Table 5. All Serious Adverse Events (non-related events and related adverse drug reactions) by System Organ Class (bold) and Preferred Term according to MedDRA.

System organ class and preferred MedDRA term	SSG		PMb		SSG & PMd
	N = 386		N = 205		N = 381
	NR	SADR	NR	SADR	NR	SADR
Cardiac disorders	0	1	0	0	0	0
Cardiotoxicity	0	1	0	0	0	0
Gastrointestinal disorders	1	1	0	0	0	1
Pancreatitis acute	0	0	0	0	0	1
Pancreatitis	0	1	0	0	0	0
Peritoneal haemorrhage	1	0	0	0	0	0
General disorders and administrative site conditions	1	0	0	0	0	0
Deatha	1	0	0	0	0	0
Hepatobiliary disorders	0	0	0	0	0	1
Hepatic function abnormalb	0	0	0	0	0	1
Immune system disorders	2	0	0	0	0	0
Anaphylactic shock	2	0	0	0	0	0
Infections and Infestations	1	2	2	2	3	0
Abdominal sepsisc	0	1	0	0	0	0
Malariac	0	1	0	0	1	0
Hepatitis A	0	0	0	1	0	0
Herpes Zoster	1	0	0	0	0	0
Otitis Media	0	0	1	0	0	0
Pericarditis tuberculosis	0	0	0	0	1	0
Pneumonia	0	0	0	0	1	0
Pulmonary tuberculosis	0	0	1	0	0	0
Visceral leishmaniasis	0	0	0	1	0	0
Investigations	0	4	0	2	0	9
Alanine amino transferase increased (ALT only)	0	0	0	0	0	1
Blood alkaline phosphatase increased (ALP only)	0	0	0	0	0	1
Blood amylase increased	0	1	0	0	0	0
Electrocardiogram QT prolonged	0	0	0	0	0	1
Hepatic enzymes increased (bilirubin, ALT/AST/ALP)	0	1	0	1	0	3
Transaminases increased (ALT/AST)	0	2	0	1	0	3
Nervous system disorders	0	0	0	1	0	0
Febrile convulsion	0	0	0	1	0	0
Renal and urinary disorders	0	2	0	1	0	2
Renal impairment	0	2	0	1	0	2
Reproductive system and breast disorders	1	0	0	0	0	0
Priapism	1	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders	1	0	0	0	0	0
Epistaxis	1	0	0	0	0	0

MedDRA, Medical Dictionary of Regulatory Activities; SSG, sodium stibogluconate (20 mg/kg/day for 30 days); PM paromomycin sulphate (20 mg/kg/day for 21 days); SSG & PM (SSG 20 mg/kg/day & PM at 15 mg/kg/day for 17 days); NR, non-related Serious Adverse Events; SADR, Serious Adverse Drug Reaction.

^aDeath due to an unknown cause.

^bRaised bilirubin/jaundice.

^cAbdominal sepsis and malaria were considered as unlikely related to the drug by the investigators.

^d2 PM patients withdrew consent after 4 and 6 days on treatment and 1 SSG & PM patient after 6 days on treatment, no SAE reported prior to withdrawal.