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Table 4 Pregnant women with an adverse event till 63 days having received at least one malaria treatment dose in Nchelenge, Zambia (2010–2014)

From: Artemisinin-based combination therapy in pregnant women in Zambia: efficacy, safety and risk of recurrent malaria

Safety population AL (N = 300) MQAS (N = 299) DHAPQ (N = 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)
  1. AE adverse event; SAE serious adverse event; Related SAE serious adverse event which the investigator classified as possibly, probably or definitely related to study drug
  2. aAEs and related AEs recorded in, respectively, at least 10 and 5% of patients in any treatment group