Table 4 Pregnant women with an adverse event till 63 days having received at least one malaria treatment dose in Nchelenge, Zambia (2010–2014)
Safety population | AL (NÂ =Â 300) | MQAS (NÂ =Â 299) | DHAPQ (NÂ =Â 300) |
|---|---|---|---|
At least one AE, n (%) | 248 (82.7) | 254(84.9) | 238 (79.3) |
Most common AEsa, n (%) | |||
 Headache | 136 (45.3) | 142 (47.5) | 134 (44.7) |
 Nausea | 8 (2.7) | 39 (13.0) | 23 (7.7) |
 Cough | 99 (33.0) | 116 (38.8) | 120 (40.0) |
 Asthenia | 36 (12.0) | 69 (23.1) | 49 (16.3) |
 Dizziness | 11 (3.7) | 88 (29.4) | 17 (5.7) |
 Vomiting | 14 (4.7) | 47 (15.7) | 26 (8.7) |
 Abdominal pain | 73 (24.3) | 71 (23.7) | 70 (23.3) |
 Musculoskeletal pain | 43 (14.3) | 47 (15.7) | 30 (10.0) |
 Backache | 51 (17.0) | 40 (13.4) | 28 (9.3) |
 Influenza | 24 (8.0) | 32 (10.7) | 40 (13.3) |
At least one related AE, n (%) | 54 (18.0) | 127 (42.5) | 72 (24.0) |
Most common related AEsa, n (%) | |||
 Dizziness | 5 (1.7) | 72 (24.1) | 8 (2.7) |
 Nausea | 5 (1.7) | 34 (11.4) | 16 (5.3) |
 Vomiting | 5 (1.7) | 43 (14.4) | 17 (5.7) |
 Asthenia | 9 (3.0) | 38 (12.7) | 14 (4.7) |
 Headache | 14 (4.7) | 16 (5.4) | 15 (5.0) |
SAE n (%) | 0 | 4 (1.3) | 3 (1.0) |
Related SAE, n (%) | 0 | 1 (0.3) | 0 |
At least one SAE which caused death, n (%) | 0 | 1 (0.3) | 0 |
Birth outcomes, n (%) | |||
 Still birth | 8 (2.8) | 3 (1.1) | 10 (3.7) |
 Miscarriage | 0 (0) | 2 (0.7) | 1 (0.4) |
 Prematurity | 13 (4.6) | 6 (2.2) | 10 (3.7) |
 Congenital abnormality | 7 (2.6) | 4 (1.5) | 4 (1.6) |