Comparison · NCT02116803-sae
Dovitinib vs Dovitinib+Fulvestrant: 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. Dovitinib vs Dovitinib+Fulvestrant: serious adverse events. Trial comparisons, record NCT02116803-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02116803-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 | 0.4 | 0.168 | 0.687 | wilson | |
| Risk in group 2 | 1 | 0.342 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | -0.6 | -0.832 | 0.118 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.4 | 0.187 | 0.855 | log | |
| 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 Dovitinib than on Dovitinib+Fulvestrant | 1.67 | 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 | Dovitinib | Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). | 4 | 10 | EG000 |
| Group 2 | Dovitinib+Fulvestrant | Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB). | 2 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All Adverse Events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 2.5 years.
Source ClinicalTrials.gov
Trial
- Title
An Open Label Multi-center Extension Study to Evaluate Long-term Safety/ Tolerability of Dovitinib in Patients With Solid Tumors Who Continue to Receive Treatment With Dovitinib (TKI258) in Novartis-sponsored Single Agent Dovitinib Studies Which Fulfilled the Requirements for the Primary Objective
- NCT number
- NCT02116803
- Phases
- PHASE2, PHASE3
- Conditions
- Solid Tumors
- Interventions
- dovitinib, fulvestrant
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2018-02-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02116803?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/NCT02116803-sae