Trial Outcomes & Findings for A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia (NCT NCT02028455)

NCT ID: NCT02028455

Last Updated: 2025-08-27

Results Overview

The safety of the T cell infusion at the maximum tolerated dose determined in Phase 1, and further characterized in Phase 2, will be described

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

167 participants

Primary outcome timeframe

Initial CAR T cell infusion through 30 days post infusion

Results posted on

2025-08-27

Participant Flow

Participant milestones

Participant milestones
Measure
Phase 1 - Cohort 1A
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1 - Cohort 1B
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1 - Cohort 1C
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1 - Cohort 1D
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1 - Cohort 1F1
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1 - Cohort 1F2
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1- Not Treated
Phase 1 subjects who were not treated
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated.
Enrollment and Preliminary Assessments
STARTED
7
12
7
5
6
6
4
120
Enrollment and Preliminary Assessments
COMPLETED
7
12
7
5
6
6
0
103
Enrollment and Preliminary Assessments
NOT COMPLETED
0
0
0
0
0
0
4
17
Treatment(T Cell Infusion) and Follow up
STARTED
7
12
7
5
6
6
0
103
Treatment(T Cell Infusion) and Follow up
COMPLETED
0
0
0
0
0
0
0
0
Treatment(T Cell Infusion) and Follow up
NOT COMPLETED
7
12
7
5
6
6
0
103

Reasons for withdrawal

Reasons for withdrawal
Measure
Phase 1 - Cohort 1A
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1 - Cohort 1B
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1 - Cohort 1C
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1 - Cohort 1D
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1 - Cohort 1F1
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1 - Cohort 1F2
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1- Not Treated
Phase 1 subjects who were not treated
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated.
Enrollment and Preliminary Assessments
Went off study without receiving CAR T cell infusion
0
0
0
0
0
0
4
17
Treatment(T Cell Infusion) and Follow up
Death
4
9
3
5
3
2
0
40
Treatment(T Cell Infusion) and Follow up
Lost to Follow-up
0
0
0
0
0
1
0
2
Treatment(T Cell Infusion) and Follow up
Still in long-term follow up
3
3
4
0
3
3
0
61

Baseline Characteristics

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD19 for Relapsed/Refractory CD19+ Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Phase 1-Cohort 1A
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
n=12 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
n=5 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
n=6 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
n=6 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1 - Not Treated
n=4 Participants
This phase 1 cohort did not receive Patient Derived CD19 specific CAR T cells
Phase 2
n=120 Participants
The phase 2 cohort received Patient Derived CD19 specific CAR T cells following lymphodepletion if indicated
Total
n=167 Participants
Total of all reporting groups
Age, Continuous
19 years
n=93 Participants
9 years
n=4 Participants
15 years
n=27 Participants
6 years
n=483 Participants
10 years
n=36 Participants
13.5 years
n=10 Participants
11 years
n=115 Participants
13 years
n=40 Participants
13 years
n=8 Participants
Sex: Female, Male
Female
4 Participants
n=93 Participants
3 Participants
n=4 Participants
3 Participants
n=27 Participants
5 Participants
n=483 Participants
3 Participants
n=36 Participants
4 Participants
n=10 Participants
1 Participants
n=115 Participants
40 Participants
n=40 Participants
63 Participants
n=8 Participants
Sex: Female, Male
Male
3 Participants
n=93 Participants
9 Participants
n=4 Participants
4 Participants
n=27 Participants
0 Participants
n=483 Participants
3 Participants
n=36 Participants
2 Participants
n=10 Participants
3 Participants
n=115 Participants
80 Participants
n=40 Participants
104 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=93 Participants
4 Participants
n=4 Participants
2 Participants
n=27 Participants
2 Participants
n=483 Participants
0 Participants
n=36 Participants
1 Participants
n=10 Participants
1 Participants
n=115 Participants
38 Participants
n=40 Participants
49 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=93 Participants
8 Participants
n=4 Participants
5 Participants
n=27 Participants
3 Participants
n=483 Participants
5 Participants
n=36 Participants
4 Participants
n=10 Participants
2 Participants
n=115 Participants
72 Participants
n=40 Participants
105 Participants
n=8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
1 Participants
n=36 Participants
1 Participants
n=10 Participants
1 Participants
n=115 Participants
10 Participants
n=40 Participants
13 Participants
n=8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
Race (NIH/OMB)
Asian
1 Participants
n=93 Participants
0 Participants
n=4 Participants
1 Participants
n=27 Participants
1 Participants
n=483 Participants
0 Participants
n=36 Participants
1 Participants
n=10 Participants
0 Participants
n=115 Participants
6 Participants
n=40 Participants
10 Participants
n=8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=40 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
4 Participants
n=40 Participants
5 Participants
n=8 Participants
Race (NIH/OMB)
White
5 Participants
n=93 Participants
8 Participants
n=4 Participants
4 Participants
n=27 Participants
2 Participants
n=483 Participants
5 Participants
n=36 Participants
3 Participants
n=10 Participants
3 Participants
n=115 Participants
66 Participants
n=40 Participants
96 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
4 Participants
n=40 Participants
6 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=93 Participants
2 Participants
n=4 Participants
1 Participants
n=27 Participants
2 Participants
n=483 Participants
1 Participants
n=36 Participants
2 Participants
n=10 Participants
1 Participants
n=115 Participants
39 Participants
n=40 Participants
49 Participants
n=8 Participants
Diagnosis
Leukemia
7 Participants
n=93 Participants
12 Participants
n=4 Participants
7 Participants
n=27 Participants
5 Participants
n=483 Participants
6 Participants
n=36 Participants
6 Participants
n=10 Participants
4 Participants
n=115 Participants
106 Participants
n=40 Participants
153 Participants
n=8 Participants
Diagnosis
Non Hodgkin's Lymphoma
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
14 Participants
n=40 Participants
14 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Initial CAR T cell infusion through 30 days post infusion

Population: Phase 1 cohorts: Toxicity-evaluable leukemia patients who received CAR T cells; Phase 2 cohort: Toxicity-evaluable leukemia patients treated with the Phase 2 dose, 1 x 10\^6 CAR T cells/kg, following lymphodepletion with fludarabine and cyclophosphamide

The safety of the T cell infusion at the maximum tolerated dose determined in Phase 1, and further characterized in Phase 2, will be described

Outcome measures

Outcome measures
Measure
Phase 1 - Cohort 1A
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
n=12 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
n=5 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
n=6 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
n=6 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
n=81 Participants
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
Number of Participants Who Experienced an Adverse Event Meeting the Dose-Limiting Toxicity Definition
Number of participants who experienced an AE meeting the Dose-Limiting Toxicity definition
1 Participants
1 Participants
2 Participants
2 Participants
0 Participants
1 Participants
17 Participants
Number of Participants Who Experienced an Adverse Event Meeting the Dose-Limiting Toxicity Definition
Number of participants who did not experience an AE meeting the Dose-Limiting Toxicity definition
6 Participants
11 Participants
5 Participants
3 Participants
6 Participants
5 Participants
64 Participants

PRIMARY outcome

Timeframe: Initial CAR T cell infusion through Day 63 post infusion assessment (+/- 14 days)

Population: Efficacy-evaluable leukemia patients in Phase 2, plus Phase 1 patients treated at the Phase 2 dose in cohort 1F2, who received SCRIv1 or SCRIv1.5 CAR T cells following prescribed lymphodepletion with fludarabine and cyclophosphamide

The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the initial T cell infusion

Outcome measures

Outcome measures
Measure
Phase 1 - Cohort 1A
n=71 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
Number of Participants With an MRD Negative Complete Remission After Initial CAR T Cell Infusion
Number of Participants with an MRD Negative Complete Remission after Initial CAR T Infusion
63 Participants
Number of Participants With an MRD Negative Complete Remission After Initial CAR T Cell Infusion
Number of Participants without an MRD Negative Complete Remission after Initial CAR T Infusion
8 Participants

PRIMARY outcome

Timeframe: Up to 28 days per manufacturing attempt

Population: Participants evaluable for manufacturing feasibility.

