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NCT01401530 · OUTCOME

Time to Cmax (Tmax) of Denileukin Diftitox in Serum

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
MEDIAN
Unit
Minutes
Interval / dispersion
Full Range
Time frame
Cycle 1 (Day 1)

What was measured

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed in minutes.

Analysis population: PK analysis set

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 Diftitox5
Cohort 3: 12 ug/kg/Day Denileukin Diftitox2

Reported measurements

Source class 1
Values in Minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: 6 ug/kg/Day Denileukin Diftitox64.000Not reported64.0086.00Not reported
Cohort 2: 9 ug/kg/Day Denileukin Diftitox64.000Not reported60.0098.00Not reported
Cohort 3: 12 ug/kg/Day Denileukin Diftitox74.500Not reported64.0085.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.00
        upper Limit
        86.00
        value
        64.000
      2. group Id
        OG001
        lower Limit
        60.00
        upper Limit
        98.00
        value
        64.000
      3. group Id
        OG002
        lower Limit
        64.00
        upper Limit
        85.00
        value
        74.500
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed in minutes.
dispersion Type
Full Range
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
MEDIAN
population Description
PK analysis set
reporting Status
POSTED
time Frame
Cycle 1 (Day 1)
title
Time to Cmax (Tmax) of Denileukin Diftitox in Serum
type
SECONDARY
unit Of Measure
Minutes

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

Preserved source evidence · Not medical advice