Comparison · NCT00472108-sae
Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) vs Photodynamic Therapy (PDT) With Placebo Cream: 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. Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) vs Photodynamic Therapy (PDT) With Placebo Cream: serious adverse events. Trial comparisons, record NCT00472108-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00472108-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 | 0.0303 | 0.00537 | 0.153 | wilson | |
| Risk in group 2 | 0.156 | 0.0686 | 0.318 | wilson | |
| Risk difference, group 1 minus group 2 | -0.126 | -0.289 | 0.025 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.194 | 0.024 | 1.57 | log | |
| Odds ratio, group 1 over group 2 | 0.169 | 0.0186 | 1.53 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) than on Photodynamic Therapy (PDT) With Placebo Cream | 7.94 | 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 | Photodynamic Therapy (PDT) With Metvix Cream 160 Milligrams/Gram (mg/g) | Participants with basal cell carcinoma (BCC) lesions were administered to PDT with Metvix® cream 160 mg/g applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of less than 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. | 1 | 33 | EG000 |
| Group 2 | Photodynamic Therapy (PDT) With Placebo Cream | Participants with BCC lesions were administered to PDT with Placebo cream applied topically for three hours, followed by illumination using noncoherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 50-200 milliwatt per centimeter square (mW/cm\*2) up to 14 weeks. All participants received two consecutive treatments, one week apart thereby completing one PDT treatment cycle. | 5 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 6 months
Source ClinicalTrials.gov
Trial
- Title
- Photodynamic Therapy (PDT) With Metvix Cream 160 mg/g Versus PDT With Placebo Cream in Participants With Primary Nodular Basal Cell Carcinoma
- NCT number
- NCT00472108
- Phases
- PHASE3
- Conditions
- Basal Cell Carcinoma
- Interventions
- Photodynamic Therapy (PDT), Metvix cream, Placebo Cream
- Lead sponsor
- Galderma R&D
- Results first posted
- 2024-08-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00472108?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT00472108-sae