TriangleNCT02676778 · OUTCOME
Objective Response Rate (ORR)
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 completion of the study or treatment discontinuation, up to approximately 3 years 1 month
What was measured
ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.
Analysis population: The full analysis set (FAS) was defined as a group of participants who received at least 1 dose of the study drug.
Groups in this outcome
PTCL: E7777 9 mcg/kg/Day
Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
CTCL: E7777 9 mcg/kg/Day
Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
Other: E7777 9 mcg/kg/Day
Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
| Group | Source count |
|---|---|
| PTCL: E7777 9 mcg/kg/Day | 17 |
| CTCL: E7777 9 mcg/kg/Day | 19 |
| Other: E7777 9 mcg/kg/Day | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PTCL: E7777 9 mcg/kg/Day | 41.2 | Not reported | 18.4 | 67.1 | Not reported |
| CTCL: E7777 9 mcg/kg/Day | 31.6 | Not reported | 12.6 | 56.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.4
- upper Limit
- 67.1
- value
- 41.2
- group Id
- OG001
- lower Limit
- 12.6
- upper Limit
- 56.6
- value
- 31.6
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- ORR was defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) based on independent review of Efficacy and Safety Evaluation Committee. ORR was assessed according to modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease were assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed or refractory PTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
- id
- OG000
- title
- PTCL: E7777 9 mcg/kg/Day
- description
- Participants with CTCL received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
- id
- OG001
- title
- CTCL: E7777 9 mcg/kg/Day
- description
- Participant with extranodal NK/T-cell lymphoma received E7777 9 mcg/kg/day as intravenous infusion, once daily from Day 1 through Day 5 in each treatment cycle until discontinuation or Cycle 8 (each Cycle length = 3 weeks).
- id
- OG002
- title
- Other: E7777 9 mcg/kg/Day
- param Type
- NUMBER
- population Description
- The full analysis set (FAS) was defined as a group of participants who received at least 1 dose of the study drug.
- reporting Status
- POSTED
- time Frame
- From the date of administration of the first dose of the study drug until completion of the study or treatment discontinuation, up to approximately 3 years 1 month
- title
- Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice