Comparison · NCT01012297-sae
Arm I vs Arm II: 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 vs Arm II: serious adverse events. Trial comparisons, record NCT01012297-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01012297-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 | 0.315 | 0.207 | 0.447 | wilson | |
| Risk in group 2 | 0.396 | 0.276 | 0.531 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0814 | -0.254 | 0.0977 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.795 | 0.475 | 1.33 | log | |
| Odds ratio, group 1 over group 2 | 0.7 | 0.316 | 1.55 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I than on Arm II | 12.3 | 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 | Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC~Placebo: Given IV | 17 | 54 | EG000 |
| Group 2 | Arm II | Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.~Bevacizumab: Given IV~Docetaxel: Given IV~Filgrastim: Given SC~Gemcitabine Hydrochloride: Given IV~Pegfilgrastim: Given SC | 21 | 53 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
- NCT number
- NCT01012297
- Phases
- PHASE3
- Conditions
Recurrent Uterine Corpus Sarcoma, Stage IIIA Uterine Sarcoma, Stage IIIB Uterine Sarcoma, Stage IIIC Uterine Sarcoma, Stage IVA Uterine Sarcoma, Stage IVB Uterine Sarcoma, Uterine Corpus Leiomyosarcoma
- Interventions
- Bevacizumab, Docetaxel, Filgrastim, Gemcitabine Hydrochloride, Pegfilgrastim, Placebo
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2017-07-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01012297?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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