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NCT02676778 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month)

Analysis population: The safety analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 evaluable postbaseline safety data.

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/Day1

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day17Not reportedNot reportedNot reportedNot reported
CTCL: E7777 9 mcg/kg/Day19Not reportedNot reportedNot reportedNot reported
Other: E7777 9 mcg/kg/Day1Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day9Not reportedNot reportedNot reportedNot reported
CTCL: E7777 9 mcg/kg/Day8Not reportedNot reportedNot reportedNot reported
Other: E7777 9 mcg/kg/Day0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        1
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        0
    title
    SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      1
    units
    Participants
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
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 evaluable postbaseline safety data.
reporting Status
POSTED
time Frame
From the date of administration of the first dose of the study drug up to 30 days after the last dose of study drug (approximately up to 3 years 1 month)
title
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice