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NCT01602224 · OUTCOME

PK: Time to Maximum Plasma Concentration (Tmax) 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
MEAN
Unit
hours
Interval / dispersion
95% Confidence Interval
Time frame
C1 D1: 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

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

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+Bortezomib73
300 mg Tabalumab+Dexamethasone+Bortezomib74

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib73
300 mg Tabalumab+Dexamethasone+Bortezomib74
Values in hours · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib1.5Not reported0.75503.75Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib1.58Not reported0.92162.58Not reported
Cycle 2

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib73
300 mg Tabalumab+Dexamethasone+Bortezomib74
Values in hours · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib0.92Not reported0.47503.77Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib0.76Not reported0.5503.58Not reported
Steady State (Cycle 6-10)

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib47
300 mg Tabalumab+Dexamethasone+Bortezomib74
Values in hours · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib0.75Not reported0.3389.92Not reported
300 mg Tabalumab+Dexamethasone+Bortezomib0.73Not reported01.75Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.75
        upper Limit
        503.75
        value
        1.5
      2. group Id
        OG001
        lower Limit
        0.92
        upper Limit
        162.58
        value
        1.58
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.47
        upper Limit
        503.77
        value
        0.92
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        503.58
        value
        0.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.338
        upper Limit
        9.92
        value
        0.75
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        1.75
        value
        0.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Steady State (Cycle 6-10)
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    2. group Id
      OG001
      value
      74
    units
    Participants
dispersion Type
95% Confidence Interval
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
MEAN
population Description
All randomized participants who received at least 1 dose of study drug with evaluable PK values.
reporting Status
POSTED
time Frame
C1 D1: 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
PK: Time to Maximum Plasma Concentration (Tmax) of Tabalumab
type
SECONDARY
unit Of Measure
hours

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Preserved source evidence · Not medical advice