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) |
Enrolled population: pregnant women who gave informed consent.
MedDRA = medical dictionary for regulatory activities
A pregnant woman with multiple occurrences of an adverse event is counted only once in the corresponding adverse event category.
*Preferred terms occurring in at least 1% of women in either exposure group are presented along with the corresponding primary system organ class.