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Table 1 Possible outcomes in antimalarial studies of uncomplicated P. falciparum malaria

From: Competing risk events in antimalarial drug trials in uncomplicated Plasmodium falciparum malaria: a WorldWide Antimalarial Resistance Network individual participant data meta-analysis

Possible outcomes Description
Recrudescence of P. falciparum Recurrent infection caused by the parasites that survived treatment. This is the primary endpoint in antimalarial efficacy studies of uncomplicated P. falciparum malaria
Novel infections due to P. falciparum or P. vivax Recurrent infection due to a new parasite strain or strains during the follow-up. This can be due to a different Plasmodium species or due to the same species but different genotype from the initial parasite infection
Indeterminate recurrent infection Recurrent infection with the same parasite species but in which molecular analysis is unable to discriminate between a recrudescent or new infection (e.g. due to unsuccessful amplification of DNA). These patients are usually excluded when deriving efficacy estimates
Patients in whom follow-up is curtailed before the end of the study or the occurrence of the primary event Incomplete follow-up can occur in patients who fail to return to the clinic for follow-up, withdraw their consent or other reasons for discontinuation. These patients are censored in K–M survival analysis and excluded from per protocol analysis
Adequate clinical and parasitological response (ACPR) Treatment success, defined as the absence of parasitaemia at the end of the study follow-up