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. Author manuscript; available in PMC: 2014 Sep 10.
Published in final edited form as: N Engl J Med. 2014 Jan 23;370(4):322–333. doi: 10.1056/NEJMoa1304839

Table 3.

Adverse Events.*

Adverse Event Placebo Bapineuzumab, 0.5 mg/kg Bapineuzumab, 1.0 mg/kg Bapineuzumab, 2.0 mg/kg
number of patients (percent)
Carrier study
 Amyloid-related imaging abnormalities with edema 1 (0.2) 103 (15.3)
 Fall 64 (14.3) 100 (14.9)
 Headache 48 (10.7)  78 (11.6)
Noncarrier study
 Amyloid-related imaging abnormalities with edema 1 (0.2) 14 (4.2) 31 (9.4)  20 (14.2)
 Fall 73 (13.9)  43 (12.8) 43 (13.1) 23 (16.3)
 Urinary tract infection 59 (11.3)  40 (11.9) 42 (12.8) 15 (10.6)
 Anxiety 43 (8.2)   19 (5.6) 39 (11.9) 11 (7.8)  
 Headache 49 (9.4)   30 (8.9) 34 (10.3) 16 (11.3)
 Agitation 37 (7.1)   26 (7.7) 15 (4.6)  16 (11.3)
*

Included are adverse events that occurred during treatment in 10% or more of patients in any study group and occurring more frequently with bapineuzumab than with placebo.

The safety analysis in the carrier study was performed on data from 448 patients in the placebo group and 673 in the 0.5-mg-per-kilogram bapineuzumab group.

The safety analysis in the noncarrier study was performed on data from 524 patients in the placebo group, 337 in the 0.5-mg-per-kilogram bapineuzumab group, 329 in the 1.0-mg-per-kilogram bapineuzumab group, and 141 in the 2.0-mg-per-kilogram bapineuzumab group.