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NCT00355472 · OUTCOME

Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)

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
ng·h/mL
Interval / dispersion
Standard Deviation
Time frame
0-7 days post final dose

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: AUC0-7 days

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 ng·h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg365862987Not reportedNot reportedNot reported
KW-0761 0.1mg327609322298Not reportedNot reportedNot reported
KW-0761 0.5mg1625609142277Not reportedNot reportedNot reported
KW-0761 1.0mg4190238544757Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2987
        value
        36586
      2. group Id
        OG001
        spread
        322298
        value
        327609
      3. group Id
        OG002
        spread
        142277
        value
        1625609
      4. group Id
        OG003
        spread
        544757
        value
        4190238
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
AUC0-7 days
reporting Status
POSTED
time Frame
0-7 days post final dose
title
Pharmacokinetics-Pharmacokinetic Parameters of KW-0761 (AUC0-7 Days)
type
PRIMARY
unit Of Measure
ng·h/mL

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

Preserved source evidence · Not medical advice