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NCT00789373 · OUTCOME

Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)

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

Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).

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 Pemetrexed300
Pemetrexed + Cisplatin Followed by Placebo148

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed300
Pemetrexed + Cisplatin Followed by Placebo148
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed71.116.6Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo71.015.8Not reportedNot reportedNot reported
Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed266
Pemetrexed + Cisplatin Followed by Placebo126
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed1.659.86Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo1.4210.2Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed239
Pemetrexed + Cisplatin Followed by Placebo127
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed1.2411.2Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo3.1513.0Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed162
Pemetrexed + Cisplatin Followed by Placebo81
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed1.8210.9Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo4.9016.9Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed147
Pemetrexed + Cisplatin Followed by Placebo65
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed0.6913.1Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo6.1516.4Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed107
Pemetrexed + Cisplatin Followed by Placebo48
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed1.5512.4Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo5.9913.1Not 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 Pemetrexed3.0112.5Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo5.7612.9Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed74
Pemetrexed + Cisplatin Followed by Placebo21
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed2.714.5Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo3.9810.9Not 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 Pemetrexed4.1214.1Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo7.5814.8Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed47
Pemetrexed + Cisplatin Followed by Placebo14
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed4.1914.2Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo7.6116.7Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed37
Pemetrexed + Cisplatin Followed by Placebo11
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed5.1415.1Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo6.2318.7Not 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 Pemetrexed2.5814.7Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo0.9415.4Not reportedNot reportedNot reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed27
Pemetrexed + Cisplatin Followed by Placebo8
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed2.1116.0Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo4.6313.1Not reportedNot reportedNot reported
Cycle 13 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed14
Pemetrexed + Cisplatin Followed by Placebo4
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed6.2916.4Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo10.03.27Not 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 Pemetrexed3.6418.4Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo14.04.55Not reportedNot reportedNot reported
Cycle 15 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed10
Pemetrexed + Cisplatin Followed by Placebo3
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed8.4012.9Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo12.03.46Not reportedNot reportedNot reported
Cycle 16 Day 1

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed6
Pemetrexed + Cisplatin Followed by Placebo1
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed5.839.99Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo15.00.0Not 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 Pemetrexed15.721.1Not 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 Pemetrexed5.014.1Not reportedNot reportedNot reported
30 days post-study

Analysis denominator · Participants

GroupSource count
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed78
Pemetrexed + Cisplatin Followed by Placebo49
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed-4.7717.3Not reportedNot reportedNot reported
Pemetrexed + Cisplatin Followed by Placebo-3.9216.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.6
        value
        71.1
      2. group Id
        OG001
        spread
        15.8
        value
        71.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        300
      2. group Id
        OG001
        value
        148
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.86
        value
        1.65
      2. group Id
        OG001
        spread
        10.2
        value
        1.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        266
      2. group Id
        OG001
        value
        126
      units
      Participants
    title
    Cycle 1 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        11.2
        value
        1.24
      2. group Id
        OG001
        spread
        13.0
        value
        3.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        239
      2. group Id
        OG001
        value
        127
      units
      Participants
    title
    Cycle 2 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.9
        value
        1.82
      2. group Id
        OG001
        spread
        16.9
        value
        4.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        162
      2. group Id
        OG001
        value
        81
      units
      Participants
    title
    Cycle 3 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.1
        value
        0.69
      2. group Id
        OG001
        spread
        16.4
        value
        6.15
    denoms
    1. counts
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        65
      units
      Participants
    title
    Cycle 4 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.4
        value
        1.55
      2. group Id
        OG001
        spread
        13.1
        value
        5.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        107
      2. group Id
        OG001
        value
        48
      units
      Participants
    title
    Cycle 5 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.5
        value
        3.01
      2. group Id
        OG001
        spread
        12.9
        value
        5.76
    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
        14.5
        value
        2.7
      2. group Id
        OG001
        spread
        10.9
        value
        3.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    Cycle 7 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.1
        value
        4.12
      2. group Id
        OG001
        spread
        14.8
        value
        7.58
    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
        14.2
        value
        4.19
      2. group Id
        OG001
        spread
        16.7
        value
        7.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        14
      units
      Participants
    title
    Cycle 9 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.1
        value
        5.14
      2. group Id
        OG001
        spread
        18.7
        value
        6.23
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Cycle 10 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.7
        value
        2.58
      2. group Id
        OG001
        spread
        15.4
        value
        0.94
    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
      300
    2. group Id
      OG001
      value
      148
    units
    Participants
description
Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
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 EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice