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NCT01271712 · OUTCOME

Overall Survival

Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST) · Source last updated 2021-01-29

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

Measure
NUMBER
Unit
Percentage of patients with death
Interval / dispersion
Not reported
Time frame
From randomization of the first subject until date of database cutoff (08 Jun 2015)

What was measured

Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system.

Analysis population: Full Analysis Set (FAS). 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015

Groups in this outcome

Regorafenib (Stivarga, BAY73-4506)

Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

Placebo

Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks

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

Analysis denominator · Participants

GroupSource count
Regorafenib (Stivarga, BAY73-4506)133
Placebo66

Reported measurements

Source class 1
Values in Percentage of patients with death · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regorafenib (Stivarga, BAY73-4506)82.0Not reportedNot reportedNot reportedNot reported
Placebo80.3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.285777
    statistical Comment
    stratified
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.653
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.265
    estimate Comment
    regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.
    group Description
    Hazard ratio and its 95% CI was based on stratified Cox Regression Model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.909
    statistical Comment
    stratified
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.285777
    statistical Comment
    stratified
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.653
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.265
    estimate Comment
    regorafenib over control. 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015.
    group Description
    Hazard ratio and its 95% CI was based on stratified Cox Regression Model
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Hazard Ratio (HR)
    param Value
    0.909
    statistical Comment
    stratified
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        82.0
      2. group Id
        OG001
        value
        80.3
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      66
    units
    Participants
description
Overall Survival (OS) was defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Median OS was not observed at the time of PFS analysis and first analysis of OS, therefore only the proportion of death events was reported in the results posting system. This approach was maintained for the subsequent updates in the results posting system.
groups
  1. description
    Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    OG000
    title
    Regorafenib (Stivarga, BAY73-4506)
  2. description
    Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Full Analysis Set (FAS). 58 (87.9%) patients in placebo group and 91 (68.4%) patients in regorafenib had started open-label treatment with regorafenib before time of final database cutoff 08 Jun 2015
reporting Status
POSTED
time Frame
From randomization of the first subject until date of database cutoff (08 Jun 2015)
title
Overall Survival
type
SECONDARY
unit Of Measure
Percentage of patients with death

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

Preserved source evidence · Not medical advice