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NCT01938001 · BASELINE

Baseline characteristics

Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) · Source last updated 2023-02-22

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
      178
    2. group Id
      BG001
      value
      180
    3. group Id
      BG002
      value
      358
    units
    Participants
groups
  1. description
    Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
    id
    BG000
    title
    Rituximab + Lenalidomide (R^2)
  2. description
    Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
    id
    BG001
    title
    Rituximab + Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.227
          value
          62.30
        2. group Id
          BG001
          spread
          11.160
          value
          61.48
        3. group Id
          BG002
          spread
          11.186
          value
          61.89
    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
          103
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          186
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          172
        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
          24
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          44
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          305
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        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
          118
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          233
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          118
        title
        Other Races
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Not Collected or Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intent to treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received investigational product (IP) or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      178
    2. group Id
      BG001
      value
      180
    3. group Id
      BG002
      value
      358
    units
    Participants
groups
  1. description
    Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
    id
    BG000
    title
    Rituximab + Lenalidomide (R^2)
  2. description
    Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
    id
    BG001
    title
    Rituximab + Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.227
          value
          62.30
        2. group Id
          BG001
          spread
          11.160
          value
          61.48
        3. group Id
          BG002
          spread
          11.186
          value
          61.89
    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
          103
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          186
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          172
        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
          24
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          44
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          147
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          305
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        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
          118
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          233
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          118
        title
        Other Races
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        title
        Not Collected or Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intent to treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received investigational product (IP) or not.

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Preserved source evidence · Not medical advice