Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01154140 · OUTCOME

Overall Survival Probability at Month 12 and 18

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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

Measure
NUMBER
Unit
percent probability
Interval / dispersion
95% Confidence Interval
Time frame
Month 12, 18

What was measured

Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.

Analysis population: The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.

Groups in this outcome

Crizotinib

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

Chemotherapy

Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.

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

Analysis denominator · Participants

GroupSource count
Crizotinib172
Chemotherapy171

Reported measurements

Month 12
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Crizotinib83.5Not reported77.088.3Not reported
Chemotherapy78.4Not reported71.383.9Not reported
Month 18
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Crizotinib71.5Not reported64.077.7Not reported
Chemotherapy66.6Not reported58.873.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.0
        upper Limit
        88.3
        value
        83.5
      2. group Id
        OG001
        lower Limit
        71.3
        upper Limit
        83.9
        value
        78.4
    title
    Month 12
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.0
        upper Limit
        77.7
        value
        71.5
      2. group Id
        OG001
        lower Limit
        58.8
        upper Limit
        73.2
        value
        66.6
    title
    Month 18
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    2. group Id
      OG001
      value
      171
    units
    Participants
description
Overall survival probability at Month 12 and 18 was defined as the probability of overall survival at 12 and 18 months respectively, where the OS was defined as the duration from date of randomization to date of death due to any cause. The survival probability was estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
    id
    OG000
    title
    Crizotinib
  2. description
    Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
    id
    OG001
    title
    Chemotherapy
param Type
NUMBER
population Description
The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.
reporting Status
POSTED
time Frame
Month 12, 18
title
Overall Survival Probability at Month 12 and 18
type
SECONDARY
unit Of Measure
percent probability

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

Preserved source evidence · Not medical advice