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NCT01087970 · BASELINE

Baseline characteristics

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2014-05-19

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

denoms
  1. counts
    1. group Id
      BG000
      value
      69
    units
    Participants
groups
  1. description
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    id
    BG000
    title
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.3
          value
          61.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          63
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          56
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.248
          value
          0.721
      title
      Index Score (n=47)
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.658
          value
          66.106
      title
      Visual Analog Scale (VAS) Score (n=47)
    description
    Participants assessed health-related QoL in 5 D (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as no problems/some or moderate problems/extreme problems. A regression equation defines a utility value for these health states to generate an index score from -0.594 (severe problems in all 5 D) to 1 (no problem in all 5 D) where 1=best possible health state. EQ-5D VAS rates participant's current health-related QoL on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
    unit Of Measure
    units on a scale
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          37.87
          value
          56.32
      title
      NOD (n=57)
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          32.20
          value
          78.51
      title
      UOS (n=57)
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          34.42
          value
          71.93
      title
      EIP (n=57)
    description
    Clinician measured speaking and eating disabilities of HNC participants that consists 3 subscales: normalcy of diet (NOD) measures ability of eating a normal diet, scale from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) measures the degree a clinician was able to understand participant's speech, scale from 0 (never understandable) to 100 (always understandable); eating in public (EIP) is based on clinician's question to the participant, scale from 0 (always eats alone) to 100 (no restriction of place, food, or companion).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Performance Status Scale for Head and Neck Cancer (PSS-HNC)
    unit Of Measure
    units on a scale
population Description
All enrolled participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      69
    units
    Participants
groups
  1. description
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    id
    BG000
    title
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.3
          value
          61.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          63
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          56
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.248
          value
          0.721
      title
      Index Score (n=47)
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.658
          value
          66.106
      title
      Visual Analog Scale (VAS) Score (n=47)
    description
    Participants assessed health-related QoL in 5 D (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) as no problems/some or moderate problems/extreme problems. A regression equation defines a utility value for these health states to generate an index score from -0.594 (severe problems in all 5 D) to 1 (no problem in all 5 D) where 1=best possible health state. EQ-5D VAS rates participant's current health-related QoL on the day of questionnaire administration and is captured on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L)
    unit Of Measure
    units on a scale
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          37.87
          value
          56.32
      title
      NOD (n=57)
    2. categories
      1. measurements
        1. group Id
          BG000
          spread
          32.20
          value
          78.51
      title
      UOS (n=57)
    3. categories
      1. measurements
        1. group Id
          BG000
          spread
          34.42
          value
          71.93
      title
      EIP (n=57)
    description
    Clinician measured speaking and eating disabilities of HNC participants that consists 3 subscales: normalcy of diet (NOD) measures ability of eating a normal diet, scale from 0 (non-oral feeding) to 100 (unrestricted diet); understandability of speech (UOS) measures the degree a clinician was able to understand participant's speech, scale from 0 (never understandable) to 100 (always understandable); eating in public (EIP) is based on clinician's question to the participant, scale from 0 (always eats alone) to 100 (no restriction of place, food, or companion).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Performance Status Scale for Head and Neck Cancer (PSS-HNC)
    unit Of Measure
    units on a scale
population Description
All enrolled participants who received at least 1 dose of study drug.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice