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NCT00102804 · OUTCOME

Time to Worsening of Symptoms (TWS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Randomization to worsening of each LCSS item (up to 39 months)

What was measured

TWS was the elapsed time from the date of randomization to the first date of worsening \[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). 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 (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.

Analysis population: Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.

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 BSC441
Placebo and BSC222

Reported measurements

Loss of appetite
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC3.78Not reported2.864.44Not reported
Placebo and BSC4.40Not reported2.9615.61Not reported
Fatigue
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC3.06Not reported2.635.29Not reported
Placebo and BSC3.09Not reported2.433.98Not reported
Cough
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC6.05Not reported4.217.82Not reported
Placebo and BSC4.67Not reported3.0615.61Not reported
Dyspnea
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC5.36Not reported4.2110.87Not reported
Placebo and BSC4.40Not reported2.8315.61Not reported
Hemoptysis
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSCNANot reportedNANAMedian (95% confidence interval) TWS for hemoptysis was not calculated due to the high level of censoring.
Placebo and BSCNANot reportedNANAMedian (95% confidence interval) TWS for hemoptysis was not calculated due to the high level of censoring.
Pain
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC6.11Not reported4.579.56Not reported
Placebo and BSC4.63Not reported3.325.98Not reported
Symptomatic distress
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC4.21Not reported3.585.55Not reported
Placebo and BSC3.78Not reported2.9918.53Not reported
Interference with activity level
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC6.51Not reported4.348.18Not reported
Placebo and BSC3.98Not reported2.8315.61Not reported
Global quality of life
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC5.75Not reported4.378.41Not reported
Placebo and BSC3.71Not reported2.995.49Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.86
        upper Limit
        4.44
        value
        3.78
      2. group Id
        OG001
        lower Limit
        2.96
        upper Limit
        15.61
        value
        4.40
    title
    Loss of appetite
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.63
        upper Limit
        5.29
        value
        3.06
      2. group Id
        OG001
        lower Limit
        2.43
        upper Limit
        3.98
        value
        3.09
    title
    Fatigue
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.21
        upper Limit
        7.82
        value
        6.05
      2. group Id
        OG001
        lower Limit
        3.06
        upper Limit
        15.61
        value
        4.67
    title
    Cough
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.21
        upper Limit
        10.87
        value
        5.36
      2. group Id
        OG001
        lower Limit
        2.83
        upper Limit
        15.61
        value
        4.40
    title
    Dyspnea
  5. categories
    1. measurements
      1. comment
        Median (95% confidence interval) TWS for hemoptysis was not calculated due to the high level of censoring.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median (95% confidence interval) TWS for hemoptysis was not calculated due to the high level of censoring.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    Hemoptysis
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.57
        upper Limit
        9.56
        value
        6.11
      2. group Id
        OG001
        lower Limit
        3.32
        upper Limit
        5.98
        value
        4.63
    title
    Pain
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.58
        upper Limit
        5.55
        value
        4.21
      2. group Id
        OG001
        lower Limit
        2.99
        upper Limit
        18.53
        value
        3.78
    title
    Symptomatic distress
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.34
        upper Limit
        8.18
        value
        6.51
      2. group Id
        OG001
        lower Limit
        2.83
        upper Limit
        15.61
        value
        3.98
    title
    Interference with activity level
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.37
        upper Limit
        8.41
        value
        5.75
      2. group Id
        OG001
        lower Limit
        2.99
        upper Limit
        5.49
        value
        3.71
    title
    Global quality of life
denoms
  1. counts
    1. group Id
      OG000
      value
      441
    2. group Id
      OG001
      value
      222
    units
    Participants
description
TWS was the elapsed time from the date of randomization to the first date of worsening \[defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale\] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). 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 (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.
reporting Status
POSTED
time Frame
Randomization to worsening of each LCSS item (up to 39 months)
title
Time to Worsening of Symptoms (TWS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice