NCT00105443 · OUTCOME

Overall Survival (OS)

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2014-10-31

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

Measure: MEDIAN
Unit: days
Interval / dispersion: 95% Confidence Interval
Time frame: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment

What was measured

Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

Analysis population: In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.

Groups in this outcome

Sorafenib (Nexavar, BAY43-9006)

Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.

Placebo

Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

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 (Nexavar, BAY43-9006)	299
Placebo	303

Reported measurements

Source class 1

Values in days · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib (Nexavar, BAY43-9006)	324	Not reported	286	405	Not reported
Placebo	241	Not reported	206	276	Not reported

Source statistical analyses

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

ci Lower Limit
0.5549
ci Pct Value
95
ci Upper Limit
0.8658
estimate Comment
This is the sorafenib to placebo hazard ratio.
group Description
The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and "tumor burden". In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.00583
p Value Comment
According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).
param Type
Hazard Ratio (HR)
param Value
0.6931
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
0.5549
ci Pct Value
95
ci Upper Limit
0.8658
estimate Comment
This is the sorafenib to placebo hazard ratio.
group Description
The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.02 stratified by region, ECOG PS and "tumor burden". In addition to the final analysis at the end of the study, 2 formal interim analyses of overall survival were planned. An alpha spending function was used to ensure that the false positive rate is less than or equal to 0.02 (1-sided). The study was stopped at the second interim analysis, the results of which are reported here.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.00583
p Value Comment
According to the pre-specified O'Brien-Fleming alpha spending function, the alpha value for this second interim analysis was 0.0073 (corresponding to a nominal value of 0.0077 after taking into account the first interim analysis).
param Type
Hazard Ratio (HR)
param Value
0.6931
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
lower Limit
286
upper Limit
405
value
324
group Id
OG001
lower Limit
206
upper Limit
276
value
241

denoms

counts
group Id
OG000
value
299
group Id
OG001
value
303
units
Participants

description

Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

dispersion Type

95% Confidence Interval

groups

description
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
id
OG000
title
Sorafenib (Nexavar, BAY43-9006)
description
Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
id
OG001
title
Placebo

param Type

MEDIAN

population Description

In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.

reporting Status

POSTED

time Frame

from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment

title

Overall Survival (OS)

type

PRIMARY

unit Of Measure

days

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Preserved source evidence · Not medical advice