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NCT01018979 · FLOW

Participant flow

Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · Source last updated 2021-05-11

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

groups
  1. description
    TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    FG000
    title
    TG-0054 (2.24 mg/kg)
  2. description
    TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    FG001
    title
    TG-0054 (3.14 mg/kg)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      type
      Peak CD34+ cell count in PB < 10 cell/uL
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Not received at least one dose
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. comment
        A total of 20 subjects were randomized.
        group Id
        FG001
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        12
      type
      Received at Least One Dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054.
Complete source fields
groups
  1. description
    TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    FG000
    title
    TG-0054 (2.24 mg/kg)
  2. description
    TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    FG001
    title
    TG-0054 (3.14 mg/kg)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        9
      type
      Peak CD34+ cell count in PB < 10 cell/uL
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Not received at least one dose
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. comment
        A total of 20 subjects were randomized.
        group Id
        FG001
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        12
      type
      Received at Least One Dose
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054.

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

Preserved source evidence · Not medical advice