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NCT02409342 · OUTCOME

Percentage of Participants With at Least One Adverse Event

A Study of Atezolizumab (MPDL3280A) Compared With a Platinum Agent (Cisplatin or Carboplatin) + (Pemetrexed or Gemcitabine) in Participants With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC) [IMpower110] · Source last updated 2023-03-15

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
Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)

What was measured

Percentage of participants with at least one adverse event.

Analysis population: Safety analyses included treated participants, defined as randomized participants who received any amount of study treatment.

Groups in this outcome

Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)

Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).

Atezolizumab

Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).

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

Analysis denominator · Participants

GroupSource count
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)263
Atezolizumab286

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)95.1Not reportedNot reportedNot reportedNot reported
Atezolizumab92.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        95.1
      2. group Id
        OG001
        value
        92.3
denoms
  1. counts
    1. group Id
      OG000
      value
      263
    2. group Id
      OG001
      value
      286
    units
    Participants
description
Percentage of participants with at least one adverse event.
groups
  1. description
    Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months).
    id
    OG000
    title
    Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine)
  2. description
    Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
    id
    OG001
    title
    Atezolizumab
param Type
NUMBER
population Description
Safety analyses included treated participants, defined as randomized participants who received any amount of study treatment.
reporting Status
POSTED
time Frame
Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months)
title
Percentage of Participants With at Least One Adverse Event
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice