NCT01712490 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (approximately 1 year) for a serious adverse event after the last dose of study drug
Other-event reporting threshold: 5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. The safety population included all enrolled participants who received at least 1 dose of any study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	284 / 662	644 / 662	9 / 662
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.	178 / 659	632 / 659	13 / 659

Group identifiers: EG000: A+AVD · EG001: ABVD

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
114
num At Risk
662
num Events
151
group Id
EG001
num Affected
43
num At Risk
659
num Events
52
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
19
num At Risk
662
num Events
30
group Id
EG001
num Affected
4
num At Risk
659
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
7
num At Risk
662
num Events
10
group Id
EG001
num Affected
3
num At Risk
659
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
662
num Events
0
group Id
EG001
num Affected
1
num At Risk
659
num Events
1
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
1
group Id
EG001
num Affected
0
num At Risk
659
num Events
0
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
662
num Events
2
group Id
EG001
num Affected
0
num At Risk
659
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
1
group Id
EG001
num Affected
1
num At Risk
659
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
2
group Id
EG001
num Affected
0
num At Risk
659
num Events
0
term
Histiocytosis haematophagic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
18
num At Risk
662
num Events
19
group Id
EG001
num Affected
15
num At Risk
659
num Events
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
662
num Events
4
group Id
EG001
num Affected
2
num At Risk
659
num Events
2
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
662
num Events
2
group Id
EG001
num Affected
3
num At Risk
659
num Events
3
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
1
group Id
EG001
num Affected
2
num At Risk
659
num Events
2
term
Bronchitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
374
num At Risk
662
num Events
1169
group Id
EG001
num Affected
291
num At Risk
659
num Events
813
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
136
num At Risk
662
num Events
237
group Id
EG001
num Affected
65
num At Risk
659
num Events
97
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
42
num At Risk
662
num Events
124
group Id
EG001
num Affected
37
num At Risk
659
num Events
118
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
346
num At Risk
662
num Events
673
group Id
EG001
num Affected
369
num At Risk
659
num Events
735
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
273
num At Risk
662
num Events
361
group Id
EG001
num Affected
239
num At Risk
659
num Events
336
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
212
num At Risk
662
num Events
342
group Id
EG001
num Affected
183
num At Risk
659
num Events
284
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
176
num At Risk
662
num Events
231
group Id
EG001
num Affected
121
num At Risk
659
num Events
155
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
138
num At Risk
662
num Events
182
group Id
EG001
num Affected
104
num At Risk
659
num Events
135
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
135
num At Risk
662
num Events
185
group Id
EG001
num Affected
65
num At Risk
659
num Events
79
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
84
num At Risk
662
num Events
100
group Id
EG001
num Affected
75
num At Risk
659
num Events
93
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
64
num At Risk
662
num Events
74
group Id
EG001
num Affected
34
num At Risk
659
num Events
37
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
33
num At Risk
662
num Events
36
group Id
EG001
num Affected
47
num At Risk
659
num Events
49
term
Gastrooesophageal reflux disease

Complete source fields

description

event Groups

deaths Num Affected
9
deaths Num At Risk
662
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
EG000
other Num Affected
644
other Num At Risk
662
serious Num Affected
284
serious Num At Risk
662
title
A+AVD
deaths Num Affected
13
deaths Num At Risk
659
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
EG001
other Num Affected
632
other Num At Risk
659
serious Num Affected
178
serious Num At Risk
659
title
ABVD

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
374
num At Risk
662
num Events
1169
group Id
EG001
num Affected
291
num At Risk
659
num Events
813
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
136
num At Risk
662
num Events
237
group Id
EG001
num Affected
65
num At Risk
659
num Events
97
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
42
num At Risk
662
num Events
124
group Id
EG001
num Affected
37
num At Risk
659
num Events
118
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
346
num At Risk
662
num Events
673
group Id
EG001
num Affected
369
num At Risk
659
num Events
735
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
273
num At Risk
662
num Events
361
group Id
EG001
num Affected
239
num At Risk
659
num Events
336
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
212
num At Risk
662
num Events
342
group Id
EG001
num Affected
183
num At Risk
659
num Events
284
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
176
num At Risk
662
num Events
231
group Id
EG001
num Affected
121
num At Risk
659
num Events
155
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
138
num At Risk
662
num Events
182
group Id
EG001
num Affected
104
num At Risk
659
num Events
135
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
135
num At Risk
662
num Events
185
group Id
EG001
num Affected
65
num At Risk
659
num Events
79
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
84
num At Risk
662
num Events
100
group Id
EG001
num Affected
75
num At Risk
659
num Events
93
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
64
num At Risk
662
num Events
74
group Id
EG001
num Affected
34
num At Risk
659
num Events
37
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
33
num At Risk
662
num Events
36
group Id
EG001
num Affected
47
num At Risk
659
num Events
49
term
Gastrooesophageal reflux disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
114
num At Risk
662
num Events
151
group Id
EG001
num Affected
43
num At Risk
659
num Events
52
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
19
num At Risk
662
num Events
30
group Id
EG001
num Affected
4
num At Risk
659
num Events
5
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
7
num At Risk
662
num Events
10
group Id
EG001
num Affected
3
num At Risk
659
num Events
3
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
0
num At Risk
662
num Events
0
group Id
EG001
num Affected
1
num At Risk
659
num Events
1
term
Lymphadenitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
1
group Id
EG001
num Affected
0
num At Risk
659
num Events
0
term
Lymphadenopathy mediastinal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
662
num Events
2
group Id
EG001
num Affected
0
num At Risk
659
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
1
group Id
EG001
num Affected
1
num At Risk
659
num Events
1
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
2
group Id
EG001
num Affected
0
num At Risk
659
num Events
0
term
Histiocytosis haematophagic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
18
num At Risk
662
num Events
19
group Id
EG001
num Affected
15
num At Risk
659
num Events
18
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
4
num At Risk
662
num Events
4
group Id
EG001
num Affected
2
num At Risk
659
num Events
2
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
2
num At Risk
662
num Events
2
group Id
EG001
num Affected
3
num At Risk
659
num Events
3
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.0)
stats
group Id
EG000
num Affected
1
num At Risk
662
num Events
1
group Id
EG001
num Affected
2
num At Risk
659
num Events
2
term
Bronchitis

time Frame

TEAEs are adverse events that started after the first dose of study drug and no more than 30 days (approximately 1 year) for a serious adverse event after the last dose of study drug

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