NCT03434379 · OUTCOME

Overall Survival (OS) 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: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)

What was measured

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

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

Group	Source count
Sorafenib - Global	165
Atezolizumab + Bevacizumab - Global	336

Reported measurements

At CCOD 18 months

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib - Global	13.24	Not reported	10.41	NA	NA = not estimable due to the limited number of events observed
Atezolizumab + Bevacizumab - Global	NA	Not reported	NA	NA	NA = not estimable due to the limited number of events observed

At CCOD 30 months

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib - Global	13.40	Not reported	11.37	16.85	Not reported
Atezolizumab + Bevacizumab - Global	19.22	Not reported	17.02	23.66	Not reported

Source statistical analyses

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

ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.79
group Description
At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0006
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Method
Log Rank
ci Lower Limit
0.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.85
group Description
At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0009
param Type
Hazard Ratio (HR)
param Value
0.66
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.42
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.79
group Description
At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0006
param Type
Hazard Ratio (HR)
param Value
0.58
statistical Method
Log Rank
ci Lower Limit
0.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.85
group Description
At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0009
param Type
Hazard Ratio (HR)
param Value
0.66
statistical Method
Log Rank

classes

categories
measurements
comment
NA = not estimable due to the limited number of events observed
group Id
OG000
lower Limit
10.41
upper Limit
NA
value
13.24
comment
NA = not estimable due to the limited number of events observed
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
title
At CCOD 18 months
categories
measurements
group Id
OG000
lower Limit
11.37
upper Limit
16.85
value
13.40
group Id
OG001
lower Limit
17.02
upper Limit
23.66
value
19.22
title
At CCOD 30 months

denoms

counts
group Id
OG000
value
165
group Id
OG001
value
336
units
Participants

description

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

dispersion Type

95% Confidence Interval

groups

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
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

MEDIAN

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 the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)

title

Overall Survival (OS) in the Global Population

type

PRIMARY

unit Of Measure

months

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Preserved source evidence · Not medical advice