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NCT00104650 · FLOW

Participant flow

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates · Source last updated 2011-01-24

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

groups
  1. description
    Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
    id
    FG000
    title
    Bisphosphonate IV Q4W
  2. description
    Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
    id
    FG001
    title
    Denosumab 180 mg Q12W
  3. description
    Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
    id
    FG002
    title
    Denosumab 180 mg Q4W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Ineligibility determined
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol deviation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        38
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        35
      3. group Id
        FG002
        num Subjects
        38
      type
      Received Investigational Product
    3. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        28
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Treatment Period (25 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        18
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Follow-up Period
recruitment Details
Participants were enrolled from 2 December 2004 through 30 March 2007
Complete source fields
groups
  1. description
    Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
    id
    FG000
    title
    Bisphosphonate IV Q4W
  2. description
    Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
    id
    FG001
    title
    Denosumab 180 mg Q12W
  3. description
    Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
    id
    FG002
    title
    Denosumab 180 mg Q4W
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        6
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      Disease progression
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Ineligibility determined
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Protocol deviation
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      2. group Id
        FG001
        num Subjects
        36
      3. group Id
        FG002
        num Subjects
        38
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        35
      2. group Id
        FG001
        num Subjects
        35
      3. group Id
        FG002
        num Subjects
        38
      type
      Received Investigational Product
    3. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        28
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Treatment Period (25 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Lost to Follow-up
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        28
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        18
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        13
      3. group Id
        FG002
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Follow-up Period
recruitment Details
Participants were enrolled from 2 December 2004 through 30 March 2007

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Preserved source evidence · Not medical advice