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NCT00949650 · OUTCOME

Trough Plasma Concentrations of Afatinib at Day 43

BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation · Source last updated 2018-04-06

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL.
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 43.

What was measured

Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.

Analysis population: Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.

Groups in this outcome

Afatinib 20 mg

Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.

Afatinib 30 mg

Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.

Afatinib 40 mg

Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.

Afatinib 50 mg

Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.

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

Analysis denominator · Participants

GroupSource count
Afatinib 20 mg2
Afatinib 30 mg39
Afatinib 40 mg126
Afatinib 50 mg14

Reported measurements

Source class 1
Values in ng/mL. · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Afatinib 20 mg24.4260Not reportedNot reportedNot reported
Afatinib 30 mg24.763.9Not reportedNot reportedNot reported
Afatinib 40 mg23.566.2Not reportedNot reportedNot reported
Afatinib 50 mg27.564.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        260
        value
        24.4
      2. group Id
        OG001
        spread
        63.9
        value
        24.7
      3. group Id
        OG002
        spread
        66.2
        value
        23.5
      4. group Id
        OG003
        spread
        64.4
        value
        27.5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      126
    4. group Id
      OG003
      value
      14
    units
    Participants
description
Trough plasma concentrations of Afatinib at Day 43 (course 3, visit 1) after multiple daily dosing of 40 mg Afatinib and after dose escalation to 50 mg or dose reduction to 30 mg or 20 mg.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Patients received Afatinib monotherapy 20 mg film-coated tablets orally once daily after a dose reduction.
    id
    OG000
    title
    Afatinib 20 mg
  2. description
    Patients received Afatinib monotherapy 30 mg film-coated tablets orally once daily after a dose reduction.
    id
    OG001
    title
    Afatinib 30 mg
  3. description
    Patients received Afatinib monotherapy 40 mg film-coated tablets orally once daily.
    id
    OG002
    title
    Afatinib 40 mg
  4. description
    Patients received Afatinib monotherapy 50 mg film-coated tablets orally once daily after a dose escalation.
    id
    OG003
    title
    Afatinib 50 mg
param Type
GEOMETRIC_MEAN
population Description
Patients from the treated set with evaluable data and who had at least 1 valid Afatinib plasma concentration available on this time point.
reporting Status
POSTED
time Frame
Day 43.
title
Trough Plasma Concentrations of Afatinib at Day 43
type
SECONDARY
unit Of Measure
ng/mL.

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

Preserved source evidence · Not medical advice