Table 3.
AEs leading to dose reductions per USPI recommendations a.
| AEs Leading to Dose Reductions | On Ibrutinib Treatment for ≥5 Years n = 79 |
All Ibrutinib- Treated Patients n = 135 |
|---|---|---|
| Patients with any AE, n (%) | 4 (5) | 11 (8) |
| Median time from first dose reduction to discontinuation, months (range) | 36.1 (8.4–56.0+) | 32.9 (0.0–56.0+) |
| First dose reduced to, n/N (%) b | ||
| 420 mg to 280 mg | 3/4 (75) | 9/11 (82) |
| 420 mg to 140 mg | 1/4 (25) | 1/11 (9) |
| 280 mg to 140 mg | 0/4 (0) | 1/11 (9) |
| Outcome of first AE leading to dose reduction, n/N (%) b | ||
| Initial AE resolved | 3/4 (75) | 10/11 (91) |
| No recurrence or recurred at lower grade | 3/4 (75) | 7/11 (64) |
| Recurred at same or higher grade | 1/4 (25) | 4/11 (36) c |
a AEs for which dose reductions are recommended in the ibrutinib USPI (grade 2 cardiac failure, grade 3 cardiac arrhythmia, grade 3 or 4 nonhematologic AEs [excluding cardiac failure and cardiac arrhythmia], grade 3 or 4 neutropenia with infection or fever, and grade 4 hematologic AEs). b Denominator is patients with dose reductions because of AEs per recommendations in the ibrutinib USPI. c Four patients had AEs that recurred at the same grade (grade 3 atrial fibrillation that recurred after 3 years [n = 1], grade 3 pleural effusion that recurred after 2 years [n = 1], grade 3 diarrhea that recurred after 4 days [n = 1], and grade 3 headache that recurred after 1 week [n = 1]). Abbreviations: AE, adverse event; USPI, US prescribing information.