Comparison · NCT01594762-sae
Topical Pexiganan Cream 0.8% vs Topical Placebo Control: 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. Topical Pexiganan Cream 0.8% vs Topical Placebo Control: serious adverse events. Trial comparisons, record NCT01594762-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01594762-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 | 0.0825 | 0.0424 | 0.154 | wilson | |
| Risk in group 2 | 0.0194 | 0.00534 | 0.0681 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0631 | 0.0000277 | 0.136 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.25 | 0.925 | 19.5 | log | |
| Odds ratio, group 1 over group 2 | 4.54 | 0.939 | 21.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Topical Pexiganan Cream 0.8% than on Topical Placebo Control | 15.9 | 7.34 | 36,100 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Topical Pexiganan Cream 0.8% | Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment | 8 | 97 | EG000 |
| Group 2 | Topical Placebo Control | Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment | 2 | 103 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 28 days
Source ClinicalTrials.gov
Trial
- Title
- Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
- NCT number
- NCT01594762
- Phases
- PHASE3
- Conditions
- Diabetic Foot Infection
- Interventions
- Topical pexiganan cream 0.8%, Topical placebo cream, Standard wound care
- Lead sponsor
- Dipexium Pharmaceuticals, Inc.
- Results first posted
- 2017-06-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01594762?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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