinoma | 3 (1.9) | 1 (0.6) | 2 (1.3) | 6* (3.9) | 5 (3.2) | |
| Any AE of clinical interest, n (%) | 113 (71.5) | 86 (54.4) | 27 (17.1) | 77 (49.7) | 53 (34.2) | 24 (15.5) |
| Total no. of AEs of clinical interest | 280 | 245 | 35 | 164 | 135 | 29 |
| Cardiac arrhythmias | 34 (21.5) | 21 (13.3) | 13 (8.2) | 12 (7.7) | 10 (6.5) | 2 (1.3) |
| Bleeding | 53 (33.5) | 47 (29.7) | 6 (3.8) | 23 (14.8) | 20 (12.9) | 3 (1.9) |
| Hypertensive disorders | 18 (11.4) | 15 (9.5) | 3 (1.9) | 7 (4.5) | 4 (2.6) | 3 (1.9) |
| Cardiac event other than arrhythmia | 12 (7.6) | 7 (4.4) | 5 (3.2) | 16 (10.3) | 7 (4.5) | 9 (5.8) |
| Diarrhea | 63 (39.9) | 60 (38.0) | 3 (1.9) | 46 (29.7) | 39 (25.2) | 7 (4.5) |
| . | Ibrutinib (n = 158) . | Placebo (n = 155) . | ||||
|---|---|---|---|---|---|---|
| . | Any grade . | Grade 1-2 . | Grade ≥3 . | Any grade . | Grade 1-2 . | Grade ≥3 . |
| Any serious AEs, n (%) | 62 (39.2) | 11 (6.9) | 51 (32.3) | 58* (37.4) | 4 (2.6) | 53 (34.2) |
| Total n of serious adverse events | 112 | 18 | 94 | 108* | 8 | 99 |
| Serious AEs with ≥2% incidence in either group, n (%)† | ||||||
| Atrial fibrillation | 9 (5.7) | 1 (0.6) | 8 (5.1) | 1 (0.6) | 1 (0.6) | |
| Acute myocardial infarction | 1 (0.6) | 1 (0.6) | 4 (2.6) | 4 (2.6) | ||
| Pneumonia | 7 (4.4) | 7 (4.4) | 6 (3.9) | 6 (3.9) | ||
| Basal cell carcinoma | 3 (1.9) | 1 (0.6) | 2 (1.3) | 6* (3.9) | 5 (3.2) | |
| Any AE of clinical interest, n (%) | 113 (71.5) | 86 (54.4) | 27 (17.1) | 77 (49.7) | 53 (34.2) | 24 (15.5) |
| Total no. of AEs of clinical interest | 280 | 245 | 35 | 164 | 135 | 29 |
| Cardiac arrhythmias | 34 (21.5) | 21 (13.3) | 13 (8.2) | 12 (7.7) | 10 (6.5) | 2 (1.3) |
| Bleeding | 53 (33.5) | 47 (29.7) | 6 (3.8) | 23 (14.8) | 20 (12.9) | 3 (1.9) |
| Hypertensive disorders | 18 (11.4) | 15 (9.5) | 3 (1.9) | 7 (4.5) | 4 (2.6) | 3 (1.9) |
| Cardiac event other than arrhythmia | 12 (7.6) | 7 (4.4) | 5 (3.2) | 16 (10.3) | 7 (4.5) | 9 (5.8) |
| Diarrhea | 63 (39.9) | 60 (38.0) | 3 (1.9) | 46 (29.7) | 39 (25.2) | 7 (4.5) |
AEs are reported according to the Medical Dictionary for Regulatory Activities preferred terms and National Cancer Institute Common Terminology Criteria for Adverse Events grade.
AEs of clinical interest include preferred terms, high-level (group) terms and standardized medical queries (SMQ) according to the Medical Dictionary for Regulatory Activities.