| Treatment-emergent AEs | PLA | PRU 2 mg | PRU 4 mg | |
|---|---|---|---|---|
| Most frequent AEs (≥10%), n (%) | Headache | 96 (14.5) | 169 (25.6) | 186 (28.3) |
| Nausea | 66 (10) | 129 (19.6) | 144 (21.9) | |
| Diarrhoea | 31 (4.7) | 84 (12.7) | 96 (14.6) | |
| Abdominal pain | 71 (10.7) | 82 (12.4) | 70 (10.7) | |
| n (%) with one or more AE | 450 (68.1) | 509 (77.2) | 501 (76.3) | |
| n (%) with SAEs | 18 (2.7) | 13 (2.0) | 19 (2.9) | |
| n (%) with AEs at least poss. related | 179 (27.1) | 281 (42.6) | 302 (46.0) | |
| n (%) with severe AEs | 97 (14.7) | 123 (18.7) | 139 (21.2) | |
| n (%) discontinued due to AE | 24 (3.6) | 39 (5.9) | 64 (9.7) |