Comparison · NCT00316173-sae
Dose-finding Phase vs Activity Assessment Phase: 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. Dose-finding Phase vs Activity Assessment Phase: serious adverse events. Trial comparisons, record NCT00316173-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00316173-sae
On this page
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 | 0.273 | 0.132 | 0.482 | wilson | |
| Risk in group 2 | 0.218 | 0.129 | 0.344 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0545 | -0.134 | 0.281 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.536 | 2.91 | log | |
| Odds ratio, group 1 over group 2 | 1.34 | 0.432 | 4.18 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Dose-finding Phase than on Activity Assessment Phase | 18.3 | 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 | Dose-finding Phase | Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days) | 6 | 22 | EG000 |
| Group 2 | Activity Assessment Phase | Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days. | 12 | 55 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Second-Line Therapy Study For Potentially Platinum-Sensitive Relapsed Ovarian Cancer
- NCT number
- NCT00316173
- Phases
- PHASE2
- Conditions
- Ovarian Cancer, Neoplasms, Ovarian
- Interventions
- topotecan, CARBOPLATIN
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2009-11-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00316173?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00316173-sae