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NCT02676778 · OUTCOME

Overall Survival (OS)

Study of E7777 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma and Cutaneous T-cell Lymphoma · Source last updated 2021-07-15

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 date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month

What was measured

OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause. Participants who were alive at 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
PTCL: E7777 9 mcg/kg/Day17
CTCL: E7777 9 mcg/kg/Day19
Other: E7777 9 mcg/kg/Day0

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day11.79Not reported4.1119.29Not reported
CTCL: E7777 9 mcg/kg/Day31.87Not reported16.85NAUpper limit of confidence interval could not be estimated due to an insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.11
        upper Limit
        19.29
        value
        11.79
      2. comment
        Upper limit of confidence interval could not be estimated due to an insufficient number of events.
        group Id
        OG001
        lower Limit
        16.85
        upper Limit
        NA
        value
        31.87
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      0
    units
    Participants
description
OS was defined as the time between the date of administration of the first dose of the study drug and the date of death due to any cause. Participants who were alive at cut-off were censored.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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 date of administration of the first dose of the study drug until the date of death due to any cause up to approximately 3 years 1 month
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice