Safety of a New Chewable Formulation of Mebendazole for Preventive Chemotherapy Interventions to Treat Young Children in Countries with Moderate-to-High Prevalence of Soil Transmitted Helminth Infections

Table 4

TEAEs by intensity of helminth infection.

	Not done	No infection	Light	Moderate	Total
	(𝑁=44)	(𝑁=157)	(𝑁=181)	(𝑁=14)	(𝑁=396)
	𝑛 (%)	𝑛 (%)	𝑛 (%)	𝑛 (%)	𝑛 (%)
Total number of children with adverse events	2 (5)	18 (11)	23 (13)	1 (7)	44 (11)
Diarrhea	1 (2)	5 (3)	4 (2)	0	10 (3)
Abdominal pain	0	1 (1)	1 (1)	0	2 (1)
Abdominal distension	0	0	1 (1)	0	1 (<1)
Aphthous stomatitis	0	1 (1)	0	0	1 (<1)
Nausea	0	1 (1)	0	0	1 (<1)
Oral pain	0	0	1 (1)	0	1 (<1)
Pyrexia	0	4 (3)	7 (4)	0	11 (3)
Lymphadenopathy	0	5 (3)	3 (2)	0	8 (2)
Cough	0	3 (2)	2 (1)	0	5 (1)
Asthma	0	0	1 (1)	0	1 (<1)
Dyspnoea	0	1 (1)	0	0	1 (<1)
Epistaxis	0	1 (1)	0	0	1 (<1)
Rhonchi	0	1 (1)	0	0	1 (<1)
Respiratory rate increased	0	0	2 (1)	0	2 (1)
Cardiac murmur	1 (2)	0	0	0	1 (<1)
Respiratory rate	0	0	1 (1)	0	1 (<1)
Bronchitis	0	2 (1)	0	0	2 (1)
Upper respiratory tract infection	0	1 (1)	0	0	1 (<1)
Urinary tract infection	0	1 (1)	0	0	1 (<1)
Rash popular	0	0	3 (2)	0	3 (1)
Dizziness	0	0	0	1 (7)	1 (<1)
Headache	0	0	1 (1)	0	1 (<1)
Jaundice	0	0	1 (1)	0	1 (<1)

TEAE: treatment-emergent adverse event.