Fig 1.
Study design, patient disposition and main efficacy outcomes.
*The three patients with early treatment failure (at day 7) in the tafenoquine group cleared parasitemia spontaneously on day 8 without additional treatment, and were relapse free for the duration of their follow-up (until day 28 for one patient, day 60 for the second and day 120 for the third).
Fig 2.
The planned enrollment for this study was 70 patients in each of two cohorts in order to yield at least 60 evaluable patients in each cohort. Using a 2:1 randomization ratio and assuming a true success rate on treatment of at least 98%, the sample size of 40 evaluable tafenoquine patients provided 90% power to show that the lower limit of the one-sided 95% confidence interval for the day 28 cure rate was above 85%.
Table 1.
Baseline characteristics of the study participants in intention-to-treat/safety population.
Fig 3.
Individual patient tafenoquine plasma concentrations.
*The three patients with early treatment failure (at day 7) in the tafenoquine group and slow parasite clearance had similar tafenoquine plasma concentrations to the population that had parasite clearance at day 7.
Table 2.
Per-protocol population analysis of parasite, gametocyte and fever clearance time.
Table 3.
Most common adverse events overall (regardless of causality) occurring in at least two patients in either treatment group (intention-to-treat/safety population).