Table 2.

Description of possible outcomes on the last day of follow-up for patients enrolled in clinical efficacy studies

Variable code	Description
	Patients who complete the study
0	ACPR
1	ETF and Death
2	ETF with Severe Malaria
3	ETF with Danger Signs
4	ETF with Parasitological Criteria (day 2 > day 0 or day 3 > 25% day 0)
5	ETF with Clinical Criteria (documented fever and parasitaemia on day 3)
6	ETF not otherwise specified (for when details of why ETF classified not available)
7	LCF and Death
8	LCF with Severe Signs
9	LCF with Danger Signs
10	LCF with fever (either measured or subjective)
11	LPF
12	LPF/LCF Indistinguishable (for when details of why LCF/LPF classified not available)
	Patients who do not complete the study
13	Adverse event requiring change in therapy prior to completion of full dose
14	Protocol violation
15	Death not due to malaria
16	Lost to follow-up
17	Use of other antimalarials outside of study protocol in the absence of parasitaemia
18	Withdrawal of consent by patient prohibiting further follow-up
19	Investigator initiated withdrawal from further follow-up
20	Patient who does not complete follow-up for any other reason not listed above
21	Enrolment Violations

ACPR – Adequate Clinical and Parasitological Response; ETF – Early Treatment

Failure; LPF – Late Parasitological Failure; LCF – Late Clinical Failure