Table 3.

Age-stratified adverse events following azithromycin or placebo treatment among children aged 0–59 months (N = 430)

	Azithromycin N = 23, n (%)	Placebo N = 26, n (%)	OR (95% CI)	P-value
Age 0–11 months*
Any adverse event†	9 (39.1)	7 (26.9)	1.74 (0.53–6.0)	0.37
Fever (self-report)†	8 (34.8)	6 (23.1)	1.78 (0.51–6.47)	0.37
Abdominal pain†	0	0	N/A	N/A
Vomiting†	4 (17.4)	1 (3.9)	5.26 (0.71–107.5)	0.15
Diarrhea†	3 (13.0)	1 (3.9)	3.75 (0.44 to 79.1)	0.27
Constipation†	1 (4.4)	0	N/A	N/A
Skin rash†	0	0	N/A	N/A
Age 12–23 months	N = 75	N = 52
Any adverse event†	15 (20.0)	13 (25.0)	0.75 (0.32–1.76)	0.50
Fever (self-report)†	12 (16.0)	9 (17.3)	0.91 (0.35–2.41)	0.85
Abdominal pain†	0	1 (1.9)	N/A	N/A
Vomiting†	5 (6.7)	0	N/A	N/A
Diarrhea†	11 (14.7)	8 (15.4)	0.95 (0.35–2.62)	0.91
Constipation†	0	0	N/A	N/A
Skin rash†	0	0	N/A	N/A
Age 24–59 months	N = 123	N = 131
Any adverse event†	20 (16.3)	22 (16.8)	0.96 (0.49–1.87)	0.91
Fever (self-report)†	17 (13.8)	20 (15.3)	0.89 (0.44–1.79)	0.74
Abdominal pain†	0	1 (0.8)	N/A	N/A
Vomiting†	7 (5.7)	3 (2.3)	2.57 (0.70–12.2)	0.18
Diarrhea†	4 (3.3)	4 (3.1)	1.07 (0.25–4.60)	0.93
Constipation†	0	1 (0.8)	N/A	N/A
Skin rash†	0	1 (0.8)	N/A	N/A

^*No children < 1 month of age were enrolled.

^†Care-giver reported adverse events occurring at any time during the 14-day post-treatment period.