Table 3.
Event | Solanezumab (N = 572) | Placebo (N = 591) |
---|---|---|
number (percent) | ||
Any adverse event | 560 (97.9) | 577 (97.6) |
Adverse event definitely related to solanezumab or placebo† | 6 (1.0) | 8 (14) |
Serious adverse event | 172 (30.1) | 158 (26.7) |
Death | 6 (1.0) | 7 (12) |
Adverse event leading to discontinuation of solanezumab or placebo | 28 (4.9) | 34 (5.8) |
ARIA | 167 (29.2) | 194 (32.8) |
ARIA with edema | 1 (02) | 2 (0.3) |
ARIA with microhemorrhage or hemosiderosis | 167 (29.2) | 194 (32.8) |
Microhemorrhage | 158 (27.6) | 189 (32.0) |
Superficial siderosis | 19 (3.3) | 19 (3.2) |
Shown are adverse events that emerged or worsened after the first dose of solanezumab or placebo. ARIA denotes amyloid-related imaging abnormalities.
The relatedness of the adverse event to solanezumab or placebo was determined by the site investigator.