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← Gastrointestinal Stromal Tumors

NCT01271712 · STUDY IN CONTEXT

Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.

Full Analysis Set (FAS) - defined as all randomized participants.

→

secondary · POSTED

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.

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

→

secondary · POSTED

Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST \[Response Evaluation Criteria in Solid Tumors\] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.

Full Analysis Set (FAS)

→

secondary · POSTED

Tumor Response of a subject was defined as the best tumor response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\], Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], Stable Disease \[SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], or Progressive Disease \[PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.\]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.

Full Analysis Set (FAS)

→

secondary · POSTED

Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.

Full Analysis Set (FAS)

→

secondary · POSTED

Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.

Full Analysis Set (FAS)

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-gastrointestinal-stromal-tumors
nct id
NCT01271712
trial label
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
5
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0000
    source section id
    NCT01271712-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival
    endpoint definition
    Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.
    time origin
    From randomization of the first subject until approximately 144 progression-free survival events had occurred (study duration approximately one year)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS) - defined as all randomized participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0001
    source section id
    NCT01271712-om-0001
    source outcome index
    1
    endpoint
    Overall Survival
    endpoint definition
    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.
    time origin
    From randomization of the first subject until date of database cutoff (08 Jun 2015)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0002
    source section id
    NCT01271712-om-0002
    source outcome index
    2
    endpoint
    Time to Progression (TTP)
    endpoint definition
    Time to progression (TTP) was defined as the time from date of randomization to disease progression (based on central radiological assessment using modified RECIST \[Response Evaluation Criteria in Solid Tumors\] v.1.1). Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appearance of new lesions. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. Results are based on central evaluation.
    time origin
    From randomization of the first subject until until date of database cutoff (26 Jan 2012); study duration approximately 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0003
    source section id
    NCT01271712-om-0003
    source outcome index
    3
    endpoint
    Tumor Response
    endpoint definition
    Tumor Response of a subject was defined as the best tumor response (Complete Response \[CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).\], Partial Response \[PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], Stable Disease \[SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.\], or Progressive Disease \[PD: at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study or unequivocal progression of existing non-target lesions, or appearance of new lesions.\]) observed during the trial period and assessed according to RECIST v1.1 criteria. Results are based on central evaluation.
    time origin
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0004
    source section id
    NCT01271712-om-0004
    source outcome index
    4
    endpoint
    Objective Response Rate
    endpoint definition
    Objective response rate was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Results are based on central evaluation.
    time origin
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0005
    source section id
    NCT01271712-om-0005
    source outcome index
    5
    endpoint
    Disease Control Rate (DCR)
    endpoint definition
    Disease Control Rate (DCR) was defined as the percentage of subjects whose best response was Complete Response (CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target).), Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.), or Stable Disease (SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, no unequivocal progression of existing non-target lesions, and no appearance of new lesions.) according to RECIST v1.1 criteria. SD had to be maintained for at least 12 weeks from the first demonstration of that rating. Results are based on central evaluation.
    time origin
    From randomization of the first subject until date of database cutoff (26 Jan 2012); study duration approximately 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Full Analysis Set (FAS)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Regorafenib (Stivarga, BAY73-4506)
    regimen
    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
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    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
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Regorafenib (Stivarga, BAY73-4506)
    regimen
    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
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    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
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Regorafenib (Stivarga, BAY73-4506)
    regimen
    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
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo
    regimen
    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
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Regorafenib (Stivarga, BAY73-4506)
    regimen
    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
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo
    regimen
    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
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Regorafenib (Stivarga, BAY73-4506)
    regimen
    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
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo
    regimen
    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
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Regorafenib (Stivarga, BAY73-4506)
    regimen
    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
    analyzed count
    133
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo
    regimen
    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
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01271712-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    harm key
    EG000
    source section id
    NCT01271712-ae
    event group key
    EG000
    event group label
    Regorafenib (Double Blind Only)
    serious affected
    23
    serious at risk
    41
    other affected
    40
    other at risk
    41
    frequency threshold
    5
    collection period
    From first administration of treatment till 30 days after last dose of treatment.
    event definition
    At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    harm key
    EG001
    source section id
    NCT01271712-ae
    event group key
    EG001
    event group label
    Placebo (Double Blind Only)
    serious affected
    8
    serious at risk
    8
    other affected
    7
    other at risk
    8
    frequency threshold
    5
    collection period
    From first administration of treatment till 30 days after last dose of treatment.
    event definition
    At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    harm key
    EG002
    source section id
    NCT01271712-ae
    event group key
    EG002
    event group label
    Placebo, Open Label Only (Switch to Regorafenib)
    serious affected
    31
    serious at risk
    58
    other affected
    58
    other at risk
    58
    frequency threshold
    5
    collection period
    From first administration of treatment till 30 days after last dose of treatment.
    event definition
    At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    harm key
    EG003
    source section id
    NCT01271712-ae
    event group key
    EG003
    event group label
    Treated With Regorafenib at Any Time
    serious affected
    103
    serious at risk
    190
    other affected
    189
    other at risk
    190
    frequency threshold
    5
    collection period
    From first administration of treatment till 30 days after last dose of treatment.
    event definition
    At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastrointestinal-stromal-tumors
    nct id
    NCT01271712
    harm key
    EG004
    source section id
    NCT01271712-ae
    event group key
    EG004
    event group label
    Treated With Regorafenib for > 1 Year
    serious affected
    39
    serious at risk
    75
    other affected
    75
    other at risk
    75
    frequency threshold
    5
    collection period
    From first administration of treatment till 30 days after last dose of treatment.
    event definition
    At primary completion (cutoff 26JAN2012) blinded patients who received either regorafenib or placebo were reported in "Regorafenib (DoubleBlindOnly)" and "Placebo (DoubleBlindOnly)" respectively; patients who received regorafenib after unblinding were reported in "Placebo, OpenLabelOnly(Switch to Regorafenib)". This safety update (cutoff 15APR2019) was reported in "Treated with Regorafenib at any time" and "Treated with Regorafenib for\>1 year".
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice