Endpoints
recrudescence, parasitaemia, overdose, fever
ADVERSE EVENTS, ADVERSE EVENT, SECONDARY, REINFECTION
The primary efficacy endpoint was PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28, defined as the absence of parasitaemia without previous treatment failure or rescue therapy, adjusted for re-infection using PCR genotyping [Secondary efficacy endpoints were Day 28 ACPR unadjusted for re-infection (crude ACPR); parasitaemia at baseline then every 6 h during the first 36 h post-dose, then at 48 h and every 24 h until Day 7; parasite clearance time; time to parasitaemia re-emergence, recrudescence, or reinfection; time elapsed below the LLQ of parasitaemia; fever clearance time; observed parasite reduction ratio at 24, 48 and 72 h post-dose (observed PRRSafety endpoints were the frequency, severity, and causality of all adverse events coded using MedDRA (version 22.0), the frequency of serious adverse events, clinically important changes in clinical laboratory data, ECGs, vital signs, or physical examination. Adverse events of special interest were pregnancy, symptomatic overdose, increase in ALT ≥ 3xULN (or ≥ 2 × the baseline value if baseline ALT was ≥ ULN), QTcF ≥ 500 ms, or QTcF prolongation > 60 ms from baseline.Pharmacokinetic assessments were secondary endpoints, but also supported the primary analysis evaluating the exposure–response for artefenomel (Additional files 