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NCT00949650 · OUTCOME

Trough Plasma Concentrations of Afatinib at Day 29

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 29.

What was measured

Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) 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 mg0
Afatinib 30 mg25
Afatinib 40 mg143
Afatinib 50 mg16

Reported measurements

Source class 1
Values in ng/mL. · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Afatinib 30 mg28.082.4Not reportedNot reportedNot reported
Afatinib 40 mg25.869.5Not reportedNot reportedNot reported
Afatinib 50 mg29.679.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        spread
        82.4
        value
        28.0
      2. group Id
        OG002
        spread
        69.5
        value
        25.8
      3. group Id
        OG003
        spread
        79.2
        value
        29.6
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      143
    4. group Id
      OG003
      value
      16
    units
    Participants
description
Trough plasma concentrations of Afatinib at day 29 (course 2, visit 2) 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 29.
title
Trough Plasma Concentrations of Afatinib at Day 29
type
SECONDARY
unit Of Measure
ng/mL.

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

Preserved source evidence · Not medical advice