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NCT00932893 · OUTCOME

Overall Survival Probability at Months 6 and 12

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

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

Measure
NUMBER
Unit
percent chance of survival
Interval / dispersion
95% Confidence Interval
Time frame
Month 6, 12

What was measured

Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.

Analysis population: FAS included all participants who were randomized to study treatment.

Groups in this outcome

Crizotinib

Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

Chemotherapy

Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

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

Analysis denominator · Participants

GroupSource count
Crizotinib173
Chemotherapy174

Reported measurements

Month 6
Values in percent chance of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Crizotinib86.6Not reported80.590.9Not reported
Chemotherapy83.8Not reported77.488.5Not reported
Month 12
Values in percent chance of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Crizotinib70.4Not reported62.976.7Not reported
Chemotherapy66.7Not reported59.173.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80.5
        upper Limit
        90.9
        value
        86.6
      2. group Id
        OG001
        lower Limit
        77.4
        upper Limit
        88.5
        value
        83.8
    title
    Month 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.9
        upper Limit
        76.7
        value
        70.4
      2. group Id
        OG001
        lower Limit
        59.1
        upper Limit
        73.2
        value
        66.7
    title
    Month 12
denoms
  1. counts
    1. group Id
      OG000
      value
      173
    2. group Id
      OG001
      value
      174
    units
    Participants
description
Overall survival probability at Month 6 and 12 was defined as the probability of survival at 6 and 12 months respectively, after the randomization of study treatment. The survival probability was estimated using the Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
    id
    OG000
    title
    Crizotinib
  2. description
    Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
    id
    OG001
    title
    Chemotherapy
param Type
NUMBER
population Description
FAS included all participants who were randomized to study treatment.
reporting Status
POSTED
time Frame
Month 6, 12
title
Overall Survival Probability at Months 6 and 12
type
SECONDARY
unit Of Measure
percent chance of survival

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

Preserved source evidence · Not medical advice