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NCT02632786 · FLOW

Participant flow

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis · Source last updated 2019-04-05

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

groups
  1. description
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    id
    FG000
    title
    NEOD001 24mg/kg
  2. description
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        63
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        63
      type
      Informed Consent Obtained
    3. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        63
      type
      Randomized and Dosed
    4. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        56
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    NEOD001, 24 mg/kg IV every 4 weeks for 12 months
    id
    FG000
    title
    NEOD001 24mg/kg
  2. description
    Placebo, 0.9% Saline IV every 4 weeks for 12 months
    id
    FG001
    title
    Placebo
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        63
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        63
      type
      Informed Consent Obtained
    3. achievements
      1. group Id
        FG000
        num Subjects
        66
      2. group Id
        FG001
        num Subjects
        63
      type
      Randomized and Dosed
    4. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        56
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice