Table 5.
Overview of AE incidence during the treatment phase (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) | |
| AnyAE | 62 (38) | 27 (31) | 60 (36) | 30 (35) | 69 (42) | 36 (42) | 42 (51) | 19 (45) |
| Severe AE | 5 (3) | 0 (0) | 3 (2) | 2 (2) | 2 (1) | 1 (1) | 5 (6) | 1 (2) |
| Drug-related AE | 23 (14) | 11 (13) | 23 (14) | 11 (13) | 40 (24) | 21 (24) | 19 (23) | 10 (24) |
| SAE (fatal or nonfatal) | 10 (6) | 5 (6) | 7 (4) | 4 (5) | 8 (5) | 3 (3) | 6 (7) | 2 (5) |
| AE leading to discontinuation | 8 (5) | 6 (7) | 8 (5) | 3 (4) | 10 (6) | 7 (8) | 11 (13) | 5 (12) |
Values in parentheses denote percentages. SAE = Serious AE.