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NCT00954174 · OUTCOME

Patient-reported Peripheral Neuropathy Symptoms - Post Baseline

Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer · Source last updated 2021-09-30

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

Measure
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1

What was measured

Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.

Analysis population: Provided baseline and ≥ 1 follow-up assessments

Groups in this outcome

Regimen I - Uterine and Non-Uterine Subjects

Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies

Regimen II - Uterine and Non-Uterine Subjects

Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I. Ifosfamide: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary 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
Regimen I - Uterine and Non-Uterine Subjects205
Regimen II - Uterine and Non-Uterine Subjects184

Reported measurements

Prior to cycle 3
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects37.20.4Not reportedNot reportedNot reported
Regimen II - Uterine and Non-Uterine Subjects37.00.5Not reportedNot reportedNot reported
Prior to cycle 6
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects34.10.6Not reportedNot reportedNot reported
Regimen II - Uterine and Non-Uterine Subjects34.20.6Not reportedNot reportedNot reported
30 weeks post cycle 1
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Regimen I - Uterine and Non-Uterine Subjects34.80.6Not reportedNot reportedNot reported
Regimen II - Uterine and Non-Uterine Subjects34.90.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.4
        value
        37.2
      2. group Id
        OG001
        spread
        0.5
        value
        37.0
    title
    Prior to cycle 3
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.6
        value
        34.1
      2. group Id
        OG001
        spread
        0.6
        value
        34.2
    title
    Prior to cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.6
        value
        34.8
      2. group Id
        OG001
        spread
        0.6
        value
        34.9
    title
    30 weeks post cycle 1
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      184
    units
    Participants
description
Patient reported peripheral neuropathy symptoms was measured with the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - neurotoxicity subscale (short version) (FACT/GOG-Ntx subscale). The FACT/GOG-Ntx subscale contains 11 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The Ntx score ranges 0-44 with a large score suggesting less peripheral neuropathy symptoms.Quality of Life was analyzed across cohorts since disease site was considered independent of Quality of Life.
dispersion Type
Standard Error
groups
  1. description
    Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1. Carboplatin: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG000
    title
    Regimen I - Uterine and Non-Uterine Subjects
  2. description
    Patients receive ifosfamide IV over 1 hour on days 1-3 followed by paclitaxel as in Arm I. Ifosfamide: Given IV Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies
    id
    OG001
    title
    Regimen II - Uterine and Non-Uterine Subjects
param Type
LEAST_SQUARES_MEAN
population Description
Provided baseline and ≥ 1 follow-up assessments
reporting Status
POSTED
time Frame
Prior to cycle 3, Prior to cycle 6, 30 weeks post cycle 1
title
Patient-reported Peripheral Neuropathy Symptoms - Post Baseline
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice