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NCT01920932 · OUTCOME

To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0)

Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma · Source last updated 2026-05-06

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

Measure: MEAN
Unit: score on a scale
Interval / dispersion: Standard Deviation
Time frame: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)

What was measured

Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.

Analysis population: Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient.

Groups in this outcome

AEPA/CAPDac

Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants received 2 cycles of AEPE/CAPDac chemotherapy and reported symptoms distress scale (SDS).

HOD99 Unfavorable Risk 2 Arm (UR2)

Ann Arbor stage IIB, IIIB, or any IV risk participants received 12 weeks Stanford V Chemotherapy

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

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	77
HOD99 Unfavorable Risk 2 Arm (UR2)	146

Reported measurements

PedsQL v.4.0 Total Score-T1

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	63
HOD99 Unfavorable Risk 2 Arm (UR2)	78

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	72.94	17.63	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	72.48	17.37	Not reported	Not reported	Not reported

PedsQL v.4.0 Total Score-T2

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	62
HOD99 Unfavorable Risk 2 Arm (UR2)	76

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	79.38	17.43	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	73.54	16.71	Not reported	Not reported	Not reported

PedsQL v.4.0 Total Score-T3

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	58
HOD99 Unfavorable Risk 2 Arm (UR2)	70

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	80.39	14.96	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	77.68	17.25	Not reported	Not reported	Not reported

PedsQL v.4.0 Total Score-T4

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	52
HOD99 Unfavorable Risk 2 Arm (UR2)	59

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	86.06	14.53	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	84.58	15.02	Not reported	Not reported	Not reported

PedsQL v.4.0 Physical Functioning-T1

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	63
HOD99 Unfavorable Risk 2 Arm (UR2)	85

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	69.54	21.78	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	70.41	26.09	Not reported	Not reported	Not reported

PedsQL v.4.0 Physical Functioning-T2

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	62
HOD99 Unfavorable Risk 2 Arm (UR2)	88

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	73.86	24.14	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	70.06	22.73	Not reported	Not reported	Not reported

PedsQL v.4.0 Physical Functioning-T3

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	58
HOD99 Unfavorable Risk 2 Arm (UR2)	79

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	74.02	22.13	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	72.94	25.25	Not reported	Not reported	Not reported

PedsQL v.4.0 Physical Functioning-T4

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	52
HOD99 Unfavorable Risk 2 Arm (UR2)	66

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	82.45	23.24	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	83.57	18.86	Not reported	Not reported	Not reported

PedsQL v.4.0 Emotional Functioning-T1

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	63
HOD99 Unfavorable Risk 2 Arm (UR2)	85

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	71.75	24.38	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	67.18	18.25	Not reported	Not reported	Not reported

PedsQL v.4.0 Emotional Functioning-T2

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	62
HOD99 Unfavorable Risk 2 Arm (UR2)	88

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	83.06	16.63	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	71.31	20.96	Not reported	Not reported	Not reported

PedsQL v.4.0 Emotional Functioning-T3

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	58
HOD99 Unfavorable Risk 2 Arm (UR2)	79

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	82.07	18.43	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	75.06	22.38	Not reported	Not reported	Not reported

PedsQL v.4.0 Emotional Functioning-T4

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	52
HOD99 Unfavorable Risk 2 Arm (UR2)	66

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	84.81	19.75	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	80.87	20.63	Not reported	Not reported	Not reported

PedsQL v.4.0 Social Functioning-T1

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	63
HOD99 Unfavorable Risk 2 Arm (UR2)	85

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	86.21	17.05	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	86.22	17.69	Not reported	Not reported	Not reported

PedsQL v.4.0 Social Functioning-T2

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	62
HOD99 Unfavorable Risk 2 Arm (UR2)	88

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	88.47	15.85	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	86.82	15.42	Not reported	Not reported	Not reported

PedsQL v.4.0 Social Functioning-T3

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	58
HOD99 Unfavorable Risk 2 Arm (UR2)	79

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	90.22	12.41	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	88.86	13.84	Not reported	Not reported	Not reported

PedsQL v.4.0 Social Functioning-T4

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	52
HOD99 Unfavorable Risk 2 Arm (UR2)	66

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	92.31	11.57	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	91.44	14.35	Not reported	Not reported	Not reported

PedsQL v.4.0 School Functioning-T1

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	61
HOD99 Unfavorable Risk 2 Arm (UR2)	78

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	65.49	22.72	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	67.82	19.65	Not reported	Not reported	Not reported

PedsQL v.4.0 School Functioning-T2

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	61
HOD99 Unfavorable Risk 2 Arm (UR2)	76

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	75.66	24.66	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	66.91	21.79	Not reported	Not reported	Not reported

PedsQL v.4.0 School Functioning-T3

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	56
HOD99 Unfavorable Risk 2 Arm (UR2)	70

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	79.2	21.49	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	69.1	24.27	Not reported	Not reported	Not reported

