Neurologic safety event rates in the SENTIS trial control population

H. L. Lutsep, I. M. Altafullah, R. Roberts, I. E. Silverman, M. A. Turco, A. G. Vaishnav

Research output: Contribution to journalComment/debate

1 Scopus citations

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 languageEnglish (US)
Pages (from-to)e5-e7
JournalActa Neurologica Scandinavica
Volume127
Issue number2
DOIs
StatePublished - Feb 2013

Keywords

  • Intracerebral hemorrhage
  • Intracranial hemorrhage
  • Safety
  • Stroke

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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    Lutsep, H. L., Altafullah, I. M., Roberts, R., Silverman, I. E., Turco, M. A., & Vaishnav, A. G. (2013). Neurologic safety event rates in the SENTIS trial control population. Acta Neurologica Scandinavica, 127(2), e5-e7. https://doi.org/10.1111/ane.12005