TriangleNCT01140347 · STUDY IN CONTEXT
A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After
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
OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.
PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.
ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) \* 100.
TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.
The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).
The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.
Reported safety
Quality of life and patient-reported measures
FACT · Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
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-liver-neoplasm
- nct id
- NCT01140347
- qol key
- qol-0004
- source section id
- NCT01140347-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact' in the study's own wording
- scale title
- Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
- measure definition
- The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).
- time frame
- Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Randomized participants who had FHSI-8 at baseline and the specified time points.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State 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-liver-neoplasm
- nct id
- NCT01140347
- qol key
- qol-0005
- source section id
- NCT01140347-om-0005
- source outcome index
- 5
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score
- measure definition
- The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.
- time frame
- Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Randomized participants who had an EQ-5D score at baseline and the specified time points.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- trial label
- A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0000
- source section id
- NCT01140347-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.
- time origin
- Randomization to death from any cause (up to 37 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat (ITT) Population: All randomized participants. Participants censored: Ramucirumab+BSC (Ram)=65, Placebo+BSC (Pl)=58.
- 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-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0001
- source section id
- NCT01140347-om-0001
- source outcome index
- 1
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.
- time origin
- Randomization to PD (up to 36 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population: All randomized participants. Participants censored: Ram=43, Pl=19.
- 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-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0002
- source section id
- NCT01140347-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
- endpoint definition
- ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to \<10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) \* 100.
- time origin
- Baseline to the date of first evidence of confirmed CR or PR (up to 37 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population: 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-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0003
- source section id
- NCT01140347-om-0003
- source outcome index
- 3
- endpoint
- Time to Radiographic Progression (TTP)
- endpoint definition
- TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.
- time origin
- Randomization to PD (up to 36 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population: All randomized participants. Participants censored: Ram=86, Pl=52.
- 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-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0004
- source section id
- NCT01140347-om-0004
- source outcome index
- 4
- endpoint
- Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
- endpoint definition
- The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).
- time origin
- Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized participants who had FHSI-8 at baseline and the specified time points.
- 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-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0005
- source section id
- NCT01140347-om-0005
- source outcome index
- 5
- endpoint
- Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score
- endpoint definition
- The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.
- time origin
- Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized participants who had an EQ-5D score at baseline and the specified time points.
- 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-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Ramucirumab (IMC-1121B) + BSC
- regimen
- Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 283
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo + BSC
- regimen
- Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 282
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Ramucirumab (IMC-1121B) + BSC
- regimen
- Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 283
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo + BSC
- regimen
- Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 282
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Ramucirumab (IMC-1121B) + BSC
- regimen
- Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 283
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo + BSC
- regimen
- Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 282
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Ramucirumab (IMC-1121B) + BSC
- regimen
- Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 283
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo + BSC
- regimen
- Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 282
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Ramucirumab (IMC-1121B) + BSC
- regimen
- Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 169
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo + BSC
- regimen
- Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 199
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Ramucirumab (IMC-1121B) + BSC
- regimen
- Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 166
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo + BSC
- regimen
- Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
- analyzed count
- 190
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01140347-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- harm key
- EG000
- source section id
- NCT01140347-ae
- event group key
- EG000
- event group label
- Ramucirumab (IMC-1121B) + BSC
- serious affected
- 124
- serious at risk
- 277
- other affected
- 254
- other at risk
- 277
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- harm key
- EG001
- source section id
- NCT01140347-ae
- event group key
- EG001
- event group label
- Placebo + BSC
- serious affected
- 92
- serious at risk
- 276
- other affected
- 235
- other at risk
- 276
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-liver-neoplasm
- nct id
- NCT01140347
- qol key
- qol-0004
- source section id
- NCT01140347-om-0004
- source outcome index
- 4
- instrument
- FACT
- instrument basis
- matched 'fact' in the study's own wording
- scale title
- Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
- measure definition
- The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).
- time frame
- Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Randomized participants who had FHSI-8 at baseline and the specified time points.
- 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-liver-neoplasm
- nct id
- NCT01140347
- qol key
- qol-0005
- source section id
- NCT01140347-om-0005
- source outcome index
- 5
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score
- measure definition
- The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.
- time frame
- Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Randomized participants who had an EQ-5D score at baseline and the specified time points.
- 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