Comparison · NCT01702571-sae
Trastuzumab Emtansine (All Participants) vs Trastuzumab Emtansine (Asian Participants): 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. Trastuzumab Emtansine (All Participants) vs Trastuzumab Emtansine (Asian Participants): serious adverse events. Trial comparisons, record NCT01702571-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01702571-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 | 0.213 | 0.196 | 0.232 | wilson | |
| Risk in group 2 | 0.199 | 0.147 | 0.263 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0144 | -0.0521 | 0.0692 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.791 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.747 | 1.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Trastuzumab Emtansine (All Participants) than on Trastuzumab Emtansine (Asian Participants) | 69.5 | 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 | Trastuzumab Emtansine (All Participants) | This cohort (Cohort 1) enrolled all participants with HER2 positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression. | 427 | 2,002 | EG000 |
| Group 2 | Trastuzumab Emtansine (Asian Participants) | This cohort (Cohort 2) enrolled Asian race participants with HER2-positive, unresectable, LABC or mBC who had received prior anti-HER2 and chemotherapy treatment and had progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. Participants received trastuzumab emtansine every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression. | 36 | 181 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to approximately 7 years
Source ClinicalTrials.gov
Trial
- Title
- A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
- NCT number
- NCT01702571
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Trastuzumab Emtansine
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2021-08-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01702571?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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