Pain Research and Management / 2021 / Article / Tab 8 / Research Article
Pharmacokinetic Characterisation and Comparison of Bioavailability of Intranasal Fentanyl, Transmucosal, and Intravenous Administration through a Three-Way Crossover Study in 24 Healthy Volunteers Table 8 Summary of adverse events.
Total Naltrexone INTRANASAL INTRAVENOUS TRANSMUCOSAL Absolute Relative (%) Absolute Relative (%) Absolute Relative (%) Absolute Relative (%) Absolute Relative (%) Adverse events (AEs) 38 100 Volunteers without AEs 10 37 Volunteers with AEs 17 63 Maximum intensity Mild 31 82 3 60 11 79 12 100 5 71 Moderate 7 18 2 40 3 21 0 0 2 29 Severe 0 0 0 0 0 0 0 0 0 0 Drug relationship Probable 0 0 0 0 0 0 0 0 0 0 Possible 14 37 0 0 7 50 3 25 4 57 No causal relationship 11 29 3 60 2 14 5 42 1 14 Unclassified 13 34 2 40 5 36 4 33 2 29 Outcome Recovered 38 100 5 100 14 100 12 100 7 100 Recovered with sequelae 0 0 0 0 0 0 0 0 0 0 Not yet recovered 0 0 0 0 0 0 0 0 0 0 Death 0 0 0 0 0 0 0 0 0 0 Unknown 0 0 0 0 0 0 0 0 0 0 Seriousness Serious 0 0 0 0 0 0 0 0 0 0 Not serious 38 100 5 100 14 100 12 100 7 100 Frequency of top 5 AEs Headache 5 13 0 0 2 14 1 8 2 29 Nausea 7 18 0 0 1 7 4 33 2 29 Vomiting 3 8 1 20 2 14 0 0 0 0 Tiredness 2 5 0 0 2 14 0 0 0 0 Abdominal pain 2 5 0 0 1 7 1 8 0 0