Table 9 Common* adverse events by exposure group
MedDRA Primary System Organ Class: MedDRA Preferred Term | Artemether-lumefantrine N = 495 n (%) | Sulphadoxine-pyrimethamine N = 506 n (%) |
|---|---|---|
Total number of patients with any adverse events | 171 (34.5) | 186 (36.8) |
Blood and lymphatic system disorders: | 7 (1.4) | 16 (3.4) |
   Anaemia | 7 (1.4) | 15 (3.2) |
Infections and infestations: | 61 (12.3) | 66 (13.0) |
   Malaria | 17 (3.4) | 34 (6.7) |
   Syphilis | 24 (4.8) | 20 (4.0) |
   Respiratory tract infection | 9 (1.8) | 5 (1.0) |
   Urinary tract infection | 5 (1.0) | 5 (1.0) |
Nervous system disorders: | 1 (0.2) | 8 (1.6) |
   Headache | 1 (0.2) | 6 (1.2) |
Pregnancy, puerperium, and perinatal conditions: | 108 (21.8) | 120 (23.7) |
   Premature baby | 69 (13.9) | 87 (17.2) |
   Stillbirth | 9 (1.8) | 13 (2.6) |
   Cephalo-pelvic disproportion | 11 (2.2) | 6 (1.2) |
   Abortion spontaneous | 6 (1.2) | 5 (1.0) |