Comparison · NCT01167712-sae
Arm I (Adjuvant Chemotherapy Suboptimally Debulked) vs Arm II (Neoadjuvant Chemotherapy): 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 (Adjuvant Chemotherapy Suboptimally Debulked) vs Arm II (Neoadjuvant Chemotherapy): serious adverse events. Trial comparisons, record NCT01167712-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01167712-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 | 0.353 | 0.304 | 0.404 | wilson | |
| Risk in group 2 | 0.483 | 0.43 | 0.535 | wilson | |
| Risk difference, group 1 minus group 2 | -0.13 | -0.202 | -0.0566 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.731 | 0.61 | 0.874 | log | |
| Odds ratio, group 1 over group 2 | 0.584 | 0.43 | 0.792 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Adjuvant Chemotherapy Suboptimally Debulked) than on Arm II (Neoadjuvant Chemotherapy) | 7.69 | 4.96 | 17.7 | 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 (Adjuvant Chemotherapy Suboptimally Debulked) | Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV | 122 | 346 | EG000 |
| Group 2 | Arm II (Neoadjuvant Chemotherapy) | Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. Patients undergo interval cytoreductive surgery between courses 3 and 4.~Bevacizumab: Given IV~Carboplatin: Given IV~Computed Tomography: Correlative studies~Paclitaxel: Given IV~Therapeutic Conventional Surgery: Undergo surgery | 167 | 346 | 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.
Source ClinicalTrials.gov
Trial
- Title
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
- NCT number
- NCT01167712
- Phases
- PHASE3
- Conditions
Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Mucinous Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Ovarian Brenner Tumor, Ovarian Clear Cell Adenocarcinofibroma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Ovarian Undifferentiated Carcinoma, Primary Peritoneal Serous Adenocarcinoma, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIC Fallopian Tube Cancer AJCC v6 and v7, Stage IIC Ovarian Cancer AJCC v6 and v7, Stage IIIA Fallopian Tube Cancer AJCC v7, Stage IIIA Ovarian Cancer AJCC v6 and v7, Stage IIIA Primary Peritoneal Cancer AJCC v7, Stage IIIB Fallopian Tube Cancer AJCC v7, Stage IIIB Ovarian Cancer AJCC v6 and v7, Stage IIIB Primary Peritoneal Cancer AJCC v7, Stage IIIC Fallopian Tube Cancer AJCC v7, Stage IIIC Ovarian Cancer AJCC v6 and v7, Stage IIIC Primary Peritoneal Cancer AJCC v7, Stage IV Fallopian Tube Cancer AJCC v6 and v7, Stage IV Ovarian Cancer AJCC v6 and v7, Stage IV Primary Peritoneal Cancer AJCC v7
- Interventions
- Bevacizumab, Carboplatin, Computed Tomography, Paclitaxel, Therapeutic Conventional Surgery
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2018-01-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01167712?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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