Table 5.
Integrated safety analysis: frequency (by severity) of and outcomes with hematologic AEs
| Neutropenia | Anemia | Thrombocytopenia | Febrile neutropenia | |
|---|---|---|---|---|
| Any-grade AE, n (% of all patients) | 78 (24) | 88 (27) | 53 (16) | 14 (4) |
| Grade 1 | 6 (2) | 24 (7) | 18 (5) | 0 (0) |
| Grade 2 | 12 (4) | 41 (12) | 15 (5) | 1 (< 1) |
| Grade 3 | 22 (7) | 21 (6) | 12 (4) | 13 (4) |
| Grade 4 | 38 (12) | 2 (1) | 8 (2) | 0 (0) |
| Grade 5 | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| AE management and resolution, n (% of patients with the AE) | ||||
| AE(s) resolved* | 66 (85) | 64 (73) | 26 (49) | 14 (100) |
| Received concomitant medication for management | 16 (21) | 28 (32) | 2 (4) | 7 (50) |
| Ibrutinib dose held for >7 d† | 18 (23) | 9 (10) | 7 (13) | 3 (21) |
| Ibrutinib dose reduction | 4 (5) | 3 (3) | 3 (6) | 0 (0) |
| Ibrutinib discontinuation‡ | 1 (1) | 3 (3) | 3 (6) | 0 (0) |
| Median duration until resolution of AE(s),§ d | 14 | 17 | 15 | 5 |
*
Resolved or resolved with sequelae, as assessed by the investigator. If patient had multiple AEs, then all AEs must have been deemed by the investigator to be resolved to be counted as resolved.
†
The onset of the missing dose event must have occurred on or ≤7 d after the related AE onset date.
‡
Includes patients with any AEs contributing to treatment discontinuation.
§
Median event duration based on all resolved AEs.