NCT01771107 · ADVERSE EVENTS

Adverse events

Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With Stage II-IV HIV-Associated Hodgkin Lymphoma · Source last updated 2025-08-15

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: 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I - Brentuximab 1.2 mg/kg Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV	3 / 6	6 / 6	0 / 6
Phase II - Brentuximab 1.2 mg/kg Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV	16 / 35	34 / 35	3 / 35

Group identifiers: EG000: Phase I - Brentuximab 1.2 mg/kg · EG001: Phase II - Brentuximab 1.2 mg/kg

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
35
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Coronary artery disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
35
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
35
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Death, NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Catheter related infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Neurosyphilis

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
17
num At Risk
35
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
35
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
13
num At Risk
35
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
8
num At Risk
35
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
35
term
Oral mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
11
num At Risk
35
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
6
num At Risk
35
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
35
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
11
num At Risk
35
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
35
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
7
num At Risk
35
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
35
term
Mucosal infection

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Phase I - Brentuximab 1.2 mg/kg
deaths Num Affected
3
deaths Num At Risk
35
description
Patients receive doxorubicin hydrochloride IV, vinblastine sulfate IV, and dacarbazine IV on days 1 and 15. Patients also receive brentuximab vedotin IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Dacarbazine: Given IV Doxorubicin Hydrochloride: Given IV Pharmacological Study: Correlative studies Vinblastine: Given IV
id
EG001
other Num Affected
34
other Num At Risk
35
serious Num Affected
16
serious Num At Risk
35
title
Phase II - Brentuximab 1.2 mg/kg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
17
num At Risk
35
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
35
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
13
num At Risk
35
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
3
num At Risk
6
group Id
EG001
num Affected
8
num At Risk
35
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
35
term
Oral mucositis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
11
num At Risk
35
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
6
num At Risk
35
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
35
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
11
num At Risk
35
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
35
term
Fever
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
7
num At Risk
35
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
35
term
Mucosal infection

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
35
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Coronary artery disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Sinus tachycardia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
35
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
35
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Death, NOS
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Catheter related infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
35
term
Neurosyphilis

time Frame

2 years

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Preserved source evidence · Not medical advice