Exposure to study drug in the phase 3 safety population
| UC (n=1114) | CD (n=1770) | UC and CD* (N=2884) | |
|---|---|---|---|
| Patients exposed to vedolizumab, n (%) | |||
| ≥1 dose | 1077 (97) | 1712 (97) | 2789 (97) |
| ≥6 months | 837 (75) | 1163 (66) | 2000 (69) |
| ≥12 months | 574 (52) | 827 (47) | 1401 (49) |
| ≥18 months | 473 (42) | 677 (38) | 1150 (40) |
| ≥24 months | 428 (38) | 478 (27) | 906 (31) |
| ≥36 months | 198 (18) | 209 (12) | 407 (14) |
| ≥48 months | 30 (3) | 10 (1) | 40 (1) |
| Extent of vedolizumab exposure, days | |||
| Median (Min, Max) | 378 (1, 1977) | 338 (1, 1927) | 365 (1, 1977) |
| UC | CD | ||
| Extent of placebo exposure, days | GEMINI 1 (n=149) | GEMINI 2 (n=148) | GEMINI 3 (n=207) |
| Median (Min, Max) | 99 (1, 362) | 106 (1, 372) | 42 (1, 72) |
*Patients participated in studies GEMINI 1, GEMINI 2, GEMINI 3 and GEMINI LTS. Patients in study C13004 who rolled over to GEMINI LTS are included.
CD, Crohn's disease; LTS, long-term safety; UC, ulcerative colitis.