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NCT02676778 · OUTCOME

Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody

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
Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)

Analysis population: The PD analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment.

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

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
PTCL: E7777 9 mcg/kg/Day17
CTCL: E7777 9 mcg/kg/Day19
Other: E7777 9 mcg/kg/Day1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day0Not reportedNot reportedNot reportedNot reported
CTCL: E7777 9 mcg/kg/Day0Not reportedNot reportedNot reportedNot reported
Other: E7777 9 mcg/kg/Day0Not reportedNot reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
PTCL: E7777 9 mcg/kg/Day11
CTCL: E7777 9 mcg/kg/Day14
Other: E7777 9 mcg/kg/Day1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day2Not reportedNot reportedNot reportedNot reported
CTCL: E7777 9 mcg/kg/Day9Not reportedNot reportedNot reportedNot reported
Other: E7777 9 mcg/kg/Day0Not reportedNot reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
PTCL: E7777 9 mcg/kg/Day8
CTCL: E7777 9 mcg/kg/Day13
Other: E7777 9 mcg/kg/Day0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day2Not reportedNot reportedNot reportedNot reported
CTCL: E7777 9 mcg/kg/Day11Not reportedNot reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
PTCL: E7777 9 mcg/kg/Day4
CTCL: E7777 9 mcg/kg/Day11
Other: E7777 9 mcg/kg/Day0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day1Not reportedNot reportedNot reportedNot reported
CTCL: E7777 9 mcg/kg/Day8Not reportedNot reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
PTCL: E7777 9 mcg/kg/Day0
CTCL: E7777 9 mcg/kg/Day7
Other: E7777 9 mcg/kg/Day0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CTCL: E7777 9 mcg/kg/Day6Not reportedNot reportedNot reportedNot reported
Discontinuation/Completion

Analysis denominator · Participants

GroupSource count
PTCL: E7777 9 mcg/kg/Day16
CTCL: E7777 9 mcg/kg/Day18
Other: E7777 9 mcg/kg/Day1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL: E7777 9 mcg/kg/Day8Not reportedNot reportedNot reportedNot reported
CTCL: E7777 9 mcg/kg/Day12Not 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
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        11
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG001
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Cycle 8 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Discontinuation/Completion
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 PD analysis set was defined as a group of participants who received at least 1 dose of the study drug with at least 1 each of evaluable pre- and post-baseline PD data. Participants who were evaluable for this measure at given time point were included for the assessment.
reporting Status
POSTED
time Frame
Cycles 1, 2, 3, 5, 8: Day 1 pre-dose; at treatment discontinuation or completion (Cycle 8 Day 21) (each Cycle length = 3 weeks)
title
Number of Participants With Positive Neutralizing Activity of Anti-E7777 Antibody
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice