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NCT01524783 · OUTCOME

Pharmacokinetics (PK): Predose Concentration (Cmin) of Everolimus at Day 29

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) · Source last updated 2021-08-05

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

Measure
MEAN
Unit
nanogram/milliliter (ng/mL)
Interval / dispersion
Standard Deviation
Time frame
Pre-dose at Day 29.

What was measured

A pre-dose blood sample at day 29 was collected to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin). Cmin is provided for participants randomized to everolimus+BSC who received 10mg of everolimus daily and also for participants randomized to everolimus+BSC who received 5mg of everolimus daily which was required for a number of participants in the study experiencing adverse events requiring dose modifications

Analysis population: All patients who received at least one dose of the study drug with evaluable blood samples for this endpoint.

Groups in this outcome

Everolimus + BSC

Participants received everolimus 10 mg once daily BSC throughout the study

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 + BSC48

Reported measurements

10mg daily dose

Analysis denominator · Participants

GroupSource count
Everolimus + BSC48
Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus + BSC16.38213.2767Not reportedNot reportedNot reported
5mg daily dose

Analysis denominator · Participants

GroupSource count
Everolimus + BSC3
Values in nanogram/milliliter (ng/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus + BSC4.7003.8396Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.2767
        value
        16.382
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      units
      Participants
    title
    10mg daily dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.8396
        value
        4.700
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    5mg daily dose
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
A pre-dose blood sample at day 29 was collected to determine the exposure of everolimus at the steady-state pre-dose concentration (Cmin). Cmin is provided for participants randomized to everolimus+BSC who received 10mg of everolimus daily and also for participants randomized to everolimus+BSC who received 5mg of everolimus daily which was required for a number of participants in the study experiencing adverse events requiring dose modifications
dispersion Type
Standard Deviation
groups
  1. description
    Participants received everolimus 10 mg once daily BSC throughout the study
    id
    OG000
    title
    Everolimus + BSC
param Type
MEAN
population Description
All patients who received at least one dose of the study drug with evaluable blood samples for this endpoint.
reporting Status
POSTED
time Frame
Pre-dose at Day 29.
title
Pharmacokinetics (PK): Predose Concentration (Cmin) of Everolimus at Day 29
type
SECONDARY
unit Of Measure
nanogram/milliliter (ng/mL)

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

Preserved source evidence · Not medical advice