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← Targretin: refractory Cutaneous T-cell lymphoma

NCT00425555 · STUDY IN CONTEXT

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as: * Complete Response (CR): no evidence of skin disease * Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline * Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score * Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.

The analysis was performed in Full Analysis Set (FAS) population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

→

secondary · POSTED

Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

→

secondary · POSTED

Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

→

secondary · POSTED

Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

→

secondary · POSTED

PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

→

secondary · POSTED

Skin index measurement (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 emotions 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.

The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

Unnamed quality-of-life measure · Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cutaneous-t-cell-lymphomas-targretin-130474a6
nct id
NCT00425555
qol key
qol-0005
source section id
NCT00425555-om-0005
source outcome index
5
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12
measure definition
Skin index measurement (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 emotions 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.
time frame
Baseline up to Cycle 12, an average of 12 months
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher scores indicating worse
population note
The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cutaneous-t-cell-lymphomas-targretin-130474a6
nct id
NCT00425555
qol key
qol-0006
source section id
NCT00425555-om-0006
source outcome index
6
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12
measure definition
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 functioning 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.
time frame
Baseline up to Cycle 12, an average of 12 months
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher scores indicating worse
population note
The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12

Score direction: Lower is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-cutaneous-t-cell-lymphomas-targretin-130474a6
nct id
NCT00425555
qol key
qol-0007
source section id
NCT00425555-om-0007
source outcome index
7
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
measure definition
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.
time frame
Baseline up to Cycle 12, an average of 12 months
analysis role
secondary
reporting status
POSTED
higher is better
0
direction quote
higher scores indicating worse
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-cutaneous-t-cell-lymphomas-targretin-130474a6
nct id
NCT00425555
trial label
Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0000
    source section id
    NCT00425555-om-0000
    source outcome index
    0
    endpoint
    Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
    endpoint definition
    Skin response was primarily classified based on an assessment using mSWAT, provided there was documented evidence of stable disease or better in lymph node/viscera.The mSWAT is a tool specifically developed to evaluate the extent of skin disease in CTCL (Olsen et al 2007). Responses in the skin based on SWAT are defined as: * Complete Response (CR): no evidence of skin disease * Partial Response (PR): ≥ 50% decrease of the modified SWAT score compared with baseline * Stable Disease (SD): Neither CR, PR, or PD as compared with baseline, i.e. change from baseline is less than a 50% decrease but also less than a 25 % increase in the modified SWAT score * Progressive Disease (PD): ≥ 25% increase in the modified SWAT score compared with baseline.
    time origin
    Baseline up to 6 Months of Follow up
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis was performed in Full Analysis Set (FAS) population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0001
    source section id
    NCT00425555-om-0001
    source outcome index
    1
    endpoint
    The Overall Response Rate Using mSWAT Skin Score
    endpoint definition
    Estimate of the response rate of participants with resistant cutaneous T-cell lymphoma (CTCL) treated with Panobinostat using the mSWAT skin scores and 95% CI will be analyzed.
    time origin
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0002
    source section id
    NCT00425555-om-0002
    source outcome index
    2
    endpoint
    Time to Response for Responders
    endpoint definition
    Time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
    time origin
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0003
    source section id
    NCT00425555-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DOS)
    endpoint definition
    Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
    time origin
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0004
    source section id
    NCT00425555-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment
    time origin
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0005
    source section id
    NCT00425555-om-0005
    source outcome index
    5
    endpoint
    Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12
    endpoint definition
    Skin index measurement (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 emotions 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.
    time origin
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Bexarotene Exposed
    regimen
    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.
    analyzed count
    79
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Bexarotene Naive
    regimen
    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.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0000
    arm key
    OG002
    arm label
    All Participants
    regimen
    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.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Bexarotene Exposed
    regimen
    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.
    analyzed count
    79
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Bexarotene Naive
    regimen
    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.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0001
    arm key
    OG002
    arm label
    All Participants
    regimen
    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.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Bexarotene Exposed
    regimen
    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.
    analyzed count
    79
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Bexarotene Naive
    regimen
    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.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0002
    arm key
    OG002
    arm label
    All Participants
    regimen
    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.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Bexarotene Exposed
    regimen
    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.
    analyzed count
    79
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Bexarotene Naive
    regimen
    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.
    analyzed count
    60
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    outcome key
    om-0003
    arm key
    OG002
    arm label
    All Participants
    regimen
    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.
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00425555-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    harm key
    EG000
    source section id
    NCT00425555-ae
    event group key
    EG000
    event group label
    Bexarotene Exposed
    serious affected
    33
    serious at risk
    79
    other affected
    77
    other at risk
    79
    frequency threshold
    5
    collection period
    From Start of the Study up to 7 years approximately
    event definition
    The analysis was performed on Safety analysis population (SAP) consisted of all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    harm key
    EG001
    source section id
    NCT00425555-ae
    event group key
    EG001
    event group label
    Bexarotene Naive
    serious affected
    23
    serious at risk
    60
    other affected
    59
    other at risk
    60
    frequency threshold
    5
    collection period
    From Start of the Study up to 7 years approximately
    event definition
    The analysis was performed on Safety analysis population (SAP) consisted of all participants who received at least one dose of study drug and had at least one valid post-baseline assessment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    qol key
    qol-0005
    source section id
    NCT00425555-om-0005
    source outcome index
    5
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Skindex-29 Measurements of Average Sub-scores for Emotions From Baseline up to Cycle 12
    measure definition
    Skin index measurement (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 emotions 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.
    time frame
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    higher scores indicating worse
    population note
    The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    qol key
    qol-0006
    source section id
    NCT00425555-om-0006
    source outcome index
    6
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Skindex-29 Measurements of Average Sub-scores for Functioning From Baseline up to Cycle 12
    measure definition
    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 functioning 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.
    time frame
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    higher scores indicating worse
    population note
    The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-targretin-130474a6
    nct id
    NCT00425555
    qol key
    qol-0007
    source section id
    NCT00425555-om-0007
    source outcome index
    7
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Skindex-29 Measurements of Average Sub-scores for Physical Symptoms From Baseline up to Cycle 12
    measure definition
    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.
    time frame
    Baseline up to Cycle 12, an average of 12 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    0
    direction quote
    higher scores indicating worse
    population note
    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.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice