title: Neurologic safety event rates in the SENTIS trial control population.
abstract: BACKGROUND
  Adverse event (AE) rates for interventional stroke trials are not well established.
  
  
  OBJECTIVE
  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.
authors.affiliation: Oregon Health and Science University, Portland, USA. lutseph@ohsu.edu
authors.forename: H L
authors.initials: HL
authors.lastname: Lutsep
authors.forename: I M
authors.initials: IM
authors.lastname: Altafullah
authors.forename: R
authors.initials: R
authors.lastname: Roberts
authors.forename: I E
authors.initials: IE
authors.lastname: Silverman
authors.forename: M A
authors.initials: MA
authors.lastname: Turco
authors.forename: A G
authors.initials: AG
authors.lastname: Vaishnav
mesh_terms: D000368:Aged; D002560:Cerebrovascular Circulation / Q000502:physiology; D005260:Female; D006801:Humans; D008297:Male; D015424:Reperfusion / Q000009:adverse effects* / Q000379:methods*; D012107:Research Design; D020521:Stroke / Q000601:surgery*