Comparison · NCT01327053-sae
LDE225 200 mg qd vs LDE225 800 mg qd: 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. LDE225 200 mg qd vs LDE225 800 mg qd: serious adverse events. Trial comparisons, record NCT01327053-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01327053-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 | 0.203 | 0.129 | 0.304 | wilson | |
| Risk in group 2 | 0.387 | 0.312 | 0.467 | wilson | |
| Risk difference, group 1 minus group 2 | -0.184 | -0.293 | -0.0585 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.524 | 0.324 | 0.848 | log | |
| Odds ratio, group 1 over group 2 | 0.403 | 0.213 | 0.764 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on LDE225 200 mg qd than on LDE225 800 mg qd | 5.43 | 3.41 | 17.1 | from the risk difference interval |
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 | LDE225 200 mg qd | Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent. | 16 | 79 | EG000 |
| Group 2 | LDE225 800 mg qd | Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent. | 58 | 150 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 76.2 months.
Source ClinicalTrials.gov
Trial
- Title
- A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
- NCT number
- NCT01327053
- Phases
- PHASE2
- Conditions
- Basal Cell Carcinoma
- Interventions
- LDE225
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2015-11-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01327053?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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