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← Neuroendocrine Tumor

NCT01524783 · STUDY IN CONTEXT

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

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

PFS is defined as the time from randomization to the date of the first documented tumor progression or death from any cause, whichever comes first. Progression was defined using modified RECIST 1.0 and as per central radiology assessment as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Progression was assessed by cat scan (CT) and/or magnetic resonance imaging (MRI). For participants who had not progressed or died at the analysis cut-off date, PFS was censored at the date of the last adequate tumor evaluation date. An adequate tumour assessment is a tumour assessment with an overall response other than unknown. The percentage event-free probability estimate is the estimated probability that a patient will remain event-free in PFS up to the specified time point.

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.

→

secondary · POSTED

OS is defined as the time from the date of randomization to date of death due to any cause. If a death had not been observed by the date of analysis cut-off, then OS was censored at the date of last contact. All participants randomized to placebo arm who crossed over to everolimus were censored.

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.

→

secondary · POSTED

ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), according to central evaluation and as per modified RECIST 1.0. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.

→

secondary · POSTED

DCR is defined as the proportion of subjects with best overall response of CR or PR or stable disease based on modified RECIST 1.0 and as per central radiology assessment. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Stable disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.

→

secondary · POSTED

FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions examining physical, social/family, emotional, and functional well-being. Participants responded to the items on a five-point scale, ranging from 0: "Not at all" to 4: "Very much." The total score ranges from 0 to 108, with higher scores indicating a better patient-reported outcome/quality of life. Definitive deterioration is defined as a decrease in the total score by at least 7 points compared to baseline with no further improvement. Death was considered as worsening of the FACT-G total score if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.

→

secondary · POSTED

CgA is a potential biomarker for tumor response. Blood samples were collected for assessment of CgA levels. Change from Baseline at a particular visit was calculated as the CgA level at that visit minus Baseline.

The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.

→

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

FACT · Time to Definitive Deterioration in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire Total Score

