Step | Event to be assessed | Per Protocol | Pure ITT |
---|---|---|---|
1 | Withdrawal BEFORE OR AT D28: any reason except lost to follow-up | Depending on reason, a patient can be excluded or evaluated as Failure | Failure |
2 | Withdrawal BEFORE OR AT D28: lost to follow-up | Excluded | Failure |
3 * | Withdrawal AFTER D28: any reason except lost to follow-up | Failure | Failure |
4 * | Withdrawal AFTER D28: lost to follow-up | Failure | Failure |
5 | ETF, LCF, and LPF in accordance with the WHO criteria | Failure | Failure |
6** | Presence of major protocol violations | Excluded | No effect |
7** | Occurrence of adverse events highlighting recurrence of malaria | Failure | Failure |
8** | Presence of missing parasitaemia at two or more consecutive scheduled visits or presence of an isolated missing parasitaemia not preceded and followed by a negative parasitaemia | Failure | Failure |
9** | Administration of drugs with a known or suspected anti-malaria action as rescue treatment | Failure | Failure |
10** | Administration of drugs with a known or suspected anti-malaria action as non rescue treatment | Excluded | Failure |
11** | Administration of anti-malarial drugs for Plasmodium vivax, Plasmodium malariae, or Plasmodium ovale during the course of the study in patients not classified as ETF or LTF | Failure with new infection | Failure with new infection |
12 | PCR not done BETWEEN DAY 4 AND DAY 13 | Recrudescence | Recrudescence |
13 | PCR: non interpretable or missing or not done BETWEEN DAY 14 AND D28 | Excluded | Recrudescence |
14** | PCR: non interpretable or missing or not done AFTER D28 | Rule *** | Recrudescence |
15 | PCR = new infection or uncorrected ACPR = Failure with new infection | Success | Success |
16 | PCR = recrudescence | Recrudescence | Recrudescence |