Comparison · NCT00440999-sae
Pyronaridine Artesunate vs Chloroquine: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Pyronaridine Artesunate vs Chloroquine: serious adverse events. Trial comparisons, record NCT00440999-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00440999-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00877 | 0.00241 | 0.0314 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0166 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00877 | -0.00898 | 0.0314 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Pyronaridine Artesunate than on Chloroquine | 114 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pyronaridine Artesunate | Subjects receive oral active-pyronaridine artesunate (tablet 180:60 mg) + chloroquine-placebo, once a day for 3 consecutive days (D0, 1, and 2).~Posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The actual dose range covered by this regimen was 7.2:2.4 mg/kg to 13.8:4.6 mg/kg. | 2 | 228 | EG000 |
| Group 2 | Chloroquine | Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2).~The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults. | 0 | 228 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study or resolution of the event, whichever was earlier
Source ClinicalTrials.gov
Trial
- Title
- Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
- NCT number
- NCT00440999
- Phases
- PHASE3
- Conditions
- Malaria
- Interventions
- Pyronaridine artesunate, Chloroquine
- Lead sponsor
- Medicines for Malaria Venture
- Results first posted
- 2021-09-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00440999?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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