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NCT03434379 · OUTCOME

Time to Deterioration (TTD) in the China 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

What was measured

TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.

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

Groups in this outcome

Sorafenib - China

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

Atezolizumab + Bevacizumab - China

Participants in the China 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 - China61
Atezolizumab + Bevacizumab - China133

Reported measurements

Physical Functioning
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - China5.62Not reported2.10NANA = not estimable due to the limited number of events observed
Atezolizumab + Bevacizumab - China13.14Not reported9.69NANA = not estimable due to the limited number of events observed
Role Functioning
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - ChinaNANot reported2.14NANA = not estimable due to the limited number of events observed
Atezolizumab + Bevacizumab - ChinaNANot reported7.20NANA = not estimable due to the limited number of events observed
GHS/QoL
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Sorafenib - China3.58Not reported1.489.82Not reported
Atezolizumab + Bevacizumab - China9.76Not reported6.24NANA = 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
    0.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    group Description
    Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0035
    param Type
    Hazard Ratio (HR)
    param Value
    0.45
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.23
    group Description
    Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2214
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    group Description
    GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0135
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.26
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.78
    group Description
    Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0035
    param Type
    Hazard Ratio (HR)
    param Value
    0.45
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.23
    group Description
    Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2214
    param Type
    Hazard Ratio (HR)
    param Value
    0.71
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.32
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.88
    group Description
    GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0135
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    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
        2.10
        upper Limit
        NA
        value
        5.62
      2. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG001
        lower Limit
        9.69
        upper Limit
        NA
        value
        13.14
    title
    Physical Functioning
  2. categories
    1. measurements
      1. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG000
        lower Limit
        2.14
        upper Limit
        NA
        value
        NA
      2. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG001
        lower Limit
        7.20
        upper Limit
        NA
        value
        NA
    title
    Role Functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.48
        upper Limit
        9.82
        value
        3.58
      2. comment
        NA = not estimable due to the limited number of events observed
        group Id
        OG001
        lower Limit
        6.24
        upper Limit
        NA
        value
        9.76
    title
    GHS/QoL
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    2. group Id
      OG001
      value
      133
    units
    Participants
description
TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG000
    title
    Sorafenib - China
  2. description
    Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    OG001
    title
    Atezolizumab + Bevacizumab - China
param Type
MEDIAN
population Description
China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
reporting Status
POSTED
time Frame
Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
title
Time to Deterioration (TTD) in the China Population
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice