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NCT02187783 · FLOW

Participant flow

LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE) · Source last updated 2019-07-18

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

groups
  1. description
    LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
    id
    FG000
    title
    Ribociclib 600 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        80
      type
      Progressive disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        106
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        105
      type
      Patients With Solid Tumors
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        106
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
There were 176 patients screened
Complete source fields
groups
  1. description
    LEE011 600 mg (hard gelatin capsules) was administered orally once daily for 3 weeks on/1 week off. A complete treatment cycle was defined as 28 days.
    id
    FG000
    title
    Ribociclib 600 mg
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        80
      type
      Progressive disease
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Withdrawal by Subject
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Study terminated by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        106
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        105
      type
      Patients With Solid Tumors
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        106
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
There were 176 patients screened

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice