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NCT01010061 · BASELINE

Baseline characteristics

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

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
      238
    2. group Id
      BG001
      value
      118
    3. group Id
      BG002
      value
      356
    units
    Participants
groups
  1. description
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
    id
    BG000
    title
    Obinutuzumab + Chlorambucil (GClb)
  2. description
    Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
    id
    BG001
    title
    Chlorambucil (Clb)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          68
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          288
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          215
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Baseline measures are based on the participants who were included in the Stage 1a analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      238
    2. group Id
      BG001
      value
      118
    3. group Id
      BG002
      value
      356
    units
    Participants
groups
  1. description
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
    id
    BG000
    title
    Obinutuzumab + Chlorambucil (GClb)
  2. description
    Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
    id
    BG001
    title
    Chlorambucil (Clb)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          68
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          288
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          98
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          141
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          140
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          215
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Baseline measures are based on the participants who were included in the Stage 1a analysis.

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

Preserved source evidence · Not medical advice