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← CYRAMZA: metastatic gastric cancer after prior therapy

NCT00917384 · STUDY IN CONTEXT

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive

Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.

→

secondary · POSTED

PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).

Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.

→

secondary · POSTED

The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.

Intent-to-treat population: all randomized participants.

→

secondary · POSTED

ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.

Intent-to-treat population: all randomized participants.

→

secondary · POSTED

DOR is the interval from date of initial documented response (complete response \[CR\] or partial response \[PR\]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.

Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.

→

secondary · POSTED

EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.

All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.

→

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

EORTC QLQ · Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)

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-gastric-cancer-cyramza-d69c4b15
nct id
NCT00917384
qol key
qol-0005
source section id
NCT00917384-om-0005
source outcome index
5
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
measure definition
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
time frame
Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent a better
population note
All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
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-gastric-cancer-cyramza-d69c4b15
nct id
NCT00917384
trial label
Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0000
    source section id
    NCT00917384-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive
    time origin
    Randomization up to 28 months post-randomization
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0001
    source section id
    NCT00917384-om-0001
    source outcome index
    1
    endpoint
    Progression-Free Survival (PFS)
    endpoint definition
    PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).
    time origin
    Randomization up to 17 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0002
    source section id
    NCT00917384-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
    endpoint definition
    The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.
    time origin
    Week 12 post-randomization
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: all randomized participants.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0003
    source section id
    NCT00917384-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants With Objective Response (Objective Response Rate [ORR])
    endpoint definition
    ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.
    time origin
    Randomization up to 17 months post-randomization
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-treat population: all randomized participants.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0004
    source section id
    NCT00917384-om-0004
    source outcome index
    4
    endpoint
    Duration of Response (DOR)
    endpoint definition
    DOR is the interval from date of initial documented response (complete response \[CR\] or partial response \[PR\]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.
    time origin
    Randomization up to 17 months post-randomization
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0005
    source section id
    NCT00917384-om-0005
    source outcome index
    5
    endpoint
    Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
    endpoint definition
    EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
    time origin
    Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0000
    arm key
    OG000
    arm label
    IMC-1121B (Ramucirumab)
    regimen
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    238
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0001
    arm key
    OG000
    arm label
    IMC-1121B (Ramucirumab)
    regimen
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    238
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0002
    arm key
    OG000
    arm label
    IMC-1121B (Ramucirumab)
    regimen
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    238
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0003
    arm key
    OG000
    arm label
    IMC-1121B (Ramucirumab)
    regimen
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    238
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    117
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0004
    arm key
    OG000
    arm label
    IMC-1121B (Ramucirumab)
    regimen
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0005
    arm key
    OG000
    arm label
    IMC-1121B (Ramucirumab)
    regimen
    Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    114
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo
    regimen
    Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
    analyzed count
    26
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00917384-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    harm key
    EG000
    source section id
    NCT00917384-ae
    event group key
    EG000
    event group label
    IMC-1121B (Ramucirumab)
    serious affected
    112
    serious at risk
    236
    other affected
    213
    other at risk
    236
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    harm key
    EG001
    source section id
    NCT00917384-ae
    event group key
    EG001
    event group label
    Placebo
    serious affected
    51
    serious at risk
    115
    other affected
    91
    other at risk
    115
    frequency threshold
    5
    collection period
    Source null
    event definition
    Source null
    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-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT00917384
    qol key
    qol-0005
    source section id
    NCT00917384-om-0005
    source outcome index
    5
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
    measure definition
    EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
    time frame
    Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores represent a better
    population note
    All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
    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