NCT03434379 · OUTCOME

Time to Deterioration (TTD) 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: 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: 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

Physical Functioning

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib - Global	4.86	Not reported	3.48	6.24	Not reported
Atezolizumab + Bevacizumab - Global	13.14	Not reported	9.69	NA	NA = not estimable due to the limited number of events observed

Role Functioning

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib - Global	3.58	Not reported	2.20	5.98	Not reported
Atezolizumab + Bevacizumab - Global	9.13	Not reported	6.51	NA	NA = not estimable due to the limited number of events observed

GHS/QoL

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib - Global	3.58	Not reported	3.02	6.97	Not reported
Atezolizumab + Bevacizumab - Global	11.24	Not reported	5.98	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
0.39
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.73
group Description
Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), 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
<.0001
param Type
Hazard Ratio (HR)
param Value
0.53
statistical Method
Log Rank
ci Lower Limit
0.46
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.84
group Description
Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), 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
0.62
statistical Method
Log Rank
ci Lower Limit
0.46
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.85
group Description
GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), 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
0.0028
param Type
Hazard Ratio (HR)
param Value
0.63
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.39
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.73
group Description
Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), 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
<.0001
param Type
Hazard Ratio (HR)
param Value
0.53
statistical Method
Log Rank
ci Lower Limit
0.46
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.84
group Description
Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), 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
0.62
statistical Method
Log Rank
ci Lower Limit
0.46
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.85
group Description
GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), 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
0.0028
param Type
Hazard Ratio (HR)
param Value
0.63
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
3.48
upper Limit
6.24
value
4.86
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
categories
measurements
group Id
OG000
lower Limit
2.20
upper Limit
5.98
value
3.58
comment
NA = not estimable due to the limited number of events observed
group Id
OG001
lower Limit
6.51
upper Limit
NA
value
9.13
title
Role Functioning
categories
measurements
group Id
OG000
lower Limit
3.02
upper Limit
6.97
value
3.58
comment
NA = not estimable due to the limited number of events observed
group Id
OG001
lower Limit
5.98
upper Limit
NA
value
11.24
title
GHS/QoL

denoms

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

description

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

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 Global Population

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice