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NCT01412957 · FLOW

Participant flow

Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer · Source last updated 2017-03-15

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

groups
  1. description
    Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
    id
    FG000
    title
    Panitumumab + BSC
  2. description
    Participants received best supportive care until disease progression, withdrawal of consent, or death.
    id
    FG001
    title
    BSC Alone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        22
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        136
      2. group Id
        FG001
        num Subjects
        133
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        188
      type
      STARTED
    2. achievements
      1. comment
        Participants continuing study at the time of data cut-off
        group Id
        FG000
        num Subjects
        40
      2. comment
        Participants continuing study at the time of data cut-off
        group Id
        FG001
        num Subjects
        31
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        149
      2. group Id
        FG001
        num Subjects
        157
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were stratified according to geographic region (Europe vs Asia vs rest of the world) and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2) and randomized (1:1 ratio) to 1 of 2 treatment groups.
recruitment Details
A total of 377 participants were randomized at 66 centers in Europe, Asia, North and South America from 8 November 2011 until 30 July 2013. Results are reported as of the primary analysis data cut-off date of 10 June 2014.
Complete source fields
groups
  1. description
    Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
    id
    FG000
    title
    Panitumumab + BSC
  2. description
    Participants received best supportive care until disease progression, withdrawal of consent, or death.
    id
    FG001
    title
    BSC Alone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        22
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        136
      2. group Id
        FG001
        num Subjects
        133
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        189
      2. group Id
        FG001
        num Subjects
        188
      type
      STARTED
    2. achievements
      1. comment
        Participants continuing study at the time of data cut-off
        group Id
        FG000
        num Subjects
        40
      2. comment
        Participants continuing study at the time of data cut-off
        group Id
        FG001
        num Subjects
        31
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        149
      2. group Id
        FG001
        num Subjects
        157
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were stratified according to geographic region (Europe vs Asia vs rest of the world) and Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1 vs 2) and randomized (1:1 ratio) to 1 of 2 treatment groups.
recruitment Details
A total of 377 participants were randomized at 66 centers in Europe, Asia, North and South America from 8 November 2011 until 30 July 2013. Results are reported as of the primary analysis data cut-off date of 10 June 2014.

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Preserved source evidence · Not medical advice