NCT01777152 · ADVERSE EVENTS

Adverse events

ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas · Source last updated 2021-11-30

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: Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months
Other-event reporting threshold: 5%

Safety Analysis Population: Includes all randomized participants who received at least one dose of study treatment. Investigator and study personnel report all adverse events (AEs) and serious adverse events (SAEs) whether elicited during patient questioning, discovered during physical examination, laboratory testing and/or other means.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
A+CHP brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	89 / 223	220 / 223	67 / 223
CHOP cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles	90 / 226	218 / 226	89 / 226
A+CHP Subgroup Includes only participants in A+CHP arm who were randomized but did not receive treatment.	0 / 0	0 / 0	1 / 3

Group identifiers: EG000: A+CHP · EG001: CHOP · EG002: A+CHP Subgroup

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 (21.0)
stats
group Id
EG000
num Affected
32
num At Risk
223
group Id
EG001
num Affected
26
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
11
num At Risk
223
group Id
EG001
num Affected
3
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
9
num At Risk
223
group Id
EG001
num Affected
8
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
8
num At Risk
223
group Id
EG001
num Affected
6
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
5
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
5
num At Risk
223
group Id
EG001
num Affected
4
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
4
num At Risk
223
group Id
EG001
num Affected
3
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
2
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
2
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Tumour lysis syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Cellulitis

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 (21.0)
stats
group Id
EG000
num Affected
87
num At Risk
223
group Id
EG001
num Affected
81
num At Risk
226
group Id
EG002
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
64
num At Risk
223
group Id
EG001
num Affected
49
num At Risk
226
group Id
EG002
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
21
num At Risk
223
group Id
EG001
num Affected
14
num At Risk
226
group Id
EG002
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
18
num At Risk
223
group Id
EG001
num Affected
13
num At Risk
226
group Id
EG002
num At Risk
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
16
num At Risk
223
group Id
EG001
num Affected
9
num At Risk
226
group Id
EG002
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
12
num At Risk
223
group Id
EG001
num Affected
11
num At Risk
226
group Id
EG002
num At Risk
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
114
num At Risk
223
group Id
EG001
num Affected
91
num At Risk
226
group Id
EG002
num At Risk
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
98
num At Risk
223
group Id
EG001
num Affected
94
num At Risk
226
group Id
EG002
num At Risk
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
93
num At Risk
223
group Id
EG001
num Affected
55
num At Risk
226
group Id
EG002
num At Risk
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
60
num At Risk
223
group Id
EG001
num Affected
37
num At Risk
226
group Id
EG002
num At Risk
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
28
num At Risk
223
group Id
EG001
num Affected
27
num At Risk
226
group Id
EG002
num At Risk
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
26
num At Risk
223
group Id
EG001
num Affected
22
num At Risk
226
group Id
EG002
num At Risk
0
term
Abdominal pain

Complete source fields

description

event Groups

deaths Num Affected
67
deaths Num At Risk
223
description
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
id
EG000
other Num Affected
220
other Num At Risk
223
serious Num Affected
89
serious Num At Risk
223
title
A+CHP
deaths Num Affected
89
deaths Num At Risk
226
description
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
id
EG001
other Num Affected
218
other Num At Risk
226
serious Num Affected
90
serious Num At Risk
226
title
CHOP
deaths Num Affected
1
deaths Num At Risk
3
description
Includes only participants in A+CHP arm who were randomized but did not receive treatment.
id
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
A+CHP Subgroup

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
87
num At Risk
223
group Id
EG001
num Affected
81
num At Risk
226
group Id
EG002
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
64
num At Risk
223
group Id
EG001
num Affected
49
num At Risk
226
group Id
EG002
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
21
num At Risk
223
group Id
EG001
num Affected
14
num At Risk
226
group Id
EG002
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
18
num At Risk
223
group Id
EG001
num Affected
13
num At Risk
226
group Id
EG002
num At Risk
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
16
num At Risk
223
group Id
EG001
num Affected
9
num At Risk
226
group Id
EG002
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
12
num At Risk
223
group Id
EG001
num Affected
11
num At Risk
226
group Id
EG002
num At Risk
0
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
114
num At Risk
223
group Id
EG001
num Affected
91
num At Risk
226
group Id
EG002
num At Risk
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
98
num At Risk
223
group Id
EG001
num Affected
94
num At Risk
226
group Id
EG002
num At Risk
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
93
num At Risk
223
group Id
EG001
num Affected
55
num At Risk
226
group Id
EG002
num At Risk
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
60
num At Risk
223
group Id
EG001
num Affected
37
num At Risk
226
group Id
EG002
num At Risk
0
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
28
num At Risk
223
group Id
EG001
num Affected
27
num At Risk
226
group Id
EG002
num At Risk
0
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
26
num At Risk
223
group Id
EG001
num Affected
22
num At Risk
226
group Id
EG002
num At Risk
0
term
Abdominal pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
32
num At Risk
223
group Id
EG001
num Affected
26
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
11
num At Risk
223
group Id
EG001
num Affected
3
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
9
num At Risk
223
group Id
EG001
num Affected
8
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
8
num At Risk
223
group Id
EG001
num Affected
6
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
5
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
5
num At Risk
223
group Id
EG001
num Affected
4
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
4
num At Risk
223
group Id
EG001
num Affected
3
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
2
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Deep vein thrombosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
2
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Respiratory failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
3
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Tumour lysis syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (21.0)
stats
group Id
EG000
num Affected
2
num At Risk
223
group Id
EG001
num Affected
0
num At Risk
226
group Id
EG002
num Affected
0
num At Risk
0
term
Cellulitis

time Frame

Non-serious AEs followed up to 8 months. Serious AEs followed up to 90 months

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Preserved source evidence · Not medical advice