TriangleNCT01064310 · OUTCOME
Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
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
- 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])
What was measured
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).
Analysis population: 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.
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 | 80 |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 86 |
Reported measurements
Thermometer Score, Day 1; n=74, 79
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 75.7 | 17.65 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 74.8 | 18.54 | Not reported | Not reported | Not reported |
Thermometer Score, Washout; n=60, 63
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 74.4 | 16.76 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 69.8 | 19.94 | Not reported | Not reported | Not reported |
Thermometer Score, End of Study; n=51, 45
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 71.3 | 16.19 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 65.1 | 22.55 | Not reported | Not reported | Not reported |
Utility Score, Day 1; n=76, 81
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 0.7625 | 0.25331 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 0.7664 | 0.22946 | Not reported | Not reported | Not reported |
Utility Score, Washout; n=61, 67
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 0.8103 | 0.20776 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 0.7595 | 0.26826 | Not reported | Not reported | Not reported |
Utility Score, End of Study; n=52, 47
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | 0.7487 | 0.21324 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 0.6325 | 0.29635 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.65
- value
- 75.7
- group Id
- OG001
- spread
- 18.54
- value
- 74.8
- title
- Thermometer Score, Day 1; n=74, 79
- categories
- measurements
- group Id
- OG000
- spread
- 16.76
- value
- 74.4
- group Id
- OG001
- spread
- 19.94
- value
- 69.8
- title
- Thermometer Score, Washout; n=60, 63
- categories
- measurements
- group Id
- OG000
- spread
- 16.19
- value
- 71.3
- group Id
- OG001
- spread
- 22.55
- value
- 65.1
- title
- Thermometer Score, End of Study; n=51, 45
- categories
- measurements
- group Id
- OG000
- spread
- 0.25331
- value
- 0.7625
- group Id
- OG001
- spread
- 0.22946
- value
- 0.7664
- title
- Utility Score, Day 1; n=76, 81
- categories
- measurements
- group Id
- OG000
- spread
- 0.20776
- value
- 0.8103
- group Id
- OG001
- spread
- 0.26826
- value
- 0.7595
- title
- Utility Score, Washout; n=61, 67
- categories
- measurements
- group Id
- OG000
- spread
- 0.21324
- value
- 0.7487
- group Id
- OG001
- spread
- 0.29635
- value
- 0.6325
- title
- Utility Score, End of Study; n=52, 47
- denoms
- counts
- group Id
- OG000
- value
- 80
- group Id
- OG001
- value
- 86
- units
- Participants
- description
- 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).
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- 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.
- reporting Status
- POSTED
- 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])
- title
- Quality of Life as Assessed by the EuroQoL-5 Dimensions (EQ-5D) Thermometer and Utility Scores
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
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Preserved source evidence · Not medical advice