NCT02004275 · OUTCOME
Baseline Level of Perceived Fatigue and QOL, Assessed Using the Registration Fatigue/Uniscale Assessment Form (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- baseline
What was measured
Pre-treatment patient-report of fatigue and overall quality of life (based on a 10-point Likert scale). A higher number indicates a better quality of life where 10 is the best outcome and 0 is the worst.
Analysis population: All patients that completed and returned the QoL survey
Groups in this outcome
Arm I (Pomalidomide, Dexamethasone)
Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
Arm II (Pomalidomide, Dexamethasone, Ixazomib)
Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (Pomalidomide, Dexamethasone) | 37 |
| Arm II (Pomalidomide, Dexamethasone, Ixazomib) | 37 |
Reported measurements
High QoL(7-10)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pomalidomide, Dexamethasone) | 21 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Pomalidomide, Dexamethasone, Ixazomib) | 27 | Not reported | Not reported | Not reported | Not reported |
Medium or Low QoL (0-7)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Pomalidomide, Dexamethasone) | 16 | Not reported | Not reported | Not reported | Not reported |
| Arm II (Pomalidomide, Dexamethasone, Ixazomib) | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 27
- title
- High QoL(7-10)
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 11
- title
- Medium or Low QoL (0-7)
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 37
- units
- Participants
- description
- Pre-treatment patient-report of fatigue and overall quality of life (based on a 10-point Likert scale). A higher number indicates a better quality of life where 10 is the best outcome and 0 is the worst.
- groups
- description
- Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
- id
- OG000
- title
- Arm I (Pomalidomide, Dexamethasone)
- description
- Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm II (Pomalidomide, Dexamethasone, Ixazomib)
- param Type
- NUMBER
- population Description
- All patients that completed and returned the QoL survey
- reporting Status
- POSTED
- time Frame
- baseline
- title
- Baseline Level of Perceived Fatigue and QOL, Assessed Using the Registration Fatigue/Uniscale Assessment Form (Phase II)
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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