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NCT00355472 · OUTCOME

Pharmacokinetics-Plasma KW-0761 Concentrations

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

What was measured

Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.

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

Cmax
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg350.047.8Not reportedNot reportedNot reported
KW-0761 0.1mg2806.71664.5Not reportedNot reportedNot reported
KW-0761 0.5mg15181.2872.0Not reportedNot reportedNot reported
KW-0761 1.0mg40428.45350.8Not reportedNot reportedNot reported
Ctrough
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
KW-0761 0.01mg158.27.4Not reportedNot reportedNot reported
KW-0761 0.1mg1515.21873.4Not reportedNot reportedNot reported
KW-0761 0.5mg6824.7872.9Not reportedNot reportedNot reported
KW-0761 1.0mg19516.84264.7Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        47.8
        value
        350.0
      2. group Id
        OG001
        spread
        1664.5
        value
        2806.7
      3. group Id
        OG002
        spread
        872.0
        value
        15181.2
      4. group Id
        OG003
        spread
        5350.8
        value
        40428.4
    title
    Cmax
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.4
        value
        158.2
      2. group Id
        OG001
        spread
        1873.4
        value
        1515.2
      3. group Id
        OG002
        spread
        872.9
        value
        6824.7
      4. group Id
        OG003
        spread
        4264.7
        value
        19516.8
    title
    Ctrough
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
Plasma KW-0761 concentrations were to be summarized in tabular form with the descriptive statistics on a dose-by-dose basis. Individual and mean (+ standard deviation) plasma KW-0761 concentrations on an actual or logarithmic scale were to be plotted against the time of blood sampling.
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
reporting Status
POSTED
time Frame
0-7 days post final dose
title
Pharmacokinetics-Plasma KW-0761 Concentrations
type
PRIMARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice