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NCT01774721 · OUTCOME

Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.03: Biochemistry and Haematology

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. · Source last updated 2023-11-14

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From randomization until death or last date known as alive, up to 61 months

What was measured

Parameters included anaemia, activated partial thromboplastin time, haemoglobin, international normalized ratio, lymphocyte count, lymphopenia, neutrophils (absolute), platelets, prothrombin time and white blood cells. Biochemistry parameters included alanine aminotransferase (increased), alkaline phosphatase (increased), aspartate aminotransferase (increased), bilirubin (total), creatinine (increased), hypercalcaemia, hyperglycaemia, hyperkalaemia, hypermagnesaemia, hypernatraemia, hypoalbuminaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia, hyponatraemia. Test abnormalities were graded by AEs according to the Common Terminology Criteria for Adverse Events(NCI CTCAE) version 4.03 as Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=death related to AE. Only categories with at least 1 participant with abnormality are reported in this outcome measure.

Analysis population: Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.

Groups in this outcome

Dacomitinib

Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.

Gefitinib

Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Dacomitinib227
Gefitinib224

Reported measurements

Anaemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib5Not reportedNot reportedNot reportedNot reported
Gefitinib6Not reportedNot reportedNot reportedNot reported
Haemoglobin increased(Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib0Not reportedNot reportedNot reportedNot reported
Gefitinib1Not reportedNot reportedNot reportedNot reported
Lymphopenia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib13Not reportedNot reportedNot reportedNot reported
Gefitinib6Not reportedNot reportedNot reportedNot reported
Neutrophil count (absolute) (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib0Not reportedNot reportedNot reportedNot reported
Gefitinib2Not reportedNot reportedNot reportedNot reported
WBC count (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib1Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib5Not reportedNot reportedNot reportedNot reported
Gefitinib26Not reportedNot reportedNot reportedNot reported
Alanine aminotransferase increased (Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib0Not reportedNot reportedNot reportedNot reported
Gefitinib3Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib2Not reportedNot reportedNot reportedNot reported
Gefitinib15Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase increased (Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib0Not reportedNot reportedNot reportedNot reported
Gefitinib3Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib2Not reportedNot reportedNot reportedNot reported
Gefitinib5Not reportedNot reportedNot reportedNot reported
Bilirubin increased (total) (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib1Not reportedNot reportedNot reportedNot reported
Creatinine increased (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib1Not reportedNot reportedNot reportedNot reported
Hypercalcemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
Hyperglycemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib2Not reportedNot reportedNot reportedNot reported
Gefitinib5Not reportedNot reportedNot reportedNot reported
Hyperkalemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib0Not reportedNot reportedNot reportedNot reported
Gefitinib1Not reportedNot reportedNot reportedNot reported
Hyperkalemia (Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib0Not reportedNot reportedNot reportedNot reported
Gefitinib2Not reportedNot reportedNot reportedNot reported
Hypermagnesemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib9Not reportedNot reportedNot reportedNot reported
Gefitinib7Not reportedNot reportedNot reportedNot reported
Hypocalcemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib3Not reportedNot reportedNot reportedNot reported
Gefitinib4Not reportedNot reportedNot reportedNot reported
Hypoglycemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib0Not reportedNot reportedNot reportedNot reported
Gefitinib2Not reportedNot reportedNot reportedNot reported
Hypoglycemia (Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
Hypokalemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib13Not reportedNot reportedNot reportedNot reported
Gefitinib5Not reportedNot reportedNot reportedNot reported
Hypokalemia (Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib2Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
Hypomagnesemia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib2Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
Hyponatremia (Grade 3)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib5Not reportedNot reportedNot reportedNot reported
Gefitinib4Not reportedNot reportedNot reportedNot reported
Hyponatremia (Grade 4)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
    title
    Anaemia (Grade 3)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Haemoglobin increased(Grade 3)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        6
    title
    Lymphopenia (Grade 3)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Neutrophil count (absolute) (Grade 3)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    WBC count (Grade 3)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        26
    title
    Alanine aminotransferase increased (Grade 3)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Alanine aminotransferase increased (Grade 4)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        15
    title
    Aspartate aminotransferase increased (Grade 3)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Aspartate aminotransferase increased (Grade 4)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        5
    title
    Alkaline phosphatase increased (Grade 3)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Bilirubin increased (total) (Grade 3)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Creatinine increased (Grade 3)
denoms
  1. counts
    1. group Id
      OG000
      value
      227
    2. group Id
      OG001
      value
      224
    units
    Participants
description
Parameters included anaemia, activated partial thromboplastin time, haemoglobin, international normalized ratio, lymphocyte count, lymphopenia, neutrophils (absolute), platelets, prothrombin time and white blood cells. Biochemistry parameters included alanine aminotransferase (increased), alkaline phosphatase (increased), aspartate aminotransferase (increased), bilirubin (total), creatinine (increased), hypercalcaemia, hyperglycaemia, hyperkalaemia, hypermagnesaemia, hypernatraemia, hypoalbuminaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia, hyponatraemia. Test abnormalities were graded by AEs according to the Common Terminology Criteria for Adverse Events(NCI CTCAE) version 4.03 as Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=death related to AE. Only categories with at least 1 participant with abnormality are reported in this outcome measure.
groups
  1. description
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    id
    OG000
    title
    Dacomitinib
  2. description
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    id
    OG001
    title
    Gefitinib
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
reporting Status
POSTED
time Frame
From randomization until death or last date known as alive, up to 61 months
title
Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.03: Biochemistry and Haematology
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice