Comparison · NCT00471146-sae
Axitinib + Gemcitabine vs Placebo + 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. Axitinib + Gemcitabine vs Placebo + Gemcitabine: serious adverse events. Trial comparisons, record NCT00471146-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00471146-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 | 0.355 | 0.304 | 0.411 | wilson | |
| Risk in group 2 | 0.33 | 0.28 | 0.384 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0252 | -0.0498 | 0.0998 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.864 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.801 | 1.56 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Axitinib + Gemcitabine than on Placebo + Gemcitabine | 39.7 | 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 | Axitinib + Gemcitabine | Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. | 108 | 304 | EG000 |
| Group 2 | Placebo + Gemcitabine | Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. | 102 | 309 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
- NCT number
- NCT00471146
- Phases
- PHASE3
- Conditions
- Carcinoma, Pancreatic Ductal
- Interventions
- AG-013736, Gemcitabine, Gemcitabine, placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2012-07-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00471146?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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