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NCT02807454 · OUTCOME

Time of Maximum Observed Concentration (Tmax) - 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
MEDIAN
Unit
Hour
Interval / dispersion
Full Range
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. Tmax 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 Arm30

Reported measurements

Source class 1
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Simon Stage 1: D2 Arm1.150Not reported1.031.83Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.03
        upper Limit
        1.83
        value
        1.150
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Pharmacokinetics of Durvalumab derived from serum concentration versus time data.
dispersion Type
Full Range
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
MEDIAN
population Description
All participants who received at least 1 dose of study medication and who have at least 1 measurable plasma concentration. Tmax 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
Time of Maximum Observed Concentration (Tmax) - Simon Stage 1: D2 Arm
type
SECONDARY
unit Of Measure
Hour

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

Preserved source evidence · Not medical advice