Table 3.

Adverse events

	10 mg/kg	15 mg/kg	15 vs 10 p value	20 mg/kg	20 vs 10 p value	Control group
SAEs
Number of children ever having an SAE	3 (9%)	3 (9%)	1.00	4 (11%)	1.00	2 (4%)
Number of SAEs	3	3		4		2
SAE criteria
Fatal	1 (33%)	1 (33%)		1 (25%)		0 (0%)
Life-threatening	0 (0%)	0 (0%)		0 (0%)		0 (0%)
Caused or prolonged hospitalisation	2 (67%)	2 (67%)		3 (75%)		2 (100%)
Persistent or significant disability/incapacity	0 (0%)	0 (0%)		0 (0%)		0 (0%)
Other important medical condition	0 (0%)	0 (0%)		0 (0%)		0 (0%)

No further grade 3/4 AEs were reported that were not SAEs. No SAEs were judged to be related to azithromycin, the dose of azithromycin, or lead to a change in azithromycin