Comparison · NCT00565448-sae
Cisplatin/5-FU vs Docetaxel /Cisplatin/5-FU: 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. Cisplatin/5-FU vs Docetaxel /Cisplatin/5-FU: serious adverse events. Trial comparisons, record NCT00565448-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00565448-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 | 0.44 | 0.267 | 0.629 | wilson | |
| Risk in group 2 | 0.4 | 0.276 | 0.538 | wilson | |
| Risk difference, group 1 minus group 2 | 0.04 | -0.182 | 0.266 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.63 | 1.92 | log | |
| Odds ratio, group 1 over group 2 | 1.18 | 0.446 | 3.11 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cisplatin/5-FU than on Docetaxel /Cisplatin/5-FU | 25 | 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 | Cisplatin/5-FU | Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. | 11 | 25 | EG000 |
| Group 2 | Docetaxel /Cisplatin/5-FU | Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. | 20 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Docetaxel in Combination With Cisplatin-5-fluorouracil for the Induction Treatment of Nasopharyngeal Carcinoma in Children and Adolescents
- NCT number
- NCT00565448
- Phases
- PHASE2
- Conditions
- Nasopharyngeal Neoplasms, Carcinoma
- Interventions
- docetaxel, cisplatin, 5-fluorouracil
- Lead sponsor
- Sanofi
- Results first posted
- 2010-03-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00565448?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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