Table 3.

Safety and Adverse Effects.

Outcome	Sulfadoxine–Pyrimethamine	Three-Dose Dihydroartemisinin–piperaquine	Monthly Dihydroartemisinin–Piperaquine
	no. of events/total no. of doses (%)
Vomiting after administration of study agent
Observed after administration of first dose in clinic	2/617 (0.3)	0/542	1/594 (0.2)
Reported after administration of second or third dose at home	2/1222 (0.2)	0/1067	5/1180 (0.4)
	no. of events (incidence per person-year at risk)
Adverse event of any severity*
Abdominal pain	172 (3.14)	122 (2.52)	132 (2.47)
Cough	94 (1.72)	71 (1.47)	77 (1.44)
Headache	90 (1.64)	70 (1.45)	78 (1.46)
Chills	21 (0.38)	14 (0.29)	12 (0.22)
Diarrhea	12 (0.22)	10 (0.21)	13 (0.24)
Malaise	16 (0.29)	9 (0.19)	8 (0.15)
Dysphagia	9 (0.16)	2 (0.04)	14 (0.26)†
Vomiting	8 (0.15)	8 (0.17)	8 (0.15)
Nausea	2 (0.04)	4 (0.08)	2 (0.04)
Urinary tract infection	3 (0.05)	2 (0.04)	2 (0.04)
Anorexia	2 (0.04)	0	4 (0.07)
Grade 3 or 4 adverse event
Anemia	12 (0.22)	4 (0.08)	6 (0.11)
Congenital anomaly	2 (0.04)	4 (0.08)	0
Stillbirth	1 (0.02)	1 (0.02)	1 (0.02)
Thrombocytopenia	2 (0.04)	0	0
Vaginal bleeding during second trimester	1 (0.02)	0	0
Retained products of conception	0	1 (0.02)	0
Preeclampsia	0	0	1 (0.02)
Hypotension	0	0	1 (0.02)
Pyelonephritis	0	1 (0.02)	0
Respiratory distress	0	1 (0.02)	0
All grade 3 or 4 adverse events	18 (0.33)	12 (0.25)	9 (0.17)
Grade 3 or 4 adverse events possibly related to study agents	0	0	1 (0.02)
All serious adverse events	6 (0.11)	9 (0.19)	4 (0.07)

^*Only categories with at least 5 total events are included.

^†P=0.02 for the comparison of monthly dihydroartemisinin–piperaquine versus three-dose dihydroartemisinin–piperaquine.