The feasibility of manufacturing and releasing T cell products from pediatric and young adult patients with CD19+ relapsed or refractory leukemia

Outcome measures

Outcome measures
Measure
Phase 1 - Cohort 1A
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
n=12 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
n=5 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
n=6 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
n=6 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
n=3 Participants
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Phase 2
n=119 Participants
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
Number of Participants Who Have a Releasable Cell Product Generated
Number of participants for whom a releasable CAR T cell product was manufactured
7 Participants
12 Participants
7 Participants
5 Participants
6 Participants
6 Participants
1 Participants
116 Participants
Number of Participants Who Have a Releasable Cell Product Generated
Number of participants for whom no releasable CAR T cell product was manufactured
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
3 Participants

SECONDARY outcome

Timeframe: Initial CAR T Infusion through Day 63 post infusion assessment (+/- 14 days)

Population: Efficacy-evaluable leukemia patients in Phase 2, plus Phase 1 patients treated at the Phase 2 dose in Cohort 1F2, who received SCRIv1 or SCRIv1.5 CAR T cells following prescribed lymphodepletion with fludarabine and cyclophosphamide and who were followed for loss of persistence through the Day 63 assessment window. Excludes one participant with insufficient samples collected to determine Day 63 persistence status.

Participants will be followed for 63 days to determine if the transferred T cells remain detectable in the blood and bone marrow

Outcome measures

Outcome measures
Measure
Phase 1 - Cohort 1A
n=70 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
Persistence of Functional CD19 CAR+ T Cells
Number of participants with functional CAR T cell persistence through the Day 63 study assessment
42 Participants
Persistence of Functional CD19 CAR+ T Cells
Number of participants without functional CAR T cell persistence through the Day 63 study assessment
28 Participants

SECONDARY outcome

Timeframe: Initial CAR T Infusion through Day 63 post infusion assessment (+/- 14 days)

Population: Number of participants with a history of prior allogeneic HSCT (hematopoietic stem cell transplantation) who received CAR T infusion

Outcome measures

Outcome measures
Measure
Phase 1 - Cohort 1A
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
n=7 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
n=4 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
n=3 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
n=4 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
n=3 Participants
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
n=36 Participants
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
Number of Participants With Recrudescence or Development of Acute GVHD (Graft Versus Host Disease) Symptoms Post CAR T Infusion
Number of subjects without recrudescence or development of Acute GVHD symptoms post CAR T infusion
6 Participants
7 Participants
4 Participants
3 Participants
4 Participants
3 Participants
36 Participants
Number of Participants With Recrudescence or Development of Acute GVHD (Graft Versus Host Disease) Symptoms Post CAR T Infusion
Number of subjects with recrudescence or development of Acute GVHD symptoms post CAR T infusion
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: 3 years

Population: Number of subjects receiving cetuximab on study for ablation of CAR T cells

The efficacy of cetuximab to ablate the T cells will be measured by loss of detection of T cells and any associated toxicities as well as facilitating B cell recovery.

Outcome measures

Outcome measures
Measure
Phase 1 - Cohort 1A
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1-Cohort 1B
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1-Cohort 1C
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1-Cohort 1D
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1-Cohort 1F1
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1-Cohort 1F2
This phase 1 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
n=2 Participants
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Phase 2
The phase 2 cohort received Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following lymphodepletion if indicated
Number of Participants That Received Cetuximab Who Have T Cells Successfully Ablated
Number of participants whose CAR T cells were successfully ablated by cetuximab administration
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants That Received Cetuximab Who Have T Cells Successfully Ablated
Number of participants receiving cetuximab on study for ablation of CAR T cells
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants

Adverse Events

Phase 1 - Cohort 1A

Serious events: 6 serious events
Other events: 7 other events
Deaths: 4 deaths

Phase 1 - Cohort 1B

Serious events: 10 serious events
Other events: 12 other events
Deaths: 9 deaths

Phase 1 - Cohort 1C

Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths

Phase 1 - Cohort 1D

Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths

Phase 1 - Cohort 1F1

Serious events: 2 serious events
Other events: 6 other events
Deaths: 3 deaths

Phase 1 - Cohort 1F2

Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths

Phase 2

Serious events: 48 serious events
Other events: 103 other events
Deaths: 40 deaths

