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NCT00025259 · OUTCOME

Event-free Survival

Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease · Source last updated 2017-04-12

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
5 years

What was measured

Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.

Analysis population: Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).

Groups in this outcome

Arm I (Patients Off-therapy Before Callback-Induction Only)

All patients-off therapy before callback-Induction only

Arm II (RER With CR [ABVE-PC, IFRT])

RER with Complete Response - IFRT (Standard Arm)

Arm III (RER With CR [ABVE-PC])

RER with Complete Response - no IFRT (Reduced Therapy Arm)

Arm IV (RER With Less Than CR [ABVE-PC, IFRT])

RER with less than Complete Response - IFRT

Arm V (RER With PD)

RER with Progressive Disease - Off Therapy

Arm VI (SER [DECA, ABVE-PC, IFRT])

SER - randomized to DECAX2 + ABVE-PCX2 + IFRT

Arm VII (SER [ABVE-PC, IFRT])

SER - randomized to ABVE-PCX2 + IFRT

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

Analysis denominator · Participants

GroupSource count
Arm I (Patients Off-therapy Before Callback-Induction Only)38
Arm II (RER With CR [ABVE-PC, IFRT])380
Arm III (RER With CR [ABVE-PC])382
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])571
Arm V (RER With PD)36
Arm VI (SER [DECA, ABVE-PC, IFRT])153
Arm VII (SER [ABVE-PC, IFRT])152

Reported measurements

Source class 1
Values in Probability of survival · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Patients Off-therapy Before Callback-Induction Only)0.89Not reported0.690.96Not reported
Arm II (RER With CR [ABVE-PC, IFRT])0.87Not reported0.830.90Not reported
Arm III (RER With CR [ABVE-PC])0.84Not reported0.800.87Not reported
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])0.87Not reported0.830.89Not reported
Arm V (RER With PD)0.70Not reported0.510.82Not reported
Arm VI (SER [DECA, ABVE-PC, IFRT])0.79Not reported0.710.85Not reported
Arm VII (SER [ABVE-PC, IFRT])0.74Not reported0.660.80Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.69
        upper Limit
        0.96
        value
        0.89
      2. group Id
        OG001
        lower Limit
        0.83
        upper Limit
        0.90
        value
        0.87
      3. group Id
        OG002
        lower Limit
        0.80
        upper Limit
        0.87
        value
        0.84
      4. group Id
        OG003
        lower Limit
        0.83
        upper Limit
        0.89
        value
        0.87
      5. group Id
        OG004
        lower Limit
        0.51
        upper Limit
        0.82
        value
        0.70
      6. group Id
        OG005
        lower Limit
        0.71
        upper Limit
        0.85
        value
        0.79
      7. group Id
        OG006
        lower Limit
        0.66
        upper Limit
        0.80
        value
        0.74
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      380
    3. group Id
      OG002
      value
      382
    4. group Id
      OG003
      value
      571
    5. group Id
      OG004
      value
      36
    6. group Id
      OG005
      value
      153
    7. group Id
      OG006
      value
      152
    units
    Participants
description
Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients-off therapy before callback-Induction only
    id
    OG000
    title
    Arm I (Patients Off-therapy Before Callback-Induction Only)
  2. description
    RER with Complete Response - IFRT (Standard Arm)
    id
    OG001
    title
    Arm II (RER With CR [ABVE-PC, IFRT])
  3. description
    RER with Complete Response - no IFRT (Reduced Therapy Arm)
    id
    OG002
    title
    Arm III (RER With CR [ABVE-PC])
  4. description
    RER with less than Complete Response - IFRT
    id
    OG003
    title
    Arm IV (RER With Less Than CR [ABVE-PC, IFRT])
  5. description
    RER with Progressive Disease - Off Therapy
    id
    OG004
    title
    Arm V (RER With PD)
  6. description
    SER - randomized to DECAX2 + ABVE-PCX2 + IFRT
    id
    OG005
    title
    Arm VI (SER [DECA, ABVE-PC, IFRT])
  7. description
    SER - randomized to ABVE-PCX2 + IFRT
    id
    OG006
    title
    Arm VII (SER [ABVE-PC, IFRT])
param Type
NUMBER
population Description
Eligible participants are analyzed and ineligible participants (n=22) are excluded from Arms I (n=14), II (n=1), III (n=0), IV (n=6), V (n=0), VI (n=1), and VII (n=0).
reporting Status
POSTED
time Frame
5 years
title
Event-free Survival
type
PRIMARY
unit Of Measure
Probability of survival

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Preserved source evidence · Not medical advice