Neurologic safety event rates in the SENTIS trial control population
Article first published online: 18 SEP 2012
© 2012 John Wiley & Sons A/S
Acta Neurologica Scandinavica
Volume 127, Issue 2, pages e5–e7, February 2013
How to Cite
Neurologic safety event rates in the SENTIS trial control population. Acta Neurol Scand 2013; 127: e5–e7. © 2012 John Wiley & Sons A/S., , , , , .
- Issue published online: 22 JAN 2013
- Article first published online: 18 SEP 2012
- Manuscript Accepted: 13 AUG 2012
- intracerebral hemorrhage;
- intracranial hemorrhage
Adverse event (AE) rates for interventional stroke trials are not well established.
We prospectively evaluated control arm AEs from a randomized stroke trial to establish expected rates of neurologic AEs.
Control data from the Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS) Trial were evaluated. Patients were ≥ 18 years with National Institutes of Health Stroke Scale (NIHSS) scores 5–18 within 14 h of stroke onset. Follow-up was 90 days. Neurological AEs and serious AEs (SAEs) were adjudicated and the following defined times used to determine treatment relatedness: 24-h imaging for intracranial hemorrhage (ICnH) including hemorrhagic transformation, 7 days each for cerebral edema and neurologic worsening/stroke progression, and 30 days for new ischemic strokes.
The control group included 257 patients, 49.4% female, mean age of 68.3 years, and median NIHSS of 10. Neurologic AEs occurred at the following rates: ICnH 27.6%, cerebral edema 6.6%, neurologic worsening 18.3%, and new stroke 4.7%. Most of these events occurred within the defined times: ICnH 74.6%, cerebral edema 94.1%, neurologic worsening 87.2%, and new stroke 83.3%.
SENTIS Trial control arm neurologic events provide estimates of expected AE rates and defined times that can be used for future stroke trial's safety assessments.