Comparison · NCT02392637-sae
High Dose vs Low Dose: 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. High Dose vs Low Dose: serious adverse events. Trial comparisons, record NCT02392637-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02392637-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 | 0.156 | 0.0686 | 0.318 | wilson | |
| Risk in group 2 | 0.0357 | 0.00633 | 0.177 | wilson | |
| Risk difference, group 1 minus group 2 | 0.121 | -0.0458 | 0.284 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.38 | 0.543 | 35.2 | log | |
| Odds ratio, group 1 over group 2 | 5 | 0.547 | 45.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on High Dose than on Low Dose | 8.3 | 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 | High Dose | Gemcitabine 1000mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 125mg/m2 on days 1 \& 8 of a 21 day cycle. | 5 | 32 | EG000 |
| Group 2 | Low Dose | Gemcitabine 800mg/m2, Cisplatin 25mg/m2 \& Nab-Paclitaxel 100mg/m2 on days 1 \& 8 of a 21 day cycle. | 1 | 28 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 3 years
Source ClinicalTrials.gov
Trial
- Title
- Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary Cancers
- NCT number
- NCT02392637
- Phases
- PHASE2
- Conditions
Stage III Intrahepatic Cholangiocarcinoma AJCC v7, Stage IIIA Gallbladder Cancer AJCC v7, Stage IIIB Gallbladder Cancer AJCC v7, Stage IVA Gallbladder Cancer AJCC v7, Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7, Stage IVB Gallbladder Cancer AJCC v7, Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma
- Interventions
- Cisplatin, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Nab-paclitaxel
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2022-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02392637?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
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