Table 3. Incidence of AEs and drug-related AEs (>1 patient in either treatment group) in patients during treatment with nifedipine GITS 60 mg (constant daily dose or up-titrated from 30 mg) combination therapy.

	Nifedipine GITS 60 mg (n = 686)		Nifedipine GITS 30–60 mg (n = 392)
	AEs	Drug-related AEs	AEs	Drug-related AEs
All patients (%)	24 (3.5)	22 (3.2)	11 (2.8)	8 (2.0)
AE, n (%)
Peripheral edema	9 (1.3)	9 (1.3)	4 (1.0)	3 (0.8)
Headache	6 (0.9)	6 (0.9)	3 (0.8)	3 (0.8)
Edema	3 (0.4)	2 (0.3)	0	0
Flushing	3 (0.4)	3 (0.4)	1 (0.3)	1 (0.3)
Dizziness	3 (0.4)	3 (0.4)	0	0
BP inadequately controlled	0	0	2 (0.5)	0
Tachycardia	2 (0.3)	2 (0.3)	0	0

AEs experienced by only 1 patient in the 60-mg group were: allergic dermatitis, anxiety, constipation, dry mouth, fatigue, hypokalemia, hypotension, increased heart rate, loss of consciousness, orthopnea, palpitations, postural dizziness, and somnolence; and in the 30–60-mg group were: dyspnea, flushing, hypotension, nausea, and palpitations. Drug-related AEs experienced by only 1 patient in the 60-mg group were: allergic dermatitis, anxiety, constipation, hypotension, increased heart rate, orthopnea, and somnolence; and in the 30–60-mg group were: dyspnea, flushing, hypotension, nausea, and palpitations.

AEs, adverse events; BP, blood pressure; GITS, gastrointestinal therapeutic system.