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Neurologic safety event rates in the SENTIS trial control population
Author(s) -
Lutsep H. L.,
Altafullah I. M.,
Roberts R.,
Silverman I. E.,
Turco M. A.,
Vaishnav A. G.
Publication year - 2013
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/ane.12005
Subject(s) - medicine , stroke (engine) , adverse effect , randomized controlled trial , clinical trial , population , anesthesia , cerebral edema , surgery , mechanical engineering , environmental health , engineering
Background Adverse event (AE) rates for interventional stroke trials are not well established. Aims We prospectively evaluated control arm AE s from a randomized stroke trial to establish expected rates of neurologic AE s. 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 AE s and serious AE s ( SAE s) were adjudicated and the following defined times used to determine treatment relatedness: 24‐h imaging for intracranial hemorrhage ( IC nH) 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 AE s occurred at the following rates: IC nH 27.6%, cerebral edema 6.6%, neurologic worsening 18.3%, and new stroke 4.7%. Most of these events occurred within the defined times: IC nH 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.