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NCT01970865 · OUTCOME

Overall Survival (OS) (Phase 1)

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12

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
3 years

What was measured

OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.

Analysis population: The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.

Groups in this outcome

ALK Positive Population (Phase 1)

This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.

ROS1 Positive Population (Phase 1)

This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.

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

Analysis denominator · Participants

GroupSource count
ALK Positive Population (Phase 1)41
ROS1 Positive Population (Phase 1)12

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ALK Positive Population (Phase 1)22.3Not reported11.4NAA large proportion of participants in the analysis set had their OS data censored, and number of participants dead by the cutoff date of this report was small, so it's impossible to derive such summary statistics.
ROS1 Positive Population (Phase 1)NANot reported4.7NAA large proportion of participants in the analysis set had their OS data censored, and number of participants dead by the cutoff date of this report was small, so it's impossible to derive such summary statistics.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        A large proportion of participants in the analysis set had their OS data censored, and number of participants dead by the cutoff date of this report was small, so it's impossible to derive such summary statistics.
        group Id
        OG000
        lower Limit
        11.4
        upper Limit
        NA
        value
        22.3
      2. comment
        A large proportion of participants in the analysis set had their OS data censored, and number of participants dead by the cutoff date of this report was small, so it's impossible to derive such summary statistics.
        group Id
        OG001
        lower Limit
        4.7
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      12
    units
    Participants
description
OS was defined as the time from first dose to the date of death due to any cause. For participants still alive at the time of analysis, the OS time was censored on the last date the participants were known to be alive. Estimates of OS and its 95% confidence interval were determined using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
    id
    OG000
    title
    ALK Positive Population (Phase 1)
  2. description
    This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
    id
    OG001
    title
    ROS1 Positive Population (Phase 1)
param Type
MEDIAN
population Description
The intent-to-treat (ITT) analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.
reporting Status
POSTED
time Frame
3 years
title
Overall Survival (OS) (Phase 1)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice