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NCT01642004 · FLOW

Participant flow

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017) · Source last updated 2022-12-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
    id
    FG000
    title
    Nivolumab
  2. description
    Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    id
    FG001
    title
    Docetaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event unrelated to study drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Participant withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      No longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        137
      comment
      Started=Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        129
      comment
      Completed= participants that received treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Randomization
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        79
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        13
      type
      Study drug toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        13
      type
      Adverse event unrelated to study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        9
      type
      Maximum clinical benefit
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/non-compliance
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      No longer meets study criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Other reasons
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Not reported
    10. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      type
      Participant request to discontinue study treatment
    11. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      type
      Participant withdrew consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        129
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      type
      Participants Transitioned to Nivolumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Completed = continue in the treatment period
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        129
      type
      NOT COMPLETED
    title
    Treatment
Complete source fields
groups
  1. description
    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
    id
    FG000
    title
    Nivolumab
  2. description
    Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    id
    FG001
    title
    Docetaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event unrelated to study drug
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        6
      type
      Participant withdrew consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      No longer meets study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        135
      2. group Id
        FG001
        num Subjects
        137
      comment
      Started=Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        129
      comment
      Completed= participants that received treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Randomization
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        95
      2. group Id
        FG001
        num Subjects
        79
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        13
      type
      Study drug toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        13
      type
      Adverse event unrelated to study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        9
      type
      Maximum clinical benefit
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/non-compliance
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      No longer meets study criteria
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Other reasons
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Not reported
    10. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        4
      type
      Participant request to discontinue study treatment
    11. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      type
      Participant withdrew consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        129
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      type
      Participants Transitioned to Nivolumab
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Completed = continue in the treatment period
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        131
      2. group Id
        FG001
        num Subjects
        129
      type
      NOT COMPLETED
    title
    Treatment

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Preserved source evidence · Not medical advice