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NCT00510068 · OUTCOME

Evaluation of Pharmacokinetics (PK) Parameter: Tmax -Time to Maximum (Peak) Drug Concentration

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
MEDIAN
Unit
h
Interval / dispersion
Full Range
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. Values for tmax where summarized in median (range).

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 h · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day1.17Not reported0.524.0Not reported
Everolimus 5 mg/Day3.0Not reportedNANASummary 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
        lower Limit
        0.5
        upper Limit
        24.0
        value
        1.17
      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
        lower Limit
        NA
        upper Limit
        NA
        value
        3.0
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. Values for tmax where summarized in median (range).
dispersion Type
Full Range
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
MEDIAN
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: Tmax -Time to Maximum (Peak) Drug Concentration
type
SECONDARY
unit Of Measure
h

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

Preserved source evidence · Not medical advice