Table 3.

Treatment-emergent adverse events and adverse drug reactions reported in the treatment period.

Category of events		No. of events	No. of patients affected (%) (n = 72)
TE AE		94	48 (66.7%)
TE ADR		9	9 (12.5%)
Grade 3 or higher TE AE		1	1 (1.4%)
Grade 4 or higher TE AE		0	0 (0.0%)
TE AE resulting in premature discontinuation		0	0 (0.0%)
TE AE leading to death		0	0 (0.0%)
Serious TE AE		0	0 (0.0%)
Clinically significant TE AE		0	0 (0.0%)
SOC	PT
TE AE with incidence ≥ 2%
Gastrointestinal disorders
	Diarrhea	2	2 (2.8%)
	Gastroenteritis	3	3 (4.2%)
Infections and infestations
	Nasopharyngitis	48	29 (40.3%)
Investigations
	Blood creatine phosphokinase increased	3	3 (4.2%)
Musculoskeletal and connective tissue disorders
	Back pain	2	2 (2.8%)
Nervous system disorders
	Somnolence	9	9 (12.5%)
Skin and subcutaneous tissue disorders
	Eczema	2	2 (2.8%)
TE ADR with incidence ≥2%
Nervous system disorders
	Somnolence	7	7 (9.7%)

AEs and ADRs were coded using the Medical Dictionary for Regulatory Activities Version 19.0. Grades are based on the Common Terminology Criteria for Adverse Events Version 4.0.

Abbreviations. AE, adverse event; ADR, adverse drug reaction; SOC, system organ class; PT, preferred term; TE, treatment-emergent.