Comparison · NCT00086957-sae
Dose Level 1 - Docetaxel 75 mg/m^2 vs Dose Level 2 - Docetaxel 60 mg/m^2: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Dose Level 1 - Docetaxel 75 mg/m^2 vs Dose Level 2 - Docetaxel 60 mg/m^2: serious adverse events. Trial comparisons, record NCT00086957-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00086957-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 | 1 | 0.342 | 1 | wilson | |
| Risk in group 2 | 0.241 | 0.122 | 0.421 | wilson | |
| Risk difference, group 1 minus group 2 | 0.759 | 0.0769 | 0.878 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.14 | 2.17 | 7.9 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Dose Level 1 - Docetaxel 75 mg/m^2 than on Dose Level 2 - Docetaxel 60 mg/m^2 | 1.32 | 1.14 | 13 | 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 | Dose Level 1 - Docetaxel 75 mg/m^2 | Subjects receive gefitinib 250 mg orally daily, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 75 mg/m\^2 intravenously every 3 weeks. | 2 | 2 | EG000 |
| Group 2 | Dose Level 2 - Docetaxel 60 mg/m^2 | Subjects receive gefitinib 250 mg orally daily or 250 mg daily on days 2 through 14 depending on study findings, trastuzumab 6 mg/kg intravenously every 3 weeks (after an initial dose of 8 mg/kg with cycle 1), and docetaxel 60 mg/m\^2 intravenously every 3 weeks. | 7 | 29 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events occurred over a period of 5 years and 3 months.
Source ClinicalTrials.gov
Trial
- Title
- Gefitinib, Trastuzumab, and Docetaxel in Treating Patients With Metastatic Breast Cancer
- NCT number
- NCT00086957
- Phases
- PHASE1, PHASE2
- Conditions
- Breast Cancer
- Interventions
- trastuzumab, docetaxel, gefitinib
- Lead sponsor
- City of Hope Medical Center
- Results first posted
- 2017-02-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00086957?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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