NCT04322539 · STUDY IN CONTEXT

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With 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 (months) from date of randomization to death from any cause. OS was calculated as (date of death or last known alive - date of randomization + 1)/30.4375. Participants without report of death at the time of analysis will be censored at the date last known alive.

ITT population included all randomized participants.

→

secondary · POSTED

PFS was defined as the time (months) from randomization until the first radiographic documentation of objective progression as assessed by investigator using RECIST v1.1, or death from any cause, whichever comes first. More specifically, PFS was determined using all data until the last evaluable visit prior to or on the date of: (i) radiographic disease progression (PD) per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than the study drugs, whichever was earlier. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

ITT population included all randomized participants.

→

secondary · POSTED

ORR was defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), per RECIST v1.1, as determined by the investigator. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).

ITT population included all randomized participants.

→

secondary · POSTED

DCR was defined as percentage of participants achieving a best overall response of confirmed CR, PR, or stable disease (SD) (for at least 7 weeks) per RECIST v1.1, as determined by the investigator. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline.

ITT population included all randomized participants.

→

secondary · POSTED

DOR was defined as the time (in months) from the first occurrence of PR or CR by RECIST Version 1.1, until the first date that progressive disease is documented by RECIST Version 1.1, or death, whichever comes first. Only those participants with confirmed responses of CR or PR were included in this analysis. DOR was calculated as (date of death or PD or last assessment - date of first occurrence of confirmed CR or PR + 1)/30.4375.

Analysis was performed on subset of participants who had a response. Here, '0' in 'overall number of participants analyzed represents that DOR could only be analyzed in participants who achieved a response. As no participant in the Placebo Plus BSC Group cohort achieved any response, no DOR is available.

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secondary · POSTED

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE was considered a TEAE if the onset date was on or after the start of study treatment or if the onset date was missing, or if the AE had an onset date before the start of study treatment but worsened in severity after the study treatment until 30 days after the last dose of study treatment or a new treatment of anti-tumor therapy, whichever was earlier. After this period, treatment-related SAEs were also considered as TEAEs. AEs with an unknown/not reported onset date were also included.

SP included all randomized participants who received at least 1 dose of study drug.

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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 Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score

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

release id: clinical-indications-draft-1
disease state id: ds-colon-cancer
nct id: NCT04322539
qol key: qol-0011
source section id: NCT04322539-om-0011
source outcome index: 11
instrument: EORTC QLQ
instrument basis: matched 'eortc' in the study's own wording
scale title: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score
measure definition: EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores are standardized and converted into scale scores ranging from 0 to 100. For global health status/QOL scale, higher scores represent better QOL. A negative change from baseline value indicates patient condition worsened. Change from baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Scale scores was performed by visit (i.e., cycle), using a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach.
time frame: Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher scores represent better
population note: ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified timepoints.
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 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score

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

release id: clinical-indications-draft-1
disease state id: ds-colon-cancer
nct id: NCT04322539
qol key: qol-0012
source section id: NCT04322539-om-0012
source outcome index: 12
instrument: EQ-5D
instrument basis: matched 'eq-5d' in the study's own wording
scale title: Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
measure definition: The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score and a general VAS score for health status. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. The higher the score the better the health status. A negative change from baseline value represents patient condition worsened. Change from baseline in the EQ-5D-5L VAS scores was performed by visit (i.e. cycle), using a REML-based MMRM approach.
time frame: Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
analysis role: secondary
reporting status: POSTED
higher is better: 1
direction quote: higher the score the better
population note: ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
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 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores

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

release id: clinical-indications-draft-1
disease state id: ds-colon-cancer
nct id: NCT04322539
qol key: qol-0013
source section id: NCT04322539-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 in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores
measure definition: EQ-5D-5L consisted of 2 components: health state profile and optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problem, 2= slight problem, 3= moderate problem, 4= severe problem, and 5= extreme problem. The response levels collected from the EQ-5D-5L five dimensions as a health profile are converted into an EQ-5D-5L index (utility) scores to represent participants' utility value. The range of health utility index score is from -0.285 to 1, where higher value indicates perfect health and a negative value represents a state worse than dead. Change from baseline in EQ-5D-5L health utility index scores was performed by visit (i.e., cycle), using a REML-based MMRM approach.
time frame: Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
analysis role: secondary
reporting status: POSTED
higher is better: 0
direction quote: higher value indicates perfect health and a negative value represents a state worse
population note: ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
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-colon-cancer
nct id: NCT04322539
trial label: A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With 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: 3

