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