NCT02215967 · ADVERSE EVENTS

Adverse events

Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma · Source last updated 2019-10-08

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: Date treatment consent signed to date off study, approximately 3 months and 7 days for dose level 0.3 x 10^6 CAR + T cells, 4 months and 4 days for 1.0 x 10^6 CAR + T cells, 9 months and 13 days for 3.0 x 10^6 CAR + T cells, and 48 months and 12 days for 9.0 x 10^6 CAR + T cells.
Other-event reporting threshold: 0%

One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
0.3 x 10^6 CAR-BCMA T-cells Infused Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0	1 / 3	3 / 3	0 / 3
1 x 10^6 CAR-BCMA T-cells Infused Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0	0 / 3	3 / 3	0 / 3
3 x 10^6 CAR-BCMA T-cells Infused Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0	1 / 4	4 / 4	0 / 4
9 x 10^6 CAR-BCMA T-cells Infused Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0	11 / 16	16 / 16	0 / 16

Group identifiers: EG000: 0.3 x 10^6 CAR-BCMA T-cells Infused · EG001: 1 x 10^6 CAR-BCMA T-cells Infused · EG002: 3 x 10^6 CAR-BCMA T-cells Infused · EG003: 9 x 10^6 CAR-BCMA T-cells Infused

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
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
5
num At Risk
16
num Events
7
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
5
num At Risk
16
num Events
6
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
16
num Events
5
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
5
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
term
Cardiac troponin T increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
3
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Delirium

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
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
4
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
4
num At Risk
4
num Events
7
group Id
EG003
num Affected
13
num At Risk
16
num Events
42
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
3
num At Risk
16
num Events
4
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
7
num At Risk
16
num Events
9
term
Hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
5
group Id
EG003
num Affected
14
num At Risk
16
num Events
59
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
9
group Id
EG001
num Affected
3
num At Risk
3
num Events
7
group Id
EG002
num Affected
4
num At Risk
4
num Events
10
group Id
EG003
num Affected
14
num At Risk
16
num Events
49
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
12
num At Risk
16
num Events
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
13
group Id
EG001
num Affected
3
num At Risk
3
num Events
12
group Id
EG002
num Affected
4
num At Risk
4
num Events
14
group Id
EG003
num Affected
16
num At Risk
16
num Events
68
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
5
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
5
group Id
EG003
num Affected
11
num At Risk
16
num Events
58
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
8
num At Risk
16
num Events
11
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
14
group Id
EG001
num Affected
3
num At Risk
3
num Events
14
group Id
EG002
num Affected
4
num At Risk
4
num Events
18
group Id
EG003
num Affected
16
num At Risk
16
num Events
69
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
7
num At Risk
16
num Events
9
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Atrial fibrillation

Complete source fields

description

One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
0.3 x 10^6 CAR-BCMA T-cells Infused
deaths Num Affected
0
deaths Num At Risk
3
description
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
1 x 10^6 CAR-BCMA T-cells Infused
deaths Num Affected
0
deaths Num At Risk
4
description
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
id
EG002
other Num Affected
4
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
3 x 10^6 CAR-BCMA T-cells Infused
deaths Num Affected
0
deaths Num At Risk
16
description
Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
id
EG003
other Num Affected
16
other Num At Risk
16
serious Num Affected
11
serious Num At Risk
16
title
9 x 10^6 CAR-BCMA T-cells Infused

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
4
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
4
num At Risk
4
num Events
7
group Id
EG003
num Affected
13
num At Risk
16
num Events
42
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
3
num At Risk
16
num Events
4
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
7
num At Risk
16
num Events
9
term
Hypocalcemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
5
group Id
EG003
num Affected
14
num At Risk
16
num Events
59
term
Hypophosphatemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
9
group Id
EG001
num Affected
3
num At Risk
3
num Events
7
group Id
EG002
num Affected
4
num At Risk
4
num Events
10
group Id
EG003
num Affected
14
num At Risk
16
num Events
49
term
Lymphocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
2
num At Risk
3
num Events
2
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
12
num At Risk
16
num Events
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
13
group Id
EG001
num Affected
3
num At Risk
3
num Events
12
group Id
EG002
num Affected
4
num At Risk
4
num Events
14
group Id
EG003
num Affected
16
num At Risk
16
num Events
68
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
5
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
4
num Events
5
group Id
EG003
num Affected
11
num At Risk
16
num Events
58
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
8
num At Risk
16
num Events
11
term
Upper respiratory infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
3
num At Risk
3
num Events
14
group Id
EG001
num Affected
3
num At Risk
3
num Events
14
group Id
EG002
num Affected
4
num At Risk
4
num Events
18
group Id
EG003
num Affected
16
num At Risk
16
num Events
69
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
7
num At Risk
16
num Events
9
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Atrial fibrillation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
2
group Id
EG003
num Affected
0
num At Risk
16
num Events
0
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
5
num At Risk
16
num Events
7
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
5
num At Risk
16
num Events
6
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
3
num At Risk
16
num Events
5
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
2
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
5
term
CPK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
1
term
Cardiac troponin T increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
16
num Events
3
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
2
num At Risk
16
num Events
2
term
Delirium

time Frame

Date treatment consent signed to date off study, approximately 3 months and 7 days for dose level 0.3 x 10^6 CAR + T cells, 4 months and 4 days for 1.0 x 10^6 CAR + T cells, 9 months and 13 days for 3.0 x 10^6 CAR + T cells, and 48 months and 12 days for 9.0 x 10^6 CAR + T cells.

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

Preserved source evidence · Not medical advice