Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00789373 · OUTCOME

Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer · Source last updated 2018-12-14

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)

What was measured

The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).

Analysis population: Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.

Groups in this outcome

Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed

pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care

Pemetrexed + Cisplatin Followed by Placebo

pemetrexed + cisplatin followed by placebo plus best supportive care

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

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed303
Pemetrexed + Cisplatin Followed by Placebo153

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed303
Pemetrexed + Cisplatin Followed by Placebo153
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.770.21Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.790.18Not reportedNot reportedNot reported
Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed265
Pemetrexed + Cisplatin Followed by Placebo132
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.010.15Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo-0.010.17Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed241
Pemetrexed + Cisplatin Followed by Placebo129
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.00.19Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.010.17Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed160
Pemetrexed + Cisplatin Followed by Placebo83
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.00.15Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.030.17Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed149
Pemetrexed + Cisplatin Followed by Placebo66
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.010.15Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.020.18Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed108
Pemetrexed + Cisplatin Followed by Placebo48
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.010.16Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.010.22Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed98
Pemetrexed + Cisplatin Followed by Placebo36
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.020.18Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.040.14Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed73
Pemetrexed + Cisplatin Followed by Placebo21
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.010.20Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.010.13Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed64
Pemetrexed + Cisplatin Followed by Placebo18
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.010.18Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.050.15Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed48
Pemetrexed + Cisplatin Followed by Placebo14
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.030.20Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.060.18Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed39
Pemetrexed + Cisplatin Followed by Placebo11
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.00.16Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.080.15Not reportedNot reportedNot reported
Cycle 11 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed33
Pemetrexed + Cisplatin Followed by Placebo8
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.020.19Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.040.17Not reportedNot reportedNot reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed28
Pemetrexed + Cisplatin Followed by Placebo8
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.060.27Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.060.16Not reportedNot reportedNot reported
Cycle 13 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed15
Pemetrexed + Cisplatin Followed by Placebo3
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.010.27Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.00.0Not reportedNot reportedNot reported
Cycle 14 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed11
Pemetrexed + Cisplatin Followed by Placebo4
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.030.26Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.030.05Not reportedNot reportedNot reported
Cycle 15 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed12
Pemetrexed + Cisplatin Followed by Placebo3
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.070.34Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.010.02Not reportedNot reportedNot reported
Cycle 16 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed7
Pemetrexed + Cisplatin Followed by Placebo1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.010.36Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.00.0Not reportedNot reportedNot reported
Cycle 17 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed3
Pemetrexed + Cisplatin Followed by Placebo0
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.320.43Not reportedNot reportedNot reported
Cycle 18 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed2
Pemetrexed + Cisplatin Followed by Placebo0
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.450.52Not reportedNot reportedNot reported
30 Day Post-Study Visit

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed82
Pemetrexed + Cisplatin Followed by Placebo51
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-0.130.27Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo-0.090.26Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.21
        value
        0.77
      2. group Id
        OG001
        spread
        0.18
        value
        0.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        303
      2. group Id
        OG001
        value
        153
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.01
      2. group Id
        OG001
        spread
        0.17
        value
        -0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      2. group Id
        OG001
        value
        132
      units
      Participants
    title
    Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.19
        value
        0.0
      2. group Id
        OG001
        spread
        0.17
        value
        0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        241
      2. group Id
        OG001
        value
        129
      units
      Participants
    title
    Cycle 2 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.0
      2. group Id
        OG001
        spread
        0.17
        value
        0.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        160
      2. group Id
        OG001
        value
        83
      units
      Participants
    title
    Cycle 3 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        -0.01
      2. group Id
        OG001
        spread
        0.18
        value
        0.02
    denoms
    1. counts
      1. group Id
        OG000
        value
        149
      2. group Id
        OG001
        value
        66
      units
      Participants
    title
    Cycle 4 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.16
        value
        0.01
      2. group Id
        OG001
        spread
        0.22
        value
        0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        48
      units
      Participants
    title
    Cycle 5 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.18
        value
        -0.02
      2. group Id
        OG001
        spread
        0.14
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    Cycle 6 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.20
        value
        0.01
      2. group Id
        OG001
        spread
        0.13
        value
        0.01
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    Cycle 7 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.18
        value
        0.01
      2. group Id
        OG001
        spread
        0.15
        value
        0.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Cycle 8 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.20
        value
        -0.03
      2. group Id
        OG001
        spread
        0.18
        value
        0.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Cycle 9 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.16
        value
        0.0
      2. group Id
        OG001
        spread
        0.15
        value
        0.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Cycle 10 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.19
        value
        -0.02
      2. group Id
        OG001
        spread
        0.17
        value
        0.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Cycle 11 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      303
    2. group Id
      OG001
      value
      153
    units
    Participants
description
The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
dispersion Type
Standard Deviation
groups
  1. description
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    id
    OG000
    title
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
  2. description
    pemetrexed + cisplatin followed by placebo plus best supportive care
    id
    OG001
    title
    Pemetrexed + Cisplatin Followed by Placebo
param Type
MEAN
population Description
Participants who were randomized and completed the EQ-5D at baseline and at least once post-baseline. For Cycle 17 and 18, there is no data available for the pemetrexed + cisplatin followed by placebo arm. No participants completed so zero participants were analyzed.
reporting Status
POSTED
time Frame
Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
title
Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice