Abstract
Background: Adverse event (AE) rates for interventional stroke trials are not well established. Aims: We prospectively evaluated control arm AEs from a randomized stroke trial to establish expected rates of neurologic AEs. Methods: 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. Results: 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%. Conclusions: 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.
Original language | English (US) |
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Pages (from-to) | e5-e7 |
Journal | Acta Neurologica Scandinavica |
Volume | 127 |
Issue number | 2 |
DOIs |
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State | Published - Feb 2013 |
Keywords
- Intracerebral hemorrhage
- Intracranial hemorrhage
- Safety
- Stroke
ASJC Scopus subject areas
- Neurology
- Clinical Neurology