Comparison · NCT02347332-sae
Vinflunine Plus Methotrexate vs Methotrexate: 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. Vinflunine Plus Methotrexate vs Methotrexate: serious adverse events. Trial comparisons, record NCT02347332-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02347332-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 | 0.471 | 0.407 | 0.536 | wilson | |
| Risk in group 2 | 0.357 | 0.297 | 0.421 | wilson | |
| Risk difference, group 1 minus group 2 | 0.114 | 0.0235 | 0.202 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.32 | 1.06 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 1.61 | 1.1 | 2.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Vinflunine Plus Methotrexate than on Methotrexate | 8.75 | 4.94 | 42.6 | from the risk difference interval |
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 | Vinflunine Plus Methotrexate | Vinflunine IV 280mg/m2 Day1 plus Methotrexate IV 30mg/m2 on Day 1 and Dy 8 every 3 cycles~Vinflunine | 106 | 225 | EG000 |
| Group 2 | Methotrexate | Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks~Methotrexate | 81 | 227 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
4 years 6 months 29 days. 5 subjects in the Vinflunine + Methotrexate arm and 2 patients in the Methotrexate arm did not receive any treatment. These patients were thus excluded from the safety population.The safety population consisted of all patients randomized and treated.
Source ClinicalTrials.gov
Trial
- Title
- Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
- NCT number
- NCT02347332
- Phases
- PHASE3
- Conditions
- Recurrent or Metastatic Head and Neck Carcinoma
- Interventions
- Vinflunine, Methotrexate
- Lead sponsor
- Pierre Fabre Medicament
- Results first posted
- 2019-02-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02347332?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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