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NCT01970865 · OUTCOME

Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Screening (up to 28 days)

What was measured

Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.

Analysis population: Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).

Groups in this outcome

ALK Positive Population (Phase 1)

This reporting arm includes all Phase 1 participants who had documented ALK 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)40

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALK Positive Population (Phase 1)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
Tumor tissues from archived tissue specimens and/or a de novo biopsy were analyzed for ALK kinase domain mutations. Number of participants with one or more ALK mutations is presented.
groups
  1. description
    This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
    id
    OG000
    title
    ALK Positive Population (Phase 1)
param Type
COUNT_OF_PARTICIPANTS
population Description
Tumor Tissue analysis set included all participants of the ITT analysis set who had at least 1 molecular tumor biomarker assayed from either the screening archival or screening de novo tumor biopsy sample (or both).
reporting Status
POSTED
time Frame
Screening (up to 28 days)
title
Number of Participants With ALK Mutation Based on Tumor Tissue Analysis (Phase 1)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice