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NCT01668784 · FLOW

Participant flow

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025) · Source last updated 2022-08-09

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

groups
  1. description
    Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    FG000
    title
    Nivolumab
  2. description
    Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    FG001
    title
    Everolimus
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Request to Discontinue Study Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/Non-Compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      No Longer Meets Study Criteria
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      participant requested to be treated a local facility
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        410
      2. group Id
        FG001
        num Subjects
        411
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        397
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Randomized (Pre-treatment)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        316
      2. group Id
        FG001
        num Subjects
        293
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        53
      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
        14
      2. group Id
        FG001
        num Subjects
        14
      type
      Adverse Event Unrelated to Study Drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        21
      type
      Request to Discontinue Study Treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Maximal Clinical Benefit
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      type
      Other
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative Reason by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        397
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        397
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
803 Participants Treated
Complete source fields
groups
  1. description
    Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    FG000
    title
    Nivolumab
  2. description
    Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    FG001
    title
    Everolimus
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      type
      Request to Discontinue Study Treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/Non-Compliance
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      No Longer Meets Study Criteria
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      participant requested to be treated a local facility
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        410
      2. group Id
        FG001
        num Subjects
        411
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        397
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Randomized (Pre-treatment)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        316
      2. group Id
        FG001
        num Subjects
        293
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        53
      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
        14
      2. group Id
        FG001
        num Subjects
        14
      type
      Adverse Event Unrelated to Study Drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        21
      type
      Request to Discontinue Study Treatment
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      Maximal Clinical Benefit
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        8
      type
      Other
    9. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative Reason by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        397
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        406
      2. group Id
        FG001
        num Subjects
        397
      type
      NOT COMPLETED
    title
    Treatment Period
pre Assignment Details
803 Participants Treated

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Preserved source evidence · Not medical advice