NCT04569032 · ADVERSE EVENTS

Adverse events

A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression · Source last updated 2026-08-13

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: Adverse events: From first dose of the study treatment (Day 1) maximum up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months). All-cause mortality: throughout the study (up to 41 months)
Other-event reporting threshold: 5%

Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Results are reported based on participants classified per local laboratory assessment for CD30 expression.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
CD30 <1% [Local Laboratory Assessment] Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	15 / 34	31 / 34	11 / 34
CD30 1% to <10% [Local Laboratory Assessment] Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.	16 / 48	43 / 48	13 / 48

Group identifiers: EG000: CD30 <1% [Local Laboratory Assessment] · EG001: CD30 1% to <10% [Local Laboratory Assessment]

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 v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
2
num At Risk
48
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
6
num At Risk
34
num Events
7
group Id
EG001
num Affected
9
num At Risk
48
num Events
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
0
num At Risk
48
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
0
num At Risk
48
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
0
num At Risk
48
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Ileal perforation

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 v27.0
stats
group Id
EG000
num Affected
7
num At Risk
34
num Events
7
group Id
EG001
num Affected
15
num At Risk
48
num Events
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
5
num At Risk
48
num Events
6
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
4
group Id
EG001
num Affected
12
num At Risk
48
num Events
19
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
5
num At Risk
48
num Events
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
group Id
EG001
num Affected
4
num At Risk
48
num Events
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
3
num At Risk
34
num Events
3
group Id
EG001
num Affected
7
num At Risk
48
num Events
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
6
num At Risk
34
num Events
9
group Id
EG001
num Affected
19
num At Risk
48
num Events
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
3
num At Risk
48
num Events
3
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
8
num At Risk
34
num Events
11
group Id
EG001
num Affected
14
num At Risk
48
num Events
21
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
3
group Id
EG001
num Affected
6
num At Risk
48
num Events
6
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
4
group Id
EG001
num Affected
7
num At Risk
48
num Events
8
term
Vomiting

Complete source fields

description

event Groups

deaths Num Affected
11
deaths Num At Risk
34
description
Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
id
EG000
other Num Affected
31
other Num At Risk
34
serious Num Affected
15
serious Num At Risk
34
title
CD30 <1% [Local Laboratory Assessment]
deaths Num Affected
13
deaths Num At Risk
48
description
Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
id
EG001
other Num Affected
43
other Num At Risk
48
serious Num Affected
16
serious Num At Risk
48
title
CD30 1% to <10% [Local Laboratory Assessment]

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
7
num At Risk
34
num Events
7
group Id
EG001
num Affected
15
num At Risk
48
num Events
18
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
5
num At Risk
48
num Events
6
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
4
group Id
EG001
num Affected
12
num At Risk
48
num Events
19
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
5
num At Risk
48
num Events
5
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
group Id
EG001
num Affected
4
num At Risk
48
num Events
4
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
3
num At Risk
34
num Events
3
group Id
EG001
num Affected
7
num At Risk
48
num Events
7
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
6
num At Risk
34
num Events
9
group Id
EG001
num Affected
19
num At Risk
48
num Events
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
3
num At Risk
48
num Events
3
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
8
num At Risk
34
num Events
11
group Id
EG001
num Affected
14
num At Risk
48
num Events
21
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
3
group Id
EG001
num Affected
6
num At Risk
48
num Events
6
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
4
num At Risk
34
num Events
4
group Id
EG001
num Affected
7
num At Risk
48
num Events
8
term
Vomiting

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
2
num At Risk
48
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
6
num At Risk
34
num Events
7
group Id
EG001
num Affected
9
num At Risk
48
num Events
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
0
num At Risk
48
num Events
0
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
0
num At Risk
48
num Events
0
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
group Id
EG001
num Affected
0
num At Risk
48
num Events
0
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA v27.0
stats
group Id
EG000
num Affected
0
num At Risk
34
num Events
0
group Id
EG001
num Affected
1
num At Risk
48
num Events
1
term
Ileal perforation

time Frame

Adverse events: From first dose of the study treatment (Day 1) maximum up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months). All-cause mortality: throughout the study (up to 41 months)

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