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← WELIREG: metastatic Renal cell carcinoma (adjuvant) after prior therapy

NCT00073307 · STUDY IN CONTEXT

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.

Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.

→

primary · POSTED

Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.

Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data.

→

secondary · POSTED

PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.

Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.

→

secondary · POSTED

Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.

Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.

→

secondary · POSTED

Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.

Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.

→

secondary · POSTED

Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.

Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.

→

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 · Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment

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-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT00073307
qol key
qol-0004
source section id
NCT00073307-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'fksi' in the study's own wording
scale title
Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
measure definition
Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.
time frame
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score represents better
population note
Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment

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-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT00073307
qol key
qol-0005
source section id
NCT00073307-om-0005
source outcome index
5
instrument
FACT
instrument basis
matched 'fact-g' in the study's own wording
scale title
Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
measure definition
Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
time frame
From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
analysis role
secondary
reporting status
POSTED
higher is better
1
direction quote
higher score represents better
population note
Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.
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-renal-cell-cancer-welireg-ac99f5fa
nct id
NCT00073307
trial label
Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
4
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0000
    source section id
    NCT00073307-om-0000
    source outcome index
    0
    endpoint
    Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
    endpoint definition
    Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
    time origin
    From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0001
    source section id
    NCT00073307-om-0001
    source outcome index
    1
    endpoint
    Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population
    endpoint definition
    Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
    time origin
    From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data.
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0002
    source section id
    NCT00073307-om-0002
    source outcome index
    2
    endpoint
    Final Progression-Free Survival (PFS) - Independent Radiological Review
    endpoint definition
    PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.
    time origin
    From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor 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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0003
    source section id
    NCT00073307-om-0003
    source outcome index
    3
    endpoint
    Best Overall Response - Independent Radiological Review
    endpoint definition
    Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.
    time origin
    From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0004
    source section id
    NCT00073307-om-0004
    source outcome index
    4
    endpoint
    Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
    endpoint definition
    Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.
    time origin
    From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0005
    source section id
    NCT00073307-om-0005
    source outcome index
    5
    endpoint
    Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
    endpoint definition
    Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
    time origin
    From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    analyzed count
    451
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo
    regimen
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    analyzed count
    452
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    analyzed count
    451
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo
    regimen
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    analyzed count
    452
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    analyzed count
    384
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo tablets matching in appearance were to be orally administered twice a day.
    analyzed count
    385
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    analyzed count
    335
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo
    regimen
    Placebo tablets matching in appearance were to be orally administered twice a day.
    analyzed count
    337
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    analyzed count
    451
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo
    regimen
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    analyzed count
    452
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Sorafenib (Nexavar, BAY43-9006)
    regimen
    Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
    analyzed count
    451
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo
    regimen
    Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
    analyzed count
    452
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00073307-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    harm key
    EG000
    source section id
    NCT00073307-ae
    event group key
    EG000
    event group label
    Sorafenib (Nexavar, BAY43-9006)-31May2005 DB
    serious affected
    154
    serious at risk
    451
    other affected
    407
    other at risk
    451
    frequency threshold
    5
    collection period
    In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the crossover phase and was included in the safety population only.
    event definition
    DIC (disseminated intravascular coagulation), AT (Atrial tachycardia), NOS (not otherwise specified), GI (gastro-intestinal), CTCAE (Common Terminology Criteria for Adverse Events), ANC (absolute neutrophil count), CNS (central nervous system), CN (cranial nerve), GU (genitourinary)
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    harm key
    EG001
    source section id
    NCT00073307-ae
    event group key
    EG001
    event group label
    Placebo-31May2005 DB
    serious affected
    110
    serious at risk
    451
    other affected
    346
    other at risk
    451
    frequency threshold
    5
    collection period
    In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the crossover phase and was included in the safety population only.
    event definition
    DIC (disseminated intravascular coagulation), AT (Atrial tachycardia), NOS (not otherwise specified), GI (gastro-intestinal), CTCAE (Common Terminology Criteria for Adverse Events), ANC (absolute neutrophil count), CNS (central nervous system), CN (cranial nerve), GU (genitourinary)
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    harm key
    EG002
    source section id
    NCT00073307-ae
    event group key
    EG002
    event group label
    Sorafenib (Nexavar, BAY43-9006)-30Jun2008
    serious affected
    245
    serious at risk
    452
    other affected
    425
    other at risk
    452
    frequency threshold
    5
    collection period
    In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the crossover phase and was included in the safety population only.
    event definition
    DIC (disseminated intravascular coagulation), AT (Atrial tachycardia), NOS (not otherwise specified), GI (gastro-intestinal), CTCAE (Common Terminology Criteria for Adverse Events), ANC (absolute neutrophil count), CNS (central nervous system), CN (cranial nerve), GU (genitourinary)
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    harm key
    EG003
    source section id
    NCT00073307-ae
    event group key
    EG003
    event group label
    Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008
    serious affected
    124
    serious at risk
    216
    other affected
    200
    other at risk
    216
    frequency threshold
    5
    collection period
    In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the crossover phase and was included in the safety population only.
    event definition
    DIC (disseminated intravascular coagulation), AT (Atrial tachycardia), NOS (not otherwise specified), GI (gastro-intestinal), CTCAE (Common Terminology Criteria for Adverse Events), ANC (absolute neutrophil count), CNS (central nervous system), CN (cranial nerve), GU (genitourinary)
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    qol key
    qol-0004
    source section id
    NCT00073307-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'fksi' in the study's own wording
    scale title
    Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment
    measure definition
    Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL.
    time frame
    From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score represents better
    population note
    Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.
    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-renal-cell-cancer-welireg-ac99f5fa
    nct id
    NCT00073307
    qol key
    qol-0005
    source section id
    NCT00073307-om-0005
    source outcome index
    5
    instrument
    FACT
    instrument basis
    matched 'fact-g' in the study's own wording
    scale title
    Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment
    measure definition
    Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from "0=not at all" to "4=very much" and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL.
    time frame
    From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    1
    direction quote
    higher score represents better
    population note
    Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.
    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