Comparison · NCT01367665-sae
Vismodegib - Locally Advanced vs Vismodegib - Metastatic: 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. Vismodegib - Locally Advanced vs Vismodegib - Metastatic: serious adverse events. Trial comparisons, record NCT01367665-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01367665-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 | 0.243 | 0.219 | 0.269 | wilson | |
| Risk in group 2 | 0.323 | 0.238 | 0.422 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0798 | -0.182 | 0.00919 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.753 | 0.553 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.673 | 0.43 | 1.06 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Vismodegib - Locally Advanced than on Vismodegib - Metastatic | 12.5 | 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 | Vismodegib - Locally Advanced | Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. | 272 | 1,119 | EG000 |
| Group 2 | Vismodegib - Metastatic | Participants received vismodegib 150 mg orally once a day until one of the following occurred: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator. | 31 | 96 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline to the data cut-off of 14 June 2017 (up to 6 years)
Source ClinicalTrials.gov
Trial
- Title
- STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
- NCT number
- NCT01367665
- Phases
- PHASE2
- Conditions
- Basal Cell Carcinoma
- Interventions
- vismodegib
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2019-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01367665?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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