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. 2010 Aug 21;30(2):131–146. doi: 10.1159/000318845

Table 6.

AE occurring during the treatment phase in >5% of any treatment group (safety population: full and APOE-e4-negative subgroup)

Number of subjects reporting event
placebo
2 mg RSG XR
8 mg RSG XR
10 mgdonepezil
full (n = 165) APOE ε4 negative (n = 86) full (n=166) APOE ε4 negative (n = 85) full (n = 165) APOE ε4 negative (n = 86) full (n = 83) APOE ε4 negative (n = 42)
Peripheral edema 9 (5) 4 (5) 6 (4) 2 (2) 24 (15) 11 (13) 3 (4) 2 (5)
Diarrhea 1 (<1) 0 2 (1) 1 (1) 4 (2) 3 (3) 4 (5) 1 (2)
Nasopharyngitis 4 (2) 1 (1) 11 (7) 6 (7) 4 (2) 2 (2) 1 (1) 0
Headache 0 0 2 (1) 1 (1) 2 (1) 1 (1) 7 (8) 7 (17)
Hyperlipidemia 1 (<1) 0 9 (5) 3 (4) 1 (<1) 0 2 (2) 0
Nausea 0 0 1 (<1) 0 1 (<1) 1 (1) 4 (5) 3 (7)
Gastroesophageal reflux 1 (<1) 1 (1) 0 0 0 0 2 (2) 2 (5)
Insomnia 1 (<1) 0 0 0 0 0 3 (4) 2 (5)

Values in parentheses denote percentages.