Comparison · NCT01024920-sae
Nintedanib (BIBF 1120) vs Sunitinib: 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. Nintedanib (BIBF 1120) vs Sunitinib: serious adverse events. Trial comparisons, record NCT01024920-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01024920-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 | 0.313 | 0.212 | 0.434 | wilson | |
| Risk in group 2 | 0.344 | 0.204 | 0.517 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0313 | -0.231 | 0.154 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.909 | 0.498 | 1.66 | log | |
| Odds ratio, group 1 over group 2 | 0.868 | 0.353 | 2.14 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Nintedanib (BIBF 1120) than on Sunitinib | 32 | 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 | Nintedanib (BIBF 1120) | Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled. | 20 | 64 | EG000 |
| Group 2 | Sunitinib | Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled. | 11 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.
Source ClinicalTrials.gov
Trial
- Title
- Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
- NCT number
- NCT01024920
- Phases
- PHASE2
- Conditions
- Carcinoma, Renal Cell
- Interventions
- BIBF 1120, sunitinib
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2020-06-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01024920?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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