Comparison · NCT03132636-sae
Group 1: Metastatic BCC (mBCC) vs Group 2: Unresectable Locally Advanced BCC (laBCC): 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. Group 1: Metastatic BCC (mBCC) vs Group 2: Unresectable Locally Advanced BCC (laBCC): serious adverse events. Trial comparisons, record NCT03132636-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03132636-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 | 0.333 | 0.222 | 0.466 | wilson | |
| Risk in group 2 | 0.393 | 0.295 | 0.5 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0595 | -0.214 | 0.105 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.848 | 0.535 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 0.773 | 0.378 | 1.58 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Group 1: Metastatic BCC (mBCC) than on Group 2: Unresectable Locally Advanced BCC (laBCC) | 16.8 | 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 | Group 1: Metastatic BCC (mBCC) | Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR. | 18 | 54 | EG000 |
| Group 2 | Group 2: Unresectable Locally Advanced BCC (laBCC) | Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR. | 33 | 84 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Source ClinicalTrials.gov
Trial
- Title
- PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy
- NCT number
- NCT03132636
- Phases
- PHASE2
- Conditions
- Carcinoma, Basal Cell
- Interventions
- cemiplimab
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2022-07-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03132636?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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