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Table 3 Summary of adverse events—safety analysis set

From: PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury

AE Summary, n (%) (N = 367)
Any AE 132 (36.0)
AE intensity  
 Mild 67 (18.3)
 Moderate 72 (19.6)
 Severe 22 (6.0)
 Unknown 7 (1.9)
Treatment-related AEs 55 (15.0)
Treatment-related AE intensity  
 Mild 23 (6.3)
 Moderate 28 (7.6)
 Severe 7 (1.9)
 Unknown 3 (0.8)
Serious AEs 23 (6.3)
Treatment-related serious AEs 0
AEs leading to discontinuation 36 (9.8)
Frequency of AEs by preferred term (occurring in >1 % of patients)
 Diarrhea 20 (5.4)
 Headache 15 (4.1)
 Urinary tract infection 10 (2.7)
 Dizziness 9 (2.5)
 Nausea 6 (1.6)
 Fall 6 (1.6)
 Fatigue 5 (1.4)
 Somnolence 5 (1.4)
 Dry mouth 4 (1.1)
 Gastroesophageal reflux disease 4 (1.1)
 Agitation 4 (1.1)
 Peripheral edema 4 (1.1)
  1. AE adverse event