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NCT01007942 · OUTCOME

Vinorelbine 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-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine 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

Oral everolimus of 5 mg/day

Everolimus Placebo

Oral placebo 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
Everolimus76
Everolimus Placebo64

Reported measurements

Pre-infusion - dose (Cmin) (n: 76, 64)
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus11.08566.8551Not reportedNot reportedNot reported
Everolimus Placebo0.0610.4888Not reportedNot reportedNot reported
End of infusion (Cmax) (n: 58, 49)
Values in ng/ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus867.147971.3057Not reportedNot reportedNot reported
Everolimus Placebo1068.511145.860Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        66.8551
        value
        11.085
      2. group Id
        OG001
        spread
        0.4888
        value
        0.061
    title
    Pre-infusion - dose (Cmin) (n: 76, 64)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        971.3057
        value
        867.147
      2. group Id
        OG001
        spread
        1145.860
        value
        1068.51
    title
    End of infusion (Cmax) (n: 58, 49)
denoms
  1. counts
    1. group Id
      OG000
      value
      76
    2. group Id
      OG001
      value
      64
    units
    Participants
description
Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses.
dispersion Type
Standard Deviation
groups
  1. description
    Oral everolimus of 5 mg/day
    id
    OG000
    title
    Everolimus
  2. description
    Oral placebo everolimus of 5 mg/day
    id
    OG001
    title
    Everolimus Placebo
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
Vinorelbine 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