Comparison · NCT01007942-sae
Everolimus + Trastuzumab + Vinorelbine vs Placebo + Trastuzumab + Vinorelbine: 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. Everolimus + Trastuzumab + Vinorelbine vs Placebo + Trastuzumab + Vinorelbine: serious adverse events. Trial comparisons, record NCT01007942-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01007942-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 | 0.436 | 0.379 | 0.494 | wilson | |
| Risk in group 2 | 0.206 | 0.163 | 0.257 | wilson | |
| Risk difference, group 1 minus group 2 | 0.23 | 0.154 | 0.303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.12 | 1.62 | 2.76 | log | |
| Odds ratio, group 1 over group 2 | 2.98 | 2.05 | 4.33 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Everolimus + Trastuzumab + Vinorelbine than on Placebo + Trastuzumab + Vinorelbine | 4.35 | 3.3 | 6.51 | from the risk difference interval |
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 | Everolimus + Trastuzumab + Vinorelbine | Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) | 122 | 280 | EG000 |
| Group 2 | Placebo + Trastuzumab + Vinorelbine | Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only) | 58 | 282 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
- NCT number
- NCT01007942
- Phases
- PHASE3
- Conditions
- HER2/Neu Over-expressing Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Interventions
- everolimus, Placebo, vinorelbine, trastuzumab
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2017-04-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01007942?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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