Table 4.

Summary of treatment-emergent adverse events (TEAEs) reported in ≥ 2% of patients (safety set) ^a

System organ class Preferred term	Ibrexafungerp (N = 244) n (%)	Placebo (N = 123) n (%)
Patient with ≥ 1 TEAE	154 (63.1)	52 (42.3)
Gastrointestinal disorders	124 (50.8)	13 (10.6)
Diarrhea	105 (43.0)	6 (4.9)
Nausea	22 (9.0)	0
Abdominal pain	10 (4.1)	2 (1.6)
Upper abdominal pain	7 (2.9)	0
Dry mouth	2 (0.8)	3 (2.4)
Gastroesophageal reflux disease	0	3 (2.4)
Infections and infestations	33 (13.5)	21 (17.1)
Upper respiratory tract infection	9 (3.7)	3 (2.4)
Bacterial vulvovaginitis	7 (2.9)	10 (8.1)
Vaginal infection	4 (1.6)	5 (4.1)
Bacterial vaginosis	3 (1.2)	5 (4.1)
Investigations	18 (7.4)	10 (7.1)
Positive SARS-CoV-2 test	8 (3.3)	4 (3.3)
Nervous system disorders	16 (6.6)	11 (8.9)
Dizziness	12 (4.9)	7 (5.7)
Headache	3 (1.2)	3 (2.4)

^aAt each level of patient summarization, a patient is counted once if the patient reported ≥ 1 events