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Comparison · NCT00954174-sae

Regimen I - Uterine and Non-uterine Carcinosarcoma vs Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects: 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. Regimen I - Uterine and Non-uterine Carcinosarcoma vs Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects: serious adverse events. Trial comparisons, record NCT00954174-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00954174-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2990.2470.356wilson
Risk in group 20.2750.2230.334wilson
Risk difference, group 1 minus group 20.0232-0.05510.101newcombe hybrid score
Risk ratio, group 1 over group 21.080.8251.42log
Odds ratio, group 1 over group 21.120.7641.64log
Number needed to harm, for one more participant with a serious adverse event on Regimen I - Uterine and Non-uterine Carcinosarcoma than on Regimen II - Uterine and Non-uterine Carcinsarcoma Subjects43.1from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Regimen I - Uterine and Non-uterine CarcinosarcomaPaclitaxel 175 mg/m2 IV over 3 hours Day 1 Carboplatin (AUC=6) IV Day 1 Repeat q 3 weeks x 6-10 cycles80268EG000
Group 2Regimen II - Uterine and Non-uterine Carcinsarcoma SubjectsIfosfamide 1.6 g/m2 IV days 1, 2, 3 Mesna Paclitaxel 135 mg/m2 by 3-hour infusion on Day 1 Repeat q 3 weeks x 6-10 cycles. G-CSF Support: Filgrastim or Pegfilgrastim beginning Day 4-668247EG001

Harm

What it counts
Total, serious adverse events
Time frame
Measured within 6 months of enrollment; through all cycles of chemotherapy and up to 30 days after the last cycle of chemotherapy. Up to 10 cycles of chemotherapy were allowed. Cycles were to be repeated every 3 weeks.

Source ClinicalTrials.gov

Trial

Title
Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer
NCT number
NCT00954174
Phases
PHASE3
Conditions
Mixed Mesodermal (Mullerian) Tumor, Ovarian Carcinosarcoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Stage I Ovarian Cancer AJCC v6 and v7, Stage IA Fallopian Tube Cancer AJCC v6 and v7, Stage IA Ovarian Cancer AJCC v6 and v7, Stage IA Uterine Sarcoma AJCC v7, Stage IB Fallopian Tube Cancer AJCC v6 and v7, Stage IB Ovarian Cancer AJCC v6 and v7, Stage IB Uterine Sarcoma AJCC v7, Stage IC Fallopian Tube Cancer AJCC v6 and v7, Stage IC Ovarian Cancer AJCC v6 and v7, Stage IC Uterine Sarcoma AJCC v7, Stage II Ovarian Cancer AJCC v6 and v7, Stage IIA Fallopian Tube Cancer AJCC v6 and v7, Stage IIA Ovarian Cancer AJCC V6 and v7, Stage IIA Uterine Sarcoma AJCC v7, Stage IIB Fallopian Tube Cancer AJCC v6 and v7, Stage IIB Ovarian Cancer AJCC v6 and v7, Stage IIB Uterine Sarcoma AJCC 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 IIIA Uterine Sarcoma 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 IIIB Uterine Sarcoma 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 IIIC Uterine Sarcoma 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, Stage IVA Uterine Sarcoma AJCC v7, Stage IVB Uterine Sarcoma AJCC v7, Uterine Carcinosarcoma
Interventions
Carboplatin, Ifosfamide, Paclitaxel, Quality-of-Life Assessment
Lead sponsor
GOG Foundation
Results first posted
2020-08-10

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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