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NCT02037256 · BASELINE

Baseline characteristics

Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2021-05-10

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
      3
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      20
    units
    Participants
groups
  1. description
    Pts. receive filgrastim SC on days 1-9 \& begin apheresis on day 5. Pts. undergo apheresis for up to 2 days, \& receive bortezomib intravenously (IV) over 3-5 seconds after target collection is obtained with filgrastim alone or on the 1st day of collection with the Bortezomib plus filgrastim mobilization, prior to receiving the administration of filgrastim. 2nd apheresis will continue until target stem cell dose is reached or for maximum 4 days. Pts. undergo autologous hematopoietic stem cell transplantation after receiving high dose chemotherapy \& peripheral blood stem cell (PBSC) infusion following standard of care procedures. bortezomib: Given IV filgrastim: Given SC autologous hematopoietic stem cell transplantation: Under
    id
    BG000
    title
    Arm A
  2. description
    Pts. receive filgrastim SC on days 1-8 \& receive bortezomib IV over 3-5 seconds on days 4 \& day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8
    id
    BG001
    title
    Arm B
  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
          2
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          15
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        >=65 years
      title
      g
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          67
          value
          62
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          68
          value
          56
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          68
          value
          58
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. 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
          0
        3. group Id
          BG002
          value
          0
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          16
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          3
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          20
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Evaluable participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      17
    3. group Id
      BG002
      value
      20
    units
    Participants
groups
  1. description
    Pts. receive filgrastim SC on days 1-9 \& begin apheresis on day 5. Pts. undergo apheresis for up to 2 days, \& receive bortezomib intravenously (IV) over 3-5 seconds after target collection is obtained with filgrastim alone or on the 1st day of collection with the Bortezomib plus filgrastim mobilization, prior to receiving the administration of filgrastim. 2nd apheresis will continue until target stem cell dose is reached or for maximum 4 days. Pts. undergo autologous hematopoietic stem cell transplantation after receiving high dose chemotherapy \& peripheral blood stem cell (PBSC) infusion following standard of care procedures. bortezomib: Given IV filgrastim: Given SC autologous hematopoietic stem cell transplantation: Under
    id
    BG000
    title
    Arm A
  2. description
    Pts. receive filgrastim SC on days 1-8 \& receive bortezomib IV over 3-5 seconds on days 4 \& day 7, before administration of filgrastim. Pts. undergo apheresis on days 5-8
    id
    BG001
    title
    Arm B
  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
          2
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          15
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          5
        title
        >=65 years
      title
      g
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          67
          value
          62
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          68
          value
          56
        3. group Id
          BG002
          lower Limit
          40
          upper Limit
          68
          value
          58
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. 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
          0
        3. group Id
          BG002
          value
          0
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          16
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          3
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          20
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
Evaluable participants

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

Preserved source evidence · Not medical advice