Table 3.
Significant Intracranial Hemorrhage, n (%, 95% CI) | |
Total | 4 (6.2, 1.7–15) |
Symptomatic ICH | 3 (4.6, 0.9–12.9) |
† Parenchymal Hematoma type-2 | 2 (3.1, 0.4–10.7) |
| |
Asymptomatic Intracranial Hemorrhage, n (%, 95% CI) | |
Parenchymal Hematoma type-1 | 3 (4.6, 1–12.9) |
Hemorrhagic Transformation type-2 | 4 (6.2, 1.7–15.0) |
Hemorrhagic Transformation type-1 | 8 (12, 5.5–22.8) |
Total | 15 (23, 13.5–35.2) |
| |
Other bleeding serious adverse events, n | 0 |
| |
Adverse Events, n | 187 |
| |
Serious Adverse Events, total | 32 |
Death (brain herniation or respiratory failure), n (%) | 7 (21.9) |
Stroke Progression / Neurological worsening, n (%) | 5 (15.6) |
Significant ICH, n (%) | 4 (12.5) |
Cerebral Edema, n (%) | 4 (12.5) |
Pneumonia / Respiratory failure, n (%) | 3 (9.3) |
Cardiac Arrest, n (%) | 3 (9.3) |
Asymptomatic ICH, n (%) | 2 (6.3) |
* Significant laboratory abnormality, n (%) | 2 (6.3) |
Angioedema, n (%) | 1 (3.1) |
Seizure, n (%) | 1 (3.1) |
Definitely related to treatment | 0 |
Probably related to treatment | 3 |
| |
Mortality (at discharge or Day 7), n (%) | 7 (10.8) |
One patient had a PH-2 that was also symptomatic.
1 patient had elevation in creatinine and liver function tests due to decreased cardiac output and 1 patient had severe hypokalemia.