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NCT00510068 · OUTCOME

Evaluation of Pharmacokinetics (PK) Parameter: CL/F

Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors · Source last updated 2015-07-01

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

Measure
MEAN
Unit
L/h
Interval / dispersion
Standard Deviation
Time frame
Day 1 of every cycle (28 days/cycle) throughout the study

What was measured

The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).

Analysis population: The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.

Groups in this outcome

Everolimus 10 mg/Day

Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).

Everolimus 5 mg/Day

Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Everolimus 10 mg/Day7
Everolimus 5 mg/Day1

Reported measurements

Source class 1
Values in L/h · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day20.27.7Not reportedNot reportedNot reported
Everolimus 5 mg/Day10.7NANot reportedNot reportedSummary statistics were only produced if the sample size for the dose group in the respective cycle is 3 or more.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.7
        value
        20.2
      2. comment
        Summary statistics were only produced if the sample size for the dose group in the respective cycle is 3 or more.
        group Id
        OG001
        spread
        NA
        value
        10.7
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      1
    units
    Participants
description
The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter clearance of distribution expressed as a function of bioavailability (CL/F).
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
    id
    OG000
    title
    Everolimus 10 mg/Day
  2. description
    Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
    id
    OG001
    title
    Everolimus 5 mg/Day
param Type
MEAN
population Description
The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.
reporting Status
POSTED
time Frame
Day 1 of every cycle (28 days/cycle) throughout the study
title
Evaluation of Pharmacokinetics (PK) Parameter: CL/F
type
SECONDARY
unit Of Measure
L/h

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

Preserved source evidence · Not medical advice