NCT01578499 · ADVERSE EVENTS

Adverse events

A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) · Source last updated 2021-01-05

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: All-Cause mortality: Baseline up to End of study (Up to 6 years); Serious and Other adverse events: First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
Other-event reporting threshold: 5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Brentuximab Vedotin Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).	18 / 66	60 / 66	22 / 66
Methotrexate or Bexarotene Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.	18 / 62	51 / 62	25 / 62

Group identifiers: EG000: Brentuximab Vedotin · EG001: Methotrexate or Bexarotene

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 21.0
stats
group Id
EG000
num Affected
2
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Superinfection bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred in participant with sepsis during treatment with brentuximab vedotin and is not related.
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
3
num At Risk
62
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Impetigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Parotitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Periorbital infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Erysipelas

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
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
31
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
4
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Peripheral motor neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
6
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
5
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
5
num At Risk
66
group Id
EG001
num Affected
6
num At Risk
62
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
4
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
24
num At Risk
66
group Id
EG001
num Affected
9
num At Risk
62
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
11
num At Risk
66
group Id
EG001
num Affected
3
num At Risk
62
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
18
num At Risk
66
group Id
EG001
num Affected
4
num At Risk
62
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
3
num At Risk
66
group Id
EG001
num Affected
5
num At Risk
62
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
18
num At Risk
66
group Id
EG001
num Affected
18
num At Risk
62
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
7
num At Risk
66
group Id
EG001
num Affected
5
num At Risk
62
term
Asthenia

Complete source fields

description

event Groups

deaths Num Affected
22
deaths Num At Risk
66
description
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
id
EG000
other Num Affected
60
other Num At Risk
66
serious Num Affected
18
serious Num At Risk
66
title
Brentuximab Vedotin
deaths Num Affected
25
deaths Num At Risk
62
description
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\^2, tablets, orally, once daily with meals for up to 48 weeks.
id
EG001
other Num Affected
51
other Num At Risk
62
serious Num Affected
18
serious Num At Risk
62
title
Methotrexate or Bexarotene

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
31
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Peripheral sensory neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
4
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Peripheral motor neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
6
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Paraesthesia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
5
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
5
num At Risk
66
group Id
EG001
num Affected
6
num At Risk
62
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
4
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
24
num At Risk
66
group Id
EG001
num Affected
9
num At Risk
62
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
11
num At Risk
66
group Id
EG001
num Affected
3
num At Risk
62
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
18
num At Risk
66
group Id
EG001
num Affected
4
num At Risk
62
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
3
num At Risk
66
group Id
EG001
num Affected
5
num At Risk
62
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
18
num At Risk
66
group Id
EG001
num Affected
18
num At Risk
62
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
7
num At Risk
66
group Id
EG001
num Affected
5
num At Risk
62
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
2
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Superinfection bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
notes
One treatment-emergent death occurred in participant with sepsis during treatment with brentuximab vedotin and is not related.
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
3
num At Risk
62
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Urosepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Impetigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
1
num At Risk
66
group Id
EG001
num Affected
0
num At Risk
62
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Parotitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Periorbital infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 21.0
stats
group Id
EG000
num Affected
0
num At Risk
66
group Id
EG001
num Affected
1
num At Risk
62
term
Erysipelas

time Frame

All-Cause mortality: Baseline up to End of study (Up to 6 years); Serious and Other adverse events: First dose of study drug through 30 days after last dose of study drug (Up to 450 days)

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