Data collection of symptoms
diarrhoea, itching, abdominal pain, pain, dizziness, skin rash, nausea,, headache, aches, shortness of breath
At each follow up visit a symptom questionnaire was completed. Patients were encouraged to report to the study centre if they became unwell between scheduled visits. The symptom questionnaire consisted of a 13-point symptom checklist for fever/hot body, headache, muscle/joint aches and pain, abdominal pain, poor appetite, nausea, vomiting, diarrhoea, passing red/brown/black urine, skin rash, dizziness, shortness of breath and itching. The questionnaire was available in English at all sites, except for the Indonesian sites where it was translated into Bahasa. Each symptom could be either present at the time of the interview or reported as occurring since the last visit and was graded according to study specific standard operating procedures (SOP) as either mild, moderate, severe or potentially life threating using definitions outlined in Table Severity grading scale for symptom reportingNausea/vomitingNo interferencewith activity or 1 – 2 episodes/24 hSome interferencewith activity or > 2episodes/24 hPrevents daily activity, requiresoutpatient IV hydrationEmergency department visit orhospitalisation forhypotensive shock4 – 5 stools or400 – 800 g/24hoursEmergency department visit orhospitalisationSome interferencewith activity notrequiring medicalinterventionPrevents dailyactivity andrequires medicalinterventionEmergency department visit orhospitalisation