NCT03287804 · ADVERSE EVENTS

Adverse events

APRIL CAR T Cells (AUTO2) Targeting BCMA and TACI for the Treatment of Multiple Myeloma · Source last updated 2020-10-23

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: From Day 0 until Day 60 post last AUTO2 infusion.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
AUTO2 Relapsed or refractory myeloma patients	6 / 11	11 / 11	8 / 11

Group identifiers: EG000: AUTO2

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Metaplastic breast carcinoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hedache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
5
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hypocalcaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Lung infection

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
term
Haematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Haemophagocytic lymphohistiocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Catheter site bruise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
11
num Events
4
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
10
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
4
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
8
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hallucination
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
ALT increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
AST increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Blood ALP increased

Complete source fields

event Groups

deaths Num Affected
8
deaths Num At Risk
11
description
Relapsed or refractory myeloma patients
id
EG000
other Num Affected
11
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
AUTO2

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
term
Haematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Haemophagocytic lymphohistiocytosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Catheter site bruise
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
4
num At Risk
11
num Events
4
term
Chills
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
10
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
4
term
Oedema peripheral
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
6
num At Risk
11
num Events
8
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hallucination
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
ALT increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
AST increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Blood ALP increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Metaplastic breast carcinoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Acute myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Dyspnoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hedache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
5
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Hypocalcaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (22.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Lung infection

time Frame

From Day 0 until Day 60 post last AUTO2 infusion.

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Preserved source evidence · Not medical advice