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NCT01401530 · OUTCOME

Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox

E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma · Source last updated 2018-11-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months

What was measured

Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood coagulation, blood chemistry, and urinalysis values; periodic measurement of vital signs, body weight, 12-lead electrocardiograms (ECGs), Eastern Cooperative Oncology Group performance status, physical examination findings, and ophthalmological examination findings. TEAEs were defined as an AE that had an onset date, or worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to the last assessment. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug. SAEs were defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect.

Analysis population: Safety Analysis Set (SAS) included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum.

Groups in this outcome

Cohort 1: 6 ug/kg/Day Denileukin Diftitox

Denileukin diftitox (6 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).

Cohort 2: 9 ug/kg/Day Denileukin Diftitox

Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).

Cohort 3: 12 ug/kg/Day Denileukin Diftitox

Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 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
Cohort 1: 6 ug/kg/Day Denileukin Diftitox3
Cohort 2: 9 ug/kg/Day Denileukin Diftitox7
Cohort 3: 12 ug/kg/Day Denileukin Diftitox3

Reported measurements

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 6 ug/kg/Day Denileukin Diftitox3Not reportedNot reportedNot reportedNot reported
Cohort 2: 9 ug/kg/Day Denileukin Diftitox7Not reportedNot reportedNot reportedNot reported
Cohort 3: 12 ug/kg/Day Denileukin Diftitox3Not reportedNot reportedNot reportedNot reported
Treatment-related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 6 ug/kg/Day Denileukin Diftitox3Not reportedNot reportedNot reportedNot reported
Cohort 2: 9 ug/kg/Day Denileukin Diftitox7Not reportedNot reportedNot reportedNot reported
Cohort 3: 12 ug/kg/Day Denileukin Diftitox3Not reportedNot reportedNot reportedNot reported
Treatment-emergent SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 6 ug/kg/Day Denileukin Diftitox1Not reportedNot reportedNot reportedNot reported
Cohort 2: 9 ug/kg/Day Denileukin Diftitox3Not reportedNot reportedNot reportedNot reported
Cohort 3: 12 ug/kg/Day Denileukin Diftitox1Not reportedNot reportedNot reportedNot reported
Death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1: 6 ug/kg/Day Denileukin Diftitox0Not reportedNot reportedNot reportedNot reported
Cohort 2: 9 ug/kg/Day Denileukin Diftitox0Not reportedNot reportedNot reportedNot reported
Cohort 3: 12 ug/kg/Day Denileukin Diftitox1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        3
    title
    Treatment-related TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
    title
    Treatment-emergent SAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Death
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      3
    units
    Participants
description
Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood coagulation, blood chemistry, and urinalysis values; periodic measurement of vital signs, body weight, 12-lead electrocardiograms (ECGs), Eastern Cooperative Oncology Group performance status, physical examination findings, and ophthalmological examination findings. TEAEs were defined as an AE that had an onset date, or worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to the last assessment. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug. SAEs were defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect.
groups
  1. description
    Denileukin diftitox (6 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    OG000
    title
    Cohort 1: 6 ug/kg/Day Denileukin Diftitox
  2. description
    Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    OG001
    title
    Cohort 2: 9 ug/kg/Day Denileukin Diftitox
  3. description
    Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
    id
    OG002
    title
    Cohort 3: 12 ug/kg/Day Denileukin Diftitox
param Type
NUMBER
population Description
Safety Analysis Set (SAS) included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum.
reporting Status
POSTED
time Frame
From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months
title
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice