NCT00765102 · OUTCOME

Time to Maximum Observed Concentration (Tmax)

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

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

Measure: MEDIAN
Unit: hr
Interval / dispersion: Full Range
Time frame: Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion

What was measured

Time to maximum observed concentration of Romidepsin

Analysis population: A subset of participants from the lead investigator's site had PK samples taken.

Groups in this outcome

Romidepsin 8 mg/m^2 + Bortezomib

Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m\^2.

Romidepsin 10 mg/m^2 + Bortezomib

Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.

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
Romidepsin 8 mg/m^2 + Bortezomib	6
Romidepsin 10 mg/m^2 + Bortezomib	5

Reported measurements

Source class 1

Values in hr · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Romidepsin 8 mg/m^2 + Bortezomib	1.04	Not reported	0.60	1.10	Not reported
Romidepsin 10 mg/m^2 + Bortezomib	0.58	Not reported	0.53	0.67	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.60
upper Limit
1.10
value
1.04
group Id
OG001
lower Limit
0.53
upper Limit
0.67
value
0.58

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
5
units
Participants

description

Time to maximum observed concentration of Romidepsin

dispersion Type

Full Range

groups

description
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m\^2.
id
OG000
title
Romidepsin 8 mg/m^2 + Bortezomib
description
Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
id
OG001
title
Romidepsin 10 mg/m^2 + Bortezomib

param Type

MEDIAN

population Description

A subset of participants from the lead investigator's site had PK samples taken.

reporting Status

POSTED

time Frame

Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion

title

Time to Maximum Observed Concentration (Tmax)

type

SECONDARY

unit Of Measure

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

Preserved source evidence · Not medical advice