NCT00720941 · OUTCOME
Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4
Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma · Source last updated 2025-03-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
What was measured
Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (FKSI-FWB)) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition.
Analysis population: Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.
Groups in this outcome
Pazopanib 800 mg
Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Sunitinib 50 mg
Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Pazopanib 800 mg | 326 |
|---|
| Sunitinib 50 mg | 350 |
|---|
Reported measurements
Week 4 (n=326,350)
Analysis denominator · Participants
| Group | Source count |
|---|
| Pazopanib 800 mg | 326 |
|---|
| Sunitinib 50 mg | 350 |
|---|
Values in Scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | -1.5 | 2.45 | Not reported | Not reported | Not reported |
|---|
| Sunitinib 50 mg | -2.0 | 2.35 | Not reported | Not reported | Not reported |
|---|
Week 10 (n=267,305)
Analysis denominator · Participants
| Group | Source count |
|---|
| Pazopanib 800 mg | 267 |
|---|
| Sunitinib 50 mg | 305 |
|---|
Values in Scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | -1.9 | 2.66 | Not reported | Not reported | Not reported |
|---|
| Sunitinib 50 mg | -2.4 | 2.62 | Not reported | Not reported | Not reported |
|---|
Week 16 (n=244,254)
Analysis denominator · Participants
| Group | Source count |
|---|
| Pazopanib 800 mg | 244 |
|---|
| Sunitinib 50 mg | 254 |
|---|
Values in Scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | -2.1 | 2.79 | Not reported | Not reported | Not reported |
|---|
| Sunitinib 50 mg | -2.8 | 2.46 | Not reported | Not reported | Not reported |
|---|
Week 22 (n=201,218)
Analysis denominator · Participants
| Group | Source count |
|---|
| Pazopanib 800 mg | 201 |
|---|
| Sunitinib 50 mg | 218 |
|---|
Values in Scores on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pazopanib 800 mg | -2.4 | 2.75 | Not reported | Not reported | Not reported |
|---|
| Sunitinib 50 mg | -2.4 | 2.33 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.45
- value
- -1.5
- group Id
- OG001
- spread
- 2.35
- value
- -2.0
- denoms
- counts
- group Id
- OG000
- value
- 326
- group Id
- OG001
- value
- 350
- units
- Participants
- title
- Week 4 (n=326,350)
- categories
- measurements
- group Id
- OG000
- spread
- 2.66
- value
- -1.9
- group Id
- OG001
- spread
- 2.62
- value
- -2.4
- denoms
- counts
- group Id
- OG000
- value
- 267
- group Id
- OG001
- value
- 305
- units
- Participants
- title
- Week 10 (n=267,305)
- categories
- measurements
- group Id
- OG000
- spread
- 2.79
- value
- -2.1
- group Id
- OG001
- spread
- 2.46
- value
- -2.8
- denoms
- counts
- group Id
- OG000
- value
- 244
- group Id
- OG001
- value
- 254
- units
- Participants
- title
- Week 16 (n=244,254)
- categories
- measurements
- group Id
- OG000
- spread
- 2.75
- value
- -2.4
- group Id
- OG001
- spread
- 2.33
- value
- -2.4
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 218
- units
- Participants
- title
- Week 22 (n=201,218)
- denoms
- counts
- group Id
- OG000
- value
- 326
- group Id
- OG001
- value
- 350
- units
- Participants
- description
- Health outcome and quality of life as measured by NCCN/FACT FKSI-19 questionnaire. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms specifically in renal cancer patients in 4 domains (Disease-Related Symptoms - Physical (FKSI-DRS-P), Disease-Related Symptoms - Emotional (FKSI-DRS-E), Treatment Side-Effects (FKSI-TSE), Function/Well-Being (FKSI-FWB)) experienced in the past 7 days. Participants are asked to respond to a total of 19 questions regarding symptoms, side effects, and well being by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much; possible total score of 0 to 76). A negative mean indicates a worsening of condition.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were administered pazopanib 800 mg (2 x 400 mg tablets) orally OD continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
- id
- OG000
- title
- Pazopanib 800 mg
- description
- Participants were administered sunitinib 50 mg orally once daily in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Participants received study treatment until disease progression, death, unacceptable toxicity, or withdrawal of consent for any other reasons.
- id
- OG001
- title
- Sunitinib 50 mg
- param Type
- MEAN
- population Description
- Intent-to-Treat (ITT) Population. Analysis was based on the assigned randomized treatment, not on the actual treatment received/not received. Some participants were missing scores at Baseline and were excluded from the analysis. Participants missing scores at other early time points were excluded from the analysis at those time points. Change from Baseline was calculated as the assessment week value minus the Baseline value.
- reporting Status
- POSTED
- time Frame
- Baseline (predose), Day 28 of Cycles 1-4 (average of Weeks 4, 10, 16, and 22, respectively)
- title
- Change From Baseline in the FACT-Kidney Symptom Index-19 (FKSI-19) Scale Treatment Side Effects (TSE) Domain Score at Day 28 of Cycles 1-4
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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