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NCT01049945 · BASELINE

Baseline characteristics

Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2020-02-11

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
      15
    2. group Id
      BG001
      value
      55
    3. group Id
      BG002
      value
      70
    units
    Participants
groups
  1. description
    Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
    id
    BG000
    title
    Phase I
  2. description
    Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
    id
    BG001
    title
    Maximum Tolerated Dose, Dose Level 4
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41.8
          upper Limit
          75.0
          value
          63.5
        2. group Id
          BG001
          lower Limit
          40.1
          upper Limit
          86.3
          value
          61.9
        3. group Id
          BG002
          lower Limit
          40.1
          upper Limit
          86.3
          value
          62.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          40
        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
          15
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          70
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    2. group Id
      BG001
      value
      55
    3. group Id
      BG002
      value
      70
    units
    Participants
groups
  1. description
    Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
    id
    BG000
    title
    Phase I
  2. description
    Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
    id
    BG001
    title
    Maximum Tolerated Dose, Dose Level 4
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41.8
          upper Limit
          75.0
          value
          63.5
        2. group Id
          BG001
          lower Limit
          40.1
          upper Limit
          86.3
          value
          61.9
        3. group Id
          BG002
          lower Limit
          40.1
          upper Limit
          86.3
          value
          62.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          40
        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
          15
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          70
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice