Table 4.

Characteristics of AEs identified by PV or at the T1 survey

Descriptor	PV	Descriptor	T1
No. of individuals experiencing AEs after MDA, detected at health facilities	54	No. of individuals who took MDA medications reporting AEs at survey T1	106
AEs among 36,338 treated by MDA, %	0.15	AEs among 1,183 respondents treated by MDA, % (95% CL)	9.1 (6.95–11.23)
Median age, years (range) (n = 53*)	30 (9 months–78 years)	Median age, years (range)	29.5 (1–90)
Female, %	68.5	Female, %	69.8
Took both SP + SLD PQ vs. SP only, % (n = 52)	98	NA	NA
Houses that received IRS when AE was reported, n (%) (n = 42*)	13 (31.0)	NA	NA
Relationship of symptoms to MDA, n (%) (n = 50*)	Definitely not related, 1 (2)	NA	NA
	Possible temporal relationship, 46 (9%)
	Definite relationship, 3 (6)
Severity of symptoms, n (%) (n = 40*)	Mild, 24 (60)	NA	NA
	Moderate, 15 (37.5)
	Severe, 1 (2.5)
Symptoms reported, %	Headache, 64.8	Symptoms reported, %	Dizziness, 62.3
	Weakness/asthenia, 51.9		Fatigue, 19.8
	Gastroesophageal reflux/dyspepsia, 35.2		Nausea/abdominal pain, 11.3
	Subjective fever, 31.5		Subjective fever, 9.4
	Abdominal pain, 31		Headache/body pain, 8.5
	Dizziness, 31.5		Diarrhea, 7.5
	Myalgia, 25.9		Insomnia, 5.7
	Cough, 24.1		Rash, 4.7
	Nausea, 24.1		Throat pain, 1.9
	Pruritus, 22.2		Vomiting, 1.9
	Loss of appetite, 13.0		Facial edema, < 1
	Palpitations, 7.4		Leg weakness, < 1
	Vomiting, 7.4
	Chills, 5.6
	Breathing difficulty, 5.6
	Mouth/facial edema, 5.6
	Gait disturbance, 3.7
	Visual changes, 3.7
	Diarrhea, 1.9

AEs = adverse events; CL = confidence limit; MDA = mass drug administration; NA = not applicable; PV = pharmacovigilance; SLD PQ = single low-dose primaquine; SP = sulfadoxine–pyrimethamine; T1 = 10 weeks.

^*Number of individuals with data field completed if differs from the total of 54 (for PV) or 106 (for T1).