Table 5.

Frequency of patients with ≥3 TEAEs in SAF

	All patients	Age group (years)
	(N = 1219)	<65 (N = 559)	65-75 (N = 433)	≥75 (N = 227)
Subjects with TEAEs	83 (6.8)	49 (8.8)	20 (4.6)	14 (6.2)
Nervous system disorders
Dizziness	22 (1.8)	19 (3.4)	2 (0.5)	5 (2.2)
Headache	3 (0.2)	15 (2.7)	2 (0.5)	5 (2.2)
Reproductive system and breast disorders
Ejaculation disorder	3 (0.2)	3 (0.5)	0 (0.0)	0 (0.0)
Erectile dysfunction	3 (0.2)	1 (0.2)	1 (0.2)	1 (0.4)
Vascular disorders
Orthostatic hypotension	4 (0.3)	1 (0.2)	2 (0.5)	1 (0.4)
Skin and subcutaneous tissue disorders
Pruritus	3 (0.2)	1 (0.2)	1 (0.2)	1 (0.4)

SAF, safety population; TEAEs, treatment-emergent adverse events.

TEAEs are displayed as number of subjects (percentage of subjects).