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Table 3 Adverse events with an incidence ≥ 5% in either treatment group over 24 weeks (APT set)

From: Memantine in patients with Alzheimer's disease receiving donepezil: new analyses of efficacy and safety for combination therapy

  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)
  1. 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.