NCT02335983 · OUTCOME

Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group

Phase 1b Study of Weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma · Source last updated 2020-11-06

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

Measure: MEDIAN
Unit: hours
Interval / dispersion: Full Range
Time frame: Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion

Analysis population: Participants who received at least 1 dose of study drug who had sufficient carfilzomib exposure and plasma concentration versus time data for the estimation of pharmacokinetic parameters by a non-compartmental analysis on day 8 of cycle 1.

Groups in this outcome

Carfilzomib 56 mg/m²

Participants who received carfilzomib 56 mg/m² on Cycle 1 day 8.

Carfilzomib 70 mg/m²

Participants who received carfilzomib 70 mg/m² on Cycle 1 day 8.

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
Carfilzomib 56 mg/m²	46
Carfilzomib 70 mg/m²	40

Reported measurements

Source class 1

Values in hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib 56 mg/m²	0.28	Not reported	0.17	24	Not reported
Carfilzomib 70 mg/m²	0.27	Not reported	0.17	0.68	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.17
upper Limit
24
value
0.28
group Id
OG001
lower Limit
0.17
upper Limit
0.68
value
0.27

denoms

counts
group Id
OG000
value
46
group Id
OG001
value
40
units
Participants

dispersion Type

Full Range

groups

description
Participants who received carfilzomib 56 mg/m² on Cycle 1 day 8.
id
OG000
title
Carfilzomib 56 mg/m²
description
Participants who received carfilzomib 70 mg/m² on Cycle 1 day 8.
id
OG001
title
Carfilzomib 70 mg/m²

param Type

MEDIAN

population Description

Participants who received at least 1 dose of study drug who had sufficient carfilzomib exposure and plasma concentration versus time data for the estimation of pharmacokinetic parameters by a non-compartmental analysis on day 8 of cycle 1.

reporting Status

POSTED

time Frame

Day 8 of Cycle 1 at predose, 15 minutes after the start of infusion, at the end of infusion, and 15 and 60 minutes after the end of infusion

title

Time to Maximum Plasma Concentration of Carfilzomib on Day 8 of Cycle 1 by Dose Group

type

SECONDARY

unit Of Measure

hours

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

Preserved source evidence · Not medical advice