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NCT00025259 · OUTCOME

Disease Response Assessed by Modified RECIST Criteria

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
Number of participants
Interval / dispersion
Not reported
Time frame
Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.

What was measured

Number of participants with complete response and very good partial response at the end of protocol therapy.

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 Number of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Patients Off-therapy Before Callback-Induction Only)5Not reportedNot reportedNot reportedNot reported
Arm II (RER With CR [ABVE-PC, IFRT])370Not reportedNot reportedNot reportedNot reported
Arm III (RER With CR [ABVE-PC])380Not reportedNot reportedNot reportedNot reported
Arm IV (RER With Less Than CR [ABVE-PC, IFRT])538Not reportedNot reportedNot reportedNot reported
Arm V (RER With PD)29Not reportedNot reportedNot reportedNot reported
Arm VI (SER [DECA, ABVE-PC, IFRT])105Not reportedNot reportedNot reportedNot reported
Arm VII (SER [ABVE-PC, IFRT])100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        370
      3. group Id
        OG002
        value
        380
      4. group Id
        OG003
        value
        538
      5. group Id
        OG004
        value
        29
      6. group Id
        OG005
        value
        105
      7. group Id
        OG006
        value
        100
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
Number of participants with complete response and very good partial response at the end of protocol therapy.
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
Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
title
Disease Response Assessed by Modified RECIST Criteria
type
SECONDARY
unit Of Measure
Number of participants

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Preserved source evidence · Not medical advice