Table e-1. Most Frequently Occurring Treatment Emergent Adverse Events by preferred term within System Organ Class (Preferred Term Rate ≥ 5% in any Treatment Group), Core Period (1-12 Months)

System Organ Class
Preferred Term / Treatment Group / Total (n=297)
Placebo
(N=103) / 30 mg/day
(N=95) / 60 mg/day
(N=99)
n / N / % / n / N / % / n / N / % / n / N / %
Infections and Infestations
Nasopharyngitis
Pharyngitis
Upper respiratory tract
infection / 26 / 21 / 20.4 / 47 / 26 / 27.4 / 35 / 20 / 20.2 / 108 / 67 / 22.6
9 / 9 / 8.7 / 22 / 14 / 14.7 / 14 / 9 / 9.1 / 45 / 32 / 10.8
2 / 2 / 1.9 / 5 / 5 / 5.3 / 5 / 4 / 4.0 / 12 / 11 / 3.7
6 / 6 / 5.8 / 0 / 0 / 0.0 / 2 / 1 / 1.0 / 8 / 7 / 2.4
Nervous System Disorders
Headache / 20 / 18 / 17.5 / 19 / 14 / 14.7 / 21 / 17 / 17.2 / 60 / 49 / 16.5
15 / 15 / 14.6 / 14 / 12 / 12.6 / 17 / 13 / 13.1 / 46 / 40 / 13.5
Gastrointestinal Disorders
Nausea
Vomiting / 8 / 8 / 7.8 / 14 / 11 / 11.6 / 24 / 15 / 15.2 / 46 / 34 / 11.4
1 / 1 / 1.0 / 4 / 4 / 4.2 / 6 / 6 / 6.1 / 11 / 11 / 3.7
0 / 0 / 0.0 / 3 / 3 / 3.2 / 5 / 5 / 5.1 / 8 / 8 / 2.7
Psychiatric Disorders
Insomnia / 6 / 6 / 5.8 / 14 / 11 / 11.6 / 8 / 5 / 5.1 / 28 / 22 / 7.4
1 / 1 / 1.0 / 5 / 5 / 5.3 / 2 / 2 / 2.0 / 8 / 8 / 2.7

Note: n=number of events, N=number of subjects with event, and %=number of subjects with event divided by the number of subjects in treatment group