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NCT02717455 · OUTCOME

Percentage of Patients With H3F3A K27M Mutation Detected in Blood Samples

Trial of Panobinostat in Children With Diffuse Intrinsic Pontine Glioma · Source last updated 2024-04-25

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Blood samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1.

What was measured

Cell-free DNA based assay was used to determine whether H3F3A K27M mutation could be detected in patients' blood samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point.

Analysis population: Only patients with cell-free DNA assay results available from blood samples were included in this analysis. Per the statistical section in the protocol, percentage of patients in whom the mutation was detected was summarized within each stratum and at each time point.

Groups in this outcome

Stratum 1

Recurrent or progressive DIPG patients who were treated with the "3 times/week, three weeks on, one week off" schedule

Stratum 2

Non-progressed DIPG or H3K27M+ thalamic DMG patients who were treated with the "3 times/week, every other week" schedule

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

Analysis denominator · Participants

GroupSource count
Stratum 115
Stratum 218

Reported measurements

Course 1 Day 1

Analysis denominator · Participants

GroupSource count
Stratum 115
Stratum 217
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 10Not reportedNot reportedNot reportedNot reported
Stratum 25.9Not reportedNot reportedNot reportedNot reported
Course 2 Day 1

Analysis denominator · Participants

GroupSource count
Stratum 111
Stratum 213
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 10Not reportedNot reportedNot reportedNot reported
Stratum 223.1Not reportedNot reportedNot reportedNot reported
Course 4 Day 1

Analysis denominator · Participants

GroupSource count
Stratum 14
Stratum 28
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 125.0Not reportedNot reportedNot reportedNot reported
Stratum 20Not reportedNot reportedNot reportedNot reported
Course 6 Day 1

Analysis denominator · Participants

GroupSource count
Stratum 10
Stratum 25
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 220.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Course 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        23.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        13
      units
      Participants
    title
    Course 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25.0
      2. group Id
        OG001
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Course 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG001
        value
        20.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Course 6 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Cell-free DNA based assay was used to determine whether H3F3A K27M mutation could be detected in patients' blood samples. Percentage of patients in whom this mutation was detected was summarized within each stratum and at each time point.
groups
  1. description
    Recurrent or progressive DIPG patients who were treated with the "3 times/week, three weeks on, one week off" schedule
    id
    OG000
    title
    Stratum 1
  2. description
    Non-progressed DIPG or H3K27M+ thalamic DMG patients who were treated with the "3 times/week, every other week" schedule
    id
    OG001
    title
    Stratum 2
param Type
NUMBER
population Description
Only patients with cell-free DNA assay results available from blood samples were included in this analysis. Per the statistical section in the protocol, percentage of patients in whom the mutation was detected was summarized within each stratum and at each time point.
reporting Status
POSTED
time Frame
Blood samples were collected for cell-free DNA based assay at Course 1 Day 1 (C1D1), C2D1, C4D1, and C6D1.
title
Percentage of Patients With H3F3A K27M Mutation Detected in Blood Samples
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice