Table 6 Treatment-emergent adverse events (≥5 % in any group), safety population: noncarrier study
Event | PBO + BAP 0.5 (n = 39) | BAP 0.5 + BAP 0.5 (n = 66) | PBO + BAP 1.0 (n = 37) | BAP 1.0 + BAP 1.0 (n = 56) |
|---|---|---|---|---|
ARIA-E (vasogenic cerebral edema) | 3 (7.7) | 2 (3.0) | 6 (16.2) | 3 (5.4) |
Urinary tract infection | 2 (5.1) | 7 (10.6) | 1 (2.7) | 0 |
Headache | 1 (2.6) | 1 (1.5) | 3 (8.1) | 2 (3.6) |
Gastroenteritis | 0 | 0 | 3 (8.1) | 0 |
Nasopharyngitis | 3 (7.7) | 1 (1.5) | 1 (2.7) | 2 (3.6) |
Delusion | 3 (7.7) | 3 (4.5) | 0 | 0 |
Gait disturbance | 3 (7.7) | 0 | 1 (2.7) | 0 |
Fall | 0 | 3 (4.5) | 2 (5.4) | 4 (7.1) |
Dizziness | 1 (2.6) | 4 (6.1) | 0 | 0 |
Cerebral microhemorrhage | 0 | 1 (1.5) | 0 | 3 (5.4) |
Cognitive disorder | 1 (2.6) | 2 (3.0) | 2 (5.4) | 3 (5.4) |
Depression | 0 | 0 | 2 (5.4) | 0 |
Subdural hematoma | 0 | 0 | 0 | 3 (5.4) |
Aggression | 2 (5.1) | 0 | 0 | 0 |
Anemia | 2 (5.1) | 1 (1.5) | 0 | 0 |
Cough | 2 (5.1) | 0 | 0 | 2 (3.6) |
Nausea | 2 (5.1) | 0 | 0 | 0 |