outcomes

release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0000
source section id
NCT04322539-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
OS was defined as the time (months) from date of randomization to death from any cause. OS was calculated as (date of death or last known alive - date of randomization + 1)/30.4375. Participants without report of death at the time of analysis will be censored at the date last known alive.
time origin
From date of randomization to death from any cause (up to 22 months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0001
source section id
NCT04322539-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS), as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
endpoint definition
PFS was defined as the time (months) from randomization until the first radiographic documentation of objective progression as assessed by investigator using RECIST v1.1, or death from any cause, whichever comes first. More specifically, PFS was determined using all data until the last evaluable visit prior to or on the date of: (i) radiographic disease progression (PD) per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than the study drugs, whichever was earlier. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.
time origin
From randomization until the first documentation of objective progression or death, whichever comes first (up to 22 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0002
source section id
NCT04322539-om-0002
source outcome index
2
endpoint
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
endpoint definition
ORR was defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), per RECIST v1.1, as determined by the investigator. PR: At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).
time origin
From randomization until the first documentation of best overall response (up to 22 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0003
source section id
NCT04322539-om-0003
source outcome index
3
endpoint
Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
endpoint definition
DCR was defined as percentage of participants achieving a best overall response of confirmed CR, PR, or stable disease (SD) (for at least 7 weeks) per RECIST v1.1, as determined by the investigator. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline.
time origin
From randomization until the first documentation of best overall response (up to 22 months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
ITT population included all randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0004
source section id
NCT04322539-om-0004
source outcome index
4
endpoint
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
endpoint definition
DOR was defined as the time (in months) from the first occurrence of PR or CR by RECIST Version 1.1, until the first date that progressive disease is documented by RECIST Version 1.1, or death, whichever comes first. Only those participants with confirmed responses of CR or PR were included in this analysis. DOR was calculated as (date of death or PD or last assessment - date of first occurrence of confirmed CR or PR + 1)/30.4375.
time origin
From first occurrence of PR or CR until the first documentation progression or death, whichever comes first (up to 22 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Analysis was performed on subset of participants who had a response. Here, '0' in 'overall number of participants analyzed represents that DOR could only be analyzed in participants who achieved a response. As no participant in the Placebo Plus BSC Group cohort achieved any response, no DOR is available.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0005
source section id
NCT04322539-om-0005
source outcome index
5
endpoint
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
endpoint definition
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE was considered a TEAE if the onset date was on or after the start of study treatment or if the onset date was missing, or if the AE had an onset date before the start of study treatment but worsened in severity after the study treatment until 30 days after the last dose of study treatment or a new treatment of anti-tumor therapy, whichever was earlier. After this period, treatment-related SAEs were also considered as TEAEs. AEs with an unknown/not reported onset date were also included.
time origin
From start of study drug administration up to approximately 40 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
SP included all randomized participants who received at least 1 dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0000
arm key
OG000
arm label
Fruquintinib + BSC Group
regimen
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
461
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0000
arm key
OG001
arm label
Placebo + BSC Group
regimen
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
230
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0001
arm key
OG000
arm label
Fruquintinib + BSC Group
regimen
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
461
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0001
arm key
OG001
arm label
Placebo + BSC Group
regimen
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
230
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0002
arm key
OG000
arm label
Fruquintinib + BSC Group
regimen
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
461
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0002
arm key
OG001
arm label
Placebo + BSC Group
regimen
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
230
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0003
arm key
OG000
arm label
Fruquintinib + BSC Group
regimen
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
461
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0003
arm key
OG001
arm label
Placebo + BSC Group
regimen
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
230
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0004
arm key
OG000
arm label
Fruquintinib + BSC Group
regimen
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0004
arm key
OG001
arm label
Placebo + BSC Group
regimen
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0005
arm key
OG000
arm label
Fruquintinib + BSC Group
regimen
Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
456
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
outcome key
om-0005
arm key
OG001
arm label
Placebo + BSC Group
regimen
Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
analyzed count
230
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04322539-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
harm key
EG000
source section id
NCT04322539-ae
event group key
EG000
event group label
Fruquintinib + BSC Group
serious affected
173
serious at risk
456
other affected
446
other at risk
456
frequency threshold
5
collection period
From start of study drug administration up to approximately 40 months
event definition
All-Cause Mortality data collected during the study was assessed for all randomized participants. Serious AEs and Non-Serious AEs data were collected based on safety population that included all randomized participants who received at least 1 dose.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
harm key
EG001
source section id
NCT04322539-ae
event group key
EG001
event group label
Placebo + BSC Group
serious affected
88
serious at risk
230
other affected
205
other at risk
230
frequency threshold
5
collection period
From start of study drug administration up to approximately 40 months
event definition
All-Cause Mortality data collected during the study was assessed for all randomized participants. Serious AEs and Non-Serious AEs data were collected based on safety population that included all randomized participants who received at least 1 dose.
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

release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
qol key
qol-0011
source section id
NCT04322539-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score
measure definition
EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores are standardized and converted into scale scores ranging from 0 to 100. For global health status/QOL scale, higher scores represent better QOL. A negative change from baseline value indicates patient condition worsened. Change from baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Scale scores was performed by visit (i.e., cycle), using a restricted maximum likelihood (REML)-based mixed model repeated measures (MMRM) approach.
time frame
Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher scores represent better
population note
ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified timepoints.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
qol key
qol-0012
source section id
NCT04322539-om-0012
source outcome index
12
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
measure definition
The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score and a general VAS score for health status. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. The higher the score the better the health status. A negative change from baseline value represents patient condition worsened. Change from baseline in the EQ-5D-5L VAS scores was performed by visit (i.e. cycle), using a REML-based MMRM approach.
time frame
Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher the score the better
population note
ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-colon-cancer
nct id
NCT04322539
qol key
qol-0013
source section id
NCT04322539-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 in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores
measure definition
EQ-5D-5L consisted of 2 components: health state profile and optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problem, 2= slight problem, 3= moderate problem, 4= severe problem, and 5= extreme problem. The response levels collected from the EQ-5D-5L five dimensions as a health profile are converted into an EQ-5D-5L index (utility) scores to represent participants' utility value. The range of health utility index score is from -0.285 to 1, where higher value indicates perfect health and a negative value represents a state worse than dead. Change from baseline in EQ-5D-5L health utility index scores was performed by visit (i.e., cycle), using a REML-based MMRM approach.
time frame
Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher value indicates perfect health and a negative value represents a state worse
population note
ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
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