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NCT00302003 · OUTCOME

Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).

Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma · Source last updated 2021-03-30

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

Measure
NUMBER
Unit
Probability of survival
Interval / dispersion
95% Confidence Interval
Time frame
At 60 months

What was measured

Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).

Analysis population: Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).

Groups in this outcome

Group 1

Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim

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

Analysis denominator · Participants

GroupSource count
Group 1275

Reported measurements

Source class 1
Values in Probability of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 10.49Not reported0.420.54Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.42
        upper Limit
        0.54
        value
        0.49
denoms
  1. counts
    1. group Id
      OG000
      value
      275
    units
    Participants
description
Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).
dispersion Type
95% Confidence Interval
groups
  1. description
    Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
    id
    OG000
    title
    Group 1
param Type
NUMBER
population Description
Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).
reporting Status
POSTED
time Frame
At 60 months
title
Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
type
PRIMARY
unit Of Measure
Probability of survival

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

Preserved source evidence · Not medical advice