TriangleNCT01871727 · OUTCOME
Main Study Part: Time to Skin Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Up to 30 months
What was measured
The time to skin response based on the mSWAT score was defined as time from the date of first dose to the date when criteria for skin response (CR or PR) were first met. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.
Analysis population: Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here 'overall number of participants analyzed' were those who had a skin response.
Groups in this outcome
Main Study Part: E7777 9 mcg/kg
Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
| Group | Source count |
|---|---|
| Main Study Part: E7777 9 mcg/kg | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Part: E7777 9 mcg/kg | 1.41 | Not reported | 0.7 | 5.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.7
- upper Limit
- 5.6
- value
- 1.41
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- The time to skin response based on the mSWAT score was defined as time from the date of first dose to the date when criteria for skin response (CR or PR) were first met. mSWAT was used to measure skin disease severity based on the percentage of BSA with patches, plaques, or tumors. Total scores were calculated by multiplying the BSA percentage for each category of lesion (patch, plaque, or tumor) by a weighting factor and adding the three sub-scores which ranged from 0 (unaffected) to 400 (severely affected). Lower scores indicated a lower degree of skin disease severity. CR corresponded to 100% clearance of skin lesions present at baseline (mSWAT score of 0). PR corresponded to 50-99% clearance of skin disease present at baseline (at least 50% reduction in mSWAT score), without new tumors.
- dispersion Type
- Full Range
- groups
- description
- Participants with stages I to III CTCL were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part and in Main study part and were presented together here, as planned.
- id
- OG000
- title
- Main Study Part: E7777 9 mcg/kg
- param Type
- MEDIAN
- population Description
- Primary efficacy analysis set included all participants with Stages I to III CTCL (both Main Study and Lead-In part) who received study drug at the 9 mcg/kg dose. Here 'overall number of participants analyzed' were those who had a skin response.
- reporting Status
- POSTED
- time Frame
- Up to 30 months
- title
- Main Study Part: Time to Skin Response
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice