Table 4.
AEs leading to dose holds ≥7 days.
| AEs Leading to Dose Holds ≥7 Days | On Ibrutinib Treatment for ≥5 Years n = 79 |
All Ibrutinib- Treated Patients n = 135 |
|---|---|---|
| Patients with any AE, n (%) | 45 (57) | 79 (59) |
| Number of dose holds per patient, n (%) | ||
| 1 | 20 (25) | 35 (26) |
| ≥ 2 | 25 (32) | 44 (33) |
| Dose restarted after dose hold per patient, n/N (%) a,b | ||
| 420 mg | 42/45 (93) | 65/79 (82) |
| 280 mg | 8/45 (18) | 21/79 (27) |
| 140 mg | 5/45 (11) | 8/79 (10) |
| Other | 0 | 7/79 (9) |
| AEs leading to dose hold ≥7 days by SOC, n (%) a | ||
| Infection | 20 (25) | 28 (21) |
| Neoplasms | 8 (10) | 13 (10) |
| Eye disorders | 7 (9) | 10 (7) |
| Dermatologic | 6 (8) | 12 (9) |
| Gastrointestinal | 5 (6) | 10 (7) |
| Injuries | 5 (6) | 9 (7) |
| Hematologic | 4 (5) | 9 (7) |
| Musculoskeletal | 2 (3) | 4 (3) |
| Cardiac | 1 (1) | 6 (4) |
| Other | 13 (16) | 23 (17) |
| AEs leading to dose hold ≥7 days by grade, n (%) a | ||
| Grade 1 | 6 (8) | 10 (7) |
| Grade 2 | 25 (32) | 38 (28) |
| Grade 3 | 30 (38) | 49 (36) |
| Grade 4 | 5 (6) | 12 (9) |
| AE resolution, n/N (%) b | ||
| AE resolved with dose hold(s) | 43/45 (96) | 75/79 (95) |
| Any AE not resolved | 2/45 (4) | 12/79 (15) |
a The same patient may be counted in more than one category because of multiple AE events leading to dose holds; b Denominator is patients with dose holds ≥7 days because of any AE. Abbreviations: AE, adverse event; SOC, system organ class.