Comparison · NCT05236257-sae
Larotrectinib vs External Controls: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Larotrectinib vs External Controls: serious adverse events. Trial comparisons, record NCT05236257-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05236257-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 | 0.0196 | 0.00347 | 0.103 | wilson | |
| Risk in group 2 | 0.0714 | 0.0246 | 0.19 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0518 | -0.172 | 0.0439 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.275 | 0.0296 | 2.54 | log | |
| Odds ratio, group 1 over group 2 | 0.26 | 0.026 | 2.6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Larotrectinib than on External Controls | 19.3 | 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 | Larotrectinib | Pediatric patients (up to 21 years old) with Infantile fibrosarcoma (IFS) harboring an NTRK gene fusion who have been enrolled in the SCOUT study (Bayer Study ID: 20290; NCT02637687) and treated with larotrectinib. | 1 | 51 | EG000 |
| Group 2 | External Controls | External historical control patients treated with at least one chemotherapy-based regimen, pooled from the Institut Curie (CURIE) database (N=18) and the Cooperative Weichteilsarkom Studiengruppe (CWS) database (N=24). | 3 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 5.5 years for participants in SCOUT study and 22.5 years for participants in external historical control
Source ClinicalTrials.gov
Trial
- Title
A Study Called EPI VITRAKVI to Compare Treatment Results in Patients With Infantile Fibrosarcoma (IFS), a Type of Connective Soft Tissue Cancer, Who Received a Treatment Called Larotrectinib From a Study Called SCOUT With Patient Data From an External Database
- NCT number
- NCT05236257
- Phases
- Conditions
- Locally Advanced or Metastatic Infantile Fibrosarcoma Harboring an NTRK Gene Fusion, Infantile Fibrosarcoma
- Interventions
- Larotrectinib (Vitrakvi, BAY2757556), Standard of Care
- Lead sponsor
- Bayer
- Results first posted
- 2024-12-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05236257?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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