Comparison · NCT04696055-sae
Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] vs Regorafenib+Pembrolizumab [Any Other IO Containing Treatment]: 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. Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] vs Regorafenib+Pembrolizumab [Any Other IO Containing Treatment]: serious adverse events. Trial comparisons, record NCT04696055-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04696055-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 | 0.544 | 0.427 | 0.657 | wilson | |
| Risk in group 2 | 0.407 | 0.245 | 0.593 | wilson | |
| Risk difference, group 1 minus group 2 | 0.137 | -0.0828 | 0.334 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.34 | 0.807 | 2.21 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 0.703 | 4.29 | log | |
Number needed to harm, for one more participant with a serious adverse event on Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] than on Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | 7.31 | 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 | Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab] | Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only. Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks (Q6W). Regorafenib was given orally (p.o.) at a starting dose of 90 mg once daily (QD) for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib. | 37 | 68 | EG000 |
| Group 2 | Regorafenib+Pembrolizumab [Any Other IO Containing Treatment] | Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens. Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks (Q6W). Regorafenib was given orally (p.o.) at a starting dose of 90 mg once daily (QD) for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib. | 11 | 27 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- These data extend to the final release date of the clinical database (38 months).
Source ClinicalTrials.gov
Trial
- Title
- Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors
- NCT number
- NCT04696055
- Phases
- PHASE2
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Pembrolizumab, Regorafenib (Stivarga, BAY73-4506)
- Lead sponsor
- Bayer
- Results first posted
- 2023-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04696055?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.
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GET https://conductscience.org/api/comparisons/v1/NCT04696055-sae