Comparison · NCT00807768-sae
Arm I (Pelvic Radiation Therapy) vs Arm II (Brachytherapy, Paclitaxel, Carboplatin): serious adverse events
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 (Pelvic Radiation Therapy) vs Arm II (Brachytherapy, Paclitaxel, Carboplatin): serious adverse events. Trial comparisons, record NCT00807768-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00807768-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 | 0.0318 | 0.0168 | 0.0593 | wilson | |
| Risk in group 2 | 0.11 | 0.0793 | 0.152 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0785 | -0.122 | -0.037 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.288 | 0.14 | 0.593 | log | |
| Odds ratio, group 1 over group 2 | 0.265 | 0.124 | 0.566 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Pelvic Radiation Therapy) than on Arm II (Brachytherapy, Paclitaxel, Carboplatin) | 12.7 | 8.17 | 27 | 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 (Pelvic Radiation Therapy) | Patients undergo conventional or intensity-modulated pelvic radiation therapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.~3-Dimensional Conformal Radiation Therapy: Undergo pelvic radiation therapy~Intensity-Modulated Radiation Therapy: Undergo pelvic radiation therapy~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies | 9 | 283 | EG000 |
| Group 2 | Arm II (Brachytherapy, Paclitaxel, Carboplatin) | Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Internal Radiation Therapy: Undergo vaginal cuff brachytherapy~Laboratory Biomarker Analysis: Correlative studies~Paclitaxel: Given IV~Quality-of-Life Assessment: Ancillary studies~Questionnaire Administration: Ancillary studies | 32 | 290 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AEs were assessed from the date of treatment initiation up to 30 days after the last cycle of treatment. Median treatment duration is approximately 8 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer
- NCT number
- NCT00807768
- Phases
- PHASE3
- Conditions
- Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Fatigue, Neurotoxicity Syndrome, Obesity, Stage I Uterine Corpus Cancer AJCC v7, Stage II Uterine Corpus Cancer AJCC v7
- Interventions
3-Dimensional Conformal Radiation Therapy, Carboplatin, Intensity-Modulated Radiation Therapy, Internal Radiation Therapy, Laboratory Biomarker Analysis, Paclitaxel, Quality-of-Life Assessment, Questionnaire Administration
- Lead sponsor
- Gynecologic Oncology Group
- Results first posted
- 2018-04-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00807768?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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