Table 4. Adverse events of interest for ibrutinib-treated patients by time of event onset.
| Adverse eventa | 0–6 months, n/N* (%) (N=195) | >6–12 months, n/N* (%) (N=172) | >12–18 months, n/N* (%) (N=159) | >18–24 months, n/N* (%) (N=136) |
|---|---|---|---|---|
| Atrial fibrillation | 7/195 (4%) | 7/171 (4%) | 2/156 (1%) | 0/133 (0%) |
| Arthralgia | 34/195 (17%) | 5/153 (3%) | 3/140 (2%) | 2/115 (2%) |
| Diarrhea | 92/195 (47%) | 17/142 (12%) | 12/131 (9%) | 4/110 (4%) |
| Hypertension | 10/195 (5%) | 8/165 (5%) | 7/144 (5%) | 2/120 (2%) |
| Bleeding | 84/195 (43%) | 28/141 (20%) | 16/127 (13%) | 10/103 (10%) |
| Bleeding⩾grade 3 | 1/195 (<1%) | 1/172 (<1%) | 2/159 (1%) | 0/135 (0%) |
| Infection | 147/195 (75%) | 83/135 (61%) | 57/110 (52%) | 18/91 (20%) |
| Infection⩾grade 3 | 40/195 (21%) | 22/166 (13%) | 11/155 (7%) | 5/133 (4%) |
n, number of patients who were treated and had an event onset for a given AE within each exposure period.
N*, number of patients who were treated and at risk for event onset for a given AE in each exposure period; patients whose AE started in the previous time period and continued into the current or next time period(s) are not considered at risk for event onset in the current exposure period for that AE.
N, number of patients who were treated in each exposure period.
a
Includes any severity grade unless specified as ⩾grade 3.