Table 6.

Adverse Event Overview and Summary of Common Adverse Events by Preferred Term in the Safety Population

AE Category	Gepotidacin 1500 mg (n = 52)	Gepotidacin 3000 mg (n = 53)	Total (N = 105)
Any AE	27 (52)	34 (64)	61 (58)
Related to study treatment	24 (46)	33 (62)	57 (54)
Leading to study withdrawal	0	0	0
Any serious AE	0	0	0
Common AEs by preferred term
Diarrhea	9 (17)	19 (36)	28 (27)
Flatulence	14 (27)	10 (19)	24 (23)
Abdominal pain	6 (12)	10 (19)	16 (15)
Nausea	3 (6)	11 (21)	14 (13)
Fatigue	3 (6)	5 (9)	8 (8)
Dizziness	1 (2)	6 (11)	7 (7)
Hyperhidrosis	1 (2)	6 (11)	7 (7)
Abdominal discomfort	4 (8)	2 (4)	6 (6)
Feeling hot	1 (2)	4 (8)	5 (5)
Eructation	1 (2)	3 (6)	4 (4)
Feces soft	1 (2)	3 (6)	4 (4)
Somnolence	0	3 (6)	3 (3)

Data are presented as number (%). Common adverse events were defined as an AE with ≥5% incidence in any treatment group.

Abbreviations: AE, adverse event.