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NCT03434379 · OUTCOME

Overall Survival by Baseline AFP in the Global Population

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma · Source last updated 2023-10-23

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

Measure
MEAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

What was measured

OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.

Analysis population: Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.

Groups in this outcome

Sorafenib - Global

Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Atezolizumab + Bevacizumab - Global

Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit 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
Sorafenib - Global165
Atezolizumab + Bevacizumab - Global336

Reported measurements

AFP <400 ng/mL

Analysis denominator · Participants

GroupSource count
Sorafenib - Global104
Atezolizumab + Bevacizumab - Global210
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - Global13.93Not reported11.73NANA = not estimable due to the limited number of events observed
Atezolizumab + Bevacizumab - GlobalNANot reportedNANANA = not estimable due to the limited number of events observed
AFP >/=400 ng/mL

Analysis denominator · Participants

GroupSource count
Sorafenib - Global61
Atezolizumab + Bevacizumab - Global126
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - Global9.10Not reported5.75NANA = not estimable due to the limited number of events observed
Atezolizumab + Bevacizumab - Global12.78Not reported10.15NANA = not estimable due to the limited number of events observed

Source statistical analyses

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

  1. ci Lower Limit
    0.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    group Description
    AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0019
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.06
    group Description
    AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0879
    param Type
    Hazard Ratio (HR)
    param Value
    0.67
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    group Description
    AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0019
    param Type
    Hazard Ratio (HR)
    param Value
    0.50
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.06
    group Description
    AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0879
    param Type
    Hazard Ratio (HR)
    param Value
    0.67
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG000
        lower Limit
        11.73
        upper Limit
        NA
        value
        13.93
      2. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        104
      2. group Id
        OG001
        value
        210
      units
      Participants
    title
    AFP <400 ng/mL
  2. categories
    1. measurements
      1. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG000
        lower Limit
        5.75
        upper Limit
        NA
        value
        9.10
      2. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG001
        lower Limit
        10.15
        upper Limit
        NA
        value
        12.78
    denoms
    1. counts
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        126
      units
      Participants
    title
    AFP >/=400 ng/mL
denoms
  1. counts
    1. group Id
      OG000
      value
      165
    2. group Id
      OG001
      value
      336
    units
    Participants
description
OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG000
    title
    Sorafenib - Global
  2. description
    Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG001
    title
    Atezolizumab + Bevacizumab - Global
param Type
MEAN
population Description
Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
reporting Status
POSTED
time Frame
From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
title
Overall Survival by Baseline AFP in the Global Population
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice