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NCT02425891 · FLOW

Participant flow

A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130) · Source last updated 2022-07-19

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

groups
  1. description
    Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Placebo Plus Nab-Paclitaxel
  2. description
    Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    FG001
    title
    Atezolizumab Plus Nab-Paclitaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        333
      2. group Id
        FG001
        num Subjects
        314
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Non-Compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Accidentally randomized screen failure participant
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        95
      type
      Study Terminated By Sponsor
    8. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        32
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        451
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        451
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The observation of Overall Survival events was complete. Participants still on treatment were handed over to follow-up programs or studies. The study status is "Completed" but some participants discontinued the study because the Sponsor terminated it after it reached the "Completed" state.
Complete source fields
groups
  1. description
    Participants assigned to placebo plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    FG000
    title
    Placebo Plus Nab-Paclitaxel
  2. description
    Participants assigned to atezolizumab plus nab-paclitaxel received both agents until disease progression or unacceptable toxicity.
    id
    FG001
    title
    Atezolizumab Plus Nab-Paclitaxel
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        333
      2. group Id
        FG001
        num Subjects
        314
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        6
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Non-Compliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Accidentally randomized screen failure participant
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Physician Decision
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Protocol Violation
    7. reasons
      1. group Id
        FG000
        num Subjects
        85
      2. group Id
        FG001
        num Subjects
        95
      type
      Study Terminated By Sponsor
    8. reasons
      1. group Id
        FG000
        num Subjects
        27
      2. group Id
        FG001
        num Subjects
        32
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        451
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        451
      2. group Id
        FG001
        num Subjects
        451
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The observation of Overall Survival events was complete. Participants still on treatment were handed over to follow-up programs or studies. The study status is "Completed" but some participants discontinued the study because the Sponsor terminated it after it reached the "Completed" state.

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Preserved source evidence · Not medical advice