Safety assessment
malaria, diarrhoea, vomiting, fever
MALARIA, ADVERSE EVENTS
Trained field workers visited all enrolled children daily at home starting from the evening of day 0 until 3 days after completion of the first cycle of SMC, using a purpose designed electronic diary card which recorded the presence of any side effects, including fever, vomiting, diarrhoea. In addition, all study participants who presented to the outpatient or emergency departments of Saraya health centre or health posts in the study villages were evaluated for malaria and any serious adverse events (SAE) that might have been related to administration of the study drugs. Trained research assistants visited each child 1 month after the first round of SMC cycle to check that there had been no severe reactions to the previous treatment, and if this was not the case, gave the next round of treatment. When a possible drug related SAE was reported to the study staff, the case was investigated by a Local Safety Monitor who was an experienced physician based in Senegal. The Local Safety Monitor reported the findings to the Sponsor of the study. Data obtained from all inpatient records for study children admitted to the hospital for at least 24 h within 1 month of SMC administration were evaluated for severity and a possible relationship to administration of the study drugs using standard criteria [