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NCT02807636 · OUTCOME

Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma · Source last updated 2025-02-24

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

Measure
NUMBER
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)

What was measured

Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.

Analysis population: The duration of response (DOR)-evaluable population is defined as participants with an objective response in the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2.

Groups in this outcome

Placebo+Gemcitabine+Carboplatin/Cisplatin

Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

Atezolizumab+Gemcitabine+Carboplatin/Cisplatin

Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

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+Gemcitabine+Carboplatin/Cisplatin178
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin215

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo+Gemcitabine+Carboplatin/Cisplatin8.15Not reported6.348.61Not reported
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin9.13Not reported8.0210.64Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.34
        upper Limit
        8.61
        value
        8.15
      2. group Id
        OG001
        lower Limit
        8.02
        upper Limit
        10.64
        value
        9.13
denoms
  1. counts
    1. group Id
      OG000
      value
      178
    2. group Id
      OG001
      value
      215
    units
    Participants
description
Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    id
    OG000
    title
    Placebo+Gemcitabine+Carboplatin/Cisplatin
  2. description
    Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
    id
    OG001
    title
    Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
param Type
NUMBER
population Description
The duration of response (DOR)-evaluable population is defined as participants with an objective response in the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2.
reporting Status
POSTED
time Frame
From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
title
Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice