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NCT00072475 · FLOW

Participant flow

Vatalanib in Treating Patients With Primary or Secondary Myelodysplastic Syndromes · Source last updated 2016-08-01

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

groups
  1. description
    Adult patients with MDS receive treatment with vatalanib. vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
    id
    FG000
    title
    Vatalanib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        44
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        46
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Patient/Investigator Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        142
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        97
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 155 participants recruited, 2 participants cancelled prior to starting treatment; 7 were determined to have AML at registration and 4 had diagnosis other than MDS. Thus 142 participants were evaluable for response and 153 for adverse events.
recruitment Details
A total of 155 participants were enrolled between December 2003 and April 2008.
Complete source fields
groups
  1. description
    Adult patients with MDS receive treatment with vatalanib. vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or \> tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
    id
    FG000
    title
    Vatalanib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        44
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        46
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Patient/Investigator Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        142
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        45
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        97
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Of the 155 participants recruited, 2 participants cancelled prior to starting treatment; 7 were determined to have AML at registration and 4 had diagnosis other than MDS. Thus 142 participants were evaluable for response and 153 for adverse events.
recruitment Details
A total of 155 participants were enrolled between December 2003 and April 2008.

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Preserved source evidence · Not medical advice