NCT01712490 · OUTCOME
Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT
A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma · Source last updated 2026-02-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline up to end of treatment (approximately 1 year)
What was measured
EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=very poor \[worst\] to 7= excellent \[best\]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by \>=50% of previously involved sites from nadir.
Analysis population: The ITT population included all participants randomized to treatment.
Groups in this outcome
A+AVD
Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
ABVD
Doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
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 |
|---|
| A+AVD | 664 |
|---|
| ABVD | 670 |
|---|
Reported measurements
Baseline: With mPFS event
Analysis denominator · Participants
| Group | Source count |
|---|
| A+AVD | 115 |
|---|
| ABVD | 143 |
|---|
Values in units on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+AVD | 78.15 | 16.527 | Not reported | Not reported | Not reported |
|---|
| ABVD | 76.68 | 18.661 | Not reported | Not reported | Not reported |
|---|
Without mPFS event
Analysis denominator · Participants
| Group | Source count |
|---|
| A+AVD | 533 |
|---|
| ABVD | 508 |
|---|
Values in units on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+AVD | 79.85 | 16.648 | Not reported | Not reported | Not reported |
|---|
| ABVD | 79.91 | 16.218 | Not reported | Not reported | Not reported |
|---|
Change at end of treatment: with mPFS event
Analysis denominator · Participants
| Group | Source count |
|---|
| A+AVD | 91 |
|---|
| ABVD | 112 |
|---|
Values in units on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+AVD | 2.68 | 15.434 | Not reported | Not reported | Not reported |
|---|
| ABVD | 8.58 | 17.848 | Not reported | Not reported | Not reported |
|---|
Change at end of treatment: without mPFS event
Analysis denominator · Participants
| Group | Source count |
|---|
| A+AVD | 475 |
|---|
| ABVD | 452 |
|---|
Values in units on scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+AVD | 3.35 | 17.417 | Not reported | Not reported | Not reported |
|---|
| ABVD | 6.08 | 16.141 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 16.527
- value
- 78.15
- group Id
- OG001
- spread
- 18.661
- value
- 76.68
- denoms
- counts
- group Id
- OG000
- value
- 115
- group Id
- OG001
- value
- 143
- units
- Participants
- title
- Baseline: With mPFS event
- categories
- measurements
- group Id
- OG000
- spread
- 16.648
- value
- 79.85
- group Id
- OG001
- spread
- 16.218
- value
- 79.91
- denoms
- counts
- group Id
- OG000
- value
- 533
- group Id
- OG001
- value
- 508
- units
- Participants
- title
- Without mPFS event
- categories
- measurements
- group Id
- OG000
- spread
- 15.434
- value
- 2.68
- group Id
- OG001
- spread
- 17.848
- value
- 8.58
- denoms
- counts
- group Id
- OG000
- value
- 91
- group Id
- OG001
- value
- 112
- units
- Participants
- title
- Change at end of treatment: with mPFS event
- categories
- measurements
- group Id
- OG000
- spread
- 17.417
- value
- 3.35
- group Id
- OG001
- spread
- 16.141
- value
- 6.08
- denoms
- counts
- group Id
- OG000
- value
- 475
- group Id
- OG001
- value
- 452
- units
- Participants
- title
- Change at end of treatment: without mPFS event
- denoms
- counts
- group Id
- OG000
- value
- 664
- group Id
- OG001
- value
- 670
- units
- Participants
- description
- EORTC QLQ-C30 included 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. It has 28 questions (4-point scale where 1=not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=very poor \[worst\] to 7= excellent \[best\]). Raw scores were converted into scale scores from 0 to 100. For functional scales and global health status/QOL scale, higher scores show better QOL; for symptom scales, lower scores show better QOL. mPFS was time from date of randomization to date of first of documentation of PD, death due to any cause, or for participants who were confirmed non complete responders per IRF, receipt of subsequent anticancer therapy for HL after completion of frontline therapy. PD is any new lesion or increase by \>=50% of previously involved sites from nadir.
- dispersion Type
- Standard Deviation
- groups
- description
- Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
- id
- OG000
- title
- A+AVD
- description
- Doxorubicin 25 mg/m\^2, bleomycin 10 units per square meter (units/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles.
- id
- OG001
- title
- ABVD
- param Type
- MEAN
- population Description
- The ITT population included all participants randomized to treatment.
- reporting Status
- POSTED
- time Frame
- Baseline up to end of treatment (approximately 1 year)
- title
- Change From Baseline in Patient-Reported Outcome (PRO) Scores by mPFS Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at EOT
- type
- SECONDARY
- unit Of Measure
- units on scale
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Preserved source evidence · Not medical advice
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