TriangleNCT01871727 · OUTCOME
Main Study Part: Time to Response (TTR) Per Independent Review Committee
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
- From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 3 years 6 months)
What was measured
Time to response per independent review committee was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.
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 CR or PR in Lead-in part and in Main study part.
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
- Time to response per independent review committee was defined as the time from date of first dose to the date of the first documented CR or PR. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites.
- 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 CR or PR in Lead-in part and in Main study part.
- reporting Status
- POSTED
- time Frame
- From the date of administration of the first dose of the study drug until date of the first documentation of PR or CR (Up to 3 years 6 months)
- title
- Main Study Part: Time to Response (TTR) Per Independent Review Committee
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice