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NCT01774721 · OUTCOME

Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)

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

ECG parameters included corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria for abnormality: absolute value 450 - \<480 msec, 480 - \<500 msec, \>=500msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.

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. Here, "N" (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.

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
Dacomitinib217
Gefitinib7

Reported measurements

QTcF Criteria: 450-<480
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib5Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
QTcB Criteria: 450-<480
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib22Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
QTcB Criteria: 480-<500
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib3Not reportedNot reportedNot reportedNot reported
Gefitinib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    title
    QTcF Criteria: 450-<480
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        0
    title
    QTcB Criteria: 450-<480
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    QTcB Criteria: 480-<500
denoms
  1. counts
    1. group Id
      OG000
      value
      217
    2. group Id
      OG001
      value
      7
    units
    Participants
description
ECG parameters included corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria for abnormality: absolute value 450 - \<480 msec, 480 - \<500 msec, \>=500msec. The number of participants with potentially clinically significant ECG findings at any visit were reported.
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. Here, "N" (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.
reporting Status
POSTED
time Frame
From randomization until death or last date known as alive, up to 61 months
title
Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice