Comparison · NCT01679405-sae
Dose Level 1 vs Dose Level -1: 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. Dose Level 1 vs Dose Level -1: serious adverse events. Trial comparisons, record NCT01679405-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01679405-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 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk in group 2 | 0.833 | 0.436 | 0.97 | wilson | |
| Risk difference, group 1 minus group 2 | -0.167 | -0.646 | 0.314 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.8 | 0.333 | 1.92 | log | |
| Odds ratio, group 1 over group 2 | 0.4 | 0.016 | 10 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dose Level 1 than on Dose Level -1 | 6 | 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 | Dose Level 1 | 30 mg BIBW 2992, Gemcitabine (1.000 mg/m² BSA i.v.)/Cisplatin (25 mg/m² BSA i.v.) | 2 | 3 | EG000 |
| Group 2 | Dose Level -1 | 30 mg BIBW 2992, Gemcitabine (800 mg/m² BSA i.v.)/Cisplatin (20 mg/m² BSA i.v.) | 5 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- BIBW 2992 as add-on to Gem/Cis in Advanced Biliary Tract Cancer
- NCT number
- NCT01679405
- Phases
- PHASE1
- Conditions
- Metastatic Disease
- Interventions
- BIBW 2992
- Lead sponsor
- Johannes Gutenberg University Mainz
- Results first posted
- 2019-01-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01679405?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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