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NCT00102804 · OUTCOME

Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS

Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2014-12-29

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 through 30 days post discontinuation of study treatment (up to 39 Months)

What was measured

The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.

Analysis population: Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.

Groups in this outcome

Pemetrexed and BSC

Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Placebo and BSC

Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

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 and BSC403
Placebo and BSC197

Reported measurements

Loss of appetite (n=403, 197)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC7.325.90Not reportedNot reportedNot reported
Placebo and BSC10.625.25Not reportedNot reportedNot reported
Fatigue (n=403, 197)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC10.227.10Not reportedNot reportedNot reported
Placebo and BSC10.423.92Not reportedNot reportedNot reported
Cough (n=402, 197)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC7.620.09Not reportedNot reportedNot reported
Placebo and BSC6.723.81Not reportedNot reportedNot reported
Dyspnea (n=400, 196)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC7.622.50Not reportedNot reportedNot reported
Placebo and BSC5.420.44Not reportedNot reportedNot reported
Pain (n=401, 197)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC5.420.96Not reportedNot reportedNot reported
Placebo and BSC4.321.93Not reportedNot reportedNot reported
Hemoptysis (n=402, 196)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC1.59.41Not reportedNot reportedNot reported
Placebo and BSC2.19.23Not reportedNot reportedNot reported
Symptom distress (n=401, 196)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC6.521.13Not reportedNot reportedNot reported
Placebo and BSC8.222.5Not reportedNot reportedNot reported
Interference with activity level (n=400, 197)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC10.827.08Not reportedNot reportedNot reported
Placebo and BSC9.325.50Not reportedNot reportedNot reported
Global quality of life (n=401, 195)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC10.724.94Not reportedNot reportedNot reported
Placebo and BSC10.522.98Not reportedNot reportedNot reported
ASBI (n=392, 195)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC3.712.34Not reportedNot reportedNot reported
Placebo and BSC3.813.24Not reportedNot reportedNot reported
Total LCSS (n=388, 193)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC4.0712.76Not reportedNot reportedNot reported
Placebo and BSC4.0413.03Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.90
        value
        7.3
      2. group Id
        OG001
        spread
        25.25
        value
        10.6
    title
    Loss of appetite (n=403, 197)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.10
        value
        10.2
      2. group Id
        OG001
        spread
        23.92
        value
        10.4
    title
    Fatigue (n=403, 197)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.09
        value
        7.6
      2. group Id
        OG001
        spread
        23.81
        value
        6.7
    title
    Cough (n=402, 197)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.50
        value
        7.6
      2. group Id
        OG001
        spread
        20.44
        value
        5.4
    title
    Dyspnea (n=400, 196)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.96
        value
        5.4
      2. group Id
        OG001
        spread
        21.93
        value
        4.3
    title
    Pain (n=401, 197)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        9.41
        value
        1.5
      2. group Id
        OG001
        spread
        9.23
        value
        2.1
    title
    Hemoptysis (n=402, 196)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.13
        value
        6.5
      2. group Id
        OG001
        spread
        22.5
        value
        8.2
    title
    Symptom distress (n=401, 196)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.08
        value
        10.8
      2. group Id
        OG001
        spread
        25.50
        value
        9.3
    title
    Interference with activity level (n=400, 197)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.94
        value
        10.7
      2. group Id
        OG001
        spread
        22.98
        value
        10.5
    title
    Global quality of life (n=401, 195)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.34
        value
        3.7
      2. group Id
        OG001
        spread
        13.24
        value
        3.8
    title
    ASBI (n=392, 195)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.76
        value
        4.07
      2. group Id
        OG001
        spread
        13.03
        value
        4.04
    title
    Total LCSS (n=388, 193)
denoms
  1. counts
    1. group Id
      OG000
      value
      403
    2. group Id
      OG001
      value
      197
    units
    Participants
description
The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.
dispersion Type
Standard Deviation
groups
  1. description
    Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    OG000
    title
    Pemetrexed and BSC
  2. description
    Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    OG001
    title
    Placebo and BSC
param Type
MEAN
population Description
Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.
reporting Status
POSTED
time Frame
Baseline through 30 days post discontinuation of study treatment (up to 39 Months)
title
Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice