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NCT01007942 · OUTCOME

Everolimus Blood Concentrations by Leading Dose and Time Point

Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer · Source last updated 2017-04-05

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

Measure
MEAN
Unit
ng/ml
Interval / dispersion
Standard Deviation
Time frame
Cycle 2, Day 1

What was measured

Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.

Analysis population: The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.

Groups in this outcome

Everolimus 2.5 mg

Oral everolimus of 2.5 mg/day

Everolimus

Oral everolimus of 5 mg/day

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 2.5 mg10
Everolimus43

Reported measurements

Pre-dose (Cmin) (n: 7, 32)
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus 2.5 mg2.9282.6197Not reportedNot reportedNot reported
Everolimus5.6524.1006Not reportedNot reportedNot reported
2 hours post administration (C2h) (n:10, 43)
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus 2.5 mg13.0356.6842Not reportedNot reportedNot reported
Everolimus22.00513.3800Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.6197
        value
        2.928
      2. group Id
        OG001
        spread
        4.1006
        value
        5.652
    title
    Pre-dose (Cmin) (n: 7, 32)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.6842
        value
        13.035
      2. group Id
        OG001
        spread
        13.3800
        value
        22.005
    title
    2 hours post administration (C2h) (n:10, 43)
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses.
dispersion Type
Standard Deviation
groups
  1. description
    Oral everolimus of 2.5 mg/day
    id
    OG000
    title
    Everolimus 2.5 mg
  2. description
    Oral everolimus of 5 mg/day
    id
    OG001
    title
    Everolimus
param Type
MEAN
population Description
The Safety Set consisted of all patients who received at least one dose of the study treatment and who had at least one valid post-baseline safety assessment.
reporting Status
POSTED
time Frame
Cycle 2, Day 1
title
Everolimus Blood Concentrations by Leading Dose and Time Point
type
SECONDARY
unit Of Measure
ng/ml

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

Preserved source evidence · Not medical advice