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NCT03630042 · BASELINE

Baseline characteristics

Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia · Source last updated 2024-11-07

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
      17
    units
    Participants
groups
  1. description
    Pembrolizumab: 200 mg IV dose given on day 1 of a three week cycle Rituximab: 375 mg/m2 IV dose given up to 8 times in the trial
    id
    BG000
    title
    Pembrolizumab and Rituximab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          64.5
          upper Limit
          76.1
          value
          70.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          17
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          17
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        ECOG 2
      denoms
      1. counts
        1. group Id
          BG000
          value
          17
        units
        Participants
    description
    ECOG Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      17
    units
    Participants
groups
  1. description
    Pembrolizumab: 200 mg IV dose given on day 1 of a three week cycle Rituximab: 375 mg/m2 IV dose given up to 8 times in the trial
    id
    BG000
    title
    Pembrolizumab and Rituximab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          64.5
          upper Limit
          76.1
          value
          70.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          17
        units
        Participants
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          17
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        ECOG 0
      2. measurements
        1. group Id
          BG000
          value
          7
        title
        ECOG 1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        ECOG 2
      denoms
      1. counts
        1. group Id
          BG000
          value
          17
        units
        Participants
    description
    ECOG Performance Status 0: Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice