| Adverse events reported during the entire treatment period | Adverse events reported after day 1 | |||||
| Placebo N = 240 | PRU 2 mg N = 238 | PRU 4 mg N = 238 | Placebo N = 240 | PRU 2 mg N = 238 | PRU 4 mg N = 238 | |
| No of patients with adverse events (%) | 161 (67.1) | 170 (71.4) | 178 (74.8) | 159 (66.3) | 160 (67.2) | 155 (65.1) |
| Headache | 40 (16.7) | 62 (26.1) | 71 (29.8) | 37 (15.4) | 36 (15.1) | 38 (16.0) |
| Nausea | 34 (14.2) | 57 (23.9) | 56 (23.5) | 31 (12.9) | 31 (13.0) | 27 (11.3) |
| Abdominal pain | 41 (17.1) | 55 (23.1) | 44 (18.5) | 38 (15.8) | 41 (17.2) | 32 (13.5) |
| Diarrhoea | 13 (5.4) | 31 (13.0) | 30 (12.6) | 13 (5.4) | 19 (8.0) | 14 (5.9) |
| Flatulence | 18 (7.5) | 21 (8.8) | 18 (7.6) | 15 (6.3) | 14 (5.9) | 11 (4.6) |
| Viral infection | 28 (11.7) | 21 (8.8) | 14 (5.9) | 27 (11.3) | 21 (8.8) | 14 (5.9) |
| Vomiting | 11 (4.6) | 11 (4.6) | 17 (7.1) | 9 (3.8) | 9 (3.8) | 7 (2.9) |
| Fatigue | 6 (2.5) | 12 (5.0) | 14 (5.9) | 6 (2.5) | 8 (3.4) | 12 (5.0) |
| Dizziness | 4 (1.7) | 12 (5.0) | 11 (4.6) | 4 (1.7) | 9 (3.8) | 7 (2.9) |
PRU, prucalopride.