TriangleNCT00375674 · OUTCOME
PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
What was measured
Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale \& 5 multi-item functional scales (physical, role, emotional, cognitive, \& social functioning). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning; 2 items with 7-point Likert scales for global health \& overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL.
Analysis population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
Groups in this outcome
Sunitinib
Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
Placebo
Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
| Group | Source count |
|---|---|
| Sunitinib | 309 |
| Placebo | 306 |
Reported measurements
Physical
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 83.54 | Not reported | 82.40 | 84.68 | Not reported |
| Placebo | 87.53 | Not reported | 86.42 | 88.64 | Not reported |
Role
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 78.94 | Not reported | 77.14 | 80.74 | Not reported |
| Placebo | 85.46 | Not reported | 83.70 | 87.23 | Not reported |
Emotional
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 80.92 | Not reported | 79.58 | 82.27 | Not reported |
| Placebo | 82.97 | Not reported | 81.66 | 84.29 | Not reported |
Cognitive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 85.50 | Not reported | 84.17 | 86.83 | Not reported |
| Placebo | 87.43 | Not reported | 86.13 | 88.73 | Not reported |
Social
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sunitinib | 80.62 | Not reported | 79.04 | 82.21 | Not reported |
| Placebo | 87.99 | Not reported | 86.44 | 89.53 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.40
- upper Limit
- 84.68
- value
- 83.54
- group Id
- OG001
- lower Limit
- 86.42
- upper Limit
- 88.64
- value
- 87.53
- title
- Physical
- categories
- measurements
- group Id
- OG000
- lower Limit
- 77.14
- upper Limit
- 80.74
- value
- 78.94
- group Id
- OG001
- lower Limit
- 83.70
- upper Limit
- 87.23
- value
- 85.46
- title
- Role
- categories
- measurements
- group Id
- OG000
- lower Limit
- 79.58
- upper Limit
- 82.27
- value
- 80.92
- group Id
- OG001
- lower Limit
- 81.66
- upper Limit
- 84.29
- value
- 82.97
- title
- Emotional
- categories
- measurements
- group Id
- OG000
- lower Limit
- 84.17
- upper Limit
- 86.83
- value
- 85.50
- group Id
- OG001
- lower Limit
- 86.13
- upper Limit
- 88.73
- value
- 87.43
- title
- Cognitive
- categories
- measurements
- group Id
- OG000
- lower Limit
- 79.04
- upper Limit
- 82.21
- value
- 80.62
- group Id
- OG001
- lower Limit
- 86.44
- upper Limit
- 89.53
- value
- 87.99
- title
- Social
- denoms
- counts
- group Id
- OG000
- value
- 309
- group Id
- OG001
- value
- 306
- units
- Participants
- description
- Patient-reported outcomes (PROs) assessed health-related quality of life (QoL) by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), which was a 30-item questionnaire with global QoL scale \& 5 multi-item functional scales (physical, role, emotional, cognitive, \& social functioning). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning; 2 items with 7-point Likert scales for global health \& overall QoL. All responses were converted to a 0 to 100 scale using a standard scoring algorithm, higher scores represented better level for functioning/QoL.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Sunitinib on 9 6-week cycles on 4/2 dosing schedule: 4 weeks on, 2 weeks off.
- id
- OG000
- title
- Sunitinib
- description
- Participants received Placebo on 9 6-week cycles with 4/2 dosing schedule: 4 weeks on, 2 weeks off.
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or received a different drug from that to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
- title
- PROs- EORTC QLQ C30: Functional Scale Scores Between Treatment Comparison
- type
- SECONDARY
- unit Of Measure
- Scores on scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice