NCT00425555 · OUTCOME
Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma · Source last updated 2021-08-20
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 up to Cycle 12, an average of 12 months
What was measured
Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
Analysis population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study.
Groups in this outcome
Bexarotene Exposed
Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
Bexarotene Naive
Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
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 |
|---|
| Bexarotene Exposed | 79 |
|---|
| Bexarotene Naive | 60 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 78 |
|---|
| Bexarotene Naive | 57 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 60.1 | 19.03 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 55.3 | 20.35 | Not reported | Not reported | Not reported |
|---|
Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 70 |
|---|
| Bexarotene Naive | 53 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 51.4 | 23.10 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 47.7 | 20.28 | Not reported | Not reported | Not reported |
|---|
Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 56 |
|---|
| Bexarotene Naive | 40 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 51.1 | 21.92 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 42.9 | 21.72 | Not reported | Not reported | Not reported |
|---|
Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 40 |
|---|
| Bexarotene Naive | 29 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 47.3 | 22.16 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 35.2 | 16.66 | Not reported | Not reported | Not reported |
|---|
Cycle 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 31 |
|---|
| Bexarotene Naive | 26 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 43.2 | 23.96 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 35.6 | 18.81 | Not reported | Not reported | Not reported |
|---|
Cycle 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 26 |
|---|
| Bexarotene Naive | 24 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 43.5 | 24.72 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 36.2 | 19.02 | Not reported | Not reported | Not reported |
|---|
Cycle 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 23 |
|---|
| Bexarotene Naive | 20 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 45.5 | 23.67 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 37.7 | 18.66 | Not reported | Not reported | Not reported |
|---|
Cycle 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 18 |
|---|
| Bexarotene Naive | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 42.7 | 21.45 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 36.5 | 19.29 | Not reported | Not reported | Not reported |
|---|
Cycle 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 20 |
|---|
| Bexarotene Naive | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 47.1 | 23.42 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 35.9 | 15.79 | Not reported | Not reported | Not reported |
|---|
Cycle 10
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 18 |
|---|
| Bexarotene Naive | 13 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 46.8 | 23.11 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 47.0 | 21.17 | Not reported | Not reported | Not reported |
|---|
Cycle 11
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 14 |
|---|
| Bexarotene Naive | 10 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 46.7 | 22.04 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 48.3 | 19.44 | Not reported | Not reported | Not reported |
|---|
Cycle 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Bexarotene Exposed | 11 |
|---|
| Bexarotene Naive | 8 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bexarotene Exposed | 37.7 | 15.52 | Not reported | Not reported | Not reported |
|---|
| Bexarotene Naive | 45.1 | 21.93 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.03
- value
- 60.1
- group Id
- OG001
- spread
- 20.35
- value
- 55.3
- denoms
- counts
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 57
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 23.10
- value
- 51.4
- group Id
- OG001
- spread
- 20.28
- value
- 47.7
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 21.92
- value
- 51.1
- group Id
- OG001
- spread
- 21.72
- value
- 42.9
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 40
- units
- Participants
- title
- Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 22.16
- value
- 47.3
- group Id
- OG001
- spread
- 16.66
- value
- 35.2
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 29
- units
- Participants
- title
- Cycle 4
- categories
- measurements
- group Id
- OG000
- spread
- 23.96
- value
- 43.2
- group Id
- OG001
- spread
- 18.81
- value
- 35.6
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 26
- units
- Participants
- title
- Cycle 5
- categories
- measurements
- group Id
- OG000
- spread
- 24.72
- value
- 43.5
- group Id
- OG001
- spread
- 19.02
- value
- 36.2
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 24
- units
- Participants
- title
- Cycle 6
- categories
- measurements
- group Id
- OG000
- spread
- 23.67
- value
- 45.5
- group Id
- OG001
- spread
- 18.66
- value
- 37.7
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- Cycle 7
- categories
- measurements
- group Id
- OG000
- spread
- 21.45
- value
- 42.7
- group Id
- OG001
- spread
- 19.29
- value
- 36.5
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Cycle 8
- categories
- measurements
- group Id
- OG000
- spread
- 23.42
- value
- 47.1
- group Id
- OG001
- spread
- 15.79
- value
- 35.9
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- Cycle 9
- categories
- measurements
- group Id
- OG000
- spread
- 23.11
- value
- 46.8
- group Id
- OG001
- spread
- 21.17
- value
- 47.0
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Cycle 10
- categories
- measurements
- group Id
- OG000
- spread
- 22.04
- value
- 46.7
- group Id
- OG001
- spread
- 19.44
- value
- 48.3
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 10
- units
- Participants
- title
- Cycle 11
- categories
- measurements
- group Id
- OG000
- spread
- 15.52
- value
- 37.7
- group Id
- OG001
- spread
- 21.93
- value
- 45.1
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Cycle 12
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 60
- units
- Participants
- description
- Skindex-29 was a self-administered 29-item dermatology patient-reported outcome measure that explores the domains of Functioning, Emotions and Symptoms. Data from the Skindex-29 came from the "Dermatology Survey" page. Scoring of the Skindex-29 was performed as per the developers' scoring algorithms. The score for each dimension was found by adding responses of 1 to 5 for each question, with higher scores indicating worse quality of life. The Skindex-29 yields three scale scores that assess physical symptoms scores range from 29 to 116, with higher scores indicating worse health-related quality of life. Average sub-scores for emotions, physical symptoms, and functioning was displayed.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
- id
- OG000
- title
- Bexarotene Exposed
- description
- Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
- id
- OG001
- title
- Bexarotene Naive
- param Type
- MEAN
- population Description
- The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population included all participants enrolled into the study.
- reporting Status
- POSTED
- time Frame
- Baseline up to Cycle 12, an average of 12 months
- title
- Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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