Drug safety
sleep disorder, abdominal pain, fever, edema, vomiting, cough, adenopathy, headache, anorexia, trauma
ADVERSE EVENTS, EDEMA, ADVERSE EVENT, ADENOPATHY, ANOREXIA
Overall, 11.9% (42/352) patients who reached a study endpoint presented at least one emergent adverse event. Among these adverse events, 54.8% (23/42) were in the ASAQ arm and 45.2% (19/42) in the AL arm. In the ASAQ arm, the most frequently reported AEs included: cough 30.4% (7/23), abdominal pain 21.7% (5/23), vomiting 17.3% (4/23), headache 13.04% (3/23), edema 4.3% (1/23), sleep disorder 4.3% (1/23), eye trauma 4.3% (1/23) and anorexia 4.3% (1/23). In the AL arm, the most frequently reported AEs included: cough 31.5% (6/19), flu-like symptoms 21.05% (4/19), abdominal pain 10.5% (2/19), fever (10.5% (2/19), trauma 10.5% (2/19), vomiting 5.2% (1/19), headache 5.2% (1/19), adenopathy 5.2% (1/19), and anorexia 5.2% (1/19). Of all adverse events, two in the AL arm fulfilled the severity criteria. None of the adverse events were considered treatment-related by the investigators. No significant difference was observed between the two treatment groups in terms of presence of adverse events (
Clinical characteristics from day 0 to day 7, Madagascar 2018.ATV: Antsenavolo/Mananjary, KVT: Kianjavato/Mananjary, VHT: Vohitromby/Farafangana.Data for hemoglobin values at day 0 and day 28 were available for 344 individuals; no statistical difference was observed between treatment arms at day 0 (