Comparison · NCT00738699-sae
MORAb-003 (Farletuzumab) Plus Paclitaxel vs Placebo (Normal Saline) Plus Paclitaxel: 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. MORAb-003 (Farletuzumab) Plus Paclitaxel vs Placebo (Normal Saline) Plus Paclitaxel: serious adverse events. Trial comparisons, record NCT00738699-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00738699-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 | 0.455 | 0.398 | 0.514 | wilson | |
| Risk in group 2 | 0.414 | 0.333 | 0.499 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0417 | -0.0609 | 0.141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.866 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 1.18 | 0.78 | 1.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MORAb-003 (Farletuzumab) Plus Paclitaxel than on Placebo (Normal Saline) Plus Paclitaxel | 24 | 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 | MORAb-003 (Farletuzumab) Plus Paclitaxel | Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion. | 127 | 279 | EG000 |
| Group 2 | Placebo (Normal Saline) Plus Paclitaxel | An equivalent volume of placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. Paclitaxel (80 mg/m\^2) was administered weekly by IV infusion over 1 hour following administration of FAR. During the 4-week cycle, Week 4 was to be a rest period with no study treatment (test article or paclitaxel) administered. All participants were required to be premedicated with steroids before paclitaxel administration, and with acetaminophen (650 mg orally) or clinically equivalent per clinic routine within 4 hours prior to test article infusion. | 55 | 133 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the time the participant signed the study informed consent form until 30 days after the last dose of study drug (FAR or placebo), for up to approximately 3 years.
Source ClinicalTrials.gov
Trial
- Title
- An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
- NCT number
- NCT00738699
- Phases
- PHASE2
- Conditions
- Ovarian Cancer
- Interventions
- MORAb-003 (farletuzumab), 0.9% Saline, Paclitaxel
- Lead sponsor
- Morphotek
- Results first posted
- 2017-03-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00738699?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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