Comparison · NCT01593748-sae
Experimental vs Standard of Care: 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. Experimental vs Standard of Care: serious adverse events. Trial comparisons, record NCT01593748-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01593748-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 | 0.622 | 0.476 | 0.749 | wilson | |
| Risk in group 2 | 0.689 | 0.543 | 0.805 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0667 | -0.253 | 0.126 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.903 | 0.669 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 0.744 | 0.311 | 1.78 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Experimental than on Standard of Care | 15 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Experimental | Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.~Gemcitabine and Pazopanib: Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Pazopanib 800 mg by oral tablet daily for a 21 day cycle. | 28 | 45 | EG000 |
| Group 2 | Standard of Care | Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).~Gemcitabine and Docetaxel: Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.~Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle. | 31 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- study enrollment to 30 days from last treatment; inclusive of crossover treatment
Source ClinicalTrials.gov
Trial
- Title
- A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma
- NCT number
- NCT01593748
- Phases
- PHASE2
- Conditions
- Sarcoma
- Interventions
- Gemcitabine and Pazopanib, Gemcitabine and Docetaxel
- Lead sponsor
- Medical University of South Carolina
- Results first posted
- 2020-04-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01593748?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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