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NCT02395666 · OUTCOME

Number of Participants With Event Free Survival (EFS) During Study.

Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission · Source last updated 2024-08-06

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

Measure
MEAN
Unit
percentage of subjects without an event
Interval / dispersion
95% Confidence Interval
Time frame
2 Years

What was measured

To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)

Analysis population: One subject removed from Stratum 1 due to not fitting study criteria upon review

Groups in this outcome

Stratum 1

Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.

Stratum 2

Subjects that are in remission after any previous relapse or refractory therapy. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.

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 1100
Stratum 239

Reported measurements

Source class 1
Values in percentage of subjects without an event · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stratum 184Not reported8088Not reported
Stratum 251Not reported4359Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80
        upper Limit
        88
        value
        84
      2. group Id
        OG001
        lower Limit
        43
        upper Limit
        59
        value
        51
denoms
  1. counts
    1. group Id
      OG000
      value
      100
    2. group Id
      OG001
      value
      39
    units
    Participants
description
To evaluate the preventative activity of DFMO as a single agent in patients that are in remission based on: Event free survival (EFS)
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects that are in remission at the end of upfront therapy defined as chemotherapy (5-7 cycles), surgery as indicated, consolidation therapy as indicated, radiation therapy as indicated, anti-GD2 antibody therapy with retinoic acid up to 6 cycles. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
    id
    OG000
    title
    Stratum 1
  2. description
    Subjects that are in remission after any previous relapse or refractory therapy. Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
    id
    OG001
    title
    Stratum 2
param Type
MEAN
population Description
One subject removed from Stratum 1 due to not fitting study criteria upon review
reporting Status
POSTED
time Frame
2 Years
title
Number of Participants With Event Free Survival (EFS) During Study.
type
PRIMARY
unit Of Measure
percentage of subjects without an event

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

Preserved source evidence · Not medical advice