Comparison · NCT04076579-sae
Cohort 1 vs Cohort 2: 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. Cohort 1 vs Cohort 2: serious adverse events. Trial comparisons, record NCT04076579-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04076579-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 | 0.125 | 0.035 | 0.36 | wilson | |
| Risk in group 2 | 0.308 | 0.127 | 0.576 | wilson | |
| Risk difference, group 1 minus group 2 | -0.183 | -0.466 | 0.114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.406 | 0.0878 | 1.88 | log | |
| Odds ratio, group 1 over group 2 | 0.321 | 0.0484 | 2.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort 1 than on Cohort 2 | 5.47 | 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 | Cohort 1 | Both cohorts received the same treatment:~* Cohort 1: Leiomyosarcoma and liposarcoma~* Cohort 2: Other bone or soft tissue sarcoma histologies Treatment consists of 21-day cycles for a maximum of 18 months. Olaparib: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days | 2 | 16 | EG000 |
| Group 2 | Cohort 2 | Both cohorts received the same treatment:~* Cohort 1: Leiomyosarcoma and liposarcoma~* Cohort 2: Other bone or soft tissue sarcoma histologies Treatment consists of 21-day cycles for a maximum of 18 months. Olaparib: Olaparib taken by mouth twice daily Trabectedin: Trabectedin administered intravenously (IV) every 21 days | 4 | 13 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3 year period.
Source ClinicalTrials.gov
Trial
- Title
- Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma
- NCT number
- NCT04076579
- Phases
- PHASE2
- Conditions
- Sarcoma, Sarcoma Metastatic
- Interventions
- Olaparib, Trabectedin
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Results first posted
- 2024-07-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04076579?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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