Comparison · NCT00338988-sae
Stratum: 1 Prior Regimen vs Stratum 2: No Prior Therapy: 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. Stratum: 1 Prior Regimen vs Stratum 2: No Prior Therapy: serious adverse events. Trial comparisons, record NCT00338988-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00338988-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 | 0.222 | 0.09 | 0.452 | wilson | |
| Risk in group 2 | 0.0769 | 0.0214 | 0.241 | wilson | |
| Risk difference, group 1 minus group 2 | 0.145 | -0.0657 | 0.382 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.89 | 0.591 | 14.1 | log | |
| Odds ratio, group 1 over group 2 | 3.43 | 0.555 | 21.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Stratum: 1 Prior Regimen than on Stratum 2: No Prior Therapy | 6.88 | 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 | Stratum: 1 Prior Regimen | Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Day 1-14. | 4 | 18 | EG000 |
| Group 2 | Stratum 2: No Prior Therapy | Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m\^2 Day 1 and oral capecitabine 750 mg/m\^2 twice daily on Day 1-14. | 2 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- A total 3 years from August 2003 to December 2006.
Source ClinicalTrials.gov
Trial
- Title
- Oxaliplatin and Capecitabine in Patients With Unresectable Cholangiocarcinoma
- NCT number
- NCT00338988
- Phases
- PHASE2
- Conditions
- Cancer of the Gallbladder, Cancer of the Biliary Tract
- Interventions
- Capecitabine, Oxaliplatin
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2010-12-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00338988?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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