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NCT01057589 · BASELINE

Baseline characteristics

A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2013-09-18

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
      66
    units
    Participants
groups
  1. description
    Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
    id
    BG000
    title
    Pemetrexed Cisplatin Cetuximab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.56
          value
          61.8
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          53
        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
          66
      title
      White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Italy
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Spain
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      66
    units
    Participants
groups
  1. description
    Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
    id
    BG000
    title
    Pemetrexed Cisplatin Cetuximab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.56
          value
          61.8
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          53
        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
          66
      title
      White
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Belgium
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          32
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Italy
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Spain
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      United Kingdom
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice