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NCT01903993 · OUTCOME

DOR (Modified RECIST)

A Randomized Phase 2 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy - "POPLAR" · Source last updated 2019-10-02

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)

What was measured

DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.

Analysis population: ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only.

Groups in this outcome

Atezolizumab

Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.

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

Analysis denominator · Participants

GroupSource count
Atezolizumab24

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Atezolizumab14.9Not reported11.6NAUpper limit of CI was not achieved due to low number of participants with event.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of CI was not achieved due to low number of participants with event.
        group Id
        OG000
        lower Limit
        11.6
        upper Limit
        NA
        value
        14.9
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
DOR was defined as the duration from the first tumor assessment that supports the participant's objective response (CR or PR, whichever is first recorded) to disease progression or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
    id
    OG000
    title
    Atezolizumab
param Type
MEDIAN
population Description
ITT population for efficacy analyses included all randomized participants, regardless of whether they received any study drug. Here, number of participants analyzed signifies the number of participants who were evaluable for this outcome measure. The data was planned to be reported for Atezolizumab arm only.
reporting Status
POSTED
time Frame
From the time of randomization to the date of death due to any cause or up to data cut off date: 08 May 2015 (up to 21 months)
title
DOR (Modified RECIST)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice