Comparison · NCT02421588-sae
Lurbinectedin vs Control (PLD or 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. Lurbinectedin vs Control (PLD or Topotecan): serious adverse events. Trial comparisons, record NCT02421588-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02421588-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 | 0.42 | 0.357 | 0.486 | wilson | |
| Risk in group 2 | 0.399 | 0.336 | 0.466 | wilson | |
| Risk difference, group 1 minus group 2 | 0.021 | -0.0712 | 0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.839 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.743 | 1.6 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lurbinectedin than on Control (PLD or Topotecan) | 47.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Lurbinectedin | 3.2 mg/m2 i.v. as a 1-hour infusion on Day 1 q3wk (three weeks = one treatment cycle) through peripheral or central lines. A minimum total volume of 100 mL, diluted in 5% glucose or 0.9% sodium chloride solution for infusion, had to be used for administration through a central venous catheter; if a peripheral venous catheter was used, the minimum volume was 250 mL | 92 | 219 | EG000 |
| Group 2 | Control (PLD or Topotecan) | Patients randomized to the Control arm were assigned to receive PLD if they had previously been treated with topotecan, or to receive topotecan if they had previously been treated with PLD. However, if the number of patients randomized to either PLD or topotecan reached 60% (i.e., 126 patients) of the total number of patients expected in the Control Arm, then the treatment of choice in the Control Arm would be restricted to the less frequent control drug until the end of accrual | 85 | 213 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Participants were assessed through study completion, approximately 3 years
Source ClinicalTrials.gov
Trial
- Title
- Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer Patients
- NCT number
- NCT02421588
- Phases
- PHASE3
- Conditions
- Ovarian Cancer
- Interventions
- Lurbinectedin (PM01183), Pegylated liposomal doxorubicin (PLD), Topotecan
- Lead sponsor
- PharmaMar
- Results first posted
- 2020-03-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02421588?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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