Overview of safety events in the study sample, by dose cohort
| Category of safety event . | Vedolizumab 75 mg (n = 3) . | Vedolizumab 300 mg (n = 21) . | Total (N = 24) . |
|---|---|---|---|
| TEAEs* | |||
| Total | 3 (100) | 21 (100) | 24 (100) |
| Related to study drug | 2 (66.7) | 6 (28.6) | 8 (33.3) |
| Not related to study drug | 1 (33.3) | 15 (71.4) | 16 (66.7) |
| Grade III or higher† | 3 (100) | 21 (100) | 24 (100) |
| Grade III or higher drug related† | 0 (0) | 2 (9.5) | 2 (8.3) |
| Leading to study drug discontinuation | 0 (0) | 0 (0) | 0 (0) |
| Serious AEs | |||
| Total | 2 (66.7) | 11 (52.4) | 13 (54.2) |
| Related to study drug | 0 (0) | 1 (4.8) | 1 (4.2) |
| Not related to study drug | 2 (66.7) | 10 (47.6) | 12 (50.0) |
| Leading to study drug discontinuation | 0 (0) | 0 (0) | 0 (0) |
| Relapse‡ | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Death‡ | 1 (33.3) | 2 (9.5) | 3 (12.5) |
| Category of safety event . | Vedolizumab 75 mg (n = 3) . | Vedolizumab 300 mg (n = 21) . | Total (N = 24) . |
|---|---|---|---|
| TEAEs* | |||
| Total | 3 (100) | 21 (100) | 24 (100) |
| Related to study drug | 2 (66.7) | 6 (28.6) | 8 (33.3) |
| Not related to study drug | 1 (33.3) | 15 (71.4) | 16 (66.7) |
| Grade III or higher† | 3 (100) | 21 (100) | 24 (100) |
| Grade III or higher drug related† | 0 (0) | 2 (9.5) | 2 (8.3) |
| Leading to study drug discontinuation | 0 (0) | 0 (0) | 0 (0) |
| Serious AEs | |||
| Total | 2 (66.7) | 11 (52.4) | 13 (54.2) |
| Related to study drug | 0 (0) | 1 (4.8) | 1 (4.2) |
| Not related to study drug | 2 (66.7) | 10 (47.6) | 12 (50.0) |
| Leading to study drug discontinuation | 0 (0) | 0 (0) | 0 (0) |
| Relapse‡ | 1 (33.3) | 1 (4.8) | 2 (8.3) |
| Death‡ | 1 (33.3) | 2 (9.5) | 3 (12.5) |
Data are presented as n (%).
A TEAE was defined as any AE that occurs after administration of the first dose of study drug and up to 18 weeks after the last dose of study medication.
Intensity for each AE was determined using the Common Terminology Criteria for Adverse Events, Version 4.03.22
Deaths and relapses were recorded within 18 weeks after the last dose. An additional participant relapsed and died after the 18-week treatment-emergent period.