Safety and efficacy of pyronaridine–artesunate paediatric granules in the treatment of uncomplicated malaria in children: insights from randomized clinical trials and a real-world study

Table 7 Serious adverse events by body weight category in the integrated safety analysis and CANTAM

Body weight category Preferred term	Integrated safety analysis					CANTAM PA (N = 2599)
	PA		AL		P value^a
	N	% (95% CI)	N	% (95% CI)	P value^a
Body weight ≥ 8 to < 15 kg	319		165			1268
At least one adverse event	6	1.9 (0.9, 4.0)	1	0.6 (0.03, 3.4)	0.43	9	0.7 (0.4, 1.3)
Drug-induced liver injury	1^b	0.3 (0.02, 1.8)	0	0 (0, 2.3)	1.00	0	0 (0, 0.3)
Malaria	3	0.9 (0.3, 2.7)	0	0 (0, 2.3)	0.55	3	0.2 (0.06, 0.7)
Transaminases increased	2^b	0.6 (0.1, 2.6)	0	0 (0, 2.3)	0.55	0	0 (0, 0.3)
Toxic epidermal necrolysis	0	0 (0, 1.2)	1^b	0.6 (0.03, 3.4)	0.34	0	0 (0, 0.3)
Anaemia	0	0 (0, 1.2)	0	0 (0, 2.3)	NA	5^b	0.4 (0.2, 0.9)
Sepsis	0	0 (0, 1.2)	0	0 (0, 2.3)	NA	1	0.1 (0.004, 0.4)
Stevens–Johnson syndrome	0	0 (0, 1.2)	0	0 (0, 2.3)	NA	1	0.1 (0.004, 0.4)
Body weight ≥ 15 to < 20 kg	341		190			1261
At least one adverse event	2	0.6 (0.1, 2.1)	0	0 (0, 2.0)	0.54	2	0.2 (0.03, 0.6)
Anaemia	1^b	0.3 (0.02, 1.6)	0	0 (0, 2.0)	1.00	1	0.1 (0.004, 0.4)
Multi-organ failure	1	0.3 (0.02, 1.6)	0	0 (0, 2.0)	1.00	0	0 (0, 0.3)
Malaria	1^b	0.3 (0.02, 1.6)	0	0 (0, 2.0)	1.00	1	0.1 (0.004, 0.4)
Epistaxis	0	0 (0, 1.1)	0	0 (0, 2.0)	NA	1^b	0.1 (0.004, 0.4)

There were no serious adverse events in patients with body weight ≥ 5 to < 8 kg
NA not applicable
^aPyronaridine–artesunate (PA) versus artemether–lumefantrine (AL)
^bIn the integrated safety analysis there were five serious adverse events considered drug related with PA and one with AL. In CANTAM, two cases of anaemia and one of epistaxis were considered related to drug treatment

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