TriangleNCT00420849 · OUTCOME
Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 0), Week 24
What was measured
EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.
Analysis population: Full analysis set of participants who completed the questionnaire at baseline and week 24.
Groups in this outcome
Lenalidomide - Subpopulation From Austria + Australia
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
Lenalidomide - Subpopulation From UK + Ireland
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
Lenalidomide - Subpopulation From Spain
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
| Group | Source count |
|---|---|
| Lenalidomide - Subpopulation From Austria + Australia | 152 |
| Lenalidomide - Subpopulation From UK + Ireland | 123 |
| Lenalidomide - Subpopulation From Spain | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide - Subpopulation From Austria + Australia | 2.6 | 20.93 | Not reported | Not reported | Not reported |
| Lenalidomide - Subpopulation From UK + Ireland | 5.3 | 26.59 | Not reported | Not reported | Not reported |
| Lenalidomide - Subpopulation From Spain | 1.0 | 22.07 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.93
- value
- 2.6
- group Id
- OG001
- spread
- 26.59
- value
- 5.3
- group Id
- OG002
- spread
- 22.07
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 123
- group Id
- OG002
- value
- 38
- units
- Participants
- description
- EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.
- dispersion Type
- Standard Deviation
- groups
- description
- Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
- id
- OG000
- title
- Lenalidomide - Subpopulation From Austria + Australia
- description
- Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
- id
- OG001
- title
- Lenalidomide - Subpopulation From UK + Ireland
- description
- Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
- id
- OG002
- title
- Lenalidomide - Subpopulation From Spain
- param Type
- MEAN
- population Description
- Full analysis set of participants who completed the questionnaire at baseline and week 24.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 0), Week 24
- title
- Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice