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.