Comparison · NCT01258049-sae
ArTiMist vs Quinine: 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. ArTiMist vs Quinine: serious adverse events. Trial comparisons, record NCT01258049-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01258049-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 | 0.0519 | 0.0204 | 0.126 | wilson | |
| Risk in group 2 | 0.135 | 0.0751 | 0.231 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0832 | -0.184 | 0.0122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.384 | 0.126 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.351 | 0.105 | 1.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on ArTiMist than on Quinine | 12 | 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 | ArTiMist | 4 | 77 | EG000 | |
| Group 2 | Quinine | 10 | 74 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were reported from the time of signing informed consent until the final study visit. Adverse events that started or worsened after start of treatment were considered Treatment Emergent.
Source ClinicalTrials.gov
Trial
- Title
- Superiority of ArTiMist Versus Quinine in Children With Severe Malaria
- NCT number
- NCT01258049
- Phases
- PHASE3
- Conditions
- Plasmodium Falciparum Malaria
- Interventions
- Artemether Sublingual Spray, Quinine
- Lead sponsor
- Proto Pharma Ltd
- Results first posted
- 2014-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01258049?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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