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. 2013 Mar 26;3(3):e002759. doi: 10.1136/bmjopen-2013-002759

Table 1.

Summary of outcome measures

Outcome measure Description
Efficacy
 Primary Mean number of days to gametocyte clearance (GCT) Mean number of days per treatment arm for gametocytes to become undetectable using submicroscopic molecular testing methods (QT-NASBA). Reappearance of gametocytes after day 14 will be considered as re-infection and excluded
 Secondary Mean (±SD) area under the curve of gametocyte density per day during 14 days of follow-up Total number of gametocytes (measured by QT-NASBA) seen over follow-up, averaged per day of follow-up (days 0–14)
Density of gametocytes on days 7, 10 and 14 Mean number of gametocytes (measured by QT-NASBA) per treatment arm on days 7, 10 and 14
Proportion (%) of participants with gametocytes on each day of follow-up For each treatment arm, percentage of participants with gametocytes (measured by QT-NASBA) on each day of follow-up from days 0–14
Safety
 Primary Mean (± SD) maximal fall (±) in Hb (haemoglobin, g/dl) from enrolment to day 28 of follow-up Mean maximal greatest negative difference in Hb (measured by HemoCue) from enrolment value per treatment arm over 28 days follow-up
 Secondary Follow-up day of Hb nadir Mean day of follow-up (day 0–28) per treatment arm of lowest Hb measurement (by HemoCue)
Maximal percentage fall in Hb level compared to enrolment value Size of maximal Hb drop (by HemoCue) during follow-up (day 0–28) from enrolment value, divided by enrolment value, *100
Percentage of participants with Hb<5 g/dl during follow-up Percentage (number) per treatment arm during days 0–28
Requirement for blood transfusion Percentage (number) of children receiving blood transfusion per treatment arm during days 0–28
Evidence of black urine Percentage (number) of children with documented black/dark urine with urine dipstick positive for Hb per treatment arm during days 0–28
Incidence of serious adverse events by sign, symptom, laboratory parameter and relationship to taking study drug Percentage (number) per treatment arm during days 0–28
Incidence of gastrointestinal symptoms after taking study drug Percentage (number) per treatment arm during days 2–7

GCT, gametocyte clearance time; Hb, haemoglobin; QT-NASBA, quantitative real-time nucleic acid sequence-based analysis.