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NCT01160380 · BASELINE

Baseline characteristics

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma · Source last updated 2014-11-06

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
      25
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      50
    units
    Participants
groups
  1. description
    The patients receive armodafinil for all 56 days of the study. armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
    id
    BG000
    title
    Armodafinil
  2. description
    These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets. Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
    id
    BG001
    title
    Placebo-First
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.8
          value
          63
        2. group Id
          BG001
          spread
          2.3
          value
          67
        3. group Id
          BG002
          spread
          2.1
          value
          65
    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
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      2
    description
    Grade ECOG Performance status 0 Fully active, performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. Dead
    param Type
    NUMBER
    title
    ECOG (Eastern Cooperative Oncology Group)
    unit Of Measure
    paarticipants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39
          upper Limit
          83
          value
          59
        2. group Id
          BG001
          lower Limit
          36
          upper Limit
          79
          value
          60.5
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          83
          value
          60
    description
    BFI scale: 9 items; range=0-90 (0-10 per item) Mild = 1-3 Moderate = 4-7 Severe = 8-10
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Fatigue (baseline)-Brief Fatigue Inventory (BFI)
    unit Of Measure
    units on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6
          upper Limit
          12
          value
          9
        2. group Id
          BG001
          lower Limit
          6
          upper Limit
          12
          value
          9
        3. group Id
          BG002
          lower Limit
          6
          upper Limit
          12
          value
          9
    description
    ICD-10 Criteria (Range: 0-14) A1-A11 Fatigue Criteria B. Clinically significant distress or impaired functioning C. Symptoms are a consequence of cancer or cancer therapy D. Symptoms are a consequence of comorbid psychiatric disorders
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10)
    unit Of Measure
    units on a scale
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      25
    2. group Id
      BG001
      value
      25
    3. group Id
      BG002
      value
      50
    units
    Participants
groups
  1. description
    The patients receive armodafinil for all 56 days of the study. armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
    id
    BG000
    title
    Armodafinil
  2. description
    These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets. Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
    id
    BG001
    title
    Placebo-First
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.8
          value
          63
        2. group Id
          BG001
          spread
          2.3
          value
          67
        3. group Id
          BG002
          spread
          2.1
          value
          65
    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
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          37
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      2
    description
    Grade ECOG Performance status 0 Fully active, performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. Dead
    param Type
    NUMBER
    title
    ECOG (Eastern Cooperative Oncology Group)
    unit Of Measure
    paarticipants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39
          upper Limit
          83
          value
          59
        2. group Id
          BG001
          lower Limit
          36
          upper Limit
          79
          value
          60.5
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          83
          value
          60
    description
    BFI scale: 9 items; range=0-90 (0-10 per item) Mild = 1-3 Moderate = 4-7 Severe = 8-10
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Fatigue (baseline)-Brief Fatigue Inventory (BFI)
    unit Of Measure
    units on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6
          upper Limit
          12
          value
          9
        2. group Id
          BG001
          lower Limit
          6
          upper Limit
          12
          value
          9
        3. group Id
          BG002
          lower Limit
          6
          upper Limit
          12
          value
          9
    description
    ICD-10 Criteria (Range: 0-14) A1-A11 Fatigue Criteria B. Clinically significant distress or impaired functioning C. Symptoms are a consequence of cancer or cancer therapy D. Symptoms are a consequence of comorbid psychiatric disorders
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Fatigue (baseline)-International Classification of Diseases version 10 (ICD-10)
    unit Of Measure
    units on a scale

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Preserved source evidence · Not medical advice