Table 3.
Event, n, % (95% CI) | ApoE ε4 carrier study | ApoE ε4 noncarrier study | |||
---|---|---|---|---|---|
Placebo | BAP 0.5 | Placebo | BAP 0.5 | BAP 1.0 | |
(n = 439) | (n = 654) | (n = 344) | (n = 267) | (n = 263) | |
ARIA-E | 9 | 109 | 2 | 13 | 31 |
2.05 | 16.67 | 0.58 | 4.87 | 11.79 | |
(0.94, 3.86) | (13.89, 19.75) | (0.07, 2.08) | (2.62, 8.18) | (8.15, 16.3) | |
Intracranial hemorrhage | 5 | 6 | 7 | 2 | 1 |
1.14 | 0.92 | 2.03 | 0.75 | 0.38 | |
(0.37, 2.64) | (0.34, 1.99) | (0.82, 4.15) | (0.09, 2.68) | (0.01, 2.10) | |
Seizures/convulsions | 1 | 7 | 3 | 1 | 0 |
0.23 | 1.07 | 0.87 | 0.37 | 0.00 | |
(0.01, 1.26) | (0.43, 2.19) | (0.18, 2.53) | (0.01, 2.07) | (0.00, 1.39) | |
DVT/PE | 2 | 8 | 0 | 1 | 1 |
0.46 | 1.22 | 0.00 | 0.37 | 0.38 | |
(0.06, 1.64) | (0.53, 2.40) | (0.00, 1.07) | (0.01, 2.07) | (0.01, 2.10) | |
Hypersensitivity reactions | 19 | 18 | 6 | 5 | 4 |
4.33 | 2.75 | 1.74 | 1.87 | 1.52 | |
(2.63, 6.68) | (1.64, 4.32) | (0.64, 3.76) | (0.61, 4.32) | (0.42, 3.85) | |
Intraparenchymal hemorrhage | 2 | 5 | 0 | 0 | 0 |
0.46 | 0.76 | 0.00 | 0.00 | 0.00 | |
(0.06, 1.64) | (0.25, 1.78) | (0.00, 1.07) | (0.00, 1.37) | (0.00, 1.39) |
ApoE apolipoprotein E, ARIA-E amyloid-related imaging abnormalities, edema/effusion, BAP bapineuzumab, DVT/PE deep vein thrombosis/pulmonary embolism