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NCT01602224 · OUTCOME

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab

A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM) · Source last updated 2019-10-08

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

Measure
GEOMETRIC_MEAN
Unit
micrograms per milliliter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle (C)1 Day (D)1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime

What was measured

Maximum Concentration (Cmax) of Tabalumab.

Analysis population: All randomized participants who received at least 1 dose of study drug and evaluable PK data.

Groups in this outcome

100 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

300 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

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

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib68
300 mg Tabalumab+Dexamethasone+Bortezomib71

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib68
300 mg Tabalumab+Dexamethasone+Bortezomib71
Values in micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib38.039Not reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib10343Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib63
300 mg Tabalumab+Dexamethasone+Bortezomib68
Values in micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib47.951Not reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib13140Not reportedNot reportedNot reported
Steady State (Cycle 6-10)

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib68
300 mg Tabalumab+Dexamethasone+Bortezomib71
Values in micrograms per milliliter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib69.051Not reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib18954Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        39
        value
        38.0
      2. group Id
        OG001
        spread
        43
        value
        103
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        71
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        51
        value
        47.9
      2. group Id
        OG001
        spread
        40
        value
        131
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        51
        value
        69.0
      2. group Id
        OG001
        spread
        54
        value
        189
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        71
      units
      Participants
    title
    Steady State (Cycle 6-10)
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    2. group Id
      OG001
      value
      71
    units
    Participants
description
Maximum Concentration (Cmax) of Tabalumab.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG000
    title
    100 mg Tabalumab+Dexamethasone+Bortezomib
  2. description
    Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG001
    title
    300 mg Tabalumab+Dexamethasone+Bortezomib
param Type
GEOMETRIC_MEAN
population Description
All randomized participants who received at least 1 dose of study drug and evaluable PK data.
reporting Status
POSTED
time Frame
Cycle (C)1 Day (D)1: Predose, 3O minutes, 2 hours Postdose; C1 D4, 8, 11: Predose, (D11 only, 30 minutes Postdose); C2 and C6-C10 D1: Predose and immediately Postdose; C2 D 4, 8, 11: Anytime
title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab
type
SECONDARY
unit Of Measure
micrograms per milliliter

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Preserved source evidence · Not medical advice