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Table 3 Summary of patients in the OXN-CR and OX-CR groups who experienced adverse events (AEs) during the study (safety analysis population)

From: Efficacy and safety of controlled-release oxycodone/naloxone versus controlled-release oxycodone in Korean patients with cancer-related pain: a randomized controlled trial

Variable OXN-CR [cases (%)] OX-CR [cases (%)] P value
AEs
 Any AEs 55 (85.9) 57 (89.1) 0.593
 Serious AEs 15 (23.4) 28 (43.8) 0.013
 Most common AEsa    NA
  Constipation 30 (46.9) 35 (54.7)  
  Nausea 10 (15.6) 18 (28.1)  
  Anorexia 8 (12.5) 5 (7.8)  
  Vomiting 8 (12.5) 7 (10.9)  
  Dizziness 6 (9.4) 14 (21.9)  
  Dyspnea 1 (1.6) 7 (10.9)  
ADRs
 Any ADRs 38 (59.4) 41 (64.1) 0.585
 Serious ADRs 1 (1.6) 4 (6.3) 0.168
 Most common ADRsa    NA
  Constipation 27 (42.2) 28 (43.8)  
  Nausea 7 (10.9) 11 (17.2)  
  Dizziness 5 (7.8) 12 (18.8)  
  1. ADR adverse drug reaction, NA not applicable
  2. aAEs or ADRs reported by at least 10% of patients in either treatment group