TriangleNCT01064310 · OUTCOME
Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- End of treatment of both study drugs (maximum of 22 weeks)
What was measured
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.
Analysis population: 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.
Groups in this outcome
Sunitinib 50 mg Followed by Pazopanib 800 mg
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.
Pazopanib 800 mg Followed by Sunitinib 50 mg
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.
| Group | Source count |
|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 60 |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 54 |
Reported measurements
Sunitinib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 19 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 6 | Not reported | Not reported | Not reported | Not reported |
Pazopanib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 37 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 43 | Not reported | Not reported | Not reported | Not reported |
No preference
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 4 | Not reported | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 5 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 37.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 61.5
- estimate Comment
- The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- The p value indicates the difference in preference for pazopanib versus sunitinib treatment
- param Type
- Percentage of participants
- param Value
- 49.26
- statistical Method
- Prescotts test
Complete source fields
- analyses
- ci Lower Limit
- 37.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 61.5
- estimate Comment
- The estimated value indicates the difference in the percentage of participants who preferred pazopanib versus sunitinib. This difference is adjusted for sequence.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- The p value indicates the difference in preference for pazopanib versus sunitinib treatment
- param Type
- Percentage of participants
- param Value
- 49.26
- statistical Method
- Prescotts test
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 6
- title
- Sunitinib
- categories
- measurements
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 43
- title
- Pazopanib
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- title
- No preference
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 54
- units
- Participants
- description
- 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.
- groups
- description
- 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.
- id
- OG000
- title
- Sunitinib 50 mg Followed by Pazopanib 800 mg
- description
- 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.
- id
- OG001
- title
- Pazopanib 800 mg Followed by Sunitinib 50 mg
- param Type
- NUMBER
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- End of treatment of both study drugs (maximum of 22 weeks)
- title
- Number of Participants With Preference for Pazopanib Versus Sunitinib as Assessed by the Patient Preference Questionnaire (PPQ)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice