TABLE 2.
Treatment-emergent Adverse Events in the Safety Population, n (%)
| Adverse Event | Treatment
|
|||
|---|---|---|---|---|
| Placebo (n = 8) | Bapineuzumab, 0.5 mg/kg (n = 6) | Bapineuzumab, 1.5 mg/kg (n = 6) | Bapineuzumab, 5 mg/kg (n = 10) | |
| Any adverse event | 8 (100) | 6 (100) | 5 (83.3) | 9 (90.0) |
| Abdominal pain | 2 (25.0) | 1 (16.7) | 0 | 0 |
| Accidental injury | 2 (25.0) | 2 (33.3) | 0 | 1 (10.0) |
| Asthenia | 2 (25.0) | 1 (16.7) | 0 | 1 (10.0) |
| Back pain | 2 (25.0) | 2 (33.3) | 1 (16.7) | 1 (10.0) |
| Headache | 3 (37.5) | 0 | 0 | 1 (10.0) |
| Hernia | 0 | 1 (16.7) | 0 | 1 (10.0) |
| Infection | 1 (12.5) | 2 (33.3) | 0 | 1 (10.0) |
| Pain | 2 (25.0) | 0 | 0 | 0 |
| Hypertension | 1 (12.5) | 1 (16.7) | 0 | 1 (10.0) |
| Dyspepsia | 1 (12.5) | 0 | 1 (16.7) | 0 |
| Vomiting | 2 (25.0) | 0 | 0 | 0 |
| BUN increased | 1 (12.5) | 0 | 0 | 1 (10.0) |
| Hyperglycemia | 1 (12.5) | 0 | 0 | 1 (10.0) |
| Peripheral edema | 1 (12.5) | 0 | 1 (16.7) | 0 |
| Anxiety | 0 | 0 | 0 | 2 (20.0) |
| Confusion | 0 | 1 (16.7) | 0 | 1 (10.0) |
| Depression | 2 (25.0) | 0 | 0 | 0 |
| Dizziness | 0 | 1 (16.7) | 0 | 2 (20.0) |
| Insomnia | 1 (12.5) | 0 | 0 | 1 (10.0) |
| Vertigo | 1 (12.5) | 1 (16.7) | 0 | 0 |
| Hematuria | 1 (12.5) | 0 | 0 | 1 (10.0) |
| Local reaction to procedure | 0 | 0 | 0 | 2 (20.0) |
BUN indicates blood urea nitrogen.