Neurologic safety event rates in the SENTIS trial control population

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

Research output: Contribution to journalArticle

1 Citation (Scopus)

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)
JournalActa Neurologica Scandinavica
Volume127
Issue number2
DOIs
StatePublished - Feb 2013

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Nervous System
Stroke
Technology
Safety
Population
Intracranial Hemorrhages
Brain Edema
National Institutes of Health (U.S.)
Control Groups

Keywords

  • Intracerebral hemorrhage
  • Intracranial hemorrhage
  • Safety
  • Stroke

ASJC Scopus subject areas

  • Clinical Neurology
  • Neurology

Cite this

Lutsep, H., 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). https://doi.org/10.1111/ane.12005

Neurologic safety event rates in the SENTIS trial control population. / Lutsep, Helmi; Altafullah, I. M.; Roberts, R.; Silverman, I. E.; Turco, M. A.; Vaishnav, A. G.

In: Acta Neurologica Scandinavica, Vol. 127, No. 2, 02.2013.

Research output: Contribution to journalArticle

Lutsep, H, Altafullah, IM, Roberts, R, Silverman, IE, Turco, MA & Vaishnav, AG 2013, 'Neurologic safety event rates in the SENTIS trial control population', Acta Neurologica Scandinavica, vol. 127, no. 2. https://doi.org/10.1111/ane.12005
Lutsep, Helmi ; Altafullah, I. M. ; Roberts, R. ; Silverman, I. E. ; Turco, M. A. ; Vaishnav, A. G. / Neurologic safety event rates in the SENTIS trial control population. In: Acta Neurologica Scandinavica. 2013 ; Vol. 127, No. 2.
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AB - 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.

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