Comparison · NCT02289950-sae
Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD vs Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD: 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. Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD vs Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD: serious adverse events. Trial comparisons, record NCT02289950-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02289950-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 | 0.298 | 0.229 | 0.378 | wilson | |
| Risk in group 2 | 0.257 | 0.169 | 0.37 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0407 | -0.0919 | 0.16 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.723 | 1.86 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.642 | 2.34 | log | |
Number needed to harm, for one more participant with a serious adverse event on Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD than on Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | 24.6 | 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 | Farletuzumab 5 mg/kg + Carboplatin/Paclitaxel or Carboplatin/PLD | Participants received either carboplatin (area under the concentration-time curve \[AUC\] 5) plus paclitaxel 175 milligrams per square meter (mg/m\^2) intravenously (IV) every 3 weeks or carboplatin (AUC 5) plus pegylated liposomal doxorubicin (PLD) 30 mg/m\^2 IV every 4 weeks in combination with farletuzumab loading dose of 10 milligram per kilogram (mg/kg) for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with farletuzumab 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or participant discontinued treatment for any other reason. | 42 | 141 | EG000 |
| Group 2 | Placebo + Carboplatin/Paclitaxel or Carboplatin/PLD | Participants received either carboplatin (AUC 5) plus paclitaxel 175 mg/ m\^2 IV every 3 weeks or carboplatin (AUC 5) plus PLD 30 mg/ m\^2 IV every 4 weeks in combination with placebo loading dose of 10 mg/kg for the first 2 weeks, followed by 5 mg/kg every week thereafter administered up to maximum of 8 cycles at the investigator's discretion. Participants who completed combination treatment phase and participants who experienced intolerable toxicity to chemotherapy in combination treatment phase continued to receive maintenance treatment with placebo 5 mg/kg every week alone up to maximum of 64 cycles or until disease progression was confirmed by radiographic assessment, or subject discontinued treatment for any other reason. | 18 | 70 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From date of first dose up to 30 days after the last dose of study treatment (up to approximately 5 years 5 months)
Source ClinicalTrials.gov
Trial
- Title
A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer
- NCT number
- NCT02289950
- Phases
- PHASE2
- Conditions
- Platinum-Sensitive Ovarian Cancer in First Relapse
- Interventions
- Farletuzumab, Placebo
- Lead sponsor
- Eisai Inc.
- Results first posted
- 2021-09-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02289950?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/NCT02289950-sae