Comparison · NCT03348631-sae
Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients vs Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients: 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. Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients vs Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients: serious adverse events. Trial comparisons, record NCT03348631-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03348631-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 | 0.188 | 0.0659 | 0.43 | wilson | |
| Risk in group 2 | 0.286 | 0.172 | 0.436 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0982 | -0.291 | 0.17 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.656 | 0.213 | 2.02 | log | |
| Odds ratio, group 1 over group 2 | 0.577 | 0.139 | 2.39 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients than on Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | 10.2 | 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 | Arm I: Treatment (Tazemetostat) in Endometrial Cancer Patients | Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study. | 3 | 16 | EG000 |
| Group 2 | Arm II: Treatment (Tazemetostat) Ovarian in Cancer Patients | Patients receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and MRI on study. | 12 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected for a maximum of 23.5 months (interquartile range: 1.4 months, 3.9 months). All-Cause Mortality monitored/assessed up to 51.6 months (interquartile range: 4.3 months, 19.0 months).
Source ClinicalTrials.gov
Trial
- Title
- Tazemetostat in Treating Patients With Recurrent Ovarian or Endometrial Cancer
- NCT number
- NCT03348631
- Phases
- PHASE2
- Conditions
Recurrent Endometrial Endometrioid Adenocarcinoma, Recurrent Malignant Uterine Corpus Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Ovarian Clear Cell Adenocarcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma
- Interventions
- Computed Tomography, Magnetic Resonance Imaging, Tazemetostat
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-03-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03348631?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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