NCT01892293 · ADVERSE EVENTS

Adverse events

CT Antigen TCR-Engineered T Cells for Myeloma · Source last updated 2019-01-10

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: Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Other-event reporting threshold: 5%

Participants who received NY-ESO-1ᶜ²⁵⁹T

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)	1 / 2	2 / 2	2 / 2

Group identifiers: EG000: NY-ESO-1ᶜ²⁵⁹T Cells Administered IV

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
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 18
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
2
term
Humerus 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
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
White blood cell count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Benign neoplasm
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypertriglyceridemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Sinus bradycardia

Complete source fields

description

Participants who received NY-ESO-1ᶜ²⁵⁹T

event Groups

deaths Num Affected
2
deaths Num At Risk
2
description
Participants who received cytoreductive chemotherapy followed by infusion of lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 1-10 billion cells)
id
EG000
other Num Affected
2
other Num At Risk
2
serious Num Affected
1
serious Num At Risk
2
title
NY-ESO-1ᶜ²⁵⁹T Cells Administered IV

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
White blood cell count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Lymphocyte count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
2
num At Risk
2
num Events
2
term
Neutrophil count decreased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Aspartate aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Benign neoplasm
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Hypertriglyceridemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (18.0)
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
1
term
Sinus bradycardia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA version 18
stats
group Id
EG000
num Affected
1
num At Risk
2
num Events
2
term
Humerus fracture

time Frame

Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice