Table 3.
Treatment-Emergent AEs
| AEs, n (%) | Placebo (n=326) |
Donepezil (n=648) |
|---|---|---|
| Any AE | 253 (77.6) | 523 (80.7) |
| Mild/moderate | 227 (66.6) | 441 (68.0) |
| Severe | 36 (11.0) | 82 (12.7) |
| Assessment of relation of AEs to study drug | ||
| Not related | 156(47.9) | 262 (40.4) |
| Possibly or probably related | 97 (29.8) | 261 (40.3) |
| AEs affecting ≥5% of donepezil-treated patients and at least 10% in the placebo group | ||
| Nausea | 14 (4.3) | 64 (9.9) |
| Anorexia | 9 (2.8) | 37 (5.7) |
| Abdominal pain | 8 (2.5) | 33 (5.1) |
| SAEs affecting ≥2% of patients in either group | ||
| At least 1 SAE* | 47 (14.4) | 94 (14.5) |
| Cardiovascular system | 15 (4.6) | 23 (3.5) |
| Infections and infestations | 10 (3.1) | 14 (2.2) |
| Injury, poisoning, and procedural complications | 10 (3.1) | 12 (1.9) |
| Nervous system | 13 (4.0) | 31 (4.8) |
| Respiratory system | 9 (2.8) | 12 (1.9) |
| Urogenital system | 7 (2.1) | 13 (2.0) |
| Death | 0 (0.0) | 11 (1.7) |
*
Including death.