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.