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NCT02302807 · OUTCOME

Overall Survival (OS)

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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
Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled

What was measured

OS was defined as time from randomization to death from any cause.

Analysis population: Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.

Groups in this outcome

IC2/3 Chemotherapy

PD-L1 immunohistochemistry (IHC) score of IC2/3

IC2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC2/3

IC1/2/3 Chemotherapy

PD-L1 immunohistochemistry (IHC) score of IC1/2/3

IC1/2/3 Atezolizumab

PD-L1 immunohistochemistry (IHC) score of IC1/2/3

Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Atezolizumab

Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined 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
IC2/3 Chemotherapy118
IC2/3 Atezolizumab116
IC1/2/3 Chemotherapy309
IC1/2/3 Atezolizumab316
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)464
Atezolizumab467

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IC2/3 Chemotherapy10.6Not reported8.412.2Not reported
IC2/3 Atezolizumab11.1Not reported8.615.5Not reported
IC1/2/3 Chemotherapy8.2Not reported7.49.5Not reported
IC1/2/3 Atezolizumab8.9Not reported8.210.9Not reported
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)8.0Not reported7.28.6Not reported
Atezolizumab8.6Not reported7.89.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.21
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4134
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
  3. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG004
    2. OG005
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
Complete source fields
analyses
  1. ci Lower Limit
    0.63
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.21
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.4134
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.71
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.87
  3. ci Lower Limit
    0.73
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Ids
    1. OG004
    2. OG005
    non Inferiority Type
    SUPERIORITY
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.4
        upper Limit
        12.2
        value
        10.6
      2. group Id
        OG001
        lower Limit
        8.6
        upper Limit
        15.5
        value
        11.1
      3. group Id
        OG002
        lower Limit
        7.4
        upper Limit
        9.5
        value
        8.2
      4. group Id
        OG003
        lower Limit
        8.2
        upper Limit
        10.9
        value
        8.9
      5. group Id
        OG004
        lower Limit
        7.2
        upper Limit
        8.6
        value
        8.0
      6. group Id
        OG005
        lower Limit
        7.8
        upper Limit
        9.6
        value
        8.6
denoms
  1. counts
    1. group Id
      OG000
      value
      118
    2. group Id
      OG001
      value
      116
    3. group Id
      OG002
      value
      309
    4. group Id
      OG003
      value
      316
    5. group Id
      OG004
      value
      464
    6. group Id
      OG005
      value
      467
    units
    Participants
description
OS was defined as time from randomization to death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    PD-L1 immunohistochemistry (IHC) score of IC2/3
    id
    OG000
    title
    IC2/3 Chemotherapy
  2. description
    PD-L1 immunohistochemistry (IHC) score of IC2/3
    id
    OG001
    title
    IC2/3 Atezolizumab
  3. description
    PD-L1 immunohistochemistry (IHC) score of IC1/2/3
    id
    OG002
    title
    IC1/2/3 Chemotherapy
  4. description
    PD-L1 immunohistochemistry (IHC) score of IC1/2/3
    id
    OG003
    title
    IC1/2/3 Atezolizumab
  5. description
    Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
    id
    OG004
    title
    Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
  6. description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    OG005
    title
    Atezolizumab
param Type
MEDIAN
population Description
Intent To Treat (ITT) was defined as all randomized participants, irrespective of whether the assigned treatment was actually received.
reporting Status
POSTED
time Frame
Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice