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NCT01332968 · BASELINE

Baseline characteristics

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) · Source last updated 2022-08-11

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
      699
    2. group Id
      BG001
      value
      702
    3. group Id
      BG002
      value
      1401
    units
    Participants
groups
  1. description
    Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
    id
    BG000
    title
    Rituximab+Chemotherapy - Induction Period
  2. description
    Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
    id
    BG001
    title
    Obinutuzumab+Chemotherapy - Induction Period
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          58.1
        2. group Id
          BG001
          spread
          11.6
          value
          58.9
        3. group Id
          BG002
          spread
          11.9
          value
          58.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          699
        2. group Id
          BG001
          value
          702
        3. group Id
          BG002
          value
          1401
        units
        Participants
    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
          374
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          739
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          325
        2. group Id
          BG001
          value
          337
        3. group Id
          BG002
          value
          662
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          699
        2. group Id
          BG001
          value
          702
        3. group Id
          BG002
          value
          1401
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.2
          value
          57.7
        2. group Id
          BG001
          spread
          11.5
          value
          58.2
        3. group Id
          BG002
          spread
          11.9
          value
          57.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          699
        2. group Id
          BG001
          value
          702
        3. group Id
          BG002
          value
          1401
        units
        Participants
    description
    Age continuous for participants with follicular lymphoma (FL) in each arm, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 in each arm).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous in Follicular Lymphoma Sub-Population
    unit Of Measure
    years
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          321
        2. group Id
          BG001
          value
          318
        3. group Id
          BG002
          value
          639
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          280
        2. group Id
          BG001
          value
          283
        3. group Id
          BG002
          value
          563
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          601
        2. group Id
          BG001
          value
          601
        3. group Id
          BG002
          value
          1202
        units
        Participants
    description
    Gender of participants with follicular lymphoma, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 for each arm).
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.
    title
    Gender in Follicular Lymphoma Sub-Population
    unit Of Measure
    Participants
population Description
The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      699
    2. group Id
      BG001
      value
      702
    3. group Id
      BG002
      value
      1401
    units
    Participants
groups
  1. description
    Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
    id
    BG000
    title
    Rituximab+Chemotherapy - Induction Period
  2. description
    Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
    id
    BG001
    title
    Obinutuzumab+Chemotherapy - Induction Period
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          58.1
        2. group Id
          BG001
          spread
          11.6
          value
          58.9
        3. group Id
          BG002
          spread
          11.9
          value
          58.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          699
        2. group Id
          BG001
          value
          702
        3. group Id
          BG002
          value
          1401
        units
        Participants
    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
          374
        2. group Id
          BG001
          value
          365
        3. group Id
          BG002
          value
          739
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          325
        2. group Id
          BG001
          value
          337
        3. group Id
          BG002
          value
          662
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          699
        2. group Id
          BG001
          value
          702
        3. group Id
          BG002
          value
          1401
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.2
          value
          57.7
        2. group Id
          BG001
          spread
          11.5
          value
          58.2
        3. group Id
          BG002
          spread
          11.9
          value
          57.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          699
        2. group Id
          BG001
          value
          702
        3. group Id
          BG002
          value
          1401
        units
        Participants
    description
    Age continuous for participants with follicular lymphoma (FL) in each arm, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 in each arm).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age Continuous in Follicular Lymphoma Sub-Population
    unit Of Measure
    years
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          321
        2. group Id
          BG001
          value
          318
        3. group Id
          BG002
          value
          639
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          280
        2. group Id
          BG001
          value
          283
        3. group Id
          BG002
          value
          563
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          601
        2. group Id
          BG001
          value
          601
        3. group Id
          BG002
          value
          1202
        units
        Participants
    description
    Gender of participants with follicular lymphoma, who encompassed the population for the primary outcome measure. The FL ITT included participants in the ITT population with follicular histology (n=601 for each arm).
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    As this is a sub-population, the numbers analyzed differ from the overall population numbers as not all are included here.
    title
    Gender in Follicular Lymphoma Sub-Population
    unit Of Measure
    Participants
population Description
The intent-to treat (ITT) population was defined as all randomized participants grouped according to their randomized treatment arm regardless of what treatments were actually received.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice