Frequency of highlighted adverse events on selected landmark ibrutinib studies
| Adverse event . | Phase 2, follow-up 21 mo6 (n = 85) . | Phase 3 RESONATE . | Phase 3 RESONATE2 . | ||
|---|---|---|---|---|---|
| Follow-up 9 mo4 (n = 195) . | Follow-up 19 mo16,17 (n = 195) . | Follow-up 18 mo5 (n = 135) . | Follow-up 21 mo18 (n = 135) . | ||
| Atrial fibrillation | |||||
| All grades | 3 (4) | 10 (5) | 13 (7) | 8 (6) | 14 (10) |
| Grade ≥3 | 0 | 6 (3) | 7 (4) | 2 (1) | 6 (4) |
| Bleeding | |||||
| All grades | 14 (16) | 86 (44) | NR | NR | 9 (7) |
| Grade ≥3 | 4 (5) | 2 (1) | 4 (2) | 6 (4) | 8 (6) |
| Infection | |||||
| All grades | NR | 137 (70) | NR | NR | NR |
| Grade ≥3 | NR | 47 (24) | 59 (30) | NR | 31 (23) |
| Arthralgia | |||||
| All grades | 23 (27) | 34 (17) | 44 (23) | 22(16) | 27 (20) |
| Grade ≥3 | 0 | 2 (1) | NR | 2 (1) | 3 (2) |
| Myalgia | |||||
| All grades | 16 (19) | 19 (10) | NR | NR | NR |
| Grade ≥3 | 1 (1) | 1 (1) | NR | NR | NR |
| Adverse event . | Phase 2, follow-up 21 mo6 (n = 85) . | Phase 3 RESONATE . | Phase 3 RESONATE2 . | ||
|---|---|---|---|---|---|
| Follow-up 9 mo4 (n = 195) . | Follow-up 19 mo16,17 (n = 195) . | Follow-up 18 mo5 (n = 135) . | Follow-up 21 mo18 (n = 135) . | ||
| Atrial fibrillation | |||||
| All grades | 3 (4) | 10 (5) | 13 (7) | 8 (6) | 14 (10) |
| Grade ≥3 | 0 | 6 (3) | 7 (4) | 2 (1) | 6 (4) |
| Bleeding | |||||
| All grades | 14 (16) | 86 (44) | NR | NR | 9 (7) |
| Grade ≥3 | 4 (5) | 2 (1) | 4 (2) | 6 (4) | 8 (6) |
| Infection | |||||
| All grades | NR | 137 (70) | NR | NR | NR |
| Grade ≥3 | NR | 47 (24) | 59 (30) | NR | 31 (23) |
| Arthralgia | |||||
| All grades | 23 (27) | 34 (17) | 44 (23) | 22(16) | 27 (20) |
| Grade ≥3 | 0 | 2 (1) | NR | 2 (1) | 3 (2) |
| Myalgia | |||||
| All grades | 16 (19) | 19 (10) | NR | NR | NR |
| Grade ≥3 | 1 (1) | 1 (1) | NR | NR | NR |
Values represent number (percentage) of patients.
NR, not reported.