Comparison · NCT02137785-sae
ALA-PDT vs Vehicle: 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. ALA-PDT vs Vehicle: serious adverse events. Trial comparisons, record NCT02137785-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02137785-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 | 0.037 | 0.0159 | 0.0838 | wilson | |
| Risk in group 2 | 0.0149 | 0.0041 | 0.0528 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0221 | -0.0212 | 0.0701 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.48 | 0.49 | 12.6 | log | |
| Odds ratio, group 1 over group 2 | 2.54 | 0.484 | 13.3 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ALA-PDT than on Vehicle | 45.2 | 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 | ALA-PDT | Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2 | 5 | 135 | EG000 |
| Group 2 | Vehicle | Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2 | 2 | 134 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 3 months
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
- NCT number
- NCT02137785
- Phases
- PHASE3
- Conditions
- Actinic Keratosis
- Interventions
- Aminolevulinic Acid (ALA), Topical Solution Vehicle, Blue Light Photodynamic Therapy Illuminator (BLU-U)
- Lead sponsor
- DUSA Pharmaceuticals, Inc.
- Results first posted
- 2015-09-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02137785?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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