Comparison · NCT01853046-sae
Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment vs Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment: 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(Stivarga, BAY73-4506)-Normal/Mild Impairment vs Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment: serious adverse events. Trial comparisons, record NCT01853046-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01853046-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 | 0.5 | 0.29 | 0.71 | wilson | |
| Risk in group 2 | 0.333 | 0.0968 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.256 | 0.483 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.442 | 5.09 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.29 | 13.8 | log | |
Number needed to harm, for one more participant with a serious adverse event on Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment than on Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | 6 | 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(Stivarga, BAY73-4506)-Normal/Mild Impairment | Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days. | 9 | 18 | EG000 |
| Group 2 | Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment | Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days. | 2 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of study treatment until 30 days after last dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- Pharmacokinetics and Safety of Regorafenib (BAY73-4506) in Cancer Subjects With Severe Renal Impairment
- NCT number
- NCT01853046
- Phases
- PHASE1
- Conditions
- Neoplasms
- Interventions
- Regorafenib (Stivarga, BAY73-4506)
- Lead sponsor
- Bayer
- Results first posted
- 2017-02-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01853046?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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