Comparison · NCT03975647-sae
Placebo+ Ado-trastuzumab Emtansine vs Tucatinib+ Ado-trastuzumab Emtansine: 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. Placebo+ Ado-trastuzumab Emtansine vs Tucatinib+ Ado-trastuzumab Emtansine: serious adverse events. Trial comparisons, record NCT03975647-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03975647-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 | 0.223 | 0.174 | 0.281 | wilson | |
| Risk in group 2 | 0.303 | 0.247 | 0.365 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0799 | -0.159 | 0.00031 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.736 | 0.541 | 1 | log | |
| Odds ratio, group 1 over group 2 | 0.661 | 0.435 | 1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Placebo+ Ado-trastuzumab Emtansine than on Tucatinib+ Ado-trastuzumab Emtansine | 12.5 | 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 | Placebo+ Ado-trastuzumab Emtansine | Participants with HER2+ LA/mBC were treated with placebo orally BID, and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. | 52 | 233 | EG000 |
| Group 2 | Tucatinib+ Ado-trastuzumab Emtansine | Participants with HER2+ LA/mBC were treated with tucatinib 300 mg orally BID and T-DM1 3.6 mg/kg IV every 21 days in each 21-day cycle. Participants received treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. | 70 | 231 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From start of treatment up to 30 days after the last study treatment (approximately 43 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
- NCT number
- NCT03975647
- Phases
- PHASE3
- Conditions
- HER2-positive Breast Cancer
- Interventions
- tucatinib, placebo, T-DM1
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Results first posted
- 2024-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03975647?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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