Table 4.

Secondary safety parameters by treatment group

	NECT (n = 55)	Eflornithine (n = 54)	All (n = 109)	P-value
	n (%)	n (%)	n (%)
No. of deaths during 30 days	1 (1.8)	1 (1.9)	2 (1.8)	1.00
No. of deaths during follow-up	3 (5.5)	0	3 (2.8)	0.24
At least one severe adverse event	7 (12.7)	15 (27.8)	22 (20.2)	0.16
No. of patients with permanent treatment interruption	0	1 (1.9)	1 (0.9)	0.50
No. of patients with temporary treatment interruption	0	1 (1.9)	1 (0.9)	0.50
At least one severe adverse event (intensity grade 3 & 4) (clinical & laboratory)	14 (25.5)	15 (27.8)	29 (26.6)	0.78
At least one severe adverse event (intensity grade 3 & 4) (clinical)	9 (16.4)	13 (24.1)	22 (20.2)	0.32
At least one severe adverse event (intensity grade 3 & 4) (laboratory)	9 (16.4)	8 (14.8)	17 (15.6)	0.82
At least one adverse event (clinical & laboratory)	49 (89.1)	49 (90.7)	98 (89.9)	0.78
At least one adverse event (clinical)	44 (80.0)	46 (85.2)	90 (82.6)	0.48
At least one adverse event (laboratory)	30 (54.6)	41 (75.9)	71 (65.1)	0.02a
At least one adverse event (possibly) related to treatment	37 (67.3)	39 (72.2)	76 (69.7)	0.57

^aIndicates significant differences across treatment groups

Abbreviation: NECT nifutimox-eflonithine combination treatment