Comparison · NCT01528345-sae
Fulvestrant + Dovitinib Active vs Fulvestrant + Dovitinib Placebo: 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. Fulvestrant + Dovitinib Active vs Fulvestrant + Dovitinib Placebo: serious adverse events. Trial comparisons, record NCT01528345-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01528345-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 | 0.298 | 0.187 | 0.44 | wilson | |
| Risk in group 2 | 0.2 | 0.112 | 0.33 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0979 | -0.0736 | 0.265 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.49 | 0.734 | 3.02 | log | |
| Odds ratio, group 1 over group 2 | 1.7 | 0.667 | 4.32 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Fulvestrant + Dovitinib Active than on Fulvestrant + Dovitinib Placebo | 10.2 | 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 | Fulvestrant + Dovitinib Active | Fulvestrant in combination with the study drug Dovitinib. | 14 | 47 | EG000 |
| Group 2 | Fulvestrant + Dovitinib Placebo | Fulvestrant in combination with a placebo matching Dovitinib. | 10 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
- NCT number
- NCT01528345
- Phases
- PHASE2
- Conditions
- Metastatic Breast Cancer
- Interventions
- Dovitinib, Fulvestrant, Dovitinib Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2016-07-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01528345?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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