Table 3.

Adverse events

		Ridinilazole (n=50)	Vancomycin (n=50)
Summary
Total number of adverse events		180	183
TEAEs		41 (82%)	40 (80%)
Drug-related TEAEs		8 (16%)	10 (20%)
Severe TEAEs		8 (16%)	6 (12%)
Severe drug-related TEAEs		2 (4%)	1 (2%)
Deaths		0	2 (4%)
SAEs		8 (16%)	9 (18%)
Treatment-emergent SAEs		8 (16%)	9 (18%)
Drug-related treatment-emergent SAEs		1 (2%)	2 (4%)
Discontinuations because of TEAEs		2 (4%)	1 (2%)
Discontinuations because of drug-related TEAEs		0	1 (2%)
System organ class preferred term*
Gastrointestinal disorders		20 (40%)	28 (56%)
	Nausea	10 (20%)	9 (18%)
	Abdominal pain	6 (12%)	10 (20%)
	Abdominal distension	5 (10%)	5 (10%)
	Vomiting	5 (10%)	8 (16%)
	Flatulence	4 (8%)	2 (4%)
	Diarrhoea	0	5 (10%)
General disorders and administration site conditions		12 (24%)	10 (20%)
	Asthenia	3 (6%)	2 (4%)
	Oedema (peripheral)	2 (4%)	3 (6%)
Infections and infestations		12 (24%)	12 (24%)
	Urinary tract infections	3 (6%)	2 (4%)
	Nasopharyngitis	2 (4%)	5 (10%)
Metabolism and nutrition disorders		11 (22%)	7 (14%)
	Decreased appetite	5 (10%)	4 (8%)
	Dehydration	3 (6%)	0
Nervous system disorders		10 (20%)	11 (22%)
	Headache	4 (8%)	5 (10%)
	Dizziness	3 (6%)	5 (10%)
Respiratory, thoracic, and mediastinal disorders		9 (18%)	3 (6%)
	Dyspnoea	4 (8%)	1 (2%)
Musculoskeletal and connective tissue disorders		6 (12%)	8 (16%)
	Back pain	1 (2%)	3 (6%)
	Pain in upper and lower extremities	1 (2%)	3 (6%)
Skin and subcutaneous tissue disorders		5 (10%)	5 (10%)
	Rash	3 (6%)	2 (4%)

TEAE=treatment-emergent adverse event. SAE=serious adverse event.

^*Only TEAEs (all causalities) reported in three or more participants (≥6%) treated with either ridinilazole or vancomycin have been reported.