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NCT01182350 · OUTCOME

Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate

Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) · Source last updated 2019-09-04

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
90% Confidence Interval
Time frame
2 weeks

What was measured

Grade 3-4 post-procedural surgery-related toxicity rate is the percentage of participants experiencing at least one grade 3-4 adverse event (AE) during the post-procedural time frame of 14 days attributable to the surgical procedure based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4).

Analysis population: The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.

Groups in this outcome

All Biopsied Participants

Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).

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

Analysis denominator · Participants

GroupSource count
All Biopsied Participants50

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
All Biopsied Participants10.0Not reported4.119.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        19.9
        value
        10.0
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
Grade 3-4 post-procedural surgery-related toxicity rate is the percentage of participants experiencing at least one grade 3-4 adverse event (AE) during the post-procedural time frame of 14 days attributable to the surgical procedure based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4).
dispersion Type
90% Confidence Interval
groups
  1. description
    Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days). Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
    id
    OG000
    title
    All Biopsied Participants
param Type
NUMBER
population Description
The analysis dataset is comprised of all enrolled participants who underwent stereotactic biopsy.
reporting Status
POSTED
time Frame
2 weeks
title
Grade 3-4 Post-Procedural Surgery-Related Toxicity Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice