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NCT03125902 · OUTCOME

Percentage of Participants Who Are Alive at 12 and 18 Months

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 to death from any cause, assessed up to 12 and 18 months

Analysis population: ITT population: all randomized participants, whether or not the assigned study treatment was received

Groups in this outcome

Placebo and Paclitaxel

Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Atezolizumab and Paclitaxel

Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo and Paclitaxel220
Atezolizumab and Paclitaxel431

Reported measurements

12 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel73.47Not reported67.4479.49Not reported
Atezolizumab and Paclitaxel68.86Not reported64.3773.34Not reported
18 months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel56.18Not reported48.9463.42Not reported
Atezolizumab and Paclitaxel52.32Not reported47.1557.48Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        67.44
        upper Limit
        79.49
        value
        73.47
      2. group Id
        OG001
        lower Limit
        64.37
        upper Limit
        73.34
        value
        68.86
    title
    12 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.94
        upper Limit
        63.42
        value
        56.18
      2. group Id
        OG001
        lower Limit
        47.15
        upper Limit
        57.48
        value
        52.32
    title
    18 months
denoms
  1. counts
    1. group Id
      OG000
      value
      220
    2. group Id
      OG001
      value
      431
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo and Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Atezolizumab and Paclitaxel
param Type
NUMBER
population Description
ITT population: all randomized participants, whether or not the assigned study treatment was received
reporting Status
POSTED
time Frame
From Day 1 to death from any cause, assessed up to 12 and 18 months
title
Percentage of Participants Who Are Alive at 12 and 18 Months
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice