Table 4.
Prevalence of select AEs of clinical interest over time with ibrutinib treatment in the integrated safety analysis (N = 330)
| AE, n (%) | 0-1 y (N = 330) | >1 to 2 y (n = 280) | >2 to 3 y (n = 246) |
|---|---|---|---|
| Hematologic AEs | |||
| Anemia | 68 (21) | 24 (9) | 21 (9) |
| Neutropenia | 64 (19) | 26 (9) | 15 (6) |
| Thrombocytopenia | 42 (13) | 26 (9) | 25 (10) |
| Febrile neutropenia | 8 (2) | 6 (2) | 0 |
| Nonhematologic AEs | |||
| Diarrhea | 155 (47) | 56 (20) | 38 (15) |
| Fatigue | 97 (29) | 65 (23) | 53 (22) |
| Arthralgia | 53 (16) | 35 (13) | 33 (13) |
| Atrial fibrillation | 20 (6) | 12 (4) | 19 (8) |
| Pooled AE terms* or system organ class | |||
| Hypertension | 36 (11) | 41 (15) | 48 (20) |
| Bleeding | 147 (45) | 100 (36) | 68 (28) |
| Rash | 88 (27) | 58 (21) | 38 (15) |
| Grade ≥3 infections† | 77 (23) | 38 (14) | 24 (10) |
*
Pooled AE terms include multiple preferred terms relevant to the AE of interest.
†
AEs reported under “infections and infestations” system organ class category.