Comparison · NCT01887717-sae
TheraSphere vs Sorafenib: 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. TheraSphere vs Sorafenib: serious adverse events. Trial comparisons, record NCT01887717-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01887717-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 | 0 | 0.204 | wilson | |
| Risk in group 2 | 0.75 | 0.505 | 0.898 | wilson | |
| Risk difference, group 1 minus group 2 | -0.75 | -0.898 | -0.431 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with a serious adverse event on TheraSphere than on Sorafenib | 1.33 | 1.11 | 2.32 | 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 | TheraSphere | Participants received TheraSphere at a dose consistent with the approved package insert to the treated lobe of the liver. TheraSphere was administered through the hepatic artery. The targeted dose was 120 Gy + 10%. Dose reduction to a minimum dose of 80 Gy + 10% was permitted to manage radiation exposure to the lungs. Re-treatment of the same participant/lobe with further cycles of TheraSphere was permitted if a treatable progression was detected during follow-up evaluations. Any re-treatment took place at least 28 days after the previous TheraSphere treatment administered to that lobe. Participants could receive a subsequent TheraSphere administration in the absence of radiological progression criteria at the Investigator's discretion. A maximum of 3 TheraSphere administrations was permitted. | 0 | 15 | EG000 |
| Group 2 | Sorafenib | Participants received sorafenib, oral tablets, 400 milligrams (mg) twice daily in accordance with the package insert. Treatment was to continue until the participant was no longer clinically benefiting from therapy or until unacceptable toxicity occurred. Medically appropriate dose adjustments and drug holidays due to adverse events (AEs) and toxicity were allowed. | 12 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomization up to participant's death (maximum time = up to Month 30)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy Evaluation of TheraSphere to Treat Inoperable Liver Cancer With Blockage of the Portal Vein
- NCT number
- NCT01887717
- Phases
- PHASE3
- Conditions
- Hepatocellular Carcinoma
- Interventions
- TheraSphere®, Sorafenib
- Lead sponsor
- Boston Scientific Corporation
- Results first posted
- 2019-10-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01887717?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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