. 2016 Oct 24;14:167. doi: 10.1186/s12916-016-0716-1

Table 5.

Adverse events by preferred term and system organ class – safety population (N = 399)

System organ class	Preferred term	SAM (N = 133), n (%)	Non-SAM (N = 266), n (%)
Adverse events reported with frequency > 5 %
Blood and lymphatic system disorders		6 (4.5)	19 (7.1)
	Anemia	6 (4.5)	19 (7.1)
Eye disorders		4 (3)	15 (5.6)
	Conjunctivitis	4 (3)	15 (5.6)
Gastrointestinal disorders^a		53 (39.8)^a	77 (28.9)^a
	Abdominal distension^a	10 (7.5)^a	5 (1.9)^a
	Diarrhea^a	24 (18.0)^a	46 (17.3)^a
	Gastroenteritis^a	15 (11.3)^a	10 (3.8)^a
	Vomiting	6 (4.5)	7 (2.6)
Respiratory, thoracic and mediastinal disorders		71 (53.4)	141 (53)
	Bronchitis	38 (28.6)	83 (31.2)
	Cough	11 (8.3)	16 (6)
	Nasopharyngitis	7 (5.3)	15 (5.6)
	Rhinorrhea	15 (11.3)	29 (10.9)
Serious adverse events
Blood and lymphatic system disorders		1 (0.8)	1 (0.4)
	Anemia	1 (0.8)	1 (0.4)
Gastrointestinal disorders		0 (0)	1 (0.4)
	Gastrointestinal motility disorder	0 (0)	1 (0.4)
Nervous system disorders		1 (0.8)	0 (0)
	Meningitis bacterial^b	1 (0.8)	0 (0)
Respiratory, thoracic and mediastinal disorders		1 (0.8)	0 (0)
	Lower respiratory tract infection	1 (0.8)	0 (0)
Infections and infestations		1 (0.8)	1 (0.4)
	Plasmodium falciparum infection^c	1 (0.8)	1 (0.4)
Adverse events causing treatment discontinuation		2 (1.5)	1 (0.4)
Gastrointestinal disorders		2 (1.5)	1 (0.4)
	Vomiting^d	2 (1.5)	1 (0.4)

Adverse events are reported in alphabetical order of system organ class, then preferred term, according to the MedDRA dictionary (Medical Dictionary for Regulatory Activities, version 11)

^aStatistically significant difference between SAM and non-SAM (more gastro-intestinal disorders in SAM)

^bCaused death

^cSevere malaria in an HIV-coinfected patient

^dIn all cases, children vomited less than 30 minutes after drug intake and had iterative vomiting on re-administration

SAM severe acute malnutrition