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NCT02807636 · OUTCOME

Overall Survival (OS) in Atezolizumab Monotherapy 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline until death due to any cause (up to approximately 73 months)

What was measured

OS is defined as the time from randomization to death due to any cause.

Analysis population: The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.

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 Monotherapy

Eligible participants received open-label atezolizumab as monotherapy.

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/Cisplatin359
Atezolizumab Monotherapy360

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo+Gemcitabine+Carboplatin/Cisplatin13.34Not reported11.8915.61Not reported
Atezolizumab Monotherapy15.21Not reported13.1417.68Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    group Description
    Stratification factors: PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3968
    param Type
    Hazard Ratio (HR)
    param Value
    0.98
    statistical Comment
    one-sided
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    group Description
    Stratification factors: PD-L1 status, Bajorin risk score/presence of liver metastases, and investigator choice of chemotherapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3968
    param Type
    Hazard Ratio (HR)
    param Value
    0.98
    statistical Comment
    one-sided
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.89
        upper Limit
        15.61
        value
        13.34
      2. group Id
        OG001
        lower Limit
        13.14
        upper Limit
        17.68
        value
        15.21
denoms
  1. counts
    1. group Id
      OG000
      value
      359
    2. group Id
      OG001
      value
      360
    units
    Participants
description
OS is defined as the time from randomization to death due to any cause.
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
    Eligible participants received open-label atezolizumab as monotherapy.
    id
    OG001
    title
    Atezolizumab Monotherapy
param Type
MEDIAN
population Description
The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
reporting Status
POSTED
time Frame
Baseline until death due to any cause (up to approximately 73 months)
title
Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice