← Vegzelma: metastatic Renal cell carcinoma

NCT01064310 · STUDY IN CONTEXT

Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney 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

The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.

Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.

→

primary · POSTED

The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.

mITT Population. Responses to some categories of the PPQ may be missing for some participants.

→

secondary · POSTED

Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.

Safety-Randomized Study Population: participants who received at least one dose of either drug regardless of treatment period. Participants who received mixed treatment within a period were excluded. Only those participants contributing data at the indicated time points were evaluated.

→

secondary · POSTED

The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).

Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.

→

secondary · POSTED

For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.

Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.

→

secondary · POSTED

Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.

Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.

→

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 · Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)

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-vegzelma-dfaad695
nct id: NCT01064310
qol key: qol-0000
source section id: NCT01064310-om-0000
source outcome index: 0
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
measure definition: The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
time frame: End of treatment of both study drugs (maximum of 22 weeks)
analysis role: primary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

FACT · Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference 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-renal-cell-cancer-vegzelma-dfaad695
nct id: NCT01064310
qol key: qol-0001
source section id: NCT01064310-om-0001
source outcome index: 1
instrument: FACT
instrument basis: matched 'factors' in the study's own wording
scale title: Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
measure definition: The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
time frame: End of treatment of both study drugs (maximum of 22 weeks)
analysis role: primary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: mITT Population. Responses to some categories of the PPQ may be missing for some participants.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EQ-5D · Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores

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-vegzelma-dfaad695
nct id: NCT01064310
qol key: qol-0003
source section id: NCT01064310-om-0003
source outcome index: 3
instrument: EQ-5D
instrument basis: matched 'eq-5d' in the study's own wording
scale title: Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
measure definition: The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
time frame: Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.
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-vegzelma-dfaad695
nct id: NCT01064310
trial label: Patient Preference Study of Pazopanib Versus Sunitinib in Advanced or Metastatic Kidney 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: 3
qol Count: 3

outcomes

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0000
source section id
NCT01064310-om-0000
source outcome index
0
endpoint
Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
endpoint definition
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
time origin
End of treatment of both study drugs (maximum of 22 weeks)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.
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-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0001
source section id
NCT01064310-om-0001
source outcome index
1
endpoint
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
endpoint definition
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
time origin
End of treatment of both study drugs (maximum of 22 weeks)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
mITT Population. Responses to some categories of the PPQ may be missing for some 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-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0002
source section id
NCT01064310-om-0002
source outcome index
2
endpoint
Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
endpoint definition
Change from period (P) BL is computed as participants' (par.) average post-BL fatigue score within each P minus their P-specific BL score. P 1 BL is the P 1 Pre-Dose assessment; P 2 BL is the wash-out assessment. Crossover analyses compared par. average scores on each treatment, adjusting for sequence. FACIT-Fatigue Scale: overall score (0 to 52)=the sum of scores for 13 questions. For each question, par. rated their condition for the past week on a 5-point scale: 0 (not at all) to 4 (very much). A high score indicates low fatigue. A negative change from BL represents a worsening of condition.
time origin
Day 1 (Period [P] 1 Pre-dose); Weeks 2, 4, 6, 8, and 10 of P 1; during 2-week Wash-out Period (Study Weeks 11 and 12); Weeks 2, 4, 6, and 8 of P 2 (Study Weeks 14, 16, 18, 20, and 22, respectively); End of Study (Week 10 of P 2 [Study Week 22])
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety-Randomized Study Population: participants who received at least one dose of either drug regardless of treatment period. Participants who received mixed treatment within a period were excluded. Only those participants contributing data at the indicated time points were evaluated.
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-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0003
source section id
NCT01064310-om-0003
source outcome index
3
endpoint
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
endpoint definition
The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
time origin
Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire 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-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0004
source section id
NCT01064310-om-0004
source outcome index
4
endpoint
Time to Dose Modification
endpoint definition
For the subset of participants who had a dose modification, time to dose modification was defined as the time from the first dose in each period until the first reduction in dose within a period.
time origin
End of second treatment period (maximum of 22 weeks)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety-Randomized Study Population. Only those participants who had a dose modification were evaluated.
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-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0005
source section id
NCT01064310-om-0005
source outcome index
5
endpoint
Number of Participants With the Indicated Number of Dose Reductions
endpoint definition
Participants are recorded under the treatment they were receiving at the time the dose reduction was reported.
time origin
End of second treatment period (maximum of 22 weeks)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Safety-Randomized Study Population. Only those participants who had an dose reduction were evaluated.
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-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0000
arm key
OG000
arm label
Sunitinib 50 mg Followed by Pazopanib 800 mg
regimen
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0000
arm key
OG001
arm label
Pazopanib 800 mg Followed by Sunitinib 50 mg
regimen
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
analyzed count
54
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0001
arm key
OG000
arm label
Sunitinib
regimen
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
analyzed count
25
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0001
arm key
OG001
arm label
Pazopanib
regimen
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0002
arm key
OG000
arm label
Sunitinib 50 mg Followed by Pazopanib 800 mg
regimen
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
analyzed count
77
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0002
arm key
OG001
arm label
Pazopanib 800 mg Followed by Sunitinib 50 mg
regimen
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
analyzed count
79
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0003
arm key
OG000
arm label
Sunitinib 50 mg Followed by Pazopanib 800 mg
regimen
Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
analyzed count
80
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0003
arm key
OG001
arm label
Pazopanib 800 mg Followed by Sunitinib 50 mg
regimen
Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
analyzed count
86
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0004
arm key
OG000
arm label
Sunitinib
regimen
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0004
arm key
OG001
arm label
Pazopanib
regimen
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0005
arm key
OG000
arm label
Sunitinib
regimen
Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
outcome key
om-0005
arm key
OG001
arm label
Pazopanib
regimen
Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01064310-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
harm key
EG000
source section id
NCT01064310-ae
event group key
EG000
event group label
Sunitinib
serious affected
35
serious at risk
148
other affected
143
other at risk
148
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
harm key
EG001
source section id
NCT01064310-ae
event group key
EG001
event group label
Pazopanib
serious affected
30
serious at risk
153
other affected
142
other at risk
153
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
harm key
EG002
source section id
NCT01064310-ae
event group key
EG002
event group label
Open Label Pazopanib
serious affected
15
serious at risk
84
other affected
73
other at risk
84
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-vegzelma-dfaad695
nct id
NCT01064310
qol key
qol-0000
source section id
NCT01064310-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
measure definition
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
time frame
End of treatment of both study drugs (maximum of 22 weeks)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Modified-Intent-to-Treat (mITT) Population (used for the primary analysis): participants who received at least one dose of study treatment from each treatment period and who did not have documented progressive disease (PD) at the end of Treatment Period 1 and completed the patient preference questionnaire.
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-vegzelma-dfaad695
nct id
NCT01064310
qol key
qol-0001
source section id
NCT01064310-om-0001
source outcome index
1
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Number of Participants Answering "Yes," "no," or Not Applicable (N/A) to the Question of Whether the Indicated Factors Influenced Their Preference for Sunitinib or Pazopanib Treatment as Assessed by the Patient Preference Questionnaire
measure definition
The PPQ is used to measure participants' preference for pazopanib or sunitinib for renal cell carcinoma management and is used to determine a participant's preference for 1 of the 2 drugs given in the 2 double-blind treatment periods. Participants were asked to select 1 of the following: 1. prefer the drug taken as the first treatment; 2. prefer the drug taken as the second treatment; or 3, no preference. Those participants who indicated a preference were asked to select the factors that had an influence on their treatment preference, as well as the most important reason for their preference.
time frame
End of treatment of both study drugs (maximum of 22 weeks)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
mITT Population. Responses to some categories of the PPQ may be missing for some 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-vegzelma-dfaad695
nct id
NCT01064310
qol key
qol-0003
source section id
NCT01064310-om-0003
source outcome index
3
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
measure definition
The EQ-5D is a participant-answered questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D has two separate components: utility score and thermometer score. The EQ-5D total utility score ranges from 0 (worst health state) to 1 (perfect health state); 1 reflects the best outcome. The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).
time frame
Day 1 (Period 1 Pre-dose); during 2-week Wash-out Period (Study Weeks 11 and 12); and End of Study (Week 10 of Period 2 [Study Week 22])
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Safety-Randomized Study Population. Participants (par.) who received mixed treatment within a period were excluded. Only those par. contributing data at the indicated time points were evaluated. In some instances, par. may have contributed data for one score, but not the other; thus, the number of par. analyzed reflects the entire population.
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