Comparison · NCT00114166-sae
Regimen I vs Regimen II: 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. Regimen I vs Regimen II: serious adverse events. Trial comparisons, record NCT00114166-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00114166-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 | 0.533 | 0.301 | 0.752 | wilson | |
| Risk in group 2 | 0.154 | 0.0858 | 0.261 | wilson | |
| Risk difference, group 1 minus group 2 | 0.379 | 0.124 | 0.608 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.47 | 1.65 | 7.27 | log | |
| Odds ratio, group 1 over group 2 | 6.29 | 1.86 | 21.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Regimen I than on Regimen II | 2.64 | 1.64 | 8.07 | 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 | Regimen I | Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy | 8 | 15 | EG000 |
| Group 2 | Regimen II | Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy | 10 | 65 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All patients followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity for a period of 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Topotecan in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
- NCT number
- NCT00114166
- Phases
- PHASE2
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Interventions
- topotecan hydrochloride
- Lead sponsor
- Gynecologic Oncology Group
- Results first posted
- 2014-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00114166?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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