Skip to content
TriangleGet started
← Full study record

NCT01059630 · FLOW

Participant flow

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) · Source last updated 2020-01-13

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

groups
  1. description
    Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
    id
    FG000
    title
    Bendamustine Alone
  2. description
    Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
    id
    FG001
    title
    Obinutuzumab + Bendamustine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        84
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        14
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        209
      2. group Id
        FG001
        num Subjects
        204
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        82
      2. group Id
        FG001
        num Subjects
        101
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        103
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
    id
    FG000
    title
    Bendamustine Alone
  2. description
    Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
    id
    FG001
    title
    Obinutuzumab + Bendamustine
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        100
      2. group Id
        FG001
        num Subjects
        84
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        14
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        209
      2. group Id
        FG001
        num Subjects
        204
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        82
      2. group Id
        FG001
        num Subjects
        101
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        127
      2. group Id
        FG001
        num Subjects
        103
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice