Table 3.
Adverse events with an incidence ≥ 5% in either treatment group over 24 weeks (APT set)
| MOD-SEV subgroupa | MOD subgroupb | |||
|---|---|---|---|---|
| Adverse event | Memantine added to donepezil (n = 269) |
Placebo added to donepezil (n = 251) |
Memantine added to donepezil (n = 190) |
Placebo added to donepezil (n = 185) |
| Patients with AEs | 206 (76.6) | 186 (74.1) | 144 (75.8) | 136 (73.5) |
| Dizziness | 20 (7.4) | 19 (7.6) | 17 (8.9) | 16 (8.6) |
| Agitation | 17 (6.3)* | 29 (11.6) | 9 (4.7)* | 19 (10.3) |
| Confusional state | 15 (5.6) | 6 (2.4) | - | - |
| Diarrhoea | 14 (5.2) | 21 (8.4) | 12 (6.3) | 14 (7.6) |
| Nasopharyngitis | 14 (5.2) | 6 (2.4) | - | - |
| Falls | 11 (4.1) | 15 (6.0) | 10 (5.3) | 11 (5.9) |
| Urinary tract infection | - | - | 10 (5.3) | 8 (4.3) |
| Depression | - | - | 6 (3.2) | 11 (5.9) |
Data are number (%). aModerate to severe AD (MMSE 5 to 19 at baseline), receiving donepezil (10 mg/day). bModerate AD (MMSE 10 to 19 at baseline), receiving donepezil (10 mg/day). *P < 0.05 versus placebo added to donepezil. APT, all-patients-treated; AE, adverse event; '-' denotes AEs with an incidence < 5% in both treatment groups in the respective severity subgroup.