Table 3.

Incidence of grade 3 and 4 adverse events during 12 months of cohort of the 156 HIV-infected children included in the ANRS 12206 MONOD study according to study countries (Abidjan, Ouagadougou, February 2013 t oApril 2015).

	Total,	Abidjan,	Ouagadougou,
Outcomes	N =156	N =99	N =57	p-Value
Serious adverse events (SAEs)
Hospitalizations and clinical SAE	35 (22.4)	17 (17.2)	18 (31.6)	0.04
Toxicity causing ART modification	10 (6.4)	8 (8.1)	2 (3.5)	0.33
Sleeping disorders	44 (28.2)	28 (28.3)	16 (28.1)	0.98
Specific biological adverse events
Anaemia, grade 3 and 4	8 (5.1)	5 (5.0)	3 (5.3)	1.00
Neutropenia, grade 3 and 4	28 (17.9)	23 (23.2)	5 (8.8)	0.02
Thrombopenia, grade 3 and 4	3 (1.9)	3 (3.0)	0 (0.0)	0.30
Hyperglycaemia, grade 3 and 4	0 (0.0)	0 (0.0)	0 (0.0)	–
Hypoglycaemia, grade 3 and 4	2 (1.3)	0 (0.0)	2 (3.5)	0.13
Hypercholesterolaemia, grade 3	3 (1.9)	3 (3.0)	0 (0.0)	0.30
Hypertriglyceridaemia, grade 3 and 4	0 (0.0)	0 (0.0)	0 (0.0)	–
Hypercreatininaemia, grade 3 and 4	2 (1.3)	1 (1.0)	1 (1.7)	1.00
Hypertransaminasemia AST or ALT, grade 3 and 4	1 (0.6)	0 (0.0)	1 (1.7)	0.36
Hyperbilirubinaemia, grade 3 and 4	8 (5.1)	1 (1.0)	7 (12.3)	<0.01
Hyperamylasaemia, grade 3 and 4	9 (5.8)	7 (7.1)	2 (3.5)	0.49
Hyperlipasaemia, grade 3 and 4	0 (0.0)	0 (0.0)	0 (0.0)	–

AST: aspartate contre-transfert; ALT: alanine-amino-transferase; ART: antiretroviral therapy.