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← CYRAMZA: metastatic gastric cancer after prior therapy

NCT01170663 · STUDY IN CONTEXT

A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric 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

OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.

All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.

→

secondary · POSTED

PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.

All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39.

→

secondary · POSTED

TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.

All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94.

→

secondary · POSTED

BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.

All participants according to the treatment group to which they were randomized.

→

secondary · POSTED

ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)\*100.

All participants according to the treatment group to which they were randomized.

→

secondary · POSTED

Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.

All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies.

→

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 to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status

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
NCT01170663
qol key
qol-0012
source section id
NCT01170663-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status
measure definition
EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains \[physical, role, cognitive, emotional, and social\], 9 symptom scales \[fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties\] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
time frame
Baseline, end of therapy (up to 103 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent a better
population note
All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-gastric-cancer-cyramza-d69c4b15
nct id
NCT01170663
qol key
qol-0013
source section id
NCT01170663-om-0013
source outcome index
13
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
measure definition
The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale \[1 (no problem), 2 (some problems), and 3 (major problems)\]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
time frame
Baseline, end of therapy (up to 103 weeks)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.
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
NCT01170663
trial label
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric 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
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0000
    source section id
    NCT01170663-om-0000
    source outcome index
    0
    endpoint
    Overall Survival Time (OS)
    endpoint definition
    OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
    time origin
    Randomization up to 27.5 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75.
    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
    NCT01170663
    outcome key
    om-0001
    source section id
    NCT01170663-om-0001
    source outcome index
    1
    endpoint
    Progression-Free Survival (PFS)
    endpoint definition
    PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment.
    time origin
    Randomization up to 22.2 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39.
    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
    NCT01170663
    outcome key
    om-0002
    source section id
    NCT01170663-om-0002
    source outcome index
    2
    endpoint
    Time to Progressive Disease (TTP)
    endpoint definition
    TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death.
    time origin
    Baseline up to 22.2 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94.
    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
    NCT01170663
    outcome key
    om-0003
    source section id
    NCT01170663-om-0003
    source outcome index
    3
    endpoint
    Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD
    endpoint definition
    BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria.
    time origin
    Randomization up to 22.2 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants according to the treatment group to which they were randomized.
    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
    NCT01170663
    outcome key
    om-0004
    source section id
    NCT01170663-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With CR or PR (Objective Response Rate [ORR])
    endpoint definition
    ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)\*100.
    time origin
    Randomization up to 22.2 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants according to the treatment group to which they were randomized.
    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
    NCT01170663
    outcome key
    om-0005
    source section id
    NCT01170663-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity)
    endpoint definition
    Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline.
    time origin
    Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies.
    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
    NCT01170663
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ramucirumab (IMC-1211B) Plus Paclitaxel
    regimen
    8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    330
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo Plus Paclitaxel
    regimen
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Ramucirumab (IMC-1211B) Plus Paclitaxel
    regimen
    8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    330
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo Plus Paclitaxel
    regimen
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Ramucirumab (IMC-1211B) Plus Paclitaxel
    regimen
    8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    330
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo Plus Paclitaxel
    regimen
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Ramucirumab (IMC-1211B) Plus Paclitaxel
    regimen
    8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    330
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo Plus Paclitaxel
    regimen
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Ramucirumab (IMC-1211B) Plus Paclitaxel
    regimen
    8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    330
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo Plus Paclitaxel
    regimen
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Ramucirumab (IMC-1211B) Plus Paclitaxel
    regimen
    8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    320
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo Plus Paclitaxel
    regimen
    Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
    analyzed count
    323
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01170663-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-gastric-cancer-cyramza-d69c4b15
    nct id
    NCT01170663
    harm key
    EG000
    source section id
    NCT01170663-ae
    event group key
    EG000
    event group label
    Ramucirumab and Paclitaxel
    serious affected
    161
    serious at risk
    327
    other affected
    324
    other at risk
    327
    frequency threshold
    5
    collection period
    Source null
    event definition
    One (1) participant was randomized to the placebo group but received ramucirumab in error. This participant was included in the ramucirumab group in the Safety population (as treated).
    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
    NCT01170663
    harm key
    EG001
    source section id
    NCT01170663-ae
    event group key
    EG001
    event group label
    Placebo and Paclitaxel
    serious affected
    146
    serious at risk
    329
    other affected
    321
    other at risk
    329
    frequency threshold
    5
    collection period
    Source null
    event definition
    One (1) participant was randomized to the placebo group but received ramucirumab in error. This participant was included in the ramucirumab group in the Safety population (as treated).
    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
    NCT01170663
    qol key
    qol-0012
    source section id
    NCT01170663-om-0012
    source outcome index
    12
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline to End of Therapy in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life: Questionnaire (QLQ-C30) in Global Health Status
    measure definition
    EORTC QLQ-C30 v3.0 is a 30-item, self-administered questionnaire with multidimensional scales assessing 15 domains (5 functional domains \[physical, role, cognitive, emotional, and social\], 9 symptom scales \[fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties\] and global health status scale). 28 questions assessed on a 1 (not at all) to 4 (very much) scale and the remaining 2 questions used a 1 (poor) to 7 (excellent) scale. A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
    time frame
    Baseline, end of therapy (up to 103 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores represent a better
    population note
    All participants according to the treatment group to which they were randomized with baseline and end of treatment Global Health Status observations.
    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
    NCT01170663
    qol key
    qol-0013
    source section id
    NCT01170663-om-0013
    source outcome index
    13
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline to End of Therapy in European Quality of Life Questionnaire-5 Dimension (EuroQol EQ-5D) Index Score
    measure definition
    The EQ-5D is a generic, multidimensional, health status instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale \[1 (no problem), 2 (some problems), and 3 (major problems)\]. These combinations of responses were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status.
    time frame
    Baseline, end of therapy (up to 103 weeks)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All participants according to the treatment group to which they were randomized with baseline and end of treatment EQ-5D observations.
    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