NCT00410124 · OUTCOME

Pharmacokinetics of RAD001: Normalized to Body Surface Area (CL/F)

RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib · Source last updated 2013-01-15

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

Measure: MEAN
Unit: L/hour/m^2
Interval / dispersion: Standard Deviation
Time frame: At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.

What was measured

Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.

Analysis population: The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.

Groups in this outcome

Day 15

Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.

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
Day 15	12

Reported measurements

Source class 1

Values in L/hour/m^2 · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Day 15	7.5	2.3	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
2.3
value
7.5

denoms

counts
group Id
OG000
value
12
units
Participants

description

Blood samples will be collected by direct venipuncture during regularly scheduled visits according to the collection plan provided in the study protocol.

dispersion Type

Standard Deviation

groups

description
Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
id
OG000
title
Day 15

param Type

MEAN

population Description

The pharmacokinetics population consists of all patients who have a pharmacokinetic assessment with a sufficient number of evaluable blood samples. The analsyis was limited to RAD001 + BSC arm.

reporting Status

POSTED

time Frame

At pre-dose and post-dose: 1 hour, 2 hour, 5 hour, 24 hour of Cycle 1 Day 1, Cycle 1 Day 15 and at pre-dose from Cycle 2 (Day 1) and all subsequent treatment cycles until data cut-off 28Feb2008.

title

Pharmacokinetics of RAD001: Normalized to Body Surface Area (CL/F)

type

SECONDARY

unit Of Measure

L/hour/m^2

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice