Table 2.

Treatment-emergent AEs (> 1% of patients) by preferred term and maximum severity (safety set)

Preferred term	Mild	Moderate	Severe	Missing	Overall N = 167
Number of patients with at least 1 AE, n (%)	20 (12.0)	6 (3.6)	2 (1.2)	8 (4.8)	34 (20.4)
Constipation	3 (1.8)	0	0	2 (1.2)	5 (3.0)
Insomnia	4 (2.4)	0	0	0	4 (2.4)
Influenza	2 (1.2)	0	0	1 (0.6)	3 (1.8)
Fall	1 (0.6)	1 (0.6)	0	0	2 (1.2)
Arthralgia	0	1 (0.6)	0	1 (0.6)	2 (1.2)
Headache	2 (1.2)	0	0	0	2 (1.2)
Stress	2 (1.2)	0	0	0	2 (1.2)
Dizziness	1 (0.6)	0	0	1 (0.6)	2 (1.2)

Percentages are based on the total number of patients in the safety set. A patient with multiple AEs within a primary system organ class is counted only once in the total row. A patient with multiple occurrences of an AE under one treatment is counted only once in this AE category. AE, adverse event; n, number of patients; N, total number of patients