Table 4.
Treatment-Emergent Adverse Events (SAS–Combined)
| TEAE | Induction phase |
Maintenance phase |
Total (n=49) |
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Vedolizumab IV (n=27) |
Placebo (n=10) |
Vedolizumab SC (n=10) |
Vedolizumab IV (n=2) |
||||||||
| Events | Patients | Events | Patients | Events | Patients | Events | Patients | Events | Patients | ||
| TEAEs | 37 | 20 (74.1) | 20 | 10 (100.0) | 50 | 9 (90.0) | 9 | 2 (100) | 116 | 41 (83.7) | |
| Related | 1 | 1 (3.7) | 5 | 4 (40.0) | 13 | 3 (30.0) | 1 | 1 (50.0) | 20 | 9 (18.4) | |
| Not related | 36 | 19 (70.4) | 15 | 6 (60.0) | 37 | 6 (60.0) | 8 | 1 (50.0) | 96 | 32 (65.3) | |
| Mild | 28 | 13 (48.1) | 17 | 8 (80.0) | 42 | 5 (50.0) | 6 | 0 | 93 | 26 (53.1) | |
| Moderate | 8 | 6 (22.2) | 2 | 1 (10.0) | 8 | 4 (40.0) | 3 | 2 (100.0) | 21 | 13 (26.5) | |
| Severe | 1 | 1 (3.7) | 1 | 1 (10.0) | 0 | 0 | 0 | 0 | 2 | 2 (4.1) | |
| Leading to discontinuation | 2 (7.4) | 0 | 0 | 1 (50.0) | 3 (6.1) | ||||||
| Serious TEAEs | 3 | 3 (11.1) | 1 | 1 (10.0) | 1 | 1 (10.0) | 1 | 1 (50.0) | 6 | 6 (12.2) | |
| Related | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 (50.0) | 1 | 1 (2.0) | |
| Not related | 3 | 3 (11.1) | 1 | 1 (10.0) | 1 | 1 (10.0) | 0 | 0 | 5 | 5 (10.2) | |
| Leading to discontinuation | 2 (7.4) | 0 | 0 | 1 (50.0) | 3 (6.1) | ||||||
| Deaths | 0 | 0 | 0 | 0 | 0 | ||||||
Value are presented as number or number (%).
SAS, safety analysis set; IV, intravenous; SC, subcutaneous; TEAE, treatment-emergent adverse event.