Skip to content
Triangle logo TriangleGet started
← Colorectal Neoplasm

NCT01183780 · STUDY IN CONTEXT

A Study in Second Line Metastatic Colorectal Cancer

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

OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.

All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.

→

secondary · POSTED

PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) \[according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1\] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.

All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.

→

secondary · POSTED

The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 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 at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.

All randomized participants.

→

secondary · POSTED

The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). 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 symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.

All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .

→

secondary · POSTED

The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes 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.

All randomized participants who had EQ-5D assessed at baseline and 30-day FU.

→

secondary · POSTED

Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\*100.

All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.

→

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 European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 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-colorectal-neoplasm
nct id
NCT01183780
qol key
qol-0003
source section id
NCT01183780-om-0003
source outcome index
3
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
measure definition
The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). 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 symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.
time frame
Baseline Up to 171 Weeks
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent a better
population note
All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .
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 in EuroQol- 5D (EQ-5D)

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-colorectal-neoplasm
nct id
NCT01183780
qol key
qol-0004
source section id
NCT01183780-om-0004
source outcome index
4
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in EuroQol- 5D (EQ-5D)
measure definition
The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes 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 and 30-Day Follow-Up (FU) up to 171 Weeks
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
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-colorectal-neoplasm
nct id
NCT01183780
trial label
A Study in Second Line Metastatic Colorectal Cancer
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
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0000
    source section id
    NCT01183780-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.
    time origin
    Randomization to Date of Death from Any Cause Up to 39.36 Months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139.
    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-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0001
    source section id
    NCT01183780-om-0001
    source outcome index
    1
    endpoint
    Progression-free Survival (PFS) Time
    endpoint definition
    PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) \[according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1\] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.
    time origin
    Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42.
    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-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0002
    source section id
    NCT01183780-om-0002
    source outcome index
    2
    endpoint
    Percentage of Participants Achieving an Objective Response (Objective Response Rate)
    endpoint definition
    The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 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 at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.
    time origin
    Randomization until Disease Progression Up to 38.01 Months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    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-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0003
    source section id
    NCT01183780-om-0003
    source outcome index
    3
    endpoint
    Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
    endpoint definition
    The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). 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 symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.
    time origin
    Baseline Up to 171 Weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .
    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-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0004
    source section id
    NCT01183780-om-0004
    source outcome index
    4
    endpoint
    Change From Baseline in EuroQol- 5D (EQ-5D)
    endpoint definition
    The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes 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 origin
    Baseline and 30-Day Follow-Up (FU) up to 171 Weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
    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-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0005
    source section id
    NCT01183780-om-0005
    source outcome index
    5
    endpoint
    Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
    endpoint definition
    Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\*100.
    time origin
    Cycles 1, 3, 5, and 30-Day FU
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points.
    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-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ramucirumab + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    536
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    536
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Ramucirumab + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    536
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    536
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Ramucirumab + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    536
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    536
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Ramucirumab + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    491
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    486
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Ramucirumab + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    308
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    310
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Ramucirumab + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 mg/kg administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    516
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo + FOLFIRI
    regimen
    On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.
    analyzed count
    512
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01183780-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-colorectal-neoplasm
    nct id
    NCT01183780
    harm key
    EG000
    source section id
    NCT01183780-ae
    event group key
    EG000
    event group label
    FOLFIRI + Ramucirumab
    serious affected
    198
    serious at risk
    529
    other affected
    518
    other at risk
    529
    frequency threshold
    5
    collection period
    Source null
    event definition
    One participant who was randomized into FOLFIRI + Placebo arm received Ramucirumab dose by mistake. For safety analysis of adverse events, this participant was categorized into FOLFIRI + Ramucirumab arm.
    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-colorectal-neoplasm
    nct id
    NCT01183780
    harm key
    EG001
    source section id
    NCT01183780-ae
    event group key
    EG001
    event group label
    FOLFIRI + Placebo
    serious affected
    175
    serious at risk
    528
    other affected
    510
    other at risk
    528
    frequency threshold
    5
    collection period
    Source null
    event definition
    One participant who was randomized into FOLFIRI + Placebo arm received Ramucirumab dose by mistake. For safety analysis of adverse events, this participant was categorized into FOLFIRI + Ramucirumab arm.
    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-colorectal-neoplasm
    nct id
    NCT01183780
    qol key
    qol-0003
    source section id
    NCT01183780-om-0003
    source outcome index
    3
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status
    measure definition
    The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). 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 symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change.
    time frame
    Baseline Up to 171 Weeks
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher scores represent a better
    population note
    All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline .
    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-colorectal-neoplasm
    nct id
    NCT01183780
    qol key
    qol-0004
    source section id
    NCT01183780-om-0004
    source outcome index
    4
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Change From Baseline in EuroQol- 5D (EQ-5D)
    measure definition
    The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes 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 and 30-Day Follow-Up (FU) up to 171 Weeks
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All randomized participants who had EQ-5D assessed at baseline and 30-day FU.
    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