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NCT03125902 · OUTCOME

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

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
Not reported
Time frame
From Day 1 From baseline up to 64 months

What was measured

Investigator text for AEs is coded using MedDRA version 25.1

Analysis population: Safety-evaluable population: participants who received any amount of any study drug. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.

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 Paclitaxel217
Atezolizumab and Paclitaxel432

Reported measurements

Percentage of participants with at least one AE
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel97.7Not reportedNot reportedNot reportedNot reported
Atezolizumab and Paclitaxel99.1Not reportedNot reportedNot reportedNot reported
Percentage of participants with at least one SAE
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo and Paclitaxel18.4Not reportedNot reportedNot reportedNot reported
Atezolizumab and Paclitaxel25.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        97.7
      2. group Id
        OG001
        value
        99.1
    title
    Percentage of participants with at least one AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18.4
      2. group Id
        OG001
        value
        25.9
    title
    Percentage of participants with at least one SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      217
    2. group Id
      OG001
      value
      432
    units
    Participants
description
Investigator text for AEs is coded using MedDRA version 25.1
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
Safety-evaluable population: participants who received any amount of any study drug. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.
reporting Status
POSTED
time Frame
From Day 1 From baseline up to 64 months
title
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice