TriangleNCT01064310 · OUTCOME
Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
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 [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])
What was measured
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.
Analysis population: 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.
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 | 77 |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | 79 |
Reported measurements
Period 1 Average; n=77, 79
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | -4.4 | 7.73 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | -4.6 | 9.22 | Not reported | Not reported | Not reported |
Period 2 Average; n=63, 65
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib 50 mg Followed by Pazopanib 800 mg | -3.6 | 7.11 | Not reported | Not reported | Not reported |
| Pazopanib 800 mg Followed by Sunitinib 50 mg | -7.3 | 11.16 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 7.73
- value
- -4.4
- group Id
- OG001
- spread
- 9.22
- value
- -4.6
- title
- Period 1 Average; n=77, 79
- categories
- measurements
- group Id
- OG000
- spread
- 7.11
- value
- -3.6
- group Id
- OG001
- spread
- 11.16
- value
- -7.3
- title
- Period 2 Average; n=63, 65
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 79
- units
- Participants
- description
- 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.
- 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 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.
- reporting Status
- POSTED
- time Frame
- 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])
- title
- Change From Period Baseline (BL) in Fatigue as Assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice