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NCT00105443 · STUDY IN CONTEXT

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

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.

post-hoc · POSTED

Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment

→

primary · POSTED

Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.

→

primary · POSTED

TTSP was defined as the time from randomization to the first documented symptomatic progression.

This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.

→

secondary · POSTED

TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.

The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006

→

secondary · POSTED

The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.

In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors \[RECIST\])

→

secondary · POSTED

PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.

In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline \<8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006

→

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

FACT · Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire

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
NCT00105443
qol key
qol-0004
source section id
NCT00105443-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fact-hep' in the study's own wording
scale title
Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
measure definition
PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.
time frame
from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline \<8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire

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
NCT00105443
qol key
qol-0009
source section id
NCT00105443-om-0009
source outcome index
9
instrument
FACT
instrument basis
matched 'fact-hep' in the study's own wording
scale title
Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
measure definition
PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value. At the cut-off date for this analysis, one more patient data has been gained.
time frame
from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment
analysis role
post-hoc
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline \<8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.
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-liver-neoplasm
nct id
NCT00105443
trial label
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
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
5
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0005
    source section id
    NCT00105443-om-0005
    source outcome index
    5
    endpoint
    Overall Survival
    endpoint definition
    Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
    time origin
    from randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment
    analysis role
    post-hoc
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment
    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-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0000
    source section id
    NCT00105443-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
    time origin
    from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.
    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-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0001
    source section id
    NCT00105443-om-0001
    source outcome index
    1
    endpoint
    Time to Symptomatic Progression (TTSP)
    endpoint definition
    TTSP was defined as the time from randomization to the first documented symptomatic progression.
    time origin
    from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.
    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-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0002
    source section id
    NCT00105443-om-0002
    source outcome index
    2
    endpoint
    Time to Progression (TTP)
    endpoint definition
    TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
    time origin
    from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006
    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-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0003
    source section id
    NCT00105443-om-0003
    source outcome index
    3
    endpoint
    Disease Control (DC)
    endpoint definition
    The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
    time origin
    time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors \[RECIST\])
    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-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0004
    source section id
    NCT00105443-om-0004
    source outcome index
    4
    endpoint
    Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
    endpoint definition
    PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.
    time origin
    from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline \<8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006
    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-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    analyzed count
    299
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    analyzed count
    303
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    analyzed count
    299
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    analyzed count
    303
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    analyzed count
    299
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo
    regimen
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    analyzed count
    303
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    analyzed count
    299
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo
    regimen
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    analyzed count
    303
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    analyzed count
    174
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo
    regimen
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    analyzed count
    178
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
    analyzed count
    299
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo
    regimen
    Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
    analyzed count
    303
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105443-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-liver-neoplasm
    nct id
    NCT00105443
    harm key
    EG000
    source section id
    NCT00105443-ae
    event group key
    EG000
    event group label
    Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)
    serious affected
    153
    serious at risk
    297
    other affected
    275
    other at risk
    297
    frequency threshold
    5
    collection period
    Reporting Group (RG) 1 + 2: Data for Interim Analysis, cut-off Oct 17, 2006; RG 3: Data during and after unblinding (until Nov 21, 2008); RG 4: Data prior to date of unblinding (Feb 9, 2007); RG 5: Data after unblinding (Open Label; until Nov 21, 2008)
    event definition
    RG 1 + 3 description: All subjects randomized to Sorafenib treatment; RG 2 + 4 description: All subjects randomized to Placebo before unblinding (when they were on Placebo, before they had the opportunity to switch to Sorafenib treatment); RG 5 description: All placebo subjects who switched to Sorafenib treatment after unblinding occurred.
    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-liver-neoplasm
    nct id
    NCT00105443
    harm key
    EG001
    source section id
    NCT00105443-ae
    event group key
    EG001
    event group label
    Placebo Arm Double-Blind Phase (Interim Data Only)
    serious affected
    164
    serious at risk
    302
    other affected
    259
    other at risk
    302
    frequency threshold
    5
    collection period
    Reporting Group (RG) 1 + 2: Data for Interim Analysis, cut-off Oct 17, 2006; RG 3: Data during and after unblinding (until Nov 21, 2008); RG 4: Data prior to date of unblinding (Feb 9, 2007); RG 5: Data after unblinding (Open Label; until Nov 21, 2008)
    event definition
    RG 1 + 3 description: All subjects randomized to Sorafenib treatment; RG 2 + 4 description: All subjects randomized to Placebo before unblinding (when they were on Placebo, before they had the opportunity to switch to Sorafenib treatment); RG 5 description: All placebo subjects who switched to Sorafenib treatment after unblinding occurred.
    undenominated note
    Source null
    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-liver-neoplasm
    nct id
    NCT00105443
    harm key
    EG002
    source section id
    NCT00105443-ae
    event group key
    EG002
    event group label
    Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)
    serious affected
    191
    serious at risk
    297
    other affected
    281
    other at risk
    297
    frequency threshold
    5
    collection period
    Reporting Group (RG) 1 + 2: Data for Interim Analysis, cut-off Oct 17, 2006; RG 3: Data during and after unblinding (until Nov 21, 2008); RG 4: Data prior to date of unblinding (Feb 9, 2007); RG 5: Data after unblinding (Open Label; until Nov 21, 2008)
    event definition
    RG 1 + 3 description: All subjects randomized to Sorafenib treatment; RG 2 + 4 description: All subjects randomized to Placebo before unblinding (when they were on Placebo, before they had the opportunity to switch to Sorafenib treatment); RG 5 description: All placebo subjects who switched to Sorafenib treatment after unblinding occurred.
    undenominated note
    Source null
    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-liver-neoplasm
    nct id
    NCT00105443
    harm key
    EG003
    source section id
    NCT00105443-ae
    event group key
    EG003
    event group label
    Placebo Arm, Complete Double-Blind Phase
    serious affected
    185
    serious at risk
    302
    other affected
    271
    other at risk
    302
    frequency threshold
    5
    collection period
    Reporting Group (RG) 1 + 2: Data for Interim Analysis, cut-off Oct 17, 2006; RG 3: Data during and after unblinding (until Nov 21, 2008); RG 4: Data prior to date of unblinding (Feb 9, 2007); RG 5: Data after unblinding (Open Label; until Nov 21, 2008)
    event definition
    RG 1 + 3 description: All subjects randomized to Sorafenib treatment; RG 2 + 4 description: All subjects randomized to Placebo before unblinding (when they were on Placebo, before they had the opportunity to switch to Sorafenib treatment); RG 5 description: All placebo subjects who switched to Sorafenib treatment after unblinding occurred.
    undenominated note
    Source null
    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-liver-neoplasm
    nct id
    NCT00105443
    harm key
    EG004
    source section id
    NCT00105443-ae
    event group key
    EG004
    event group label
    Subjects Switching From Placebo to Sorafenib (Open Label Only)
    serious affected
    26
    serious at risk
    47
    other affected
    43
    other at risk
    47
    frequency threshold
    5
    collection period
    Reporting Group (RG) 1 + 2: Data for Interim Analysis, cut-off Oct 17, 2006; RG 3: Data during and after unblinding (until Nov 21, 2008); RG 4: Data prior to date of unblinding (Feb 9, 2007); RG 5: Data after unblinding (Open Label; until Nov 21, 2008)
    event definition
    RG 1 + 3 description: All subjects randomized to Sorafenib treatment; RG 2 + 4 description: All subjects randomized to Placebo before unblinding (when they were on Placebo, before they had the opportunity to switch to Sorafenib treatment); RG 5 description: All placebo subjects who switched to Sorafenib treatment after unblinding occurred.
    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-liver-neoplasm
    nct id
    NCT00105443
    qol key
    qol-0004
    source section id
    NCT00105443-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fact-hep' in the study's own wording
    scale title
    Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
    measure definition
    PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.
    time frame
    from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline \<8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006
    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-liver-neoplasm
    nct id
    NCT00105443
    qol key
    qol-0009
    source section id
    NCT00105443-om-0009
    source outcome index
    9
    instrument
    FACT
    instrument basis
    matched 'fact-hep' in the study's own wording
    scale title
    Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
    measure definition
    PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value. At the cut-off date for this analysis, one more patient data has been gained.
    time frame
    from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment
    analysis role
    post-hoc
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline \<8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.
    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