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NCT02807454 · OUTCOME

Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm

A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma · Source last updated 2023-02-21

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

Measure
GEOMETRIC_MEAN
Unit
Hour*ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 - Days 2, 8, 15, 22

What was measured

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

Analysis population: All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. \[AUC(TAU)\] was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only.

Groups in this outcome

Simon Stage 1: D2 Arm

Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 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
Simon Stage 1: D2 Arm28

Reported measurements

Source class 1
Values in Hour*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Simon Stage 1: D2 Arm83966.09946.115Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        46.115
        value
        83966.099
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles.
    id
    OG000
    title
    Simon Stage 1: D2 Arm
param Type
GEOMETRIC_MEAN
population Description
All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. \[AUC(TAU)\] was a pre-specified secondary outcome measure in the Simon Stage 1: D2 arm only.
reporting Status
POSTED
time Frame
Cycle 1 - Days 2, 8, 15, 22
title
Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Simon Stage 1: D2 Arm
type
SECONDARY
unit Of Measure
Hour*ug/mL

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

Preserved source evidence · Not medical advice