Table 4. Serious and non-serious adverse events occurring during the study.

	SSG	PMa	SSG & PMa
	N = 386	N = 205	N = 381
N (%) of patients with at least one AE
At any time	271 (70.2)	126 (61.5)	251 (65.9)
TEAEsb	237 (61.4)	107 (52.2)	207 (54.3)
N (%) of patients with an SAEc
Total	17 (4.4)	8 (3.9)	16 (4.2)
TEAEsb	14 (3.6)	7 (3.4)	16 (4.2)
Adverse drug reactionsd	10 (2.6)	6 (2.9)	13 (3.4)
Deathse	4 (1.0)	1 (0.5)	2 (0.5)
Total number of all TEAEs recorded	445	192	348
Total person-days at riskf	23160	10363	17866
TEAE Rate	0.019	0.019	0.019

SSG = sodium stibogluconate; PM = paromomycin sulphate; SSG & PM = combination treatment;

AE, adverse event; SAE, serious adverse event; TEAE, treatment emergent adverse event;

^aThere were two consent withdrawals in the PM arm (after 4 and 6 days on treatment) and 1 withdrawal in the SSG & PM arm (after 6 days on treatment) - data were therefore collected only up to the day of withdrawal for these patients.

^bTreatment emergent adverse event is defined as onset being between day 1 of treatment and 30 days post end of treatment, inclusive.

^cNo patient experienced more than one SAE.

^dAdverse drug reaction is defined as any adverse event the investigator recorded as having a probable, possible or unlikely relationship to the study drug.

^eCause of deaths were as follows: SSG: unknown (1), Acute Renal Failure (2), cardiotoxicity (1); PM: VL; SSG & PM: Pericarditis tuberculosis (1), malaria (1).

^fPerson-days at risk is defined as the treatment period per study drug regimen plus an additional 30 days post end of treatment.