NCT00984282 · OUTCOME

Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer · Source last updated 2018-09-13

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 of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years

What was measured

Time to progression was defined at the time (days) from randomization to progression (based on central assessment \[radiological and clinical progression due to bone irradiation\])

Analysis population: FAS

Groups in this outcome

Sorafenib (Nexavar, BAY43-9006)

Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle

Placebo

Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle

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)	207
Placebo	210

Reported measurements

Source class 1

Values in Days · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Sorafenib (Nexavar, BAY43-9006)	337	Not reported	283	451	Not reported
Placebo	175	Not reported	160	238	Not reported

Source statistical analyses

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

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Comment
stratified by age group and region
statistical Method
Log Rank
ci Lower Limit
0.429
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.724
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.557
statistical Comment
stratified by age group and region
statistical Method
Regression, Cox

Complete source fields

analyses

group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
statistical Comment
stratified by age group and region
statistical Method
Log Rank
ci Lower Limit
0.429
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.724
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.557
statistical Comment
stratified by age group and region
statistical Method
Regression, Cox

classes

categories
measurements
group Id
OG000
lower Limit
283
upper Limit
451
value
337
group Id
OG001
lower Limit
160
upper Limit
238
value
175

denoms

counts
group Id
OG000
value
207
group Id
OG001
value
210
units
Participants

description

Time to progression was defined at the time (days) from randomization to progression (based on central assessment \[radiological and clinical progression due to bone irradiation\])

dispersion Type

95% Confidence Interval

groups

description
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
id
OG000
title
Sorafenib (Nexavar, BAY43-9006)
description
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
id
OG001
title
Placebo

param Type

MEDIAN

population Description

FAS

reporting Status

POSTED

time Frame

From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years

title

Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation

type

SECONDARY

unit Of Measure

Days

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

Preserved source evidence · Not medical advice