Comparison · NCT00179309-sae
Arm I - PANVAC + Docetaxel vs Arm II - Docetaxel Alone: 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. Arm I - PANVAC + Docetaxel vs Arm II - Docetaxel Alone: serious adverse events. Trial comparisons, record NCT00179309-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00179309-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 | 0.12 | 0.0417 | 0.3 | wilson | |
| Risk in group 2 | 0.087 | 0.0242 | 0.268 | wilson | |
| Risk difference, group 1 minus group 2 | 0.033 | -0.164 | 0.223 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.38 | 0.253 | 7.53 | log | |
| Odds ratio, group 1 over group 2 | 1.43 | 0.217 | 9.44 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm I - PANVAC + Docetaxel than on Arm II - Docetaxel Alone | 30.3 | 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 | Arm I - PANVAC + Docetaxel | Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV | 3 | 25 | EG000 |
| Group 2 | Arm II - Docetaxel Alone | Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV) | 2 | 23 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer
- NCT number
- NCT00179309
- Phases
- PHASE2
- Conditions
- Breast Cancer
- Interventions
- Docetaxel, PANVAC-V, PANVAC-F, Sargramostim
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2013-06-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00179309?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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