Comparison · NCT03620643-sae
Crizotinib Oral Capsule [Xalkori] Monotherapy vs Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection: 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. Crizotinib Oral Capsule [Xalkori] Monotherapy vs Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection: serious adverse events. Trial comparisons, record NCT03620643-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03620643-sae
On this page
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 | 0.667 | 0.3 | 0.903 | wilson | |
| Risk in group 2 | 0.185 | 0.0818 | 0.367 | wilson | |
| Risk difference, group 1 minus group 2 | 0.481 | 0.0722 | 0.74 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.6 | 1.36 | 9.52 | log | |
| Odds ratio, group 1 over group 2 | 8.8 | 1.25 | 62.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Crizotinib Oral Capsule [Xalkori] Monotherapy than on Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 2.08 | 1.35 | 13.8 | 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 | Crizotinib Oral Capsule [Xalkori] Monotherapy | Arm 1 - Basket (diffuse gastric cancer, triple negative lobular breast cancer and Other CDH1 mutated cancer) cohort. | 4 | 6 | EG000 |
| Group 2 | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | Arm 2 - ER positive lobular breast cancer | 5 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
For eligible patients, serious adverse event (SAE) and adverse event (AE) collection commenced from Day 1 (at the time the first patient provided their written informed consent to participate in the trial) and continued until 30 days after the last administration of study drug, assessed up to end of study (approximately 57 months)
Source ClinicalTrials.gov
Trial
- Title
- Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours
- NCT number
- NCT03620643
- Phases
- PHASE2
- Conditions
- Lobular Breast Carcinoma, Gastric Cancer, Triple Negative Breast Cancer, CDH1 Gene Mutation
- Interventions
- Crizotinib Oral Capsule [Xalkori], Fulvestrant 50 MG/ML Prefilled Syringe [Faslodex or generic]
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Results first posted
- 2025-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03620643?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03620643-sae