NCT01495598 · OUTCOME
Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI)
Pomalidomide for Kaposi Sarcoma in People With or Without HIV · Source last updated 2022-11-01
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
- Standard Deviation
- Time frame
- Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks
What was measured
Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses.
Analysis population: Missing responses within questionnaire in category FAHI Total at baseline (n=21). And missing responses within questionnaire in category FAHI Total after completion of therapy (n=17).
Groups in this outcome
Baseline
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
After 3 Months of Therapy
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
After Completion of Therapy
All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
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 |
|---|
| Baseline | 22 |
|---|
| After 3 Months of Therapy | 19 |
|---|
| After Completion of Therapy | 19 |
|---|
Reported measurements
FAHI Total
Analysis denominator · Participants
| Group | Source count |
|---|
| Baseline | 21 |
|---|
| After 3 Months of Therapy | 19 |
|---|
| After Completion of Therapy | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baseline | 123.0 | 30.2 | Not reported | Not reported | Not reported |
|---|
| After 3 Months of Therapy | 123.4 | 28.4 | Not reported | Not reported | Not reported |
|---|
| After Completion of Therapy | 118. | 29.0 | Not reported | Not reported | Not reported |
|---|
Physical well-being
Analysis denominator · Participants
| Group | Source count |
|---|
| Baseline | 22 |
|---|
| After 3 Months of Therapy | 19 |
|---|
| After Completion of Therapy | 19 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baseline | 30.8 | 8.7 | Not reported | Not reported | Not reported |
|---|
| After 3 Months of Therapy | 31.3 | 8.2 | Not reported | Not reported | Not reported |
|---|
| After Completion of Therapy | 31.3 | 9.1 | Not reported | Not reported | Not reported |
|---|
Emotional well-being
Analysis denominator · Participants
| Group | Source count |
|---|
| Baseline | 22 |
|---|
| After 3 Months of Therapy | 19 |
|---|
| After Completion of Therapy | 19 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baseline | 25.1 | 7.6 | Not reported | Not reported | Not reported |
|---|
| After 3 Months of Therapy | 27.7 | 7.5 | Not reported | Not reported | Not reported |
|---|
| After Completion of Therapy | 26.2 | 7.7 | Not reported | Not reported | Not reported |
|---|
Functional and global well-being
Analysis denominator · Participants
| Group | Source count |
|---|
| Baseline | 22 |
|---|
| After 3 Months of Therapy | 19 |
|---|
| After Completion of Therapy | 19 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baseline | 34.4 | 10.3 | Not reported | Not reported | Not reported |
|---|
| After 3 Months of Therapy | 34.5 | 10.1 | Not reported | Not reported | Not reported |
|---|
| After Completion of Therapy | 32.9 | 9.6 | Not reported | Not reported | Not reported |
|---|
Social well-being
Analysis denominator · Participants
| Group | Source count |
|---|
| Baseline | 22 |
|---|
| After 3 Months of Therapy | 19 |
|---|
| After Completion of Therapy | 19 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baseline | 22.1 | 6.6 | Not reported | Not reported | Not reported |
|---|
| After 3 Months of Therapy | 21.5 | 7.8 | Not reported | Not reported | Not reported |
|---|
| After Completion of Therapy | 20.9 | 6.8 | Not reported | Not reported | Not reported |
|---|
Cognitive functioning
Analysis denominator · Participants
| Group | Source count |
|---|
| Baseline | 22 |
|---|
| After 3 Months of Therapy | 19 |
|---|
| After Completion of Therapy | 19 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Baseline | 9.1 | 2.7 | Not reported | Not reported | Not reported |
|---|
| After 3 Months of Therapy | 8.5 | 2.7 | Not reported | Not reported | Not reported |
|---|
| After Completion of Therapy | 8.7 | 2.3 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 30.2
- value
- 123.0
- group Id
- OG001
- spread
- 28.4
- value
- 123.4
- group Id
- OG002
- spread
- 29.0
- value
- 118.
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 17
- units
- Participants
- title
- FAHI Total
- categories
- measurements
- group Id
- OG000
- spread
- 8.7
- value
- 30.8
- group Id
- OG001
- spread
- 8.2
- value
- 31.3
- group Id
- OG002
- spread
- 9.1
- value
- 31.3
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- Physical well-being
- categories
- measurements
- group Id
- OG000
- spread
- 7.6
- value
- 25.1
- group Id
- OG001
- spread
- 7.5
- value
- 27.7
- group Id
- OG002
- spread
- 7.7
- value
- 26.2
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- Emotional well-being
- categories
- measurements
- group Id
- OG000
- spread
- 10.3
- value
- 34.4
- group Id
- OG001
- spread
- 10.1
- value
- 34.5
- group Id
- OG002
- spread
- 9.6
- value
- 32.9
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- Functional and global well-being
- categories
- measurements
- group Id
- OG000
- spread
- 6.6
- value
- 22.1
- group Id
- OG001
- spread
- 7.8
- value
- 21.5
- group Id
- OG002
- spread
- 6.8
- value
- 20.9
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- Social well-being
- categories
- measurements
- group Id
- OG000
- spread
- 2.7
- value
- 9.1
- group Id
- OG001
- spread
- 2.7
- value
- 8.5
- group Id
- OG002
- spread
- 2.3
- value
- 8.7
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- units
- Participants
- title
- Cognitive functioning
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- units
- Participants
- description
- Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis for FAHI and the marginal homogeneity test for Kaposi sarcoma-specific questions such as physical well-being (PWB), emotional well-being (EWB), functional and global well-being (FGWB), social well-being (SWB), and cognitive functioning (CF). The range of possible scores for each subscale was as follows: PWB and EWB, 0 to 40; FGWB, 0 to 52; SWB, 0 to 32; CF, 0 to 12. The total FAHI score, with possible scores ranging from 0 to 176, was calculated as the sum of all five subscale values, with higher scores indicating better results. Questionnaires completed at early withdrawal visits were not included in the analyses.
- dispersion Type
- Standard Deviation
- groups
- description
- All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
- id
- OG000
- title
- Baseline
- description
- All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
- id
- OG001
- title
- After 3 Months of Therapy
- description
- All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
- id
- OG002
- title
- After Completion of Therapy
- param Type
- MEAN
- population Description
- Missing responses within questionnaire in category FAHI Total at baseline (n=21). And missing responses within questionnaire in category FAHI Total after completion of therapy (n=17).
- reporting Status
- POSTED
- time Frame
- Baseline, after 3 months of therapy, and after completion of therapy, up to 48 weeks
- title
- Self-Reported Health-Related Quality of Life (HRQL) Instrument: Functional Assessment of Human Immunodeficiency Virus Infection (FAHI)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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