NCT01495598 · OUTCOME
Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
What was measured
The percentage of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
Analysis population: 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other 3 participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
Groups in this outcome
Not At All
Response on the HRQL questionnaire.
A Little Bit
Response on the HRQL questionnaire.
Little or None*
Response on the HRQL questionnaire.
Somewhat
Response on the HRQL questionnaire.
Quite a Bit
Response on the HRQL questionnaire.
Very Much
Response on the HRQL questionnaire.
Somewhat or MoreϮ
Response on the HRQL questionnaire.
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 |
|---|
| Not At All | 22 |
|---|
| A Little Bit | 22 |
|---|
| Little or None* | 22 |
|---|
| Somewhat | 22 |
|---|
| Quite a Bit | 22 |
|---|
| Very Much | 22 |
|---|
| Somewhat or MoreϮ | 22 |
|---|
Reported measurements
Pain has interfered with my normal work or activities at baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 22 |
|---|
| A Little Bit | 22 |
|---|
| Little or None* | 22 |
|---|
| Somewhat | 22 |
|---|
| Quite a Bit | 22 |
|---|
| Very Much | 22 |
|---|
| Somewhat or MoreϮ | 22 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 45.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 13.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 59.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 9.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 22.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 9.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 40.9 | Not reported | Not reported | Not reported | Not reported |
|---|
Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 19 |
|---|
| A Little Bit | 19 |
|---|
| Little or None* | 19 |
|---|
| Somewhat | 19 |
|---|
| Quite a Bit | 19 |
|---|
| Very Much | 19 |
|---|
| Somewhat or MoreϮ | 19 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 36.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 63.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 5.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 5.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 36.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 19 |
|---|
| A Little Bit | 19 |
|---|
| Little or None* | 19 |
|---|
| Somewhat | 19 |
|---|
| Quite a Bit | 19 |
|---|
| Very Much | 19 |
|---|
| Somewhat or MoreϮ | 19 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 36.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 63.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 21.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 5.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 10.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 36.8 | Not reported | Not reported | Not reported | Not reported |
|---|
I am satisfied with my physical appearance at baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 22 |
|---|
| A Little Bit | 22 |
|---|
| Little or None* | 22 |
|---|
| Somewhat | 22 |
|---|
| Quite a Bit | 22 |
|---|
| Very Much | 22 |
|---|
| Somewhat or MoreϮ | 22 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 27.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 27.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 54.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 27.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 13.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 45.4 | Not reported | Not reported | Not reported | Not reported |
|---|
I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 19 |
|---|
| A Little Bit | 19 |
|---|
| Little or None* | 19 |
|---|
| Somewhat | 19 |
|---|
| Quite a Bit | 19 |
|---|
| Very Much | 19 |
|---|
| Somewhat or MoreϮ | 19 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 31.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 4.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 36.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 10.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 63.2 | Not reported | Not reported | Not reported | Not reported |
|---|
I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 19 |
|---|
| A Little Bit | 19 |
|---|
| Little or None* | 19 |
|---|
| Somewhat | 19 |
|---|
| Quite a Bit | 19 |
|---|
| Very Much | 19 |
|---|
| Somewhat or MoreϮ | 19 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 15.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 10.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 42.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 5.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 73.7 | Not reported | Not reported | Not reported | Not reported |
|---|
I have had swelling in my face, arms, or legs at baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 22 |
|---|
| A Little Bit | 22 |
|---|
| Little or None* | 22 |
|---|
| Somewhat | 22 |
|---|
| Quite a Bit | 22 |
|---|
| Very Much | 22 |
|---|
| Somewhat or MoreϮ | 22 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 27.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 9.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 22.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 18.2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 22.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 63.6 | Not reported | Not reported | Not reported | Not reported |
|---|
I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 19 |
|---|
| A Little Bit | 19 |
|---|
| Little or None* | 19 |
|---|
| Somewhat | 19 |
|---|
| Quite a Bit | 19 |
|---|
| Very Much | 19 |
|---|
| Somewhat or MoreϮ | 19 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 36.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 10.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 21.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 21.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 10.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 52.6 | Not reported | Not reported | Not reported | Not reported |
|---|
I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy
Analysis denominator · Participants
| Group | Source count |
|---|
| Not At All | 19 |
|---|
| A Little Bit | 19 |
|---|
| Little or None* | 19 |
|---|
| Somewhat | 19 |
|---|
| Quite a Bit | 19 |
|---|
| Very Much | 19 |
|---|
| Somewhat or MoreϮ | 19 |
|---|
