TriangleNCT01871727 · OUTCOME
Main Study Part: ORR Per IRC Based on Prince 2010 Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)
What was measured
ORR was defined as the percentage of participants whose BOR was CR, clinical complete response (CCR) or PR per IRC. The tumor response was based on Prince 2010 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. CCR was defined as tumor residue not visible on esophagogram, computed tomography (CT), endoscopy, positron emission tomography (PET)-CT.
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.
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 | 69 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Part: E7777 9 mcg/kg | 36.2 | Not reported | 25.0 | 48.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.0
- upper Limit
- 48.7
- value
- 36.2
- denoms
- counts
- group Id
- OG000
- value
- 69
- units
- Participants
- description
- ORR was defined as the percentage of participants whose BOR was CR, clinical complete response (CCR) or PR per IRC. The tumor response was based on Prince 2010 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. CCR was defined as tumor residue not visible on esophagogram, computed tomography (CT), endoscopy, positron emission tomography (PET)-CT.
- dispersion Type
- 95% Confidence Interval
- 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
- NUMBER
- 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.
- reporting Status
- POSTED
- time Frame
- From the date of administration of the first dose of the study drug until disease progression (Up to 3 years 6 months)
- title
- Main Study Part: ORR Per IRC Based on Prince 2010 Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice