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NCT00559273 · FLOW

Participant flow

A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis · Source last updated 2016-11-01

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

groups
  1. description
    Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
    id
    FG000
    title
    Mircera
  2. description
    Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
    id
    FG001
    title
    Darbepoetin Alfa
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant treated by another center
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Did not received study treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        151
      2. group Id
        FG001
        num Subjects
        154
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        142
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Correction Period (20 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        142
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        141
      2. group Id
        FG001
        num Subjects
        137
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Evaluation Period (8 Weeks)
Complete source fields
groups
  1. description
    Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
    id
    FG000
    title
    Mircera
  2. description
    Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
    id
    FG001
    title
    Darbepoetin Alfa
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Participant treated by another center
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Did not received study treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        153
      2. group Id
        FG001
        num Subjects
        154
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        151
      2. group Id
        FG001
        num Subjects
        154
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        142
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Correction Period (20 Weeks)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        144
      2. group Id
        FG001
        num Subjects
        142
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        141
      2. group Id
        FG001
        num Subjects
        137
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Evaluation Period (8 Weeks)

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Preserved source evidence · Not medical advice