Comparison · NCT00574275-sae
Placebo and Gemcitabine vs Aflibercept and 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. Placebo and Gemcitabine vs Aflibercept and Gemcitabine: serious adverse events. Trial comparisons, record NCT00574275-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00574275-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 | 0.45 | 0.392 | 0.51 | wilson | |
| Risk in group 2 | 0.548 | 0.489 | 0.606 | wilson | |
| Risk difference, group 1 minus group 2 | -0.098 | -0.18 | -0.0137 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.821 | 0.693 | 0.974 | log | |
| Odds ratio, group 1 over group 2 | 0.675 | 0.481 | 0.947 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Placebo and Gemcitabine than on Aflibercept and Gemcitabine | 10.2 | 5.55 | 72.9 | 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 | Placebo and Gemcitabine | * Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~* Gemcitabine: 1000 mg/m\^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles. | 122 | 271 | EG000 |
| Group 2 | Aflibercept and Gemcitabine | * Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~* Gemcitabine: 1000 mg/m\^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles. | 148 | 270 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From treatment initiation up to November 26, 2010
Source ClinicalTrials.gov
Trial
- Title
- Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
- NCT number
- NCT00574275
- Phases
- PHASE3
- Conditions
- Pancreatic Neoplasm
- Interventions
- Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), Placebo, Gemcitabine
- Lead sponsor
- Sanofi
- Results first posted
- 2012-09-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00574275?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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