Table 2.
Headache, Pyrexia, Nausea and Dizziness TEAEs by preferred term in the Placebo-controlled UC cohort and Pivotal UC cohort.
| Preferred term, n (%) (IR; 95% CI per 100 PY) | Placebo-controlled UC cohort | Pivotal UC cohort | ||||
|---|---|---|---|---|---|---|
| Placebo OD (N = 314) | Etrasimod 2 mg OD (N = 577) | Etrasimod 1 mg OD (N = 52) | Etrasimod (combined; N = 629) | Placebo OD (N = 260) | Etrasimod 2 mg OD (N = 527) | |
| Headache | 10 (3.2) [8.63; 3.28, 13.97] | 38 (6.6) [14.05; 9.58, 18.52] | 0 | 38 (6.0) [13.45; 9.17, 17.73] | 9 (3.5) [8.68; 3.01, 14.36] |
35 (6.6) [13.50; 9.03, 17.98] |
| Pyrexia | 10 (3.2) [8.57; 3.26, 13.88] | 24 (4.2) [8.56; 5.14, 11.99] | 0 | 24 (3.8) [8.21; 4.92, 11.49] | 9 (3.5) [8.62; 2.99, 14.25] |
22 (4.2) [8.19; 4.77, 11.61] |
| Nausea | 6 (1.9) [5.13; 1.03, 9.24] | 20 (3.5) [7.12; 4.00, 10.25] | 1 (1.9) [8.48; 0.00, 25.10] | 21 (3.3) [7.18; 4.11, 10.25] | 4 (1.5) [3.81; 0.08, 7.55] |
19 (3.6) [7.06; 3.89, 10.24] |
| Dizziness | 2 (0.6) [1.69; 0.00, 4.03] | 18 (3.1) [6.44; 3.47, 9.42] | 1 (1.9) [8.38; 0.00, 24.82] | 19 (3.0) [6.52; 3.59, 9.46] | 1 (0.4) [0.94; 0.00, 2.79] |
18 (3.4) [6.73; 3.62, 9.84] |
For TEAEs with 0 patients with events, % and IR are also 0, and 95% CIs were not calculated, so not displayed.
CI, confidence interval; IR, incidence rate; N, total number of patients in the safety analysis set; n, number of patients with each TEAE; PY, patient-year; OD, once daily; TEAE, treatment-emergent adverse event; UC, ulcerative colitis.