Table 5 Adverse events occurring at significantly different frequencies in the rivastigmine TID or BID groups relative to placebo.
| Adverse event | Rivastigmine TID (n = 227) | Rivastigmine BID (n = 228) | Placebo (n = 222) |
|---|---|---|---|
| Any adverse event | 91.6* | 91.2* | 76.1 |
| Serious adverse events | 17.6 | 17.5 | 14.9 |
| Discontinuations for any adverse event | 10.6 | 16.7* | 9.0 |
| Nausea | 48.0* (4.4*) | 53.9* (4.8*) | 14.0 (0.5) |
| Vomiting | 30.0* (1.3) | 38.6* (4.4*) | 6.3 (0.5) |
| Diarrhoea | 16.7* (0.4) | 17.5* (0.9) | 9.0 (0.9) |
| Anorexia | 18.5* (2.2) | 20.6* (1.8) | 2.7 (0.0) |
| Abdominal pain | 11.5* (0.4) | 14.9* (1.8) | 5.4 (0.0) |
| Flatulence | 6.6* (0.0) | 4.8 (0.4) | 1.8 (0.0) |
| Headache | 15.9 (0.4) | 17.5* (0.9) | 10.4 (0.0) |
| Dizziness | 17.2* (0.9) | 18.4* (0.0) | 7.2 (0.0) |
| Agitation | 6.2* (0.0*) | 9.2 (1.3) | 11.7 (2.3) |
| Anxiety | 3.5 (0.0) | 5.7* (0.4) | 1.4 (0.0) |
| Haemorrhoids | 0.9 (0.0) | 0.0* (0.0) | 2.7 (0.0) |
BID, twice daily; TID, three times daily.
Values are shown as percentages of patients reporting the events, with percentages withdrawing from the study in parentheses (safety population).
*p<0.05 vs placebo, based on Fisher's exact test.