Table 2 Description of possible outcomes on the last day of follow-up for patients enrolled in clinical efficacy studies
From: World Antimalarial Resistance Network I: Clinical efficacy of antimalarial drugs
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 |