NCT03483103 · ADVERSE EVENTS

Adverse events

Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006) · Source last updated 2023-12-20

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: Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (up to approximately 90 days).
Other-event reporting threshold: 5%

The total number at risk for all-cause mortality represents all participants who underwent leukapheresis. The total number at risk by any serious adverse event and other (not including serious) adverse events represents all participants that received at least 1 dose of study medication (JCAR017).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lisocabtagene Maraleucel (JCAR017) Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.	20 / 61	59 / 61	30 / 74

Group identifiers: EG000: Lisocabtagene Maraleucel (JCAR017)

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 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Obstruction gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
61
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
8
num At Risk
61
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Staphylococcal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Stenotrophomonas sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Hip fracture

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 25.1
stats
group Id
EG000
num Affected
19
num At Risk
61
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
14
num At Risk
61
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
8
num At Risk
61
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
31
num At Risk
61
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
18
num At Risk
61
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
8
num At Risk
61
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
10
num At Risk
61
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
15
num At Risk
61
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
5
num At Risk
61
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
5
num At Risk
61
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
24
num At Risk
61
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
9
num At Risk
61
term
Oedema peripheral

Complete source fields

description

event Groups

deaths Num Affected
30
deaths Num At Risk
74
description
Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
id
EG000
other Num Affected
59
other Num At Risk
61
serious Num Affected
20
serious Num At Risk
61
title
Lisocabtagene Maraleucel (JCAR017)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
19
num At Risk
61
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
14
num At Risk
61
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
8
num At Risk
61
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
31
num At Risk
61
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
18
num At Risk
61
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
8
num At Risk
61
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
10
num At Risk
61
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
15
num At Risk
61
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
5
num At Risk
61
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
5
num At Risk
61
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
24
num At Risk
61
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
9
num At Risk
61
term
Oedema peripheral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Lower gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Obstruction gastric
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
2
num At Risk
61
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
8
num At Risk
61
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
COVID-19
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
COVID-19 pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Staphylococcal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Stenotrophomonas sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Fall
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 25.1
stats
group Id
EG000
num Affected
1
num At Risk
61
term
Hip fracture

time Frame

Participants were assessed for all-cause mortality from the first participant undergoing leukapheresis until study completion (up to approximately 52 months). SAEs and Other AEs were assessed from the first participant undergoing leukapheresis to 90 days following the first participant undergoing leukapheresis (up to approximately 90 days).

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Preserved source evidence · Not medical advice