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NCT02612194 · OUTCOME

Overall Survival

LCI-GU-URO-CRI-001: Crizotinib in Patients With c-MET or RON-Positive Metastatic Urothelial Cancer · Source last updated 2022-11-03

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of treatment start to date of death, or censored as described above; assessed for approximately 2 years.

What was measured

Overall survival was defined as the duration from enrollment date to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.

Analysis population: Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.

Groups in this outcome

Total Enrolled Study Cohort

This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.

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

Analysis denominator · Participants

GroupSource count
Total Enrolled Study Cohort8

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Total Enrolled Study Cohort3.1Not reported0.26.1Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.1
    estimate Comment
    The Kaplan Meier method was used to estimate the median OS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.
    group Ids
    1. OG000
    non Inferiority Comment
    Estimation only
    non Inferiority Type
    OTHER
    param Type
    Median
    param Value
    3.1
Complete source fields
analyses
  1. ci Lower Limit
    0.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.1
    estimate Comment
    The Kaplan Meier method was used to estimate the median OS (in months) for the population. The Greenwood method was used to estimate the confidence limits of the median overall survival.
    group Ids
    1. OG000
    non Inferiority Comment
    Estimation only
    non Inferiority Type
    OTHER
    param Type
    Median
    param Value
    3.1
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        6.1
        value
        3.1
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Overall survival was defined as the duration from enrollment date to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    This group contains all subjects enrolled on the study, who received crizotinib, pooling the subjects in the three molecularly defined cohorts.
    id
    OG000
    title
    Total Enrolled Study Cohort
param Type
MEDIAN
population Description
Study was designed to evaluate outcomes overall for all enrolled subjects and not separately by molecular cohorts. Efficacy analyses were conducted on the population of subjects who began crizotinib treatment.
reporting Status
POSTED
time Frame
From date of treatment start to date of death, or censored as described above; assessed for approximately 2 years.
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice