Trial · NCT02083380
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) | Day 28 | Polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. Per protocol population (PP). 95% Clopper-Pearson 2-sided Confidence Interval (CI) constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Primary | PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years) | Day 28 | PCR-adjusted adequate clinical and parasitological response (ACPR) at Day 28: defined as: absence of parasitaemia on Day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure (ETF), late clinical failure (LCF) or late parasitological failure (LPF). Definition of ETF, LCF and LPF according to a modified standard WHO classification. 95% Clopper-Pearson 2-sided CI constructed around the single binomial proportion per treatment arm and total. |
| Secondary | PCR - Adjusted ACPR at Day 42 in the PP Population | Days 42 | PCR - adjusted adequate clinical and parasitological response at Day 42 |
| Secondary | PCR-adjusted ACPR at Day 63 in the PP Population | Day 63 | PCR-adjusted adequate clinical and parasitological response at Day 63 |
| Secondary | Crude ACPR at Day 28 in the PP Population | Day 28 | Crude adequate clinical and parasitological response at Day 28 |
| Secondary | Crude ACPR at Day 42 in the PP Population | Day 42 | Crude adequate clinical and parasitological response at Day 42 |
| Secondary | Crude ACPR at Day 63 in the PP Population | Day 63 | Crude adequate clinical and parasitological response at Day 63 |
| Secondary | PCR-adjusted ACPR at Day 28 in the ITT Population | Day 28 | PCR-adjusted adequate clinical and parasitological response at Day 28. Intent to Treat ( ITT) population. |
| Secondary | PCR-adjusted ACPR at Day 42 in the ITT Population | Day 42 | PCR-adjusted adequate clinical and parasitological response at Day 42 in the ITT population |
| Secondary | PCR-adjusted ACPR at Day 63 in the ITT Population | Day 63 | PCR-adjusted adequate clinical and parasitological response at Day 63 in the ITT population |
| Secondary | Crude ACPR at Day 28 in the ITT Population | Day 28 | Crude adequate clinical and parasitological response at Day 28 in the ITT population |
| Secondary | Crude ACPR at Day 42 in the ITT Population | Day 42 | Crude adequate clinical and parasitological response at Day 42 in the ITT population |
| Secondary | Crude ACPR at Day 63 in the ITT Population | Day 63 | Crude adequate clinical and parasitological response at Day 63 in the ITT population |
| Secondary | Kaplan-Meier Estimate of Recurrence | Day 63 | Kaplan-Meier estimate of number of recurrent infections (either recrudescence or new infection) |
| Secondary | Kaplan-Meier Estimate of Recrudescence | Day 63 | Kaplan-Meier estimate of number of patients with recrudescence |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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