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NCT00525148 · OUTCOME

Safety of BIBW 2992 as Indicated by Intensity and Incidence of Worst Adverse Events Graded According to NCI CTCAE Version 3.0

LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations · Source last updated 2016-09-16

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.

What was measured

Safety of afatinib as indicated by intensity and incidence of worst adverse events graded according to National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) Version 3.0 (R04-0474).

Analysis population: Treated set

Groups in this outcome

BIBW 40mg

Subjects receiving starting doses 40 mg of Afatinib daily.

BIBW 50mg

Subjects receiving starting doses 50 mg of Afatinib daily.

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

Analysis denominator · Participants

GroupSource count
BIBW 40mg30
BIBW 50mg99

Reported measurements

Grade 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BIBW 40mg3.3Not reportedNot reportedNot reportedNot reported
BIBW 50mg1.0Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BIBW 40mg36.7Not reportedNot reportedNot reportedNot reported
BIBW 50mg25.3Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BIBW 40mg46.7Not reportedNot reportedNot reportedNot reported
BIBW 50mg57.6Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BIBW 40mg6.7Not reportedNot reportedNot reportedNot reported
BIBW 50mg3.0Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BIBW 40mg6.7Not reportedNot reportedNot reportedNot reported
BIBW 50mg12.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3.3
      2. group Id
        OG001
        value
        1.0
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        36.7
      2. group Id
        OG001
        value
        25.3
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        46.7
      2. group Id
        OG001
        value
        57.6
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6.7
      2. group Id
        OG001
        value
        3.0
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6.7
      2. group Id
        OG001
        value
        12.1
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      99
    units
    Participants
description
Safety of afatinib as indicated by intensity and incidence of worst adverse events graded according to National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) Version 3.0 (R04-0474).
groups
  1. description
    Subjects receiving starting doses 40 mg of Afatinib daily.
    id
    OG000
    title
    BIBW 40mg
  2. description
    Subjects receiving starting doses 50 mg of Afatinib daily.
    id
    OG001
    title
    BIBW 50mg
param Type
NUMBER
population Description
Treated set
reporting Status
POSTED
time Frame
First administration of trial medication until 28 days after last administration of trial medication, up to 93 months.
title
Safety of BIBW 2992 as Indicated by Intensity and Incidence of Worst Adverse Events Graded According to NCI CTCAE Version 3.0
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice