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NCT02414139 · FLOW

Participant flow

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1) · Source last updated 2024-03-20

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

groups
  1. description
    Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG000
    title
    Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
  2. description
    Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
    id
    FG001
    title
    Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
  3. description
    Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG002
    title
    Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
  4. description
    Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG003
    title
    Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
  5. description
    Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG004
    title
    Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
  6. description
    Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
    id
    FG005
    title
    Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
  7. description
    Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
    id
    FG006
    title
    Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
  8. description
    Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
    id
    FG007
    title
    Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
  9. description
    Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
    id
    FG008
    title
    Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
  10. description
    Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
    id
    FG009
    title
    Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        8
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        4
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        43
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        16
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        20
      10. group Id
        FG009
        num Subjects
        14
      type
      Progressive disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Protocol deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      type
      Subject/Guardian decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        4
      type
      Study terminated (as per protocol) by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        54
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        69
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        28
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        31
      10. group Id
        FG009
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        54
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        69
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        28
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        31
      10. group Id
        FG009
        num Subjects
        32
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        15
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        3
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Study terminated by sponsor
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      type
      Subject/guardian decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Post-treatment Efficacy Follow-up
pre Assignment Details
Screening assessments were conducted up to 28 days prior to the start of study treatment
recruitment Details
Participants were enrolled in 95 centers across 20 countries
Complete source fields
groups
  1. description
    Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG000
    title
    Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
  2. description
    Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
    id
    FG001
    title
    Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
  3. description
    Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG002
    title
    Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
  4. description
    Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG003
    title
    Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
  5. description
    Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
    id
    FG004
    title
    Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
  6. description
    Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
    id
    FG005
    title
    Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
  7. description
    Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
    id
    FG006
    title
    Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
  8. description
    Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
    id
    FG007
    title
    Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
  9. description
    Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
    id
    FG008
    title
    Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
  10. description
    Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
    id
    FG009
    title
    Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        14
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        8
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        4
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        31
      3. group Id
        FG002
        num Subjects
        37
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        43
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        16
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        20
      10. group Id
        FG009
        num Subjects
        14
      type
      Progressive disease
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Protocol deviation
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      type
      Subject/Guardian decision
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        4
      type
      Study terminated (as per protocol) by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        54
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        69
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        28
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        31
      10. group Id
        FG009
        num Subjects
        32
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        69
      2. group Id
        FG001
        num Subjects
        42
      3. group Id
        FG002
        num Subjects
        54
      4. group Id
        FG003
        num Subjects
        30
      5. group Id
        FG004
        num Subjects
        69
      6. group Id
        FG005
        num Subjects
        15
      7. group Id
        FG006
        num Subjects
        28
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        31
      10. group Id
        FG009
        num Subjects
        32
      type
      NOT COMPLETED
    title
    Treatment Period
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        15
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        3
      type
      Progressive disease
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Study terminated by sponsor
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      type
      Subject/guardian decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        16
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        8
      type
      NOT COMPLETED
    title
    Post-treatment Efficacy Follow-up
pre Assignment Details
Screening assessments were conducted up to 28 days prior to the start of study treatment
recruitment Details
Participants were enrolled in 95 centers across 20 countries

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