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NCT00896454 · FLOW

Participant flow

Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium · Source last updated 2018-10-17

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

groups
  1. description
    Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
    id
    FG000
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Requirement for alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Ongoing in study
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
First patient was enrolled on 16 November 2009 and the last patient enrolled on 02 July 2012. Data are reported as of the primary analysis cut-off date of 13 September 2012.
Complete source fields
groups
  1. description
    Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
    id
    FG000
    title
    Denosumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        10
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Disease Progression
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Requirement for alternative therapy
    6. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Ongoing in study
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        33
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
First patient was enrolled on 16 November 2009 and the last patient enrolled on 02 July 2012. Data are reported as of the primary analysis cut-off date of 13 September 2012.

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Preserved source evidence · Not medical advice