NCT05673785 · ADVERSE EVENTS

Adverse events

A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL) · Source last updated 2026-06-12

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: AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months).
Other-event reporting threshold: 5%

The FAS consisted of all enrolled participants.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Brentuximab Vedotin + CHP Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.	18 / 52	52 / 52	3 / 52

Group identifiers: EG000: Brentuximab Vedotin + CHP

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
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Gastrointestinal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Haemophagocytic lymphohistiocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
12
num At Risk
52
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Soft tissue infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
52
term
White blood cell count decreased

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
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
26
num At Risk
52
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
4
num At Risk
52
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
35
num At Risk
52
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
22
num At Risk
52
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
4
num At Risk
52
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
6
num At Risk
52
term
Blood lactate dehydrogenase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
9
num At Risk
52
term
C-reactive protein increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
5
num At Risk
52
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
5
num At Risk
52
term
Constipation

Complete source fields

description

The FAS consisted of all enrolled participants.

event Groups

deaths Num Affected
3
deaths Num At Risk
52
description
Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
id
EG000
other Num Affected
52
other Num At Risk
52
serious Num Affected
18
serious Num At Risk
52
title
Brentuximab Vedotin + CHP

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
26
num At Risk
52
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
4
num At Risk
52
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
35
num At Risk
52
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
22
num At Risk
52
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
4
num At Risk
52
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
6
num At Risk
52
term
Blood lactate dehydrogenase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
9
num At Risk
52
term
C-reactive protein increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
5
num At Risk
52
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
5
num At Risk
52
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Gastrointestinal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Haemophagocytic lymphohistiocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
3
num At Risk
52
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
12
num At Risk
52
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Soft tissue infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
1
num At Risk
52
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 28.0
stats
group Id
EG000
num Affected
2
num At Risk
52
term
White blood cell count decreased

time Frame

AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months).

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Preserved source evidence · Not medical advice