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NCT01774721 · OUTCOME

OS at 30 Months (OS30m)

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
NUMBER
Unit
probability of survival
Interval / dispersion
95% Confidence Interval
Time frame
Up to 30 months from date of randomization

What was measured

OS30m was defined as the probability of a participant being alive at 30 months from date of randomization.

Analysis population: ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

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, for 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
Gefitinib225

Reported measurements

Source class 1
Values in probability of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dacomitinib56.4Not reported49.662.7Not reported
Gefitinib45.7Not reported39.052.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.6
        upper Limit
        62.7
        value
        56.4
      2. group Id
        OG001
        lower Limit
        39.0
        upper Limit
        52.2
        value
        45.7
denoms
  1. counts
    1. group Id
      OG000
      value
      227
    2. group Id
      OG001
      value
      225
    units
    Participants
description
OS30m was defined as the probability of a participant being alive at 30 months from date of randomization.
dispersion Type
95% Confidence Interval
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, for 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
NUMBER
population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
reporting Status
POSTED
time Frame
Up to 30 months from date of randomization
title
OS at 30 Months (OS30m)
type
SECONDARY
unit Of Measure
probability of survival

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

Preserved source evidence · Not medical advice