Table 8.

Adverse events resulting in study termination for patients in all controlled studies by age group (≥5 patients in any group)—active-comparator trials

Preferred term	Fentanyl ITS				Morphine IV PCA
	<65 years (N = 901) [n (%)]	65–74 years (N = 250) [n (%)]	75–84 years (N = 125) [n (%)]	≥85 years (N = 12) [n (%)]	<65 years (N = 931) [n (%)]	65–74 years (N = 234) [n (%)]	75–84 years (N = 135) [n (%)]	≥85 years (N = 13) [n (%)]
Discontinued study medication due to AE	46 (5.1)	8 (3.2)	6 (4.8)	1 (8.3)	63 (6.8)	11 (4.7)	11 (8.1)	1 (7.7)
Nausea	10 (1.1)	3 (1.2)	0 (0.0)	0 (0)	16 (1.7)	4 (1.7)	2 (1.5)	0 (0)
Vomiting	3 (0.3)	0 (0.0)	0 (0.0)	0 (0)	6 (0.6)	1 (0.4)	0 (0.0)	0 (0)
Dizziness	2 (0.2)	0 (0.0)	0 (0.0)	0 (0)	5 (0.5)	1 (0.4)	1 (0.7)	0 (0)
Pruritus	6 (0.7)	0 (0.0)	0 (0.0)	0 (0)	7 (0.8)	1 (0.4)	0 (0.0)	0 (0)

AE adverse event, ITS iontophoretic transdermal system, IV PCA intravenous patient-controlled analgesia