Comparison · NCT00828139-sae
Ziv-aflibercept + Topotecan vs Topotecan: 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. Ziv-aflibercept + Topotecan vs Topotecan: serious adverse events. Trial comparisons, record NCT00828139-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00828139-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 | 0.478 | 0.379 | 0.579 | wilson | |
| Risk in group 2 | 0.195 | 0.126 | 0.291 | wilson | |
| Risk difference, group 1 minus group 2 | 0.283 | 0.145 | 0.405 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.45 | 1.52 | 3.94 | log | |
| Odds ratio, group 1 over group 2 | 3.77 | 1.93 | 7.37 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ziv-aflibercept + Topotecan than on Topotecan | 3.54 | 2.47 | 6.88 | 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 | Ziv-aflibercept + Topotecan | There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis. | 44 | 92 | EG000 |
| Group 2 | Topotecan | There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis. | 17 | 87 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Source ClinicalTrials.gov
Trial
- Title
- S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
- NCT number
- NCT00828139
- Phases
- PHASE2
- Conditions
- Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer
- Interventions
- ziv-aflibercept, topotecan hydrochloride
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2016-04-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00828139?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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