NCT03434379 · OUTCOME

Overall Survival (OS) 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: 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: 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

Group	Source count
Sorafenib - China	61
Atezolizumab + Bevacizumab - China	133

Reported measurements

At CCOD 18 months

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib - China	11.37	Not reported	6.74	NA	NA = not estimable due to the limited number of events observed
Atezolizumab + Bevacizumab - China	NA	Not reported	13.50	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 - China	11.37	Not reported	6.74	16.07	Not reported
Atezolizumab + Bevacizumab - China	24.05	Not reported	17.12	NA	NA = 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.

ci Lower Limit
0.25
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.76
group Description
At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0026
param Type
Hazard Ratio (HR)
param Value
0.44
statistical Method
Log Rank
ci Lower Limit
0.35
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.80
group Description
At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0019
param Type
Hazard Ratio (HR)
param Value
0.53
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.25
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.76
group Description
At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0026
param Type
Hazard Ratio (HR)
param Value
0.44
statistical Method
Log Rank
ci Lower Limit
0.35
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.80
group Description
At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0019
param Type
Hazard Ratio (HR)
param Value
0.53
statistical Method
Log Rank

classes

categories
measurements
comment
NA = not estimable due to the limited number of events observed
group Id
OG000
lower Limit
6.74
upper Limit
NA
value
11.37
comment
NA = not estimable due to the limited number of events observed
group Id
OG001
lower Limit
13.50
upper Limit
NA
value
NA
title
At CCOD 18 months
categories
measurements
group Id
OG000
lower Limit
6.74
upper Limit
16.07
value
11.37
comment
NA = not estimable due to the limited number of events observed
group Id
OG001
lower Limit
17.12
upper Limit
NA
value
24.05
title
At CCOD 30 months

denoms

counts
group Id
OG000
value
61
group Id
OG001
value
133
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 China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
id
OG000
title
Sorafenib - China
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

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 China Population

type

PRIMARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice