Comparison · NCT02807181-sae
Chemotherapy (Cisplatin-Gemcitabine) vs Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine): 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. Chemotherapy (Cisplatin-Gemcitabine) vs Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine): serious adverse events. Trial comparisons, record NCT02807181-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02807181-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 | 0.354 | 0.234 | 0.496 | wilson | |
| Risk in group 2 | 0.512 | 0.365 | 0.657 | wilson | |
| Risk difference, group 1 minus group 2 | -0.158 | -0.346 | 0.0462 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.691 | 0.426 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.522 | 0.223 | 1.22 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Chemotherapy (Cisplatin-Gemcitabine) than on Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | 6.33 | 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 | Chemotherapy (Cisplatin-Gemcitabine) | Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.~Cisplatin-gemcitabine: Systemic chemotherapy | 17 | 48 | EG000 |
| Group 2 | Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine) | A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.~Cisplatin-gemcitabine: Systemic chemotherapy~Radiation: SIRT + chemotherapy (cisplatin-gemcitabine): SIR-Spheres microspheres followed by systemic chemotherapy | 21 | 41 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 3.6 years
Source ClinicalTrials.gov
Trial
- Title
- SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
- NCT number
- NCT02807181
- Phases
- PHASE2, PHASE3
- Conditions
- Intrahepatic Cholangiocarcinoma
- Interventions
- Cisplatin-gemcitabine, Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
- Lead sponsor
- Sirtex Medical
- Results first posted
- 2025-05-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02807181?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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