Comparison · NCT02195011-fccd6bf9
Cohort 1: Regorafenib/SIR-Spheres/Regorafenib vs Cohort 2: SIR-Spheres/Regorafenib: The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety
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. Cohort 1: Regorafenib/SIR-Spheres/Regorafenib vs Cohort 2: SIR-Spheres/Regorafenib: The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety. Trial comparisons, record NCT02195011-fccd6bf9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02195011-fccd6bf9
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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 | 1 | 0.867 | 1 | wilson | |
| Risk in group 2 | 1 | 0.207 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.133 | 0.793 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Cohort 1: Regorafenib/SIR-Spheres/Regorafenib | Patients with metastatic colorectal cancer (mCRC) with liver metastases received one cycle (28 days) of regorafenib followed by SIR-Spheres followed by re-initiation of regorafenib 2-4 weeks after SIR-Spheres.~Patients in Cohort 1 took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle. SIR-Spheres microspheres were then be administered to patients by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle | 25 | 25 | OG000 |
| Group 2 | Cohort 2: SIR-Spheres/Regorafenib | Patients with metastatic colorectal cancer (mCRC) with liver metastases received SIR-Spheres microspheres followed by regorafenib to start 2-4 weeks after SIR-Spheres.~Patients in Cohort 2 received SIR-Spheres microspheres administered by injection via trans-femoral catheter into the hepatic artery. Following treatment with SIR-Spheres, patients took 160 mg regorafenib orally once daily on Days 1-21 of each 28-day treatment cycle | 1 | 1 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- The Number of Participants With Treatment-Related Adverse Events and Serious Adverse Events as a Measure of Safety
- Description
A treatment-related adverse event or serious adverse event was any untoward medical occurrence in a participant which was considered to have a relationship with the study drug (suspected to be possibly or probably related to the study drug per the Investigator's assessment). Adverse events and serious adverse events will be assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V4.03.
- Time frame
- up to 15 months
- Population
- All patients who receive at least one dose of treatment.
Source ClinicalTrials.gov
Trial
- Title
- Safety Study of Regorafenib and SIR-Spheres® Microspheres Radioembolization in Patients With Refractory Metastatic Colorectal Cancer With Liver Metastases
- NCT number
- NCT02195011
- Phases
- PHASE2
- Conditions
- Colorectal Neoplasms
- Interventions
- SIR-Spheres, Regorafenib
- Lead sponsor
- SCRI Development Innovations, LLC
- Results first posted
- 2018-07-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02195011?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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