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Table 1 Assigning outcomes for estimating treatment efficacy under current recommendations.

From: Statistical methods to derive efficacy estimates of anti-malarials for uncomplicated Plasmodium falciparum malaria: pitfalls and challenges

End-point for day X (X = 28 or 42)

Cumulative success or failure probability (Kaplan–Meier analysis)

Proportion (per-protocol analysis)

Adequate clinical and parasitological response at day X

Success

Success

Early treatment failure

Failure

Failure

Late clinical failure before day 7

Failure

Failure

Late clinical failure or late parasitological failure on or after day 7

 Falciparum recrudescence

Failure

Failure

 Falciparum reinfection

Censored day of reinfection

Excluded from analysis

 Other species with falciparum recrudescence

Failure

Failure

 Other species infection

Censored day of infection

Excluded from analysis

 Undermined or indeterminate PCR

Excluded from PCR-corrected analysis

Excluded from analysis

Loss to follow-up

Censored last day of follow-up according to timetable

Excluded from analysis

Withdrawal and protocol violation

Censored last day of follow-up according to timetable before withdrawal or protocol violation

Excluded from analysis