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NCT01970865 · OUTCOME

Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)

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
NUMBER
Unit
Probability of events
Interval / dispersion
Not reported
Time frame
From first dose of study treatment until first event of CNS progression (maximum of 7.5 years for Phase 2)

What was measured

Probability of first event being CNS progression, non-CNS progression, or death was evaluated with competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to analysis set. Time to first event being Competing Event (either "CNS progression" or "non CNS progression" or "Death") = time from first dose until date of that specific event. Participants not known to have any of Competing Events were censored on date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as competing cause of failure for analysis of other type of events. For each type of event, cumulative incidence function corresponding to nearest time point preceding 1 year is presented. PD:20% or more increase in SLD of target lesion relative to baseline or smallest SLD (nadir) recorded since first dose. SLD must demonstrate absolute increase of atleast 5mm(\>=5 mm) relative to baseline or smallest SLD (nadir) recorded since first dose.

Analysis population: The ITT analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.

Groups in this outcome

Phase 2 ITT Population

This reporting group includes all Phase 2 participants in the ITT analysis set.

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

Analysis denominator · Participants

GroupSource count
Phase 2 ITT Population274

Reported measurements

CNS progression
Values in Probability of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 ITT Population0.179Not reportedNot reportedNot reportedNot reported
Non CNS progression
Values in Probability of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 ITT Population0.325Not reportedNot reportedNot reportedNot reported
Death
Values in Probability of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2 ITT Population0.055Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.179
    title
    CNS progression
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.325
    title
    Non CNS progression
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0.055
    title
    Death
denoms
  1. counts
    1. group Id
      OG000
      value
      274
    units
    Participants
description
Probability of first event being CNS progression, non-CNS progression, or death was evaluated with competing risk approach by estimating cumulative incidence functions (range: 0-1) relative to analysis set. Time to first event being Competing Event (either "CNS progression" or "non CNS progression" or "Death") = time from first dose until date of that specific event. Participants not known to have any of Competing Events were censored on date they were last assessed for disease status for PFS. Participants who presented one type of event were counted as competing cause of failure for analysis of other type of events. For each type of event, cumulative incidence function corresponding to nearest time point preceding 1 year is presented. PD:20% or more increase in SLD of target lesion relative to baseline or smallest SLD (nadir) recorded since first dose. SLD must demonstrate absolute increase of atleast 5mm(\>=5 mm) relative to baseline or smallest SLD (nadir) recorded since first dose.
groups
  1. description
    This reporting group includes all Phase 2 participants in the ITT analysis set.
    id
    OG000
    title
    Phase 2 ITT Population
param Type
NUMBER
population Description
The ITT analysis set included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922.
reporting Status
POSTED
time Frame
From first dose of study treatment until first event of CNS progression (maximum of 7.5 years for Phase 2)
title
Probability of First Event Being a Central Nervous System (CNS) Progression, Non CNS Progression, or Death (Phase 2)
type
SECONDARY
unit Of Measure
Probability of events

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

Preserved source evidence · Not medical advice