Table 5.

Treatment-Emergent Adverse Drug Reactions classified as Common Terminology Criteria for Adverse Events ≥ Grade 3 by System Organ Class and Preferred Term—Modified Intention-to-Treat Set

System Organ Class	Preferred Term	Arm 1, PM/MF 14 Days	Arm 2, PM/MF 28 Daysa	Arm 3, SSG/PM	Overall
		(n = 170)	(n = 98)	(n = 170)	(n = 438)
Any at least severeb treatment-emergent adverse drug reaction		12 (7.1) [13]	4 (4.1) [6]	12 (7.1) [13]	28 (6.4) [32]
Investigations		8 (4.7) [8]	3 (3.1) [4]	10 (5.9) [10]	21 (4.8) [22]
	Aspartate aminotransferase increased	6 (3.5) [6]	1 (1.0) [1]	4 (2.4) [4]	11 (2.5) [11]
	Alanine aminotransferase increased	0 (0.0) [0]	2 (2.0) [2]	1 (0.6) [1]	3 (0.7) [3]
	Electrocardiogram QT prolonged	0 (0.0) [0]	0 (0.0) [0]	3 (1.8) [3]	3 (0.7) [3]
	Blood bilirubin increased	1 (0.6) [1]	0 (0.0) [0]	1 (0.6) [1]	2 (0.5) [2]
	Liver function test increased	1 (0.6) [1]	0 (0.0) [0]	1 (0.6) [1]	2 (0.5) [2]
	Blood creatinine increased	0 (0.0) [0]	1 (1.0) [1]	0 (0.0) [0]	1 (0.2) [1]
Ear and labyrinth disorders		1 (0.6) [1]	1 (1.0) [1]	1 (0.6) [1]	3 (0.7) [3]
	Hypoacusis	0 (0.0) [0]	1 (1.0) [1]	1 (0.6) [1]	2 (0.5) [2]
	Deafness bilateral	1 (0.6) [1]	0 (0.0) [0]	0 (0.0) [0]	1 (0.2) [1]
Hepatobiliary disorders		2 (1.2) [2]	0 (0.0) [0]	0 (0.0) [0]	2 (0.5) [2]
	Hepatitis	1 (0.6) [1]	0 (0.0) [0]	0 (0.0) [0]	1 (0.2) [1]
	Drug-induced liver injury	1 (0.6) [1]	0 (0.0) [0]	0 (0.0) [0]	1 (0.2) [1]
Renal and urinary disorders		1 (0.6) [1]	1 (1.0) [1]	0 (0.0) [0]	2 (0.5) [2]
	Acute kidney injury	1 (0.6) [1]	1 (1.0) [1]	0 (0.0) [0]	2 (0.5) [2]
Blood and lymphatic system disorders		0 (0.0) [0]	0 (0.0) [0]	1 (0.6) [1]	1 (0.2) [1]
	Neutropenia	0 (0.0) [0]	0 (0.0) [0]	1 (0.6) [1]	1 (0.2) [1]
Gastrointestinal disorders		1 (0.6) [1]	0 (0.0) [0]	0 (0.0) [0]	1 (0.2) [1]
	Vomiting	1 (0.6) [1]	0 (0.0) [0]	0 (0.0) [0]	1 (0.2) [1]
Injury, poisoning, and procedural complications		0 (0.0) [0]	0 (0.0) [0]	1 (0.6) [1]	1 (0.2) [1]
	Cardiotoxicity	0 (0.0) [0]	0 (0.0) [0]	1 (0.6) [1]	1 (0.2) [1]

Data are presented as n (%) of patients with at least 1 event and number [n] of events.

Abbreviations: MF, miltefosine; PM, paromomycin; SSG, sodium stibogluconate.

Recruitment into arm 2 was discontinued.

Events with a severity classification as severe (Common Terminology Criteria for Adverse Events [CTCAE] grade 3), life-threatening (CTCAE grade 4), or death (CTCAE grade 5).