Table 4.
Treatment-related adverse events (more than 5% in either group)
| Donepezil (n=72) |
Placebo (n=73) |
|
| Visual hallucinations | 39(54.2) | 36(49.3) |
| Auditory hallucinations* | 8(11.1) | 26(35.6) |
| Hallucinations, unspecified | 8(11.1) | 7(9.6) |
| Delusions | 21(29.2) | 19(26.0) |
| Cenesthopathy | 2(2.8) | 4(5.5) |
| Nasopharyngitis* | 15(20.8) | 20(38.4) |
| Parkinsonism (worsening) | 12(16.7) | 6(8.2) |
| Dyskinesias | 6(8.3) | 2(2.7) |
| Dystonia | 4(5.6) | 1(1.4) |
| Contusion | 9(12.5) | 8(11.0) |
| Fall | 3(4.2) | 4(5.5) |
| Vomiting | 5(6.9) | 4(5.5) |
| Nausea | 5(6.9) | 2(2.7) |
| Loss of appetite | 6(8.3) | 1(1.4) |
| Diarrhoea | 4(5.6) | 2(2.7) |
| Loose stool | 4(5.6) | 0(0) |
| Body weight loss | 4(5.6) | 0(0) |
| Urinary cystitis | 8(11.1) | 13(17.8) |
| Dental caries | 5(6.9) | 4(5.5) |
| Back pain | 4(5.6) | 7(9.6) |
| Limb pain | 4(5.6) | 2(2.7) |
| Headache | 6(8.3) | 1(1.4) |
| Upper respiratory tract infection | 5(6.9) | 4(5.5) |
| Aspiration pneumonia | 0(0.0) | 5(6.8) |
| Insomnia | 5(6.9) | 5(6.8) |
The number of adverse events: number of events/patients(%).
*There were statistically significant differences in the prevalence of auditory hallucinations (p=0.00007) and nasopharyngitis (p=0.0287).