Comparison · NCT01541553-sae
PEP005 Gel, 0.015% vs Vehicle Gel: 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. PEP005 Gel, 0.015% vs Vehicle Gel: serious adverse events. Trial comparisons, record NCT01541553-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01541553-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 | 0.0419 | 0.0205 | 0.084 | wilson | |
| Risk in group 2 | 0.0247 | 0.00964 | 0.0618 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0172 | -0.0256 | 0.0619 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.7 | 0.507 | 5.69 | log | |
| Odds ratio, group 1 over group 2 | 1.73 | 0.496 | 6.02 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PEP005 Gel, 0.015% than on Vehicle Gel | 58.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PEP005 Gel, 0.015% | Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days | 7 | 167 | EG000 |
| Group 2 | Vehicle Gel | Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, baseline AKs) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days. | 4 | 162 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
- NCT number
- NCT01541553
- Phases
- PHASE3
- Conditions
- Actinic Keratosis
- Interventions
- Cryotherapy, Vehicle, Ingenol metabute
- Lead sponsor
- LEO Pharma
- Results first posted
- 2014-03-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01541553?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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