NCT02807454 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) - 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: 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. Cmax 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

Group	Source count
Simon Stage 1: D2 Arm	30

Reported measurements

Source class 1

Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Simon Stage 1: D2 Arm	315.806	34.832	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
34.832
value
315.806

denoms

counts
group Id
OG000
value
30
units
Participants

description

Pharmacokinetics of Durvalumab derived from serum concentration versus time data.

dispersion Type

Geometric Coefficient of Variation

groups

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. Cmax 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

Maximum Observed Plasma Concentration (Cmax) - Simon Stage 1: D2 Arm

type

SECONDARY

unit Of Measure

ug/mL

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

Preserved source evidence · Not medical advice