Serious adverse events

Serious adverse events
Measure
Phase 1 - Cohort 1A
n=7 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1 - Cohort 1B
n=12 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1 - Cohort 1C
n=7 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1 - Cohort 1D
n=5 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1 - Cohort 1F1
n=6 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1 - Cohort 1F2
n=6 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
n=103 participants at risk
The phase 2 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Blood and lymphatic system disorders
Febrile Neutropenia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Cardiac disorders
Atrial Fibrillation
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Cardiac disorders
Cardiac Arrest
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Cardiac disorders
Heart Failure
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Cardiac disorders
Left Ventricular Systolic Dysfunction
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Cardiac disorders
Pericardial Tamponade
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Endocrine disorders
Adrenal Insufficiency
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Eye disorders
Optic Nerve Disorder
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Eye disorders
Retinopathy
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Colitis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Nausea
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Pancreatitis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Typhlitis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Vomiting
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
General disorders
Fever
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Immune system disorders
Anaphylaxis
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Immune system disorders
Cytokine Release Syndrome
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
41.7%
5/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
71.4%
5/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
50.0%
3/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
21.4%
22/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Appendicitis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Catheter Related Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
4/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Gram-Positive Bacterial Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Lung Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Periorbital Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Sepsis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Skin Infection
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Yeast Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Injury, poisoning and procedural complications
Infusion Related Reaction
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Blood Bilirubin Increased
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Creatinine Increased
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Neutrophil Count Decreased
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Acidosis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Dehydration
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypophosphatemia
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Musculoskeletal and connective tissue disorders
Bone Pain
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Musculoskeletal and connective tissue disorders
Jaw Pain
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Leukemia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Aphasia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Edema Cerebral
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Encephalopathy
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
4/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
42.9%
3/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
2/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
11.7%
12/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Hydrocephalus
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Intracranial Hemorrhage
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Leukoencephalopathy
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Nystagmus
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Seizure
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
6.8%
7/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Confusion
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Delirium
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Hallucinations
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Psychosis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Renal and urinary disorders
Acute Kidney Injury
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Respiratory, thoracic and mediastinal disorders
Laryngeal Obstruction
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Vascular disorders
Capillary Leak Syndrome
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Vascular disorders
Hypotension
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.

