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NCT00608907 · OUTCOME

Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours

An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) · Source last updated 2012-01-30

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
Cycle 3 day 14 (72 hours post last dose)

Analysis population: Pharmacokinetic (PK) evaluable population, include all subjects completed 3 cycles of treatment and all PK assessments during the first 3 cycles of the study.

Groups in this outcome

VELCADE + Rifampicin

Treatment Arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.

VELCADE + Dexamethasone

Treatment arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.

VELCADE

Control arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.

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

Analysis denominator · Participants

GroupSource count
VELCADE + Rifampicin6
VELCADE + Dexamethasone7
VELCADE12

Reported measurements

Source class 1
Values in ng*h/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
VELCADE + Rifampicin12334.248.1463.06Not reported
VELCADE + Dexamethasone17064.582.28105.21Not reported
VELCADE21558.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.14
        spread
        34.2
        upper Limit
        63.06
        value
        123
      2. group Id
        OG001
        lower Limit
        82.28
        spread
        64.5
        upper Limit
        105.21
        value
        170
      3. group Id
        OG002
        spread
        58.4
        value
        215
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      12
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    Treatment Arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
    id
    OG000
    title
    VELCADE + Rifampicin
  2. description
    Treatment arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
    id
    OG001
    title
    VELCADE + Dexamethasone
  3. description
    Control arm, bortezomib 1.3 mg/m\^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
    id
    OG002
    title
    VELCADE
param Type
MEAN
population Description
Pharmacokinetic (PK) evaluable population, include all subjects completed 3 cycles of treatment and all PK assessments during the first 3 cycles of the study.
reporting Status
POSTED
time Frame
Cycle 3 day 14 (72 hours post last dose)
title
Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours
type
PRIMARY
unit Of Measure
ng*h/mL

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

Preserved source evidence · Not medical advice