Efficacy, safety, and pharmacokinetics of MR13A11A, a generic of remifentanil, for pain management of Japanese patients in the intensive care unit: a double-blinded, fentanyl-controlled, randomized, non-inferiority phase 3 study

Table 4 Summary of safety (SS)

	Remifentanil N = 92	Fentanyl N = 90
	n (%)	n (%)
AEs	34 (37.0)	34 (37.8)
Serious AEs except for death	2 (2.2)	2 (2.2)
AEs leading to discontinuation	0 (0.0)	0 (0.0)
Death	0 (0.0)	0 (0.0)
Adverse drug reactions	12 (13.0)	15 (16.7)
Serious adverse drug reactions	0 (0.0)	0 (0.0)
Serious adverse drug reactions leading to discontinuation	0 (0.0)	0 (0.0)
AEs (≥ 2% in any group)
Anaemia	0 (0.0)	2 (2.2)
Hypokalaemia	3 (3.3)	1 (1.1)
Delirium	3 (3.3)	4 (4.4)
Insomnia	2 (2.2)	3 (3.3)
Restlessness	1 (1.1)	3 (3.3)
Atrial fibrillation	3 (3.3)	1 (1.1)
Bradycardia	2 (2.2)	1 (1.1)
Hypertension	3 (3.3)	0 (0.0)
Hypotension	7 (7.6)	7 (7.8)
Bradypnoea	2 (2.2)	0 (0.0)
Nausea	3 (3.3)	6 (6.7)
Hepatic function abnormal	2 (2.2)	0 (0.0)
Rash	2 (2.2)	0 (0.0)
Pain	2 (2.2)	1 (1.1)
Post procedural hypotension	0 (0.0)	2 (2.2)
Adverse drug reactions (≥ 2% in any group)
Hypotension	3 (3.3)	3 (3.3)
Bradypnoea	2 (2.2)	0 (0.0)
Nausea	1 (1.1)	3 (3.3)
Post procedural hypotension	0 (0.0)	2 (2.2)

ISSN: 2052-0492