TABLE 2.
Treatment‐emergent adverse events following enpatoran single‐dose administration (safety analysis set)
| Number (%) of participants |
Placeboa n = 14 |
Enpatoran dose |
Enpatoranb n = 42 |
Overall n = 56 |
||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
1 mg n = 6 |
3 mg n = 6 |
9 mg n = 6 |
25 mg n = 6 |
50 mg n = 6 |
100 mg n = 6 |
200 mg n = 6 |
||||
| Any TEAE | 2 (14.3) | — | 4 (66.7) | — | — | — | — | 1 (16.7) | 5 (11.9) | 7 (12.5) |
| Any study‐treatment‐related TEAE | 1 (7.1) | — | 3 (50.0) | — | — | — | — | 1 (16.7) | 4 (9.5) | 5 (8.9) |
| At least one event | 2 (14.3) | — | 4 (66.7) | — | — | — | — | 1 (16.7) | 5 (11.9) | 7 (12.5) |
| Gastrointestinal disorders | ||||||||||
| Flatulence | — | — | 4 (66.7) | — | — | — | — | — | 4 (9.6) | 4 (7.1) |
| Diarrhea | — | — | 1 (16.7) | — | — | — | — | — | 1 (2.4) | 1 (1.8) |
| Nausea | 1 (7.1) | — | — | — | — | — | — | — | — | 1 (1.8) |
| Vomiting | 1 (7.1) | — | — | — | — | — | — | — | — | 1 (1.8) |
| General disorders and administration site conditions | ||||||||||
| Fatigue | — | — | 1 (16.7) | — | — | — | — | — | 1 (2.4) | 1 (1.8) |
| Vessel puncture site pain | 1 (7.1) | — | — | — | — | — | — | — | — | 1 (1.8) |
| Infections and infestations | ||||||||||
| Nasopharyngitis | — | — | 1 (16.7) | — | — | — | — | — | 1 (2.4) | 1 (1.8) |
| Nervous system disorders | ||||||||||
| Dysgeusia | — | — | — | — | — | — | — | 1 (16.7) | 1 (2.4) | 1 (1.8) |
Abbreviation: TEAE, treatment‐emergent adverse event.
a
Pooled placebo.
b
Enpatoran all doses.