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NCT00652626 · OUTCOME

Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose

Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function · Source last updated 2019-11-19

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

Measure
GEOMETRIC_MEAN
Unit
ng*hr/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose

What was measured

Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.

Analysis population: Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.

Groups in this outcome

Azacitidine 25 mg/m^2

Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.

Azacitidine 50 mg/m^2

Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.

Azacitidine 75 mg/m^2

Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.

Azacitidine 100 mg/m^2

Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Azacitidine 25 mg/m^25
Azacitidine 50 mg/m^25
Azacitidine 75 mg/m^26
Azacitidine 100 mg/m^25

Reported measurements

Source class 1
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Azacitidine 25 mg/m^2455.8626.04Not reportedNot reportedNot reported
Azacitidine 50 mg/m^2897.4331.00Not reportedNot reportedNot reported
Azacitidine 75 mg/m^2921.8739.215Not reportedNot reportedNot reported
Azacitidine 100 mg/m^21502.8625.57Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.04
        value
        455.86
      2. group Id
        OG001
        spread
        31.00
        value
        897.43
      3. group Id
        OG002
        spread
        39.215
        value
        921.87
      4. group Id
        OG003
        spread
        25.57
        value
        1502.86
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      5
    units
    Participants
description
Area under the plasma concentration-time curve from time 0 to 8 hours post-dose (AUC0-8) of azacitidine following a single dose of azacitidine on Day 1, calculated by the linear trapezoidal rule.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
    id
    OG000
    title
    Azacitidine 25 mg/m^2
  2. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
    id
    OG001
    title
    Azacitidine 50 mg/m^2
  3. description
    Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
    id
    OG002
    title
    Azacitidine 75 mg/m^2
  4. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
    id
    OG003
    title
    Azacitidine 100 mg/m^2
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants with normal renal function only.
reporting Status
POSTED
time Frame
Day 1 at predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
title
Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose
type
PRIMARY
unit Of Measure
ng*hr/mL

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

Preserved source evidence · Not medical advice