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NCT04172467 · BASELINE

Baseline characteristics

Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients · Source last updated 2022-01-10

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
      1086
    units
    Participants
groups
  1. description
    This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
    id
    BG000
    title
    Non-interventional Retrospective Observational Study.
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          267
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          819
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33
          upper Limit
          93
          value
          73
    description
    Age at the start of the therapy line under investigation
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          475
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          611
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1086
        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
          1086
      title
      Germany
    description
    This was a retrospective sample analysis of patients from practices and hospitals in Germany who were representatively screened using previously collected care parameters of the participating institutions. Previous and current treatment and infection data were collected from patients who received a line of therapy for the treatment of CLL or MM started in 2018 (1st, 2nd and 3rd or higher line). The time period was chosen to ensure that patients have been followed up for at least 12 months in order to collect data on susceptibility to infection and possible secondary immunodeficiencies.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          539
        title
        1st line
      2. measurements
        1. group Id
          BG000
          value
          317
        title
        2nd line
      3. measurements
        1. group Id
          BG000
          value
          230
        title
        3rd line
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Therapy Line
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          490
        title
        Chronic Lymphocytic Leukaemia (CLL)
      2. measurements
        1. group Id
          BG000
          value
          596
        title
        Multiple Myeloma (MM)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease
    unit Of Measure
    Participants
population Description
Patients with chronic lymphocytic leukaemia and multiple myeloma and systemic treatment in 2018
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1086
    units
    Participants
groups
  1. description
    This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
    id
    BG000
    title
    Non-interventional Retrospective Observational Study.
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          267
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          819
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33
          upper Limit
          93
          value
          73
    description
    Age at the start of the therapy line under investigation
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          475
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          611
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1086
        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
          1086
      title
      Germany
    description
    This was a retrospective sample analysis of patients from practices and hospitals in Germany who were representatively screened using previously collected care parameters of the participating institutions. Previous and current treatment and infection data were collected from patients who received a line of therapy for the treatment of CLL or MM started in 2018 (1st, 2nd and 3rd or higher line). The time period was chosen to ensure that patients have been followed up for at least 12 months in order to collect data on susceptibility to infection and possible secondary immunodeficiencies.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          539
        title
        1st line
      2. measurements
        1. group Id
          BG000
          value
          317
        title
        2nd line
      3. measurements
        1. group Id
          BG000
          value
          230
        title
        3rd line
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Therapy Line
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          490
        title
        Chronic Lymphocytic Leukaemia (CLL)
      2. measurements
        1. group Id
          BG000
          value
          596
        title
        Multiple Myeloma (MM)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease
    unit Of Measure
    Participants
population Description
Patients with chronic lymphocytic leukaemia and multiple myeloma and systemic treatment in 2018

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

Preserved source evidence · Not medical advice