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NCT01042522 · OUTCOME

Overall Survival (OS)

Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors · Source last updated 2022-01-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.

What was measured

The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported.

Analysis population: Intent to Treat

Groups in this outcome

Arm I (Paclitaxel, Carboplatin)

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV

Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)

Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Paclitaxel, Carboplatin)31
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)32

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Paclitaxel, Carboplatin)5Not reportedNot reportedNot reportedNot reported
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      32
    units
    Participants
description
The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported.
groups
  1. description
    Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
    id
    OG000
    title
    Arm I (Paclitaxel, Carboplatin)
  2. description
    Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Bleomycin Sulfate: Given IV Cisplatin: Given IV Etoposide Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG001
    title
    Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent to Treat
reporting Status
POSTED
time Frame
From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice