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NCT01282463 · BASELINE

Baseline characteristics

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma · Source last updated 2019-09-09

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
      45
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      49
    4. group Id
      BG003
      value
      140
    units
    Participants
groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
    id
    BG000
    title
    Docetaxel
  2. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
    id
    BG001
    title
    Docetaxel + Ramucirumab DP
  3. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
    id
    BG002
    title
    Docetaxel + Icrucumab
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.45
          value
          66.6
        2. group Id
          BG001
          spread
          9.06
          value
          66.7
        3. group Id
          BG002
          spread
          10.38
          value
          64.1
        4. group Id
          BG003
          spread
          10.33
          value
          65.7
    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
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          110
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          131
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        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
        4. group Id
          BG003
          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
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          95
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          45
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All randomized participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      45
    2. group Id
      BG001
      value
      46
    3. group Id
      BG002
      value
      49
    4. group Id
      BG003
      value
      140
    units
    Participants
groups
  1. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
    id
    BG000
    title
    Docetaxel
  2. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle
    id
    BG001
    title
    Docetaxel + Ramucirumab DP
  3. description
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle
    id
    BG002
    title
    Docetaxel + Icrucumab
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.45
          value
          66.6
        2. group Id
          BG001
          spread
          9.06
          value
          66.7
        3. group Id
          BG002
          spread
          10.38
          value
          64.1
        4. group Id
          BG003
          spread
          10.33
          value
          65.7
    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
          10
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          30
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          110
        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
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          131
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          11
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        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
        4. group Id
          BG003
          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
          30
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          95
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          45
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All randomized participants who received at least 1 dose of study drug.

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Preserved source evidence · Not medical advice