Comparison · NCT01772472-sae
Trastuzumab vs 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. Trastuzumab vs Trastuzumab Emtansine: serious adverse events. Trial comparisons, record NCT01772472-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01772472-sae
On this page
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 | 0.0806 | 0.0628 | 0.103 | wilson | |
| Risk in group 2 | 0.127 | 0.105 | 0.153 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0465 | -0.0779 | -0.0152 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.634 | 0.465 | 0.865 | log | |
| Odds ratio, group 1 over group 2 | 0.602 | 0.427 | 0.85 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Trastuzumab than on Trastuzumab Emtansine | 21.5 | 12.8 | 65.9 | 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 | Trastuzumab | Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. | 58 | 720 | EG000 |
| Group 2 | Trastuzumab Emtansine | Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first. | 94 | 740 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From signing of informed consent till the end of follow-up (up to approximately 131 months)
Source ClinicalTrials.gov
Trial
- Title
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
- NCT number
- NCT01772472
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- trastuzumab, trastuzumab emtansine
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2019-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01772472?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01772472-sae