Other adverse events

Other adverse events
Measure
Phase 1 - Cohort 1A
n=7 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg
Phase 1 - Cohort 1B
n=12 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg
Phase 1 - Cohort 1C
n=7 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\^6 CAR T cells/kg
Phase 1 - Cohort 1D
n=5 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\^7 CAR T cells/kg
Phase 1 - Cohort 1F1
n=6 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 5x10\^5 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 1 - Cohort 1F2
n=6 participants at risk
This phase 1 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1x10\^6 CAR T cells/kg following prescribed lymphodepletion with fludarabine and cyclophosphamide
Phase 2
n=103 participants at risk
The phase 2 cohort will receive Patient Derived CD19 specific CAR T cells at a dose of 1 x 10\^6 CAR T cells/kg following lymphodepletion if indicated
Blood and lymphatic system disorders
Anemia
57.1%
4/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
91.7%
11/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
85.7%
6/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
80.0%
4/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
83.3%
5/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
50.0%
3/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
58.3%
60/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.7%
8/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
57.1%
4/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
40.0%
2/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
83.3%
5/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
2/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.6%
15/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Blood and lymphatic system disorders
Febrile Neutropenia
100.0%
7/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
83.3%
10/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
85.7%
6/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
83.3%
5/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.7%
4/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
35.0%
36/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Cardiac disorders
Sinus Tachycardia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
25.0%
3/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Ear and labyrinth disorders
Ear Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Eye disorders
Optic Nerve Disorder
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Abdominal Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
7.8%
8/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Constipation
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Diarrhea
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
25.0%
3/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
40.0%
2/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
7.8%
8/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Gastroparesis
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Ileus
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Nausea
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
4/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
40.0%
2/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.5%
17/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Oral Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Perirectal Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Rectal Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Gastrointestinal disorders
Vomiting
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
10.7%
11/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
General disorders
Chills
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
General disorders
Fatigue
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
General disorders
Fever
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
5.8%
6/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
General disorders
Malaise
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
General disorders
Non-Cardiac Chest Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
General disorders
Pain
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
9.7%
10/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Immune system disorders
Allergic Reaction
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Immune system disorders
Cytokine Release Syndrome
57.1%
4/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
58.3%
7/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
40.0%
2/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
83.3%
5/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
2/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.0%
68/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Immune system disorders
Igg Decreased
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
5.8%
6/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Catheter Related Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
4.9%
5/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Enterocolitis Infectious
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Mucosal Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Nail Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Sinusitis
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Skin Infection
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
3.9%
4/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Infections and infestations
Upper Respiratory Infection
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
3.9%
4/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Injury, poisoning and procedural complications
Hip Fracture
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Injury, poisoning and procedural complications
Spinal Fracture
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Activated Partial Thromboplastin Time Prolonged
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
11.7%
12/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Alanine Aminotransferase Increased
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
9.7%
10/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Aspartate Aminotransferase Increased
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
7.8%
8/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Blood Bilirubin Increased
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
11.7%
12/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Creatinine Increased
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
25.0%
3/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Electrocardiogram Qt Corrected Interval Prolonged
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Fibrinogen Decreased
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
6.8%
7/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Lymphocyte Count Decreased
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
41.7%
5/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
42.9%
3/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
19.4%
20/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Neutrophil Count Decreased
71.4%
5/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
58.3%
7/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
85.7%
6/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.7%
4/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
83.3%
5/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
53.4%
55/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Platelet Count Decreased
71.4%
5/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.7%
8/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
57.1%
4/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
80.0%
4/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.7%
4/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
40.8%
42/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Urine Output Decreased
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
41.7%
5/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Weight Gain
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
4/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
Weight Loss
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
3.9%
4/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Investigations
White Blood Cell Decreased
71.4%
5/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.7%
8/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
85.7%
6/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
50.0%
3/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
66.7%
4/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
44.7%
46/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Anorexia
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
50.0%
6/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
12.6%
13/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hyperglycemia
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
5.8%
6/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypernatremia
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
6.8%
7/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypertriglyceridemia
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypoalbuminemia
42.9%
3/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
40.0%
2/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.7%
9/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypocalcemia
57.1%
4/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
50.0%
6/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
80.0%
4/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
10.7%
11/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypokalemia
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
4/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
80.0%
4/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
11.7%
12/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypomagnesemia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Metabolism and nutrition disorders
Hypophosphatemia
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
50.0%
6/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
80.0%
4/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
13.6%
14/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Musculoskeletal and connective tissue disorders
Back Pain
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
3.9%
4/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Musculoskeletal and connective tissue disorders
Joint Pain
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Musculoskeletal and connective tissue disorders
Pain In Extremity
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
4.9%
5/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Musculoskeletal and connective tissue disorders
Pain-Left Side
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Musculoskeletal and connective tissue disorders
Shoulder Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Dizziness
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Dysarthria
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Encephalopathy
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.7%
9/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Headache
71.4%
5/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
42.9%
3/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
50.0%
3/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
31.1%
32/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Neuropathic Pain
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Peripheral Sensory Neuropathy
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.97%
1/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Sensory Neuropathy
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Nervous system disorders
Tremor
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
2/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.5%
17/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Anxiety
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Confusion
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
2/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
12.6%
13/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Depression
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Hypomania
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Insomnia
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
2.9%
3/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Psychiatric disorders
Nightmares
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Renal and urinary disorders
Polydipsia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Renal and urinary disorders
Polyuria
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Reproductive system and breast disorders
Vaginal Pain
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
2/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
5.8%
6/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Skin and subcutaneous tissue disorders
Fungal Diaper Rash
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Skin and subcutaneous tissue disorders
Skin GVHD
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Skin and subcutaneous tissue disorders
Skin Ulceration
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Vascular disorders
Capillary Leak Syndrome
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
8.3%
1/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
1.9%
2/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Vascular disorders
Hypertension
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
58.3%
7/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
28.6%
2/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
60.0%
3/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
2/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
9.7%
10/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
Vascular disorders
Hypotension
14.3%
1/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
33.3%
4/12 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
0.00%
0/7 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
20.0%
1/5 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
16.7%
1/6 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.
6.8%
7/103 • All adverse event data are systematically collected from initiation of infusion through 30 days post CAR T infusion. Serious Adverse Event reports with an attribution of Possibly, Probably or Definitely related to CAR T cells are included in the data up to 1 year post-infusion.
Adverse events were assessed using NCI Common Terminology Criteria for Adverse Events v4.0, except for Cytokine Release Syndrome during Phase 2, which was assessed using modified Lee criteria.\* Neurotoxicity and CRS events with grade \>=1 and other events with grade \>=2 were systematically captured \*Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95.

Additional Information

Dr. Colleen Annesley

Seattle Children's Therapeutics

Phone: 206-987-7122

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place