TriangleNCT02516696 · OUTCOME
Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Score on a scale
- Interval / dispersion
- Full Range
- Time frame
- up to 3 years
What was measured
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The FACIT- Fatigue Subscore (FS) is comprised of 13 items, within the total 40-item FACIT-F, that assess fatigue and its impact. This analysis is only based on the FS score. Items are scored on a 5 point Likert-type scale. Item scores can range from 0 ("not at all") to 4 ("very much"), and the total, summed score from 0 to 52; lower scores indicate greater fatigue. The recall period for each item is the past 7 days. Data is descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.
Groups in this outcome
BiRD Treatment Regimen
Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
Rd Treatment Regimen
Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
| Group | Source count |
|---|---|
| BiRD Treatment Regimen | 7 |
| Rd Treatment Regimen | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BiRD Treatment Regimen | 32.75 | Not reported | 16.9 | 45.46 | Not reported |
| Rd Treatment Regimen | 37.24 | Not reported | 28.58 | 45.89 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.9
- upper Limit
- 45.46
- value
- 32.75
- group Id
- OG001
- lower Limit
- 28.58
- upper Limit
- 45.89
- value
- 37.24
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function. The FACIT- Fatigue Subscore (FS) is comprised of 13 items, within the total 40-item FACIT-F, that assess fatigue and its impact. This analysis is only based on the FS score. Items are scored on a 5 point Likert-type scale. Item scores can range from 0 ("not at all") to 4 ("very much"), and the total, summed score from 0 to 52; lower scores indicate greater fatigue. The recall period for each item is the past 7 days. Data is descriptively presented for each treatment group and no formal statistical comparison will be made between treatment arms.
- dispersion Type
- Full Range
- groups
- description
- Subjects on the BiRD arm will receive clarithromycin, lenalidomide, and dexamethasone in 28-day cycles. Clarithromycin: 500mg PO twice daily on days 1-28 for a 28-day cycle. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
- id
- OG000
- title
- BiRD Treatment Regimen
- description
- Subjects on the Rd arm will receive lenalidomide and dexamethasone in 28-day cycles. Lenalidomide: 25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle Dexamethasone: 20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
- id
- OG001
- title
- Rd Treatment Regimen
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- up to 3 years
- title
- Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FS; Version 4) Score of Patients Receiving BiRd vs Rd Treatment
- type
- SECONDARY
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice