NCT01352286 · ADVERSE EVENTS

Adverse events

Redirected Auto T Cells for Advanced Myeloma · Source last updated 2019-12-03

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: Day -40 to Year 1 post-treatment
Other-event reporting threshold: 5%

Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
NYESO-1ᶜ²⁵⁹T Cells Participants who received NYESO-1ᶜ²⁵⁹T following ASCT	17 / 25	25 / 25	14 / 25

Group identifiers: EG000: NYESO-1ᶜ²⁵⁹T Cells

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
Cardiac disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Graft versus host disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Staphylococcal infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Acute Kidney Injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Autoimmune disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Blood creatine phosphokinase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Blood lactate dehydrogenase increased

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
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
25
num At Risk
25
num Events
25
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
24
num At Risk
25
num Events
24
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
24
num At Risk
25
num Events
24
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
23
num At Risk
25
num Events
23
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
18
num At Risk
25
num Events
18
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
12
num At Risk
25
num Events
12
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
22
num At Risk
25
num Events
22
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
20
num At Risk
25
num Events
20
term
Rash maculo-papular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Erythema multiforme
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
20
num At Risk
25
num Events
20
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
19
num At Risk
25
num Events
19
term
Hypokalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
19
num At Risk
25
num Events
19
term
Vomiting

Complete source fields

description

Participants who received NY-ESO-1ᶜ²⁵⁹T following ASCT

event Groups

deaths Num Affected
14
deaths Num At Risk
25
description
Participants who received NYESO-1ᶜ²⁵⁹T following ASCT
id
EG000
other Num Affected
25
other Num At Risk
25
serious Num Affected
17
serious Num At Risk
25
title
NYESO-1ᶜ²⁵⁹T Cells

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
25
num At Risk
25
num Events
25
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
24
num At Risk
25
num Events
24
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
24
num At Risk
25
num Events
24
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
23
num At Risk
25
num Events
23
term
Decreased appetite
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
18
num At Risk
25
num Events
18
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
12
num At Risk
25
num Events
12
term
Platelet count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
22
num At Risk
25
num Events
22
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
20
num At Risk
25
num Events
20
term
Rash maculo-papular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Erythema multiforme
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
20
num At Risk
25
num Events
20
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
19
num At Risk
25
num Events
19
term
Hypokalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
19
num At Risk
25
num Events
19
term
Vomiting

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Febrile neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
3
num At Risk
25
num Events
3
term
Pyrexia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Graft versus host disease
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Hypoxia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
2
num At Risk
25
num Events
2
term
Staphylococcal infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Acute Kidney Injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Autoimmune disorder
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Blood creatine phosphokinase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA version 20
stats
group Id
EG000
num Affected
1
num At Risk
25
num Events
1
term
Blood lactate dehydrogenase increased

time Frame

Day -40 to Year 1 post-treatment

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Preserved source evidence · Not medical advice