Neurologic safety event rates in the SENTIS trial control population

• Published in: Acta neurologica Scandinavica Vol. 127; no. 2; pp. e5 - e7
• Main Authors: Lutsep, H. L., Altafullah, I. M., Roberts, R., Silverman, I. E., Turco, M. A., Vaishnav, A. G.
• Format: Journal Article
• Language: English
• Published: Denmark Blackwell Publishing Ltd 01.02.2013; Hindawi Limited
• Subjects: Aged; Cerebrovascular Circulation - physiology; Female; Humans; intracerebral hemorrhage; intracranial hemorrhage; Male; Medical research; Reperfusion - adverse effects; Reperfusion - methods; Research Design; safety; stroke; Stroke - surgery
• ISSN: 0001-6314; 1600-0404
• DOI: 10.1111/ane.12005

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.