Comparison · NCT02574455-sae
Sacituzumab Govitecan vs Treatment of Physician's Choice (TPC): 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. Sacituzumab Govitecan vs Treatment of Physician's Choice (TPC): serious adverse events. Trial comparisons, record NCT02574455-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02574455-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 | 0.267 | 0.217 | 0.325 | wilson | |
| Risk in group 2 | 0.286 | 0.231 | 0.348 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0183 | -0.0984 | 0.0611 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.936 | 0.701 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 0.913 | 0.612 | 1.36 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Sacituzumab Govitecan than on Treatment of Physician's Choice (TPC) | 54.7 | 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 | Sacituzumab Govitecan | Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. | 69 | 258 | EG000 |
| Group 2 | Treatment of Physician's Choice (TPC) | Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.~Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively).~Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.~Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.~Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy. | 64 | 224 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events: First dose date up to last follow-up (maximum up to 30.8 months); All-Cause Mortality: From randomization up to 30.8 months
Source ClinicalTrials.gov
Trial
- Title
- Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
- NCT number
- NCT02574455
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Sacituzumab govitecan, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2021-04-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02574455?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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