Table 3.
Number of AEs and Relevant Discontinuations Including Detailed Numbers of Infections in the Overall and Asian (Japanese and Korean) Populations
| Population | Placebo |
22.5 mg |
75 mg |
225 mg |
All active treatment |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| Overall | Asian | Overall | Asian | Overall | Asian | Overall | Asian | Overall | Asian | |
| No. | 63 | 4 | 66 | 5 | 65 | 7 | 68 | 4 | 199 | 16 |
| Subjects with AEs | 54 (86) | 3 (75) | 57 (85) | 4 (80) | 51 (80) | 4 (57) | 53 (78) | 4 (100) | 161 (81) | 12 (75) |
| Subjects with serious AEs | 5 (8) | 0 | 11 (16) | 1 (20) | 9 (14) | 0 | 11 (16) | 0 | 31 (16) | 1 (6) |
| Discontinuations because of AE | 3 (5) | 0 | 9 (13) | 2 (40) | 8 (13) | 0 | 4 (6) | 0 | 21 (11) | 2 (13) |
| CD | 3 (5) | 0 | 4 (6) | 0 | 3 (5) | 0 | 2 (3) | 0 | 9 (5) | 0 |
| CD-related | 0 | 0 | 2 (3) | 1 (20) | 3 (5) | 0 | 1 (1) | 0 | 6 (3) | 1 (6) |
| Other | 0 | 0 | 3 (4) | 1 (20) | 2 (3) | 0 | 1 (1) | 0 | 6 (3) | 1 (6) |
| Infections | 20 (32) | 1 (25) | 27 (40) | 1 (20) | 25 (39) | 2 (29) | 24 (35) | 3 (75) | 76 (38) | 6 (38) |
| GI tract/liver infectionsa | 1 (2) | 0 | 8 (12) | 0 | 7 (11) | 1 (14) | 4 (6) | 0 | 19 (10) | 1 (6) |
| Infections in ex-GI MAdCAM bearing tissues | 10 (16) | 0 | 6 (9) | 0 | 6 (9) | 1 (14) | 8 (12) | 2 (50) | 20 (10) | 3 (19) |
| Nasopharyngitis | 5 (8) | 0 | 3 (4) | 0 | 4 (6) | 1 (14) | 5 (7) | 1 (25) | 12 (6) | 2 (13) |
| Bladder | 5 (8) | 0 | 3 (4) | 0 | 2 (3) | 0 | 3 (4) | 1 (25) | 8 (4) | 1 (6) |
| Other (spleen, uterus) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Values are presented as number (%).
a
Anal abscess, anal fistula infection, appendicitis. Gastroenteritis, gastroenteritis viral, GI inflammation, GI infection, GI viral infection, liver abscess, perirectal abscess, and rectal abscess (MedDRA version 18.1). [10]
AE, adverse event; MAdCAM, mucosal addressin cell adhesion molecule.