TABLE 2.
Summary of safety events
| Placebo (N=87) | Seladelpar 5 mg (N=89) | Seladelpar 10 mg (N=89) | Total (N=265) | |
|---|---|---|---|---|
| Duration of exposure (wk), mean (SD) | 17.8 (11.2) | 17.6 (12.1) | 17.6 (12.0) | 17.7 (11.7) |
| TEAE, n (%) | ||||
| ≥1 TEAE | 64 (73.6) | 56 (62.9) | 58 (65.2) | 178 (67.2) |
| ≥1 serious TEAE | 3 (3.4) | 3 (3.4) | 1 (1.1) | 7 (2.6) |
| ≥1 TEAE Grade ≥ 3 | 6 (6.9) | 3 (3.4) | 5 (5.6) | 14 (5.3) |
| ≥1 TEAE leading to study drug discontinuation | 2 (2.3) | 2 (2.2) | 2 (2.2) | 6 (2.3) |
| ≥1 treatment-related TEAE | 16 (18.4) | 25 (28.1) | 15 (16.9) | 56 (21.1) |
| ≥1 serious treatment-related TEAE | 0 | 0 | 0 | 0 |
| ≥1 treatment-related TEAE Grade ≥ 3 | 0 | 0 | 0 | 0 |
| Deaths, n (%) | 0 | 0 | 0 | 0 |
| Common TEAEs (≥5% incidence in any treatment group), n (%) | ||||
| Pruritus (qualitative) | 11 (12.6) | 3 (3.4) | 10 (11.2) | 24 (9.1) |
| Abdominal pain upper | 3 (3.4) | 8 (9.0) | 6 (6.7) | 17 (6.4) |
| Nausea | 4 (4.6) | 5 (5.6) | 7 (7.9) | 16 (6.0) |
| Arthralgia | 5 (5.7) | 5 (5.6) | 4 (4.5) | 14 (5.3) |
| Fatigue | 8 (9.2) | 2 (2.2) | 4 (4.5) | 14 (5.3) |
| Headache | 1 (1.1) | 5 (5.6) | 7 (7.9) | 13 (4.9) |
| Upper respiratory tract infection | 2 (2.3) | 6 (6.7) | 4 (4.5) | 12 (4.5) |
| Constipation | 2 (2.3) | 5 (5.6) | 3 (3.4) | 10 (3.8) |
| Sinusitis | 5 (5.7) | 2 (2.2) | 1 (1.1) | 8 (3.0) |
| Urinary tract infection | 0 | 2 (2.2) | 5 (5.6) | 7 (2.6) |
| Dry mouth | 0 | 5 (5.6) | 1 (1.1) | 6 (2.3) |
Abbreviations: n, number of patients in the category; N, number of patients in the treatment group; TEAE, treatment-emergent adverse event.