Adverse events (safety cohort)
| . | Ibrutinib (n = 158) . | Placebo (n = 155) . | ||||
|---|---|---|---|---|---|---|
| . | Any grade . | Grade 1-2 . | Grade ≥3 . | Any grade . | Grade 1-2 . | Grade ≥3 . |
| Total no. of events | 1593 | 1426 | 167 | 1015* | 885 | 129 |
| Any AE, n (%) | 150 (94.9) | 70 (44.3) | 80 (50.6) | 147 (94.8) | 80 (51.6) | 67 (43.2) |
| Most common AEs occurring in ≥0% of patients in any treatment group, n (%)† | ||||||
| Atrial fibrillation | 19 (12.0) | 9 (5.7) | 10 (6.3) | 2 (1.3) | 2 (1.3) | |
| Diarrhea | 50 (31.6) | 48 (30.4) | 2 (1.3) | 28 (18.1) | 27 (17.4) | 1 (0.6) |
| Dyspepsia | 23 (14.6) | 23 (14.6) | 4 (2.6) | 4 (2.6) | ||
| Nausea | 26 (16.5) | 26 (16.5) | 15 (9.7) | 15 (9.7) | ||
| Fatigue | 40 (25.3) | 39 (24.7) | 1 (0.6) | 32 (20.6) | 31 (20.0) | 1 (0.6) |
| Nasopharyngitis | 42 (26.6) | 41 (25.9) | 1 (0.6) | 51 (32.9) | 51 (32.9) | |
| Upper respiratory tract infection | 16 (10.1) | 15 (9.5) | 1 (0.6) | 11 (7.1) | 11 (7.1) | |
| Arthralgia | 19 (12.0) | 18 (11.4) | 1 (0.6) | 14 (9.0) | 13 (8.4) | 1 (0.6) |
| Back pain | 16 (10.1) | 14 (8.9) | 2 (1.3) | 17 (11.0) | 15 (9.7) | 2 (1.3) |
| Muscle spasms | 22 (13.9) | 6 (3.9) | ||||
| Dizziness | 22 (13.9) | 20 (12.7) | 2 (1.3) | 8 (5.2) | 8 (5.2) | |
| Headache | 28 (17.7) | 28 (17.7) | 17 (11.0) | 17 (11.0) | ||
| Rash | 29 (18.4) | 24 (15.2) | 5 (3.2) | 8 (5.2) | 8 (5.2) | |
| Hematoma | 22 (13.9) | 20 (12.7) | 2 (1.3) | 6 (3.9) | 6 (3.9) | |
| Hypertension | 16 (10.1) | 14 (8.8) | 2 (1.3) | 7 (4.5) | 4 (2.6) | 3 (1.9) |
| . | Ibrutinib (n = 158) . | Placebo (n = 155) . | ||||
|---|---|---|---|---|---|---|
| . | Any grade . | Grade 1-2 . | Grade ≥3 . | Any grade . | Grade 1-2 . | Grade ≥3 . |
| Total no. of events | 1593 | 1426 | 167 | 1015* | 885 | 129 |
| Any AE, n (%) | 150 (94.9) | 70 (44.3) | 80 (50.6) | 147 (94.8) | 80 (51.6) | 67 (43.2) |
| Most common AEs occurring in ≥0% of patients in any treatment group, n (%)† | ||||||
| Atrial fibrillation | 19 (12.0) | 9 (5.7) | 10 (6.3) | 2 (1.3) | 2 (1.3) | |
| Diarrhea | 50 (31.6) | 48 (30.4) | 2 (1.3) | 28 (18.1) | 27 (17.4) | 1 (0.6) |
| Dyspepsia | 23 (14.6) | 23 (14.6) | 4 (2.6) | 4 (2.6) | ||
| Nausea | 26 (16.5) | 26 (16.5) | 15 (9.7) | 15 (9.7) | ||
| Fatigue | 40 (25.3) | 39 (24.7) | 1 (0.6) | 32 (20.6) | 31 (20.0) | 1 (0.6) |
| Nasopharyngitis | 42 (26.6) | 41 (25.9) | 1 (0.6) | 51 (32.9) | 51 (32.9) | |
| Upper respiratory tract infection | 16 (10.1) | 15 (9.5) | 1 (0.6) | 11 (7.1) | 11 (7.1) | |
| Arthralgia | 19 (12.0) | 18 (11.4) | 1 (0.6) | 14 (9.0) | 13 (8.4) | 1 (0.6) |
| Back pain | 16 (10.1) | 14 (8.9) | 2 (1.3) | 17 (11.0) | 15 (9.7) | 2 (1.3) |
| Muscle spasms | 22 (13.9) | 6 (3.9) | ||||
| Dizziness | 22 (13.9) | 20 (12.7) | 2 (1.3) | 8 (5.2) | 8 (5.2) | |
| Headache | 28 (17.7) | 28 (17.7) | 17 (11.0) | 17 (11.0) | ||
| Rash | 29 (18.4) | 24 (15.2) | 5 (3.2) | 8 (5.2) | 8 (5.2) | |
| Hematoma | 22 (13.9) | 20 (12.7) | 2 (1.3) | 6 (3.9) | 6 (3.9) | |
| Hypertension | 16 (10.1) | 14 (8.8) | 2 (1.3) | 7 (4.5) | 4 (2.6) | 3 (1.9) |