Skip to main content

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