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NCT02603432 · BASELINE

Baseline characteristics

A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) · Source last updated 2024-03-27

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
      350
    2. group Id
      BG001
      value
      350
    3. group Id
      BG002
      value
      700
    units
    Participants
groups
  1. description
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    id
    BG000
    title
    Avelumab + Best Supportive Care (BSC)
  2. description
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    id
    BG001
    title
    Best Supportive Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.52
          value
          67.20
        2. group Id
          BG001
          spread
          9.20
          value
          67.7
        3. group Id
          BG002
          spread
          9.40
          value
          67.44
    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
          84
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          275
        3. group Id
          BG002
          value
          541
        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
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          286
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          584
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          86
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          156
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          470
        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
          41
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          72
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The full analysis set included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      350
    2. group Id
      BG001
      value
      350
    3. group Id
      BG002
      value
      700
    units
    Participants
groups
  1. description
    Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    id
    BG000
    title
    Avelumab + Best Supportive Care (BSC)
  2. description
    As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
    id
    BG001
    title
    Best Supportive Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.52
          value
          67.20
        2. group Id
          BG001
          spread
          9.20
          value
          67.7
        3. group Id
          BG002
          spread
          9.40
          value
          67.44
    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
          84
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          159
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          275
        3. group Id
          BG002
          value
          541
        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
          18
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          30
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          286
        2. group Id
          BG001
          value
          298
        3. group Id
          BG002
          value
          584
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          86
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          156
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          232
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          470
        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
          41
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          72
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The full analysis set included all randomized participants.

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Preserved source evidence · Not medical advice