Comparison · NCT01325428-sae
Part A: Afatinib Once Daily (OD). vs Part B: Afatinib+V (Vinorelbine).: 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. Part A: Afatinib Once Daily (OD). vs Part B: Afatinib+V (Vinorelbine).: serious adverse events. Trial comparisons, record NCT01325428-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01325428-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 | 0.462 | 0.288 | 0.645 | wilson | |
| Risk in group 2 | 0.4 | 0.168 | 0.687 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0615 | -0.274 | 0.357 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.15 | 0.486 | 2.74 | log | |
| Odds ratio, group 1 over group 2 | 1.29 | 0.292 | 5.66 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Part A: Afatinib Once Daily (OD). than on Part B: Afatinib+V (Vinorelbine). | 16.3 | 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 | Part A: Afatinib Once Daily (OD). | Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. | 12 | 26 | EG000 |
| Group 2 | Part B: Afatinib+V (Vinorelbine). | Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. | 4 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Part A: From first study drug administration in Part A to last study drug administration in Part A + up to 28 days (max. 728). Part B: From first study drug administration in Part B to last study drug administration in Part B + up to 28 days (max. 265).
Source ClinicalTrials.gov
Trial
- Title
- Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer
- NCT number
- NCT01325428
- Phases
- PHASE2
- Conditions
- Breast Neoplasms
- Interventions
- Afatinib once daily (OD), Vinorelbine Weekly
- Lead sponsor
- Boehringer Ingelheim
- Results first posted
- 2016-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01325428?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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