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NCT01121393 · OUTCOME

Changes in Safety Laboratory Parameters

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

Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase. For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented.

Analysis population: Treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated according to the treatment actually received. Patients with a baseline and at least one on-treatment assessment of the parameter are of interest.

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

Potassium CTCAE grade 2

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy109
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)NANot reportedNot reportedNot reportedno corresponding rules defined
Gemcitabine / Cisplatin ChemotherapyNANot reportedNot reportedNot reportedno corresponding rules defined
Potassium CTCAE grade 3

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy109
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)5.1Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy15.6Not reportedNot reportedNot reportedNot reported
Potassium CTCAE grade 4

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy109
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)2.6Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy0.9Not reportedNot reportedNot reportedNot reported
AST CTCAE grade 2

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy107
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)5.1Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy1.9Not reportedNot reportedNot reportedNot reported
AST CTCAE grade 3

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy107
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)1.3Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy1.9Not reportedNot reportedNot reportedNot reported
AST CTCAE grade 4

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy107
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)0.0Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy0.0Not reportedNot reportedNot reportedNot reported
ALT CTCAE grade 2

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy108
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)8.1Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy5.6Not reportedNot reportedNot reportedNot reported
ALT CTCAE grade 3

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy108
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)3.4Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy1.9Not reportedNot reportedNot reportedNot reported
ALT CTCAE grade 4

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy108
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)0.0Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy0.0Not reportedNot reportedNot reportedNot reported
Creatinine CTCAE grade 2

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy109
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)2.1Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy2.8Not reportedNot reportedNot reportedNot reported
Creatinine CTCAE grade 3

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy109
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)0.0Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy0.0Not reportedNot reportedNot reportedNot reported
Creatinine CTCAE grade 4

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)235
Gemcitabine / Cisplatin Chemotherapy109
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)0.0Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy0.0Not reportedNot reportedNot reportedNot reported
Creatinine Kinase CTCAE grade 2

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)216
Gemcitabine / Cisplatin Chemotherapy104
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)3.7Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy1.0Not reportedNot reportedNot reportedNot reported
Creatinine Kinase CTCAE grade 3

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)216
Gemcitabine / Cisplatin Chemotherapy104
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)1.9Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy0.0Not reportedNot reportedNot reportedNot reported
Creatinine Kinase CTCAE grade 4

Analysis denominator · Participants

GroupSource count
Afatinib 40 Milligram (mg)216
Gemcitabine / Cisplatin Chemotherapy104
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Afatinib 40 Milligram (mg)0.0Not reportedNot reportedNot reportedNot reported
Gemcitabine / Cisplatin Chemotherapy0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        no corresponding rules defined
        group Id
        OG000
        value
        NA
      2. comment
        no corresponding rules defined
        group Id
        OG001
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    Potassium CTCAE grade 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5.1
      2. group Id
        OG001
        value
        15.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    Potassium CTCAE grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2.6
      2. group Id
        OG001
        value
        0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    Potassium CTCAE grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5.1
      2. group Id
        OG001
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        107
      units
      Participants
    title
    AST CTCAE grade 2
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1.3
      2. group Id
        OG001
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        107
      units
      Participants
    title
    AST CTCAE grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        107
      units
      Participants
    title
    AST CTCAE grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8.1
      2. group Id
        OG001
        value
        5.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        108
      units
      Participants
    title
    ALT CTCAE grade 2
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3.4
      2. group Id
        OG001
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        108
      units
      Participants
    title
    ALT CTCAE grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        108
      units
      Participants
    title
    ALT CTCAE grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2.1
      2. group Id
        OG001
        value
        2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    Creatinine CTCAE grade 2
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    Creatinine CTCAE grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        109
      units
      Participants
    title
    Creatinine CTCAE grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      239
    2. group Id
      OG001
      value
      113
    units
    Participants
description
Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase. For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented.
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
Treated set (TS) included all randomised patients who were documented to have taken at least 1 dose of study medication. Patients were allocated according to the treatment actually received. Patients with a baseline and at least one on-treatment assessment of the parameter are of interest.
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
Changes in Safety Laboratory Parameters
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice