TriangleNCT00334282 · STUDY IN CONTEXT
Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma
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
Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.
Overall survival is defined as the time from randomization until death. The length of this interval was estimated as the date of death minus the date of randomization plus 1 day. Participants who were still alive at the time of analysis were censored.
Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.
This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a \>=20% increase in target lesions. IRC, independent review committee.
Duration of response is defined as the time from first observation of response until progression of disease or death.
Time to response is defined as the time from randomization until the first documented evidence of complete response (all detectable tumor has disappeared) or partial response (a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first).
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48
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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0006
- source section id
- NCT00334282-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48
- measure definition
- The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 \[very poor quality of life\] to 7 \[excellent quality of life\]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.
- time frame
- Baseline and Weeks 6, 12, 18, 24, and 48
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0007
- source section id
- NCT00334282-om-0007
- source outcome index
- 7
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
- measure definition
- The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (\<0).
- time frame
- Baseline and Weeks 6, 12, 18, 24, and 48
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EQ-5D · Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0008
- source section id
- NCT00334282-om-0008
- source outcome index
- 8
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
- measure definition
- The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant's self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).
- time frame
- Baseline and Weeks 6, 12, 18, 24, and 48
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
FACT · Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants
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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0010
- source section id
- NCT00334282-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'factors' in the study's own wording
- scale title
- Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants
- measure definition
- Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors. Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.
- time frame
- Baseline
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- trial label
- Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma
- 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
- 2
- qol Count
- 4
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0000
- source section id
- NCT00334282-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival
- endpoint definition
- Progression-free survival (PFS) is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause. Assessments of progression and non-progression were made by an independent imaging review committee (IRC) for the primary analysis.
- time origin
- Randomization until progression (up to 2 years)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-Treat (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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0001
- source section id
- NCT00334282-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Overall survival is defined as the time from randomization until death. The length of this interval was estimated as the date of death minus the date of randomization plus 1 day. Participants who were still alive at the time of analysis were censored.
- time origin
- Randomization until death (up to 2 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0002
- source section id
- NCT00334282-om-0002
- source outcome index
- 2
- endpoint
- Overall Response
- endpoint definition
- Overall response is the number of participants who had a complete response (CR) or a partial response (PR). Per RECIST: CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the Baseline sum, no worsening of non-TLs, and no new lesions; Progressive disease (PD), a \>=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; Stable Disease, small changes that do not meet previously given criteria. IRC, independent review committee.
- time origin
- Baseline until either response or progression (up to 2 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0003
- source section id
- NCT00334282-om-0003
- source outcome index
- 3
- endpoint
- Participants With Complete Response, Partial Response, or 6 Months of Stable Disease
- endpoint definition
- This is similar to overall response rate, but also includes participants who had stable disease for at least 6 months. Per Response Evaluation Criteria In Solid Tumors (RECIST): CR, all detectable tumor has disappeared; PR, a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum; Stable Disease, small changes that do not meet previously given criteria; Progressive Disease, a \>=20% increase in target lesions. IRC, independent review committee.
- time origin
- Baseline until 6 months post-Baseline or progressive disease
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0004
- source section id
- NCT00334282-om-0004
- source outcome index
- 4
- endpoint
- Duration of Response
- endpoint definition
- Duration of response is defined as the time from first observation of response until progression of disease or death.
- time origin
- Time from response until progression (up to 2 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population. Only results for pazopanib are given because there were not enough placebo responders.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0005
- source section id
- NCT00334282-om-0005
- source outcome index
- 5
- endpoint
- Time to Response as Assessed by an Independent Review Committee (IRC) and the Investigator
- endpoint definition
- Time to response is defined as the time from randomization until the first documented evidence of complete response (all detectable tumor has disappeared) or partial response (a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the Baseline sum) (whichever status was recorded first).
- time origin
- Randomization until CR or PR (assessed for up to 2 years)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- ITT Population. Only participants with a complete or partial response were analyzed. Only results for pazopanib are given because there were not enough placebo responders. The different number of participants analyzed is due to differences in clinical judgement, measurement, and the selection of target lesions.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Pazopanib 800 mg
- regimen
- Pazopanib 800 mg (tablets) administered orally once a day
- analyzed count
- 290
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Matching Placebo administered once a day
- analyzed count
- 145
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Pazopanib 800 mg
- regimen
- Pazopanib 800 mg (tablets) administered orally once a day
- analyzed count
- 290
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Matching Placebo administered orally once a day
- analyzed count
- 145
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Pazopanib 800 mg
- regimen
- Pazopanib 800 mg (tablets) administered orally once a day
- analyzed count
- 290
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Matching Placebo administered orally once a day
- analyzed count
- 145
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Pazopanib 800 mg
- regimen
- Pazopanib 800 mg (tablets) administered orally once a day
- analyzed count
- 290
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Matching placebo administered orally once a day
- analyzed count
- 145
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Pazopanib 800 mg
- regimen
- Pazopanib 800 mg (tablets) administered orally once a day
- analyzed count
- 290
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Pazopanib 800 mg
- regimen
- Pazopanib 800 mg (tablets) administered orally once a day
- analyzed count
- 103
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00334282-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- harm key
- EG000
- source section id
- NCT00334282-ae
- event group key
- EG000
- event group label
- Pazopanib 800 mg
- serious affected
- 79
- serious at risk
- 290
- other affected
- 258
- other at risk
- 290
- frequency threshold
- 5
- collection period
- Date of study entry until 28 days after the last dose.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- harm key
- EG001
- source section id
- NCT00334282-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 28
- serious at risk
- 145
- other affected
- 87
- other at risk
- 145
- frequency threshold
- 5
- collection period
- Date of study entry until 28 days after the last dose.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0006
- source section id
- NCT00334282-om-0006
- source outcome index
- 6
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ C-30) Score at Weeks 6, 12, 18, 24, and 48
- measure definition
- The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer participants. The analyses for EORTC QLQ-C30 were focused on global health status/Health-Related Quality of Life (HRQOL) scores on the questionnaire. The scores (from 1 \[very poor quality of life\] to 7 \[excellent quality of life\]) for these two questions were averaged and then transformed to a 0 - 100 scale (based on published methods) prior to analysis of change from Baseline.
- time frame
- Baseline and Weeks 6, 12, 18, 24, and 48
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0007
- source section id
- NCT00334282-om-0007
- source outcome index
- 7
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline in the Index Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
- measure definition
- The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index), through application of societal weights, and a VAS score (VAS). Index is interpreted on a continuum from 1.0 (best possible health) to 0 (represents dead), to some health sates being worse than dead (\<0).
- time frame
- Baseline and Weeks 6, 12, 18, 24, and 48
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0008
- source section id
- NCT00334282-om-0008
- source outcome index
- 8
- instrument
- EQ-5D
- instrument basis
- matched 'eq-5d' in the study's own wording
- scale title
- Adjusted Mean Change From Baseline in the Visual Analog Scale (VAS) Score of the EQ-5D (EuroQoL [Quality of Life]-5D) Questionnaire at Weeks 6, 12, 18, 24, and 48
- measure definition
- The EQ-5D is comprised of a 5-item health status measure and a visual analogue rating scale, and measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (no, moderate, and extreme problems). Scoring of the EQ-5D yields an index-based summary score (Index) and a VAS score (VAS), obtained from participant's self-reports of their health on a VAS thermometer scale. The EQ-5D VAS ranges from 0% (worst imaginable health state) to 100% (best imaginable health state).
- time frame
- Baseline and Weeks 6, 12, 18, 24, and 48
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Participants in the ITT Population who completed HRQOL assessments at Baseline and had at least one post-Baseline assessment are included. Only participants who were on treatment at the given time point were asked to complete the questionnaire, and only those who completed the questionnaire could be analyzed for each individual time point.
- 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-renal-cell-cancer-alymsys-7a90c80d
- nct id
- NCT00334282
- qol key
- qol-0010
- source section id
- NCT00334282-om-0010
- source outcome index
- 10
- instrument
- FACT
- instrument basis
- matched 'factors' in the study's own wording
- scale title
- Baseline Expression Levels of the Indicated Target Proteins in Pazopanib- and Placebo-treated Participants
- measure definition
- Baseline plasma samples were obtained from participants and were tested for the indicated cytokine and angiogenesis factors. Protein levels were determined using the Searchlight multiplex system based on chemiluminescence.
- time frame
- Baseline
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Subgroup of enrolled participants who agreed to have plasma samples collected for biomarker analyses.
- 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