Comparison · NCT00884377-sae
Sodium Stibogluconate Intravenous vs ThermoMed Device: 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. Sodium Stibogluconate Intravenous vs ThermoMed Device: serious adverse events. Trial comparisons, record NCT00884377-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00884377-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 | 0.179 | 0.0788 | 0.356 | wilson | |
| Risk in group 2 | 0.0714 | 0.0198 | 0.226 | wilson | |
| Risk difference, group 1 minus group 2 | 0.107 | -0.0772 | 0.292 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.5 | 0.529 | 11.8 | log | |
| Odds ratio, group 1 over group 2 | 2.83 | 0.499 | 16 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sodium Stibogluconate Intravenous than on ThermoMed Device | 9.33 | 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 | Sodium Stibogluconate Intravenous | 20 mg/kg/day Sodium stibogluconate intravenous~Sodium stibogluconate (Pentostam): intravenous 20 mg/kg/day for 10 days | 5 | 28 | EG000 |
| Group 2 | ThermoMed Device | ThermoMed device, single heat treatment at 50 degrees Celsius~ThermoMed: ThermoMed heat treatment device, one treatment | 2 | 28 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1-10 AEs were documented daily. After day 10, AE surveillance was performed via subject interviews at 2, 6 and 12 months (window of 10-24 months) post-treatment.
Source ClinicalTrials.gov
Trial
- Title
- Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
- NCT number
- NCT00884377
- Phases
- PHASE2
- Conditions
- Cutaneous Leishmaniasis
- Interventions
- Sodium stibogluconate (Pentostam), ThermoMed
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Results first posted
- 2017-07-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00884377?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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