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NCT01774344 · OUTCOME

Progression Free Survival (PFS)

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma · Source last updated 2020-08-20

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 date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks)

What was measured

Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.

Groups in this outcome

Placebo

Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.

Regorafenib 160 mg (BAY73-4506)

Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo194
Regorafenib 160 mg (BAY73-4506)379

Reported measurements

mRECIST
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo45444447Not reported
Regorafenib 160 mg (BAY73-4506)958686127Not reported
RECIST 1.1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo45444449Not reported
Regorafenib 160 mg (BAY73-4506)1028787127Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.369
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.555
    group Description
    Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.453
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.397
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.580
    group Description
    Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.480
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.347
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.522
    group Description
    Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.425
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.376
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.548
    group Description
    Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.454
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.369
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.555
    group Description
    Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.453
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.397
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.580
    group Description
    Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.480
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.347
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.522
    group Description
    Hazard ratio and its 95% CI was based on stratified (IVRS) Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.425
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.376
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.548
    group Description
    Hazard ratio and its 95% CI was based on unstratified Cox Regression Model. One-sided p-value was calculated from log rank test and 95% CIs was computed by using Cox Regression Model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.000001
    param Type
    Hazard Ratio (HR)
    param Value
    0.454
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44
        spread
        44
        upper Limit
        47
        value
        45
      2. group Id
        OG001
        lower Limit
        86
        spread
        86
        upper Limit
        127
        value
        95
    title
    mRECIST
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44
        spread
        44
        upper Limit
        49
        value
        45
      2. group Id
        OG001
        lower Limit
        87
        spread
        87
        upper Limit
        127
        value
        102
    title
    RECIST 1.1
denoms
  1. counts
    1. group Id
      OG000
      value
      194
    2. group Id
      OG001
      value
      379
    units
    Participants
description
Progression Free Survival (PFS) was defined as the time (days) from date of randomization to date of disease progression (radiological or clinical) or death due to any cause, if death occurs before progression was documented. Death in the absence of progression was a PFS event only if it occurred within the 12+1 weeks for subjects who discontinued treatment prior to cycle 8 and 24+2 weeks for subjects who discontinued treatment after to cycle 8 of the last evaluable tumor assessment; PFS were censored at the date of the last evaluable tumor assessment, if it occurred later. Median and 95% confidence interval 95% were reported for the mRECIST and RECIST 1.1 analysis sets. Subjects still alive at the time of analysis were censored at their last date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
    id
    OG000
    title
    Placebo
  2. description
    Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
    id
    OG001
    title
    Regorafenib 160 mg (BAY73-4506)
param Type
MEDIAN
reporting Status
POSTED
time Frame
From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks)
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
days

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Preserved source evidence · Not medical advice