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Table 3 Prespecified events of clinical importance—incidence proportion (95% CI)

From: Bapineuzumab for mild to moderate Alzheimer’s disease in two global, randomized, phase 3 trials

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)
  1. ApoE apolipoprotein E, ARIA-E amyloid-related imaging abnormalities, edema/effusion, BAP bapineuzumab, DVT/PE deep vein thrombosis/pulmonary embolism