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. Author manuscript; available in PMC: 2013 Mar 1.
Published in final edited form as: Stroke. 2012 Jan 5;43(3):770–775. doi: 10.1161/STROKEAHA.111.625574

Table 3.

Safety and bleeding results.

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.