Trial · NCT01258049
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Parasitological Success (MITT) | 24 hours after start of treatment | The Modified Intention to Treat (MITT) population included all randomised subjects who received at least one dose of study medication and had evaluable parasite counts at 24 hours after first dosing.~7 subjects for ArTiMist and 3 subjects for quinine were excluded due to no baseline or 24 h parasite count | participants | NUMBER |
| SECONDARY | Parasite Clearance Time (PCT) [MITT Population] | 28 days after start of treatment | hours | MEAN | |
| SECONDARY | PCT 90 [MITT Population] | 28 days after start of treatment | hours | MEAN | |
| SECONDARY | PCT 50 [MITT Population] | 28 days after start of treatment | hours | MEAN | |
| SECONDARY | PRR 24 [MITT Population] | 28 days after start of treatment | percentage of baseline | MEAN | |
| SECONDARY | PRR 12 [MITT Population] | 28 days after start of treatment | percentage of baseline | MEAN | |
| SECONDARY | Fever Clearance Time (FCT) | 28 days after start of treatment | hours | MEAN | |
| SECONDARY | Complete Cure Rate | 28 days after the start of treatment | For some subjects, this endpoint was not evaluable and/or not all data was received. | participants | NUMBER |
| SECONDARY | Early Treatment Failure | Three days after the start of treatment | participants | NUMBER | |
| SECONDARY | Late Clinical Failure | 28 days after the start of treatment | participants | NUMBER | |
| PRIMARY | Parasitological Success (PP) | 24 hours after start of treatment | The Per Protocol (PP) population included the subjects in the MITT population who had received at least 80% of doses up to the time of discharge from the hospital, had evaluable data up to and including Day 28 and had no major protocol violations. | participants | NUMBER |
| SECONDARY | Late Parasitological Failure | 28 days after the start of treatment | participants | NUMBER | |
| SECONDARY | Time to Return to Full Consciousness | 28 days after start of treatment | hours | MEAN | |
| SECONDARY | Time to Return to Normal Per os Status | 28 days after start of treatment | hours | MEAN | |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events, of Possible, Probably and Definite Causalities | 28 days after start of treatment | participants | NUMBER | |
| SECONDARY | Number of Deaths or Neurological Sequelae at Day 28 | 28 days after start of treatment | participants | NUMBER |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01258049/outcomes