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Not At All | 31.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| A Little Bit | 15.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Little or None* | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat | 21.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Quite a Bit | 26.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Very Much | 5.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Somewhat or MoreϮ | 52.6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 45.5
- group Id
- OG001
- value
- 13.6
- group Id
- OG002
- value
- 59.1
- group Id
- OG003
- value
- 9.1
- group Id
- OG004
- value
- 22.7
- group Id
- OG005
- value
- 9.1
- group Id
- OG006
- value
- 40.9
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 22
- group Id
- OG006
- value
- 22
- units
- Participants
- title
- Pain has interfered with my normal work or activities at baseline
- categories
- measurements
- group Id
- OG000
- value
- 36.8
- group Id
- OG001
- value
- 26.3
- group Id
- OG002
- value
- 63.2
- group Id
- OG003
- value
- 26.3
- group Id
- OG004
- value
- 5.3
- group Id
- OG005
- value
- 5.3
- group Id
- OG006
- value
- 36.8
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 19
- units
- Participants
- title
- Pain has interfered with my normal work or activities - timepoint 2: after 3 months of therapy
- categories
- measurements
- group Id
- OG000
- value
- 36.8
- group Id
- OG001
- value
- 26.3
- group Id
- OG002
- value
- 63.2
- group Id
- OG003
- value
- 21.1
- group Id
- OG004
- value
- 5.3
- group Id
- OG005
- value
- 10.5
- group Id
- OG006
- value
- 36.8
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 19
- units
- Participants
- title
- Pain has interfered with my normal work or activities timepoint 3:1month after completion of therapy
- categories
- measurements
- group Id
- OG000
- value
- 27.3
- group Id
- OG001
- value
- 27.3
- group Id
- OG002
- value
- 54.6
- group Id
- OG003
- value
- 27.3
- group Id
- OG004
- value
- 13.6
- group Id
- OG005
- value
- 4.5
- group Id
- OG006
- value
- 45.4
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 22
- group Id
- OG006
- value
- 22
- units
- Participants
- title
- I am satisfied with my physical appearance at baseline
- categories
- measurements
- group Id
- OG000
- value
- 31.6
- group Id
- OG001
- value
- 4.5
- group Id
- OG002
- value
- 36.8
- group Id
- OG003
- value
- 26.3
- group Id
- OG004
- value
- 26.3
- group Id
- OG005
- value
- 10.5
- group Id
- OG006
- value
- 63.2
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 19
- units
- Participants
- title
- I am satisfied with my physical appearance - timepoint 2: after 3 months of therapy
- categories
- measurements
- group Id
- OG000
- value
- 15.8
- group Id
- OG001
- value
- 10.5
- group Id
- OG002
- value
- 26.3
- group Id
- OG003
- value
- 26.3
- group Id
- OG004
- value
- 42.1
- group Id
- OG005
- value
- 5.3
- group Id
- OG006
- value
- 73.7
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 19
- units
- Participants
- title
- I am satisfied with my physical appearance - timepoint 3: 1 month after completion of therapy
- categories
- measurements
- group Id
- OG000
- value
- 27.3
- group Id
- OG001
- value
- 9.1
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 22.7
- group Id
- OG004
- value
- 18.2
- group Id
- OG005
- value
- 22.7
- group Id
- OG006
- value
- 63.6
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 22
- group Id
- OG006
- value
- 22
- units
- Participants
- title
- I have had swelling in my face, arms, or legs at baseline
- categories
- measurements
- group Id
- OG000
- value
- 36.8
- group Id
- OG001
- value
- 10.5
- group Id
- OG002
- value
- 47
- group Id
- OG003
- value
- 21.1
- group Id
- OG004
- value
- 21.1
- group Id
- OG005
- value
- 10.5
- group Id
- OG006
- value
- 52.6
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 19
- units
- Participants
- title
- I have had swelling in my face, arms, or legs - timepoint 2: after 3 months of therapy
- categories
- measurements
- group Id
- OG000
- value
- 31.6
- group Id
- OG001
- value
- 15.8
- group Id
- OG002
- value
- 47
- group Id
- OG003
- value
- 21.1
- group Id
- OG004
- value
- 26.3
- group Id
- OG005
- value
- 5.3
- group Id
- OG006
- value
- 52.6
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 19
- group Id
- OG006
- value
- 19
- units
- Participants
- title
- I have had swelling in my face, arms, or legs - timepoint 3: 1 month after completion of therapy
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 22
- group Id
- OG005
- value
- 22
- group Id
- OG006
- value
- 22
- units
- Participants
- description
- The percentage of participants responding to each question with the indicated responses is shown. Changes in quality of life in participants receiving pomalidomide. HRQL was analyzed using a mixed-model repeated-measures analysis and the marginal homogeneity test for Kaposi sarcoma-specific questions. Three supplemental questions addressing pain, swelling, and satisfaction with physical appearance was used to collect quality of life data.
- groups
- description
- Response on the HRQL questionnaire.
- id
- OG000
- title
- Not At All
- description
- Response on the HRQL questionnaire.
- id
- OG001
- title
- A Little Bit
- description
- Response on the HRQL questionnaire.
- id
- OG002
- title
- Little or None*
- description
- Response on the HRQL questionnaire.
- id
- OG003
- title
- Somewhat
- description
- Response on the HRQL questionnaire.
- id
- OG004
- title
- Quite a Bit
- description
- Response on the HRQL questionnaire.
- id
- OG005
- title
- Very Much
- description
- Response on the HRQL questionnaire.
- id
- OG006
- title
- Somewhat or MoreϮ
- param Type
- NUMBER
- population Description
- 22 participants were analyzed at baseline. 19/22 participants were evaluable and analyzed at timepoint 2 and timepoint 3 because the QOL data was not collected on the other 3 participants at those timepoints. Baseline n=22, timepoint 2 = 19, and timepoint 3 = 19. \*Sum of two preceding columns. ϮSum of three preceding columns.
- reporting Status
- POSTED
- time Frame
- Baseline, timepoint 1: after 3 months of therapy, and timepoint 2: 1 month after completion of therapy
- title
- Percentage of Participants Who Responded to Each Question on the Self-Reported Health-Related Quality of Life (HRQL): Kaposi Sarcoma (KS) - Specific Questions
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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