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NCT01533207 · OUTCOME

Number of Participants With Recurrence

Gemcitabine Hydrochloride and Docetaxel Followed by Doxorubicin Hydrochloride or Observation in Treating Patients With High-Risk Uterine Leiomyosarcoma Previously Removed by Surgery · Source last updated 2020-04-28

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Follow-up every 4 months for 3 years, then every 6 months for 2 years.

What was measured

The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.

Analysis population: Eligible and evaluable participants

Groups in this outcome

Regimen 1

Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles

Regimen II

Observation

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

Analysis denominator · Participants

GroupSource count
Regimen 120
Regimen II18

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen 18Not reportedNot reportedNot reportedNot reported
Regimen II8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      18
    units
    Participants
description
The duration of time from study entry to time of recurrence or death, whichever occurred first, or the date of last contact.
groups
  1. description
    Gemcitabine 900 mg/m2 IV days 1 and 8 Docetaxel 75 mg/m2 IV day 8 GCSF 5 micrograms/kg days 9-15 or pegfilgrastim 6 mg day 9 or 10 Every 21 days for 4 cycles CT/MRI imaging to confirm disease-free Doxorubicin 60 mg/m2 IV every 21 days for 4 cycles
    id
    OG000
    title
    Regimen 1
  2. description
    Observation
    id
    OG001
    title
    Regimen II
param Type
NUMBER
population Description
Eligible and evaluable participants
reporting Status
POSTED
time Frame
Follow-up every 4 months for 3 years, then every 6 months for 2 years.
title
Number of Participants With Recurrence
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice