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%) 1 (2%) 
 SAE 1 (1%) 
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%) 
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%) 1 (2%) 
 SAE 1 (1%) 
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.

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