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NCT00355472 · OUTCOME

Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)

Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL · Source last updated 2012-10-18

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

Measure
MEAN
Unit
hours
Interval / dispersion
Standard Deviation
Time frame
0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).

What was measured

The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.

Analysis population: t1/2

Groups in this outcome

KW-0761 0.01mg

IV infusions of KW-0761 once/week for 4 weeks

KW-0761 0.1mg

IV infusions of KW-0761 once/week for 4 weeks

KW-0761 0.5mg

IV infusions of KW-0761 once/week for 4 weeks

KW-0761 1.0mg

IV infusions of KW-0761 once/week for 4 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
KW-0761 0.01mg3
KW-0761 0.1mg4
KW-0761 0.5mg3
KW-0761 1.0mg6

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg17940Not reportedNot reportedNot reported
KW-0761 0.1mg201196Not reportedNot reportedNot reported
KW-0761 0.5mg332122Not reportedNot reportedNot reported
KW-0761 1.0mg46251Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        40
        value
        179
      2. group Id
        OG001
        spread
        196
        value
        201
      3. group Id
        OG002
        spread
        122
        value
        332
      4. group Id
        OG003
        spread
        51
        value
        462
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    units
    Participants
description
The pharmacokinetic parameters of the subjects were to be individually calculated, and their descriptive statistics were to be calculated on a dose-by-dose basis.
dispersion Type
Standard Deviation
groups
  1. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG000
    title
    KW-0761 0.01mg
  2. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG001
    title
    KW-0761 0.1mg
  3. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG002
    title
    KW-0761 0.5mg
  4. description
    IV infusions of KW-0761 once/week for 4 weeks
    id
    OG003
    title
    KW-0761 1.0mg
param Type
MEAN
population Description
t1/2
reporting Status
POSTED
time Frame
0 to 28 days post final dose and follow-up examinations (1 month and 2 months after the end of the post-dosing observation period).
title
Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (t1/2)
type
PRIMARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice