Table 3.
Serious adverse events
| ISTp-DP (n=510 women, n=454 infants)*
|
IPTp-DP (n=510 women, n=459 infants)†
|
IPTp-SP (n=508 women, n=458 infants)‡
|
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Number with event |
Total events | Incidence per 100 person-years (95% CI) |
Number with event |
Total events | Incidence per 100 person-years (95% CI) |
Number with event |
Total events | Incidence per 100 person-years (95% CI) |
|
| Women | |||||||||
|
| |||||||||
| Any event | 55 (11%) | 82 | 40.72 (32.80–50.56) | 32 (6%) | 37 | 18.27 (13.23–5.21) | 61 (15%) | 85 | 41.35 (33.43–51.15) |
| Pregnancy, puerperium, and perinatal disorders | 31 | 37 | 18.37 (13.31–25.36) | 25 | 28 | 13.82 (9.54–20.02) | 44 | 52 | 25.30 (19.28–33.20) |
| Infections and infestations | 21 | 25 | 12.41 (8.39–18.37) | 6 | 6 | 2.96 (1.33–6.59) | 16 | 22 | 10.70 (7.05–16.26) |
| Gastrointestinal disorders | 6 | 6 | 2.98 (1.34–6.63) | 2 | 2 | 0.99 (0.25–3.95) | 3 | 3 | 1.46 (0.47–4.53) |
| Surgical and medical procedures | 3 | 3 | 1.49 (0.48–4.62) | 0 | 0 | 0 | 1 | 1 | 0.49 (0.07–3.45) |
| Blood and lymphatic system disorders | 1 | 1 | 0.50 (0.07–3.53) | 0 | 0 | 0 | 2 | 2 | 0.97 (0.24–3.89) |
| Musculoskeletal and connective tissue disorders | 2 | 2 | 0.99 (0.25–3.97) | 0 | 0 | 0 | 1 | 1 | 0.49 (0.07–3.45) |
| Nervous system disorders | 1 | 1 | 0.50 (0.07–3.53) | 1 | 1 | 0.49 | 1 | 1 | 0.49 (0.07–3.45) |
| Reproductive system and breast disorders | 2 | 2 | 0.99 (0.25–3.97) | 0 | 0 | 0 | 1 | 1 | 0.49 (0.07–3.45) |
| Injury, poisoning, and procedural complications | 1 | 1 | 0.50 (0.07–3.53) | 0 | 0 | 0 | 1 | 1 | 0.49 (0.07–3.45) |
| Respiratory, thoracic, and mediastinal disorders | 2 | 2 | 0.99 (0.25–3.97) | 0 | 0 | 0 | 0 | 0 | 0 |
| General disorders and administration site conditions | 1 | 1 | 0.50 (0.07–3.53) | 0 | 0 | 0 | 0 | 0 | 0 |
| Immune system disorders | 1 | 1 | 0.50 (0.07–3.53) | 0 | 0 | 0 | 0 | 0 | 0 |
| Vascular disorders | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0.49 (0.07–3.45) |
|
| |||||||||
| Infants§ | |||||||||
|
| |||||||||
| Any event | 26 (6%) | 31 | 6.15 (4.32–8.74) | 22 (5%) | 27 | 5.30 (3.64–773) | 36 (8%) | 41 | 7.86 (5.77–10.72) |
| Congenital, familial, and genetic disorders | 8 | 11 | 2.18 (1.21–3.94) | 10 | 11 | 2.16 (1.20–3.90) | 14 | 16 | 3.14 (1.93–5.13) |
| Pregnancy, puerperium, and perinatal disorders | 6 | 6 | 1.19 (0.53–2.65) | 6 | 6 | 1.18 (0.53–2.62) | 8 | 8 | 1.57 (0.79–3.14) |
| Infections and infestations | 8 | 9 | 1.78 (0.93–3.43) | 3 | 5 | 0.98 (0.41–2.36) | 4 | 4 | 0.79 (0.30–2.09) |
| General disorders and administration site conditions | 1 | 1 | 0.20 (0.03–1.41) | 4 | 4 | 0.79 (0.29–2.09) | 7 | 7 | 1.18 (0.53–2.63) |
| Respiratory, thoracic, and mediastinal disorders | 4 | 4 | 0.79 (0.30–2.11) | 1 | 1 | 0.20 (0.03–1.39) | 5 | 5 | 0.98 (0.41–2.36) |
| Gastrointestinal disorders | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0.20 (0.03–1.40) |
ISTp-DP=intermittent screening and treatment during pregnancy with dihydroartemisinin–piperaquine. IPTp-DP=intermittent preventive treatment during pregnancy with dihydroartemisinin–piperaquine. IPTp-SP=intermittent preventive treatment during pregnancy with sulfadoxine–pyrimethamine. Total follow-up time:
*
201.4 years in women, 48.0 years in infants;
†
202.6 years in women, 48.7 years in infants;
‡
205.5 years in women, 48.4 years in infants.
§
Excluding twin births, including liveborn and stillborn infants.