TriangleNCT02676778 · OUTCOME
Progression Free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of administration of the first dose of the study drug until date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month
What was measured
PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). PD: Any new lesion or unequivocally increase of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method. Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored.
Analysis population: The 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 | 2.14 | Not reported | 1.05 | 4.47 | Not reported |
| CTCL: E7777 9 mcg/kg/Day | 4.24 | Not reported | 2.56 | NA | Upper limit of confidence interval could not be estimated due to an insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.05
- upper Limit
- 4.47
- value
- 2.14
- comment
- Upper limit of confidence interval could not be estimated due to an insufficient number of events.
- group Id
- OG001
- lower Limit
- 2.56
- upper Limit
- NA
- value
- 4.24
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- PFS: time between the date of administration of the first dose of the study drug and the date of the first documentation of progressive disease (PD) or death due to any cause (whichever occurred first) based on independent review of Efficacy and Safety Evaluation Committee, assessed by modified response criteria based on the revised response criteria for malignant lymphoma (Cheson, 2007), skin lesion and peripheral blood disease assessed according to clinical end points and response criteria in mycosis fungoides and Sezary syndrome (Olsen, 2011). PD: Any new lesion or unequivocally increase of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method. Participants with no baseline assessments, treatment discontinuation without postbaseline tumor assessments, new anticancer treatment started prior to disease progression, death or PD after more than one missed tumor assessments and participants still on treatment without PD as of data cut-off were censored.
- 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
- MEDIAN
- population Description
- The 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 date of the first documentation of PD or death due to any cause (whichever occurred first) up to approximately 3 years 1 month
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice