Comparison · NCT04222088-sae
Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: 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. Artemether-lumefantrine (Coartem™) + Primaquine vs Chloroquine + Primaquine: serious adverse events. Trial comparisons, record NCT04222088-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04222088-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 | 0 | 0.0437 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000347 | 0.0487 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0487 | 0.0437 | 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 | from the risk difference interval | the two groups' risks are equal |
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 | Artemether-lumefantrine (Coartem™) + Primaquine | Administered to patients with mono-infection of Plasmodium falciparum with 1000-100 000 asexual forms per µl. Coartem™: 20/120 mg per tablet was administered 3 days (Days 0, 1 and 2) according to body weight. For patients with weight of 5 to \<15kg, 15 to \<25kg, 25 to \<35kg, or ≥35kg, tablets of 1, 2, 3, or 4 will be given respectively. At day 3, primaquine at 0.75 mg base/kg body weight single dose will be given. | 0 | 84 | EG000 |
| Group 2 | Chloroquine + Primaquine | Administered to patients with mono-infection of Plasmodium vivax with parasite count of ≥ 250 per µl, Chloroquine 150 mg base tablet was administered according to body weight at a total dose of 25 mg/kg over 3 days (10 mg/kg on Day 0; 10 mg/kg on Day 1 and 5 mg/kg on Day 2). After 28 days of follow-up, primaquine will be given for 14 days. | 0 | 75 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- TES of Artemether-lumefantrine for Pf and Chloroquine for Pv in the Philippines From 2013-2014
- NCT number
- NCT04222088
- Phases
- Conditions
- Malaria, Falciparum Malaria, Vivax Malaria, Malaria Recrudescence
- Interventions
- Arthemeter-lumefantrine, Chloroquine, Primaquine
- Lead sponsor
- Research Institute for Tropical Medicine, Philippines
- Results first posted
- 2023-02-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04222088?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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