Table 3.
Prevalence of select AEs by 6-month intervals
| Select AEs* n (%) | 1-6 mo (n = 111) | 7-12 mo (n = 72) | 13-18 mo (n = 51) | 19-24 mo (n = 41) | >24 mo (n = 22) |
|---|---|---|---|---|---|
| Any diarrhea | 49 (44%) | 21 (29%) | 15 (29%) | 8 (20%) | 6 (27%) |
| Grade 3† | 5 (5%) | 0 | 0 | 1 (2%) | 0 |
| SAE | 1 (1%) | 0 | 0 | 0 | 0 |
| Any infection | 76 (69%) | 43 (60%) | 30 (59%) | 22 (54%) | 9 (41%) |
| Grade ≥3 | 20 (18%) | 11 (15%) | 6 (12%) | 5 (12%) | 1 (5%) |
| SAE | 16 (14%) | 9 (13%) | 4 (8%) | 5 (12%) | 1 (5%) |
| Any bleeding | 46 (41%) | 17 (24%) | 17 (33%) | 14 (34%) | 5 (23%) |
| Major bleeding | 6 (5%) | 1 (1%) | 3 (6%) | 2 (5%) | 2 (9%) |
AE, adverse event
*
AEs were updated with an estimated median follow-up of 26.7 mo
†
No grade 4 or 5 diarrhea.