Table 3.
Numbers and proportions of patients reporting TEAEs (safety population)
| Naldemedine |
||||
|---|---|---|---|---|
| Placebo(N = 61) | 0.1 mg/day(N = 61) | 0.2 mg/day(N = 60) | 0.4 mg/day(N = 61) | |
| TEAE | 31 (50.8) | 25 (41.0) | 30 (50.0) | 34 (55.7) |
| Serious TEAE | 0 (0.0) | 2 (3.3) | 0 (0.0) | 1 (1.6) |
| Treatment-related TEAE | 10 (16.4) | 10 (16.4) | 15 (25.0) | 24* (39.3) |
| Any GI TEAE | 8 (13.1) | 13 (21.3) | 15 (25.0) | 21 (34.4) |
| Abdominal pain | 1 (1.6) | 3 (4.9) | 5 (8.3) | 9 (14.8) |
| Diarrhea | 3 (4.9) | 3 (4.9) | 3 (5.0) | 11 (18.0) |
| Flatulence | 2 (3.3) | 3 (4.9) | 3 (5.0) | 2 (3.3) |
| Nausea | 1 (1.6) | 1 (1.6) | 4 (6.7) | 3 (4.9) |
All data are N (%).
GI = gastrointestinal; TEAE = treatment-emergent adverse event.
*
P < 0.01 vs placebo.