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NCT00600353 · BASELINE

Baseline characteristics

Multi-day Doses in Prevention of Nausea and Emesis · Source last updated 2017-03-09

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
      9
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      18
    units
    Participants
groups
  1. description
    Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
    id
    BG000
    title
    Subjects With Multiple Myeloma
  2. description
    Includes patients with Hodgkin's Disease and Non-Hodgkin's lymphoma
    id
    BG001
    title
    Group B Lymphoma
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        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
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          9
          value
          9
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          9
          value
          9
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          18
          value
          9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    emetic response, adverse events, quality of care
    unit Of Measure
    participants
population Description
2 patients excluded from analysis
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      9
    2. group Id
      BG001
      value
      9
    3. group Id
      BG002
      value
      18
    units
    Participants
groups
  1. description
    Group A: Subjects with Multiple Myeloma * Conditioning regimen, over a 7 day period, includes: * Melphalan 70-100 mg, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Dexamethasone 4 mg IV and Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell infusion Group B: Subjects with Lymphoma * Conditioning regimen, over a 7 day period, includes: (BEAC) * BCNU 300 mg/m2 IV x 1,Cytarabine 100 mg/m2 IV BID, Etoposide 100 mg/m2 IV BID, administer after, Cyclophosphamide 35 mg/kg QD, Dexamethasone 4 mg IV push, Aprepitant 125 mg PO, Palonosetron 0.25 mg IV over 30 seconds, Aprepitant 80 mg PO, Lorazepam 1 mg IV x 1 dose 30 minutes prior to stem cell transplant
    id
    BG000
    title
    Subjects With Multiple Myeloma
  2. description
    Includes patients with Hodgkin's Disease and Non-Hodgkin's lymphoma
    id
    BG001
    title
    Group B Lymphoma
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        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
          9
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          18
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          9
          value
          9
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          9
          value
          9
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          18
          value
          9
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    emetic response, adverse events, quality of care
    unit Of Measure
    participants
population Description
2 patients excluded from analysis

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Preserved source evidence · Not medical advice