TriangleNCT00425555 · OUTCOME
Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to 6 Months of Follow up
What was measured
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.
Analysis population: 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.
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.
All Participants
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 | Source count |
|---|---|
| Bexarotene Exposed | 79 |
| Bexarotene Naive | 60 |
| All Participants | 139 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bexarotene Exposed | 16.7 | Not reported | 8.1 | 25.0 | Not reported |
| Bexarotene Naive | 20.3 | Not reported | 10.8 | 32.3 | Not reported |
| All Participants | 18.5 | Not reported | 11.4 | 24.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.1
- upper Limit
- 25.0
- value
- 16.7
- group Id
- OG001
- lower Limit
- 10.8
- upper Limit
- 32.3
- value
- 20.3
- group Id
- OG002
- lower Limit
- 11.4
- upper Limit
- 24.6
- value
- 18.5
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 139
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- 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
- 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
- OG002
- title
- All Participants
- param Type
- NUMBER
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- Baseline up to 6 Months of Follow up
- title
- Overall Response Rate of Participants Using the Modified Severity-Weighted Assessment Tool (mSWAT)
- type
- PRIMARY
- unit Of Measure
- percentage
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice