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NCT01121393 · OUTCOME

Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events

BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) · Source last updated 2018-12-14

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
From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.

What was measured

Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.

Analysis population: The treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.

Groups in this outcome

Afatinib 40 Milligram (mg)

Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.

Gemcitabine / Cisplatin Chemotherapy

Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.

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 40 Milligram (mg)239
Gemcitabine / Cisplatin Chemotherapy113

Reported measurements

CTCAE Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)13.8Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy8.0Not reportedNot reportedNot reportedNot reported
CTCAE Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)36.0Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy29.2Not reportedNot reportedNot reportedNot reported
CTCAE Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)39.3Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy38.1Not reportedNot reportedNot reportedNot reported
CTCAE Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)4.2Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy21.2Not reportedNot reportedNot reportedNot reported
CTCAE Grade 5
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)6.7Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy2.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13.8
      2. group Id
        OG001
        value
        8.0
    title
    CTCAE Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        36.0
      2. group Id
        OG001
        value
        29.2
    title
    CTCAE Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        39.3
      2. group Id
        OG001
        value
        38.1
    title
    CTCAE Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4.2
      2. group Id
        OG001
        value
        21.2
    title
    CTCAE Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6.7
      2. group Id
        OG001
        value
        2.7
    title
    CTCAE Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      239
    2. group Id
      OG001
      value
      113
    units
    Participants
description
Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.
groups
  1. description
    Patients received Afatinib film-coated tablets 40 mg once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction. Each treatment course was planned to be 21 days. For afatinib, patients received continuous daily dosing until disease progression, unacceptable adverse events (AEs) occurred, or withdrawal of consent for any reason.
    id
    OG000
    title
    Afatinib 40 Milligram (mg)
  2. description
    Patients received Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics. For gemcitabine / cisplatin, patients were to receive a maximum of 6 treatment courses unless they developed disease progression, experienced unacceptable AEs, or withdrawal of consent for any reason.
    id
    OG001
    title
    Gemcitabine / Cisplatin Chemotherapy
param Type
NUMBER
population Description
The treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication (i.e. afatinib or gemcitabine / cisplatin). Patients were allocated according to the treatment actually received.
reporting Status
POSTED
time Frame
From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.
title
Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice