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NCT01721746 · FLOW

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A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037) · Source last updated 2022-04-19

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 IV over 60 minutes Q2W
    id
    FG000
    title
    Nivolumab
  2. description
    Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
    id
    FG001
    title
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      type
      Participant request to discontinue Study treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/Non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant no longer met study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        272
      2. group Id
        FG001
        num Subjects
        133
      comment
      Started = Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        102
      comment
      Completed = Received Treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        192
      2. group Id
        FG001
        num Subjects
        74
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        11
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      Adverse Event unrelated to Study Drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        7
      type
      Participant request to discontinue Study treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        3
      type
      Maximum Clinical Benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/Non-compliance
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant no longer met Study criteria
    9. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        102
      comment
      Started = Received treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Completed = Completed treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        102
      type
      NOT COMPLETED
    title
    Treatment
pre Assignment Details
405 participants randomized and 370 treated.
Complete source fields
groups
  1. description
    Nivolumab 3 mg/kg IV over 60 minutes Q2W
    id
    FG000
    title
    Nivolumab
  2. description
    Dacarbazine: 1000 mg/m\^2 IV over 30 to 60 minutes Q3W, or Carboplatin: Area under the concentration-time curve (AUC) 6 IV over 30 minutes Q3W, and Paclitaxel: 175 mg/m\^2 IV over 180 minutes Q3W
    id
    FG001
    title
    Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        13
      type
      Participant request to discontinue Study treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        16
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/Non-compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant no longer met study criteria
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        272
      2. group Id
        FG001
        num Subjects
        133
      comment
      Started = Randomized
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        102
      comment
      Completed = Received Treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        31
      type
      NOT COMPLETED
    title
    Pre-Treatment
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        192
      2. group Id
        FG001
        num Subjects
        74
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        19
      2. group Id
        FG001
        num Subjects
        11
      type
      Study Drug Toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      type
      Adverse Event unrelated to Study Drug
    4. reasons
      1. group Id
        FG000
        num Subjects
        26
      2. group Id
        FG001
        num Subjects
        7
      type
      Participant request to discontinue Study treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      type
      Participant withdrew consent
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        3
      type
      Maximum Clinical Benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Poor/Non-compliance
    8. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant no longer met Study criteria
    9. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      type
      Other reasons
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        102
      comment
      Started = Received treatment
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      comment
      Completed = Completed treatment
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        268
      2. group Id
        FG001
        num Subjects
        102
      type
      NOT COMPLETED
    title
    Treatment
pre Assignment Details
405 participants randomized and 370 treated.

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

Preserved source evidence · Not medical advice