Table 2 Summary of adverse events in the open-label period
Patients, n (%) | Brazikumab/ Brazikumab (n = 52) | Placebo/ Brazikumab (n = 52) | Total (N = 104) |
|---|---|---|---|
≥ 1 TEAE | 43 (82.7) | 44 (84.6) | 87 (83.7) |
≥ 1 TESAE | 12 (23.1) | 8 (15.4) | 20 (19.2) |
TEAEs of ≥ grade 3 severity | 11 (21.2) | 4 (7.7) | 15 (14.4) |
TEAEs leading to study drug discontinuation | 7 (13.5) | 5 (9.6) | 12 (11.5) |
TEAEs leading to withdrawal from the study | 0 | 1 (1.9) | 1 (1.0) |
Total number of TEAEs | 387 | 444 | 831 |
TEAEs occurring in ≥ 10% of patients, n (%)a | |||
Headache | 11 (21.2) | 12 (23.1) | 23 (22.1) |
Nasopharyngitis | 15 (28.8) | 8 (15.4) | 23 (22.1) |
Abdominal pain | 10 (19.2) | 9 (17.3) | 19 (18.3) |
CD | 11 (21.2) | 6 (11.5) | 17 (16.3) |
Diarrhea | 7 (13.5) | 7 (13.5) | 14 (13.5) |
Influenza | 5 (9.6) | 8 (15.4) | 13 (12.5) |
Nausea | 6 (11.5) | 5 (9.6) | 11 (10.6) |
Vomiting | 3 (5.8) | 8 (15.4) | 11 (10.6) |
Pyrexia | 3 (5.8) | 6 (11.5) | 9 (8.7) |
Upper respiratory tract infection | 1 (1.9) | 8 (15.4) | 9 (8.7) |
Total number of TESAEs | 16 | 12 | 28 |
TESAEs associated with GI disorders, n (%) | |||
CD | 6 (11.5) | 1 (1.9) | 7 (6.7) |
Abdominal pain | 0 | 1 (1.9) | 1 (1.0) |
Anal fistula | 1 (1.9) | 0 | 1 (1.0) |
Diarrhea | 0 | 1 (1.9) | 1 (1.0) |