Comparison · NCT01012297-2a6ccdb1
Arm I Gem+Doce+Placebo vs Arm II Gem+Doce+Bev: Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Arm I Gem+Doce+Placebo vs Arm II Gem+Doce+Bev: Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0. Trial comparisons, record NCT01012297-2a6ccdb1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01012297-2a6ccdb1
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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 | 0.667 | 0.534 | 0.778 | wilson | |
| Risk in group 2 | 0.868 | 0.752 | 0.935 | wilson | |
| Risk difference, group 1 minus group 2 | -0.201 | -0.35 | -0.0405 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.768 | 0.619 | 0.953 | log | |
| Odds ratio, group 1 over group 2 | 0.304 | 0.115 | 0.808 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm I Gem+Doce+Placebo than on Arm II Gem+Doce+Bev | 4.97 | 2.86 | 24.7 | from the risk difference interval |
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 Gem+Doce+Placebo | 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 | 36 | 54 | OG000 |
| Group 2 | Arm II Gem+Doce+Bev | 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 | 46 | 53 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
- Description
- Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse.~Please refer to the adverse event reporting for more detail.
- Time frame
- Up to 5 years
- Population
- All randomized.
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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