Comparison · NCT01840943-sae
CAELYX vs Topotecan Hydrocloride (HCl): 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. CAELYX vs Topotecan Hydrocloride (HCl): serious adverse events. Trial comparisons, record NCT01840943-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01840943-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 | 0.0714 | 0.0127 | 0.315 | wilson | |
| Risk in group 2 | 0.0833 | 0.0149 | 0.354 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0119 | -0.289 | 0.241 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.857 | 0.0598 | 12.3 | log | |
| Odds ratio, group 1 over group 2 | 0.846 | 0.0472 | 15.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on CAELYX than on Topotecan Hydrocloride (HCl) | 84 | 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 | CAELYX | Participants received 50 milligram per square meters (mg/m\^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks. | 1 | 14 | EG000 |
| Group 2 | Topotecan Hydrocloride (HCl) | Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle. | 1 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 30 days after the last dose of study medication
Source ClinicalTrials.gov
Trial
- Title
- A Study to Compare CAELYX With Topotecan HCL in Patients With Recurrent Epithelial Ovarian Carcinoma Following Failure of First-Line, Platinum-Based Chemotherapy
- NCT number
- NCT01840943
- Phases
- PHASE3
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- CAELYX, Topotecan HCl
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Results first posted
- 2015-12-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01840943?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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