NCT00375674 · OUTCOME
Patient-Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer · Source last updated 2018-09-21
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
- Standard Error
- 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), 3 multi-item symptom scales (fatigue, nausea/vomiting, \& pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, \& the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning \& symptoms; 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 \& more severe for symptoms.
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 a different drug from that to which they were randomized. Here, 'Number analyzed' signifies the number of participants evaluable at specified time-points.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 309 |
|---|
| Placebo | 306 |
|---|
Reported measurements
Cycle 1 (Baseline)
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 292 |
|---|
| Placebo | 288 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 74.83 | 1.044 | Not reported | Not reported | Not reported |
|---|
| Placebo | 75.61 | 1.044 | Not reported | Not reported | Not reported |
|---|
Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 260 |
|---|
| Placebo | 274 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 69.71 | 1.289 | Not reported | Not reported | Not reported |
|---|
| Placebo | 75.49 | 1.097 | Not reported | Not reported | Not reported |
|---|
Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 241 |
|---|
| Placebo | 265 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 69.67 | 1.278 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.09 | 1.142 | Not reported | Not reported | Not reported |
|---|
Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 227 |
|---|
| Placebo | 249 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 66.52 | 1.307 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.93 | 1.109 | Not reported | Not reported | Not reported |
|---|
Cycle 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 219 |
|---|
| Placebo | 234 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 68.34 | 1.340 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.61 | 1.179 | Not reported | Not reported | Not reported |
|---|
Cycle 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 210 |
|---|
| Placebo | 231 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 66.27 | 1.396 | Not reported | Not reported | Not reported |
|---|
| Placebo | 75.69 | 1.172 | Not reported | Not reported | Not reported |
|---|
Cycle 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 200 |
|---|
| Placebo | 220 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 67.42 | 1.447 | Not reported | Not reported | Not reported |
|---|
| Placebo | 73.98 | 1.222 | Not reported | Not reported | Not reported |
|---|
Cycle 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 185 |
|---|
| Placebo | 212 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 68.33 | 1.376 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.49 | 1.260 | Not reported | Not reported | Not reported |
|---|
Cycle 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 177 |
|---|
| Placebo | 203 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 68.31 | 1.556 | Not reported | Not reported | Not reported |
|---|
| Placebo | 74.06 | 1.338 | Not reported | Not reported | Not reported |
|---|
End of treatment (EOT)
Analysis denominator · Participants
| Group | Source count |
|---|
| Sunitinib | 250 |
|---|
| Placebo | 250 |
|---|
Values in Scores on scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sunitinib | 64.43 | 1.367 | Not reported | Not reported | Not reported |
|---|
| Placebo | 73.37 | 1.264 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.044
- value
- 74.83
- group Id
- OG001
- spread
- 1.044
- value
- 75.61
- denoms
- counts
- group Id
- OG000
- value
- 292
- group Id
- OG001
- value
- 288
- units
- Participants
- title
- Cycle 1 (Baseline)
- categories
- measurements
- group Id
- OG000
- spread
- 1.289
- value
- 69.71
- group Id
- OG001
- spread
- 1.097
- value
- 75.49
- denoms
- counts
- group Id
- OG000
- value
- 260
- group Id
- OG001
- value
- 274
- units
- Participants
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 1.278
- value
- 69.67
- group Id
- OG001
- spread
- 1.142
- value
- 74.09
- denoms
- counts
- group Id
- OG000
- value
- 241
- group Id
- OG001
- value
- 265
- units
- Participants
- title
- Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 1.307
- value
- 66.52
- group Id
- OG001
- spread
- 1.109
- value
- 74.93
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 249
- units
- Participants
- title
- Cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 1.340
- value
- 68.34
- group Id
- OG001
- spread
- 1.179
- value
- 74.61
- denoms
- counts
- group Id
- OG000
- value
- 219
- group Id
- OG001
- value
- 234
- units
- Participants
- title
- Cycle 5
- categories
- measurements
- group Id
- OG000
- spread
- 1.396
- value
- 66.27
- group Id
- OG001
- spread
- 1.172
- value
- 75.69
- denoms
- counts
- group Id
- OG000
- value
- 210
- group Id
- OG001
- value
- 231
- units
- Participants
- title
- Cycle 6
- categories
- measurements
- group Id
- OG000
- spread
- 1.447
- value
- 67.42
- group Id
- OG001
- spread
- 1.222
- value
- 73.98
- denoms
- counts
- group Id
- OG000
- value
- 200
- group Id
- OG001
- value
- 220
- units
- Participants
- title
- Cycle 7
- categories
- measurements
- group Id
- OG000
- spread
- 1.376
- value
- 68.33
- group Id
- OG001
- spread
- 1.260
- value
- 74.49
- denoms
- counts
- group Id
- OG000
- value
- 185
- group Id
- OG001
- value
- 212
- units
- Participants
- title
- Cycle 8
- categories
- measurements
- group Id
- OG000
- spread
- 1.556
- value
- 68.31
- group Id
- OG001
- spread
- 1.338
- value
- 74.06
- denoms
- counts
- group Id
- OG000
- value
- 177
- group Id
- OG001
- value
- 203
- units
- Participants
- title
- Cycle 9
- categories
- measurements
- group Id
- OG000
- spread
- 1.367
- value
- 64.43
- group Id
- OG001
- spread
- 1.264
- value
- 73.37
- denoms
- counts
- group Id
- OG000
- value
- 250
- group Id
- OG001
- value
- 250
- units
- Participants
- title
- End of treatment (EOT)
- 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), 3 multi-item symptom scales (fatigue, nausea/vomiting, \& pain), and 6 single item symptom scales for other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, \& the financial impact of cancer). The questionnaire includes 28 items with 4-point Likert type responses from "not at all" to "very much" to assess functioning \& symptoms; 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 \& more severe for symptoms.
- dispersion Type
- Standard Error
- 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 a different drug from that to which they were randomized. Here, 'Number analyzed' signifies the number of participants evaluable at specified time-points.
- reporting Status
- POSTED
- time Frame
- Cycle 1(Day 1); subsequent cycles (Day 1) and end of treatment/withdrawal (ie, up to 1 year)
- title
- Patient-Reported Outcomes (PROs)- European Organization for Research and Treatment of Cancer (EORTC) QLQ C30: Observed Means in Global Health Status / Quality of Life Scale Scores
- type
- SECONDARY
- unit Of Measure
- Scores on scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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