NCT01805037 · ADVERSE EVENTS

Adverse events

Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas · Source last updated 2021-09-01

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 (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance).
Other-event reporting threshold: 0%

Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg) Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.	14 / 20	20 / 20	2 / 20

Group identifiers: EG000: Brentuximb Vedotin Dose Level 1 (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
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced dyspena and chest pain at the time of this event. 1 patient also experienced upper respiratory infection at the time of this event.
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Lung Infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced fever at the time of this event.
organ System
Investigations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced chills and malaise at the time of this event.
organ System
Renal and urinary disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced a decrease in neutrophil count at the time of this event.
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Vomiting

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
CTCAE 4.03
stats
group Id
EG000
num Affected
17
num At Risk
20
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Heart murmur
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Eye pain

Complete source fields

description

Brentuximab vedotin dose level -1 (dose de-escalation level) never opened. All 20 patients received dose level 1 (1.2 mg/kg) of brentuximab vedotin.

event Groups

deaths Num Affected
2
deaths Num At Risk
20
description
Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
id
EG000
other Num Affected
20
other Num At Risk
20
serious Num Affected
14
serious Num At Risk
20
title
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
17
num At Risk
20
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Heart murmur
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
4
num At Risk
20
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Ventricular arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Eye pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced dyspena and chest pain at the time of this event. 1 patient also experienced upper respiratory infection at the time of this event.
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Lung Infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced fever at the time of this event.
organ System
Investigations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced chills and malaise at the time of this event.
organ System
Renal and urinary disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient also experienced a decrease in neutrophil count at the time of this event.
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.03
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Vomiting

time Frame

Adverse Events (AEs) were collected over a 5 year period. Each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. Induction = 28 days, consolidation (optional) = 28 days, 1 maintenance cycle = 21 days, with treatment lasting up to 1 year from induction. The range of cycles attempted was 1-17 (including induction +/- consolidation, and maintenance).

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Preserved source evidence · Not medical advice