Table 2.

Summary of treatment-emergent adverse events (safety analysis set, N = 86)

Summary of adverse events	Incidence, n (%)
Any adverse event	70 (81.4)
Grade 3–4 adverse event	7 (8.1)
Any drug-related adverse event	9 (10.5)
Grade 3–4 drug-related adverse event	0
Any serious adverse event	7 (8.1)
Drug-related serious adverse event	0
Adverse event leading to premature discontinuation of study drug	3 (3.5)a
Treatment-emergent adverse events reported in ≥ 3% of participants
Bronchitis	8 (9.3)
Arthralgia	6 (7.0)
Hypertension	5 (5.8)
Nasopharyngitis	5 (5.8)
Back pain	3 (3.5)
Depression	3 (3.5)
Diarrhea	3 (3.5)
Dizziness	3 (3.5)
Hypercholesterolemia	3 (3.5)
Myalgia	3 (3.5)
Sciatica	3 (3.5)
Upper respiratory tract infection	3 (3.5)
Visual impairment	3 (3.5)

^aOne participant had an adverse event of abdominal discomfort (grade 2), considered related to study drug; one had a serious adverse event of alcohol withdrawal (grade 3), considered not related to study drug; one had an adverse event of benzodiazepine withdrawal (grade 2), considered not related to study drug