Comparison · NCT00519285-sae
Aflibercept vs Placebo: 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. Aflibercept vs Placebo: serious adverse events. Trial comparisons, record NCT00519285-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00519285-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 | 0.542 | 0.502 | 0.581 | wilson | |
| Risk in group 2 | 0.308 | 0.272 | 0.346 | wilson | |
| Risk difference, group 1 minus group 2 | 0.234 | 0.179 | 0.287 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.76 | 1.53 | 2.03 | log | |
| Odds ratio, group 1 over group 2 | 2.66 | 2.1 | 3.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Aflibercept than on Placebo | 4.27 | 3.48 | 5.59 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Aflibercept | Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily | 331 | 611 | EG001 |
| Group 2 | Placebo | Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily | 184 | 598 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events (AE) were collected from signature of the informed consent form up to the last visit in the study.
Source ClinicalTrials.gov
Trial
- Title
- Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
- NCT number
- NCT00519285
- Phases
- PHASE3
- Conditions
- Prostatic Neoplasms, Neoplasm Metastasis
- Interventions
- Aflibercept, Placebo (for aflibercept), Docetaxel, Prednisone or Prednisolone
- Lead sponsor
- Sanofi
- Results first posted
- 2013-10-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00519285?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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