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NCT01774721 · OUTCOME

Number of Participants With Laboratory Test Abnormalities: Urinalysis

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

Urinalysis parameter included urine protein, urine blood/haemoglobin, urine glucose and urine sediment. Test abnormalities was defined as deviation from normal range (higher or lower). Normal range of 24-hour urine protein test: less than 150 mg of protein per day, urine glucose: 0 to 0.8 mmol/L (millimole per liter), urine protein: 0 to 20 mg/dL (milligrams per deciliter). Urine blood/haemoglobin abnormality was defined as presence and absence of blood/haemoglobin in urine of participants. Urine sediment abnormality was defined as the presence of any bacteria, casts, crystals, and epithelial cells. 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

High Urine Protein
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib1Not reportedNot reportedNot reportedNot reported
Low Urine Glucose
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib1Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
High Urine Blood/Haemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib4Not reportedNot reportedNot reportedNot reported
Gefitinib4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    High Urine Protein
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Low Urine Glucose
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
    title
    High Urine Blood/Haemoglobin
denoms
  1. counts
    1. group Id
      OG000
      value
      227
    2. group Id
      OG001
      value
      224
    units
    Participants
description
Urinalysis parameter included urine protein, urine blood/haemoglobin, urine glucose and urine sediment. Test abnormalities was defined as deviation from normal range (higher or lower). Normal range of 24-hour urine protein test: less than 150 mg of protein per day, urine glucose: 0 to 0.8 mmol/L (millimole per liter), urine protein: 0 to 20 mg/dL (milligrams per deciliter). Urine blood/haemoglobin abnormality was defined as presence and absence of blood/haemoglobin in urine of participants. Urine sediment abnormality was defined as the presence of any bacteria, casts, crystals, and epithelial cells. 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: Urinalysis
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice