Table 3.

All treatment-emergent adverse events from grade 3 to 5

		Grade 3		Grade 4		Grade 5		Total
		n (%)	Number of events	n (%)	Number of events	n (%)	Number of events	n (%)	Number of events
Any adverse events		22 (18%)	25	2 (2%)	3	1 (1%)	2*	25 (20%)	30
Blood and lymphatic system disorders		7 (6%)	7	..	..	..	..	7 (6%)	7
	Anaemia	6 (5%)	6	..	..	..	..	6 (5%)	6
	Neutropenia	1 (1%)	1	..	..	..	..	1 (1%)	1
Infections and infestations		7 (6%)	7	..	..	..	..	7 (6%)	7
	Malaria	6 (5%)	6	..	..	..	..	6 (5%)	6
	Cerebral malaria	1 (1%)	1	..	..	..	..	1 (1%)	1
Investigations		4 (3%)	4	1 (1%)	2	..	..	5 (4%)	6
	Blood potassium increased	3 (2%)	3	..	..	..	..	3 (2%)	3
	Blood potassium decreased	1 (1%)	1	1 (1%)	1	..	..	2 (2%)	2
	Blood calcium decreased	..	..	1 (1%)	1	..	..	1 (1%)	1
Gastrointestinal disorders		4 (3%)	4	..	..	..	..	4 (3%)	4
	Vomiting	3 (2%)	3	..	..	..	..	3 (2%)	3
	Gastritis	1 (1%)	1	..	..	..	..	1 (1%)	1
Psychiatric disorders		2 (2%)	2	..	..	..	..	2 (2%)	2
	Psychotic disorder	2 (2%)	2	..	..	..	..	2 (2%)	2
General disorders and administration site conditions		1 (1%)	1	..	..	..	..	1 (1%)	1
	Pyrexia	1 (1%)	1	..	..	..	..	1 (1%)	1
Injury, poisoning, and procedural complications		..	..	..	..	1 (1%)	1	1 (1%)	1
	Injury	..	..	..	..	1 (1%)	1	1 (1%)	1
Metabolism and nutrition disorders		..	..	1 (1%)	1	..	..	1 (1%)	1
	Hyperkalaemia	..	..	1 (1%)	1	..	..	1 (1%)	1
Respiratory, thoracic, and mediastinal disorders		..	..	..	..	1 (1%)	1	1 (1%)	1
	Dyspnoea	..	..	..	..	1 (1%)	1	1 (1%)	1

Data are from the complete 18-month timepoint of the intention-to-treat population (n=125). Common Terminology Criteria for Adverse Events grade 3 corresponds to severe, grade 4 corresponds to life-threatening, and grade 5 corresponds to death.

^*One patient died following two events (dyspnoea and injury due to traumatic aggression), which was considered unrelated to fexinidazole or gambiense human African trypanosomiasis.