EP (n = 425) | TPC (n = 406) | |
---|---|---|
Number of patients with diarrheaa, n (%) | 281 (66.1) | 80 (19.7) |
Grade 1 | 177 (41.6) | 52 (12.8) |
Grade 2 | 63 (14.8) | 23 (5.7) |
Grade 3 | 41 (9.6) | 5 (1.2) |
Number of patients with diarrhea related to study druga, n (%) | 268 (63.1) | 51 (12.6) |
Grade 1 | 170 (40.0) | 36 (8.9) |
Grade 2 | 59 (13.9) | 11 (2.7) |
Grade 3 | 39 (9.2) | 4 (1.0) |
Onset of diarrhea grade 2 or higher, n (%) | ||
Number of patients | 104 | 28 |
≥60 days | 72 (16.9 %) | 13 (3.2 %) |
>60–90 days | 10 (2.4 %) | 8 (2.0 %) |
>90–150 days | 11 (2.6 %) | 4 (1.0 %) |
>150 days | 11 (2.6 %) | 3 (0.7 %) |
Onset of diarrhea grade 3, n (%) | ||
Number of patients | 41 | 5 |
≥60 days | 25 (5.9 %) | 4 (1.0 %) |
>60–90 days | 5 (1.2 %) | 1 (0.2 %) |
>90–150 days | 5 (1.2 %) | 0 |
>150 days | 6 (1.4 %) | 0 |