Comparison · NCT02065687-sae
Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) vs Arm II (Paclitaxel, Carboplatin, Placebo): 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 (Paclitaxel, Carboplatin, Metformin Hydrochloride) vs Arm II (Paclitaxel, Carboplatin, Placebo): serious adverse events. Trial comparisons, record NCT02065687-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02065687-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 | 0.197 | 0.151 | 0.252 | wilson | |
| Risk in group 2 | 0.226 | 0.177 | 0.283 | wilson | |
| Risk difference, group 1 minus group 2 | -0.029 | -0.103 | 0.045 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.872 | 0.614 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.84 | 0.539 | 1.31 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) than on Arm II (Paclitaxel, Carboplatin, Placebo) | 34.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm I (Paclitaxel, Carboplatin, Metformin Hydrochloride) | Patients receive 175 mg/m2 paclitaxel IV over 3 hours on day 1, carboplatin AUC 5 IV over 30 minutes on day 1, and 850 mg metformin hydrochloride PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 46 | 234 | EG000 |
| Group 2 | Arm II (Paclitaxel, Carboplatin, Placebo) | Patients receive 175 mg/m2 paclitaxel IV and carboplatin AUC 5 IV as in Arm I. Patients also receive placebo PO BID (approximately every 10-12 hours apart) on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | 53 | 235 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Patients are followed for the occurrence of adverse events for five years.
Source ClinicalTrials.gov
Trial
- Title
- Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
- NCT number
- NCT02065687
- Phases
- PHASE2, PHASE3
- Conditions
Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Endometrial Undifferentiated Carcinoma, Recurrent Uterine Corpus Carcinoma, Stage III Uterine Corpus Cancer AJCC v7, Stage IIIA Uterine Corpus Cancer AJCC v7, Stage IIIB Uterine Corpus Cancer AJCC v7, Stage IIIC Uterine Corpus Cancer AJCC v7, Stage IV Uterine Corpus Cancer AJCC v7, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7
- Interventions
- Carboplatin, Laboratory Biomarker Analysis, Metformin Hydrochloride, Paclitaxel, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
- Lead sponsor
- Gynecologic Oncology Group
- Results first posted
- 2021-01-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02065687?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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