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NCT01168973 · OUTCOME

Maximum Improvement on Lung Cancer Symptom Scale (LCSS)

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy · Source last updated 2019-09-25

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

Measure
MEAN
Unit
mm
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)

What was measured

The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.

Analysis population: Randomized participants grouped according to their assigned treatment at randomization, who had a baseline and at least 1 post-baseline LCSS score.

Groups in this outcome

Ramucirumab and Docetaxel

On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

Placebo and Docetaxel

On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

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

Analysis denominator · Participants

GroupSource count
Ramucirumab and Docetaxel476
Placebo and Docetaxel477

Reported measurements

Loss of Appetite (n=473, 471)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-10.926.11Not reportedNot reportedNot reported
Placebo and Docetaxel-11.026.22Not reportedNot reportedNot reported
Fatigue (n=473, 472)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-12.123.86Not reportedNot reportedNot reported
Placebo and Docetaxel-12.027.29Not reportedNot reportedNot reported
Cough (n=476, 473)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-13.824.28Not reportedNot reportedNot reported
Placebo and Docetaxel-14.326.28Not reportedNot reportedNot reported
Dyspnea (n=472, 477)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-11.023.01Not reportedNot reportedNot reported
Placebo and Docetaxel-10.524.31Not reportedNot reportedNot reported
Hemoptysis (n=475, 475)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-1.48.89Not reportedNot reportedNot reported
Placebo and Docetaxel-1.18.79Not reportedNot reportedNot reported
Pain (n=476, 475)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-11.323.62Not reportedNot reportedNot reported
Placebo and Docetaxel-11.524.85Not reportedNot reportedNot reported
Symptom Distress (n=474, 472)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-10.723.37Not reportedNot reportedNot reported
Placebo and Docetaxel-12.226.25Not reportedNot reportedNot reported
Interference With Activity Level (n=474, 472)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-8.524.13Not reportedNot reportedNot reported
Placebo and Docetaxel-7.924.95Not reportedNot reportedNot reported
Global Quality of Life (n=467, 469)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-10.422.68Not reportedNot reportedNot reported
Placebo and Docetaxel-8.923.23Not reportedNot reportedNot reported
ASBI (n=455, 456)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-6.113.75Not reportedNot reportedNot reported
Placebo and Docetaxel-6.914.50Not reportedNot reportedNot reported
Total LCSS (n=446, 446)
Values in mm · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ramucirumab and Docetaxel-5.213.75Not reportedNot reportedNot reported
Placebo and Docetaxel-6.414.66Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.11
        value
        -10.9
      2. group Id
        OG001
        spread
        26.22
        value
        -11.0
    title
    Loss of Appetite (n=473, 471)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.86
        value
        -12.1
      2. group Id
        OG001
        spread
        27.29
        value
        -12.0
    title
    Fatigue (n=473, 472)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.28
        value
        -13.8
      2. group Id
        OG001
        spread
        26.28
        value
        -14.3
    title
    Cough (n=476, 473)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.01
        value
        -11.0
      2. group Id
        OG001
        spread
        24.31
        value
        -10.5
    title
    Dyspnea (n=472, 477)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.89
        value
        -1.4
      2. group Id
        OG001
        spread
        8.79
        value
        -1.1
    title
    Hemoptysis (n=475, 475)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.62
        value
        -11.3
      2. group Id
        OG001
        spread
        24.85
        value
        -11.5
    title
    Pain (n=476, 475)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.37
        value
        -10.7
      2. group Id
        OG001
        spread
        26.25
        value
        -12.2
    title
    Symptom Distress (n=474, 472)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.13
        value
        -8.5
      2. group Id
        OG001
        spread
        24.95
        value
        -7.9
    title
    Interference With Activity Level (n=474, 472)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.68
        value
        -10.4
      2. group Id
        OG001
        spread
        23.23
        value
        -8.9
    title
    Global Quality of Life (n=467, 469)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.75
        value
        -6.1
      2. group Id
        OG001
        spread
        14.50
        value
        -6.9
    title
    ASBI (n=455, 456)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.75
        value
        -5.2
      2. group Id
        OG001
        spread
        14.66
        value
        -6.4
    title
    Total LCSS (n=446, 446)
denoms
  1. counts
    1. group Id
      OG000
      value
      476
    2. group Id
      OG001
      value
      477
    units
    Participants
description
The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms \[loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain\] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.
dispersion Type
Standard Deviation
groups
  1. description
    On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    OG000
    title
    Ramucirumab and Docetaxel
  2. description
    On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    OG001
    title
    Placebo and Docetaxel
param Type
MEAN
population Description
Randomized participants grouped according to their assigned treatment at randomization, who had a baseline and at least 1 post-baseline LCSS score.
reporting Status
POSTED
time Frame
Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)
title
Maximum Improvement on Lung Cancer Symptom Scale (LCSS)
type
SECONDARY
unit Of Measure
mm

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

Preserved source evidence · Not medical advice