PedsQL v.4.0 School Functioning-T4

Analysis denominator · Participants

Group	Source count
AEPA/CAPDac	50
HOD99 Unfavorable Risk 2 Arm (UR2)	59

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
AEPA/CAPDac	86.9	18.62	Not reported	Not reported	Not reported
HOD99 Unfavorable Risk 2 Arm (UR2)	79.32	17.77	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Description
PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.975
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.032
statistical Method
t-test, 2 sided
group Description
PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.497
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.399
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.451
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.198
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.967
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.647
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.145
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<.001
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.073
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.156
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

group Description
PedsQL v.4.0 Total Score-T1, At Diagnosis (baseline)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.975
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Total Score-T2, completion of 2 cycles of chemotherapy (approximately 2 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.032
statistical Method
t-test, 2 sided
group Description
PedsQL v.4.0 Total Score-T3, completion of 4 cycles of chemotherapy (approximately 4 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.497
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Total Score-T4, completion of radiation (approximately 8 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.399
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T1, At Diagnosis (baseline)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.451
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.198
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.967
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Physical Functioning-T4, completion of radiation (approximately 8 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.647
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T1, At Diagnosis (baseline)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.145
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T2, completion of 2 cycles of chemotherapy (approximately 2 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<.001
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T3, completion of 4 cycles of chemotherapy (approximately 4 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.073
statistical Method
Wilcoxon (Mann-Whitney)
group Description
PedsQL v.4.0 Emotional Functioning-T4, completion of radiation (approximately 8 months)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.156
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
spread
17.63
value
72.94
group Id
OG001
spread
17.37
value
72.48
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
78
units
Participants
title
PedsQL v.4.0 Total Score-T1
categories
measurements
group Id
OG000
spread
17.43
value
79.38
group Id
OG001
spread
16.71
value
73.54
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
76
units
Participants
title
PedsQL v.4.0 Total Score-T2
categories
measurements
group Id
OG000
spread
14.96
value
80.39
group Id
OG001
spread
17.25
value
77.68
denoms
counts
group Id
OG000
value
58
group Id
OG001
value
70
units
Participants
title
PedsQL v.4.0 Total Score-T3
categories
measurements
group Id
OG000
spread
14.53
value
86.06
group Id
OG001
spread
15.02
value
84.58
denoms
counts
group Id
OG000
value
52
group Id
OG001
value
59
units
Participants
title
PedsQL v.4.0 Total Score-T4
categories
measurements
group Id
OG000
spread
21.78
value
69.54
group Id
OG001
spread
26.09
value
70.41
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
85
units
Participants
title
PedsQL v.4.0 Physical Functioning-T1
categories
measurements
group Id
OG000
spread
24.14
value
73.86
group Id
OG001
spread
22.73
value
70.06
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
88
units
Participants
title
PedsQL v.4.0 Physical Functioning-T2
categories
measurements
group Id
OG000
spread
22.13
value
74.02
group Id
OG001
spread
25.25
value
72.94
denoms
counts
group Id
OG000
value
58
group Id
OG001
value
79
units
Participants
title
PedsQL v.4.0 Physical Functioning-T3
categories
measurements
group Id
OG000
spread
23.24
value
82.45
group Id
OG001
spread
18.86
value
83.57
denoms
counts
group Id
OG000
value
52
group Id
OG001
value
66
units
Participants
title
PedsQL v.4.0 Physical Functioning-T4
categories
measurements
group Id
OG000
spread
24.38
value
71.75
group Id
OG001
spread
18.25
value
67.18
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
85
units
Participants
title
PedsQL v.4.0 Emotional Functioning-T1
categories
measurements
group Id
OG000
spread
16.63
value
83.06
group Id
OG001
spread
20.96
value
71.31
denoms
counts
group Id
OG000
value
62
group Id
OG001
value
88
units
Participants
title
PedsQL v.4.0 Emotional Functioning-T2
categories
measurements
group Id
OG000
spread
18.43
value
82.07
group Id
OG001
spread
22.38
value
75.06
denoms
counts
group Id
OG000
value
58
group Id
OG001
value
79
units
Participants
title
PedsQL v.4.0 Emotional Functioning-T3
categories
measurements
group Id
OG000
spread
19.75
value
84.81
group Id
OG001
spread
20.63
value
80.87
denoms
counts
group Id
OG000
value
52
group Id
OG001
value
66
units
Participants
title
PedsQL v.4.0 Emotional Functioning-T4

denoms

counts
group Id
OG000
value
77
group Id
OG001
value
146
units
Participants

description

Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.

dispersion Type

Standard Deviation

groups

description
Ann Arbor stage IIB, IIIB, IVA, or IVB risk participants received 2 cycles of AEPE/CAPDac chemotherapy and reported symptoms distress scale (SDS).
id
OG000
title
AEPA/CAPDac
description
Ann Arbor stage IIB, IIIB, or any IV risk participants received 12 weeks Stanford V Chemotherapy
id
OG001
title
HOD99 Unfavorable Risk 2 Arm (UR2)

param Type

MEAN

population Description

Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient.

reporting Status

POSTED

time Frame

At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)

title

To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0)

type

SECONDARY

unit Of Measure

score on a scale

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Preserved source evidence · Not medical advice