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor
nct id
NCT01524783
qol key
qol-0004
source section id
NCT01524783-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-g' in the study's own wording
scale title
Time to Definitive Deterioration in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire Total Score
measure definition
FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions examining physical, social/family, emotional, and functional well-being. Participants responded to the items on a five-point scale, ranging from 0: "Not at all" to 4: "Very much." The total score ranges from 0 to 108, with higher scores indicating a better patient-reported outcome/quality of life. Definitive deterioration is defined as a decrease in the total score by at least 7 points compared to baseline with no further improvement. Death was considered as worsening of the FACT-G total score if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.
time frame
From randomization to definitive deterioration of FACT-G total score, assessed up to approximately 3 years
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores indicating a better
population note
The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor
nct id
NCT01524783
trial label
Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)
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
4
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0000
    source section id
    NCT01524783-om-0000
    source outcome index
    0
    endpoint
    Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment
    endpoint definition
    PFS is defined as the time from randomization to the date of the first documented tumor progression or death from any cause, whichever comes first. Progression was defined using modified RECIST 1.0 and as per central radiology assessment as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. Progression was assessed by cat scan (CT) and/or magnetic resonance imaging (MRI). For participants who had not progressed or died at the analysis cut-off date, PFS was censored at the date of the last adequate tumor evaluation date. An adequate tumour assessment is a tumour assessment with an overall response other than unknown. The percentage event-free probability estimate is the estimated probability that a patient will remain event-free in PFS up to the specified time point.
    time origin
    From date of randomization to progression or death, whichever comes first, assessed up to 27 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0001
    source section id
    NCT01524783-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS is defined as the time from the date of randomization to date of death due to any cause. If a death had not been observed by the date of analysis cut-off, then OS was censored at the date of last contact. All participants randomized to placebo arm who crossed over to everolimus were censored.
    time origin
    From date of randomization to date of death, assessed up to approximately 8 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0002
    source section id
    NCT01524783-om-0002
    source outcome index
    2
    endpoint
    Overall Response Rate (ORR) as Per Modified RECIST 1.0 According to Central Evaluation
    endpoint definition
    ORR is defined as the proportion of patients with best overall response (BOR) of complete response (CR) or partial response (PR), according to central evaluation and as per modified RECIST 1.0. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
    time origin
    From randomization until end of treatment, assessed up to approximately 2.5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0003
    source section id
    NCT01524783-om-0003
    source outcome index
    3
    endpoint
    Disease Control Rate (DCR) Based on Modified RECIST 1.0 and as Per Central Radiology Assessment
    endpoint definition
    DCR is defined as the proportion of subjects with best overall response of CR or PR or stable disease based on modified RECIST 1.0 and as per central radiology assessment. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Stable disease: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression.
    time origin
    From randomization until end of treatment, assessed up to approximately 2.5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0004
    source section id
    NCT01524783-om-0004
    source outcome index
    4
    endpoint
    Time to Definitive Deterioration in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire Total Score
    endpoint definition
    FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions examining physical, social/family, emotional, and functional well-being. Participants responded to the items on a five-point scale, ranging from 0: "Not at all" to 4: "Very much." The total score ranges from 0 to 108, with higher scores indicating a better patient-reported outcome/quality of life. Definitive deterioration is defined as a decrease in the total score by at least 7 points compared to baseline with no further improvement. Death was considered as worsening of the FACT-G total score if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.
    time origin
    From randomization to definitive deterioration of FACT-G total score, assessed up to approximately 3 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0005
    source section id
    NCT01524783-om-0005
    source outcome index
    5
    endpoint
    Change From Baseline in Chromogranin A (CgA) Levels
    endpoint definition
    CgA is a potential biomarker for tumor response. Blood samples were collected for assessment of CgA levels. Change from Baseline at a particular visit was calculated as the CgA level at that visit minus Baseline.
    time origin
    From baseline (every 4 weeks) up to 116 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization. Number analyzed signified number of participants with available data for this outcome measure at specified timepoints.
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Everolimus + BSC
    regimen
    Participants received everolimus 10 mg once daily BSC throughout the study
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
    analyzed count
    97
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Everolimus + BSC
    regimen
    Participants received everolimus 10 mg once daily BSC throughout the study
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
    analyzed count
    97
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Everolimus + BSC
    regimen
    Participants received everolimus 10 mg once daily BSC throughout the study
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
    analyzed count
    97
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Everolimus + BSC
    regimen
    Participants received everolimus 10 mg once daily BSC throughout the study
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
    analyzed count
    97
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Everolimus + BSC
    regimen
    Participants received everolimus 10 mg once daily BSC throughout the study
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
    analyzed count
    97
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Everolimus + BSC
    regimen
    Participants received everolimus 10 mg once daily BSC throughout the study
    analyzed count
    205
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + BSC
    regimen
    Participants received matching placebo once daily plus BSC during the blinded period. Participants were allowed to crossover to treatment with everolimus 10mg once daily plus BSC during the open-label period
    analyzed count
    97
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01524783-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    harm key
    EG000
    source section id
    NCT01524783-ae
    event group key
    EG000
    event group label
    Everolimus+BSC (Throughout Study)
    serious affected
    93
    serious at risk
    202
    other affected
    197
    other at risk
    202
    frequency threshold
    5
    collection period
    Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
    event definition
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    harm key
    EG001
    source section id
    NCT01524783-ae
    event group key
    EG001
    event group label
    Everolimus +BSC (Crossover)
    serious affected
    1
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    collection period
    Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
    event definition
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    harm key
    EG002
    source section id
    NCT01524783-ae
    event group key
    EG002
    event group label
    Everolimus+BSC (All)
    serious affected
    94
    serious at risk
    208
    other affected
    203
    other at risk
    208
    frequency threshold
    5
    collection period
    Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
    event definition
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
    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-neuroendocrine-tumor
    nct id
    NCT01524783
    harm key
    EG003
    source section id
    NCT01524783-ae
    event group key
    EG003
    event group label
    Placebo+BSC (Blinded Period)
    serious affected
    21
    serious at risk
    98
    other affected
    81
    other at risk
    98
    frequency threshold
    5
    collection period
    Adverse events and all-cause mortality were collected from date of first dose of study treatment until end of study treatment plus 30 days post treatment, assessed up to a maximum duration of approximately 8 years
    event definition
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment. The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01524783
    qol key
    qol-0004
    source section id
    NCT01524783-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fact-g' in the study's own wording
    scale title
    Time to Definitive Deterioration in Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire Total Score
    measure definition
    FACT-G is a self-assessed health-related quality of life questionnaire. The questionnaire is comprised of 27 questions examining physical, social/family, emotional, and functional well-being. Participants responded to the items on a five-point scale, ranging from 0: "Not at all" to 4: "Very much." The total score ranges from 0 to 108, with higher scores indicating a better patient-reported outcome/quality of life. Definitive deterioration is defined as a decrease in the total score by at least 7 points compared to baseline with no further improvement. Death was considered as worsening of the FACT-G total score if it occurred close to the last available assessment, where "close" was defined as twice the planned period between two assessments. Patients without definitive worsening prior to analysis cut-off or prior to start of another anticancer therapy were censored at the date of their last assessment.
    time frame
    From randomization to definitive deterioration of FACT-G total score, assessed up to approximately 3 years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores indicating a better
    population note
    The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice