AEs within the first 30 d after CAR T-cell infusion
. | No. of patients . | |
---|---|---|
All grades . | Grade ≥3 . | |
AEs | ||
Fatigure | 1 (2.1) | 0 |
Dyspnea | 4 (8.3) | 2 (4.2) |
Nausea + anorexia | 22 (45.8) | 4 (8.3) |
Diarrhea + constipation | 1 (2.1) | 0 |
Myalgia | 2 (4.2) | 0 |
Oral mucositis | 1 (2.1) | 0 |
Infection | 6 (12.5) | 2 (4.2) |
Fever | 44 (91.7) | 33 (68.8) |
Hypotension | 8 (16.7) | 4 (8.3) |
Hypoxia | 6 (12.5) | 4 (8.3) |
Tachycardia | 3 (6.3) | 2 (4.2) |
Capillary leak syndrome | 1 (2.1) | 1 (2.1) |
CRS | 43 (89.6) | 9 (18.8) |
Hematologic AEs | ||
Neutropenia | 42 (87.5) | 34 (70.8) |
Lymphocytopenia | 40 (83.3) | 35 (72.9) |
Thrombocytopenia | 29 (60.4) | 16 (33.3) |
Hypoglobinemia | 32 (66.7) | 22 (45.8) |
Multisystem AEs | ||
Gastrointestinal bleeding | 1 (2.1) | 1 (2.1) |
Hemoptysis | 1 (2.1) | 1 (2.1) |
Intracranial hemorrhage | 1 (2.1) | 1 (2.1) |
Acute pancreatitis | 1 (2.1) | 1 (2.1) |
Heart failure | 3 (6.3) | 3 (6.3) |
Renal failure | 2 (4.2) | 2 (4.2) |
Multiple organ and system failure | 1 (2.1) | 1 (2.1) |
Laboratory abnormalities | ||
ALT/AST elevation | 28 (58.3) | 11 (22.9) |
Blood bilirubin elevation | 7 (14.6) | 5 (10.4) |
Creatintine elevation | 8 (16.7) | 2 (4.2) |
Electrolyte disturbance | 1 (2.1) | 1 (2.1) |
Myocardial enzyme/BNP elevation | 14 (29.2) | 4 (8.3) |
Fibrinogen decreased | 3 (6.3) | 3 (6.3) |
NEs | ||
Encephalopathy | 11 (22.9) | 4 (8.3) |
Disturbance in attention | 6 (12.5) | 1 (2.1) |
Cognitive disorder | 6 (12.5) | 2 (4.2) |
Mental status changes | 1 (2.1) | 0 |
Memory impairment | 2 (4.2) | 1 (2.1) |
Lethargy | 4 (8.3) | 1 (2.1) |
Depressed level of consciousness | 10 (20.8) | 3 (6.3) |
Headache/dizziness | 7 (14.6) | 2 (4.2) |
Tremor | 2 (4.2) | 1 (2.1) |
Aphasia | 1 (2.1) | 1 (2.1) |
Delirium | 8 (16.7) | 2 (4.2) |
Motor dysfunction | 1 (2.1) | 1 (2.1) |
Ataxia | 2 (4.2) | 0 |
Seizure | 4 (8.3) | 4 (8.3) |
Vision disorder | 3 (6.3) | 3 (6.3) |
Tinnitus | 1 (2.1) | 1 (2.1) |
. | No. of patients . | |
---|---|---|
All grades . | Grade ≥3 . | |
AEs | ||
Fatigure | 1 (2.1) | 0 |
Dyspnea | 4 (8.3) | 2 (4.2) |
Nausea + anorexia | 22 (45.8) | 4 (8.3) |
Diarrhea + constipation | 1 (2.1) | 0 |
Myalgia | 2 (4.2) | 0 |
Oral mucositis | 1 (2.1) | 0 |
Infection | 6 (12.5) | 2 (4.2) |
Fever | 44 (91.7) | 33 (68.8) |
Hypotension | 8 (16.7) | 4 (8.3) |
Hypoxia | 6 (12.5) | 4 (8.3) |
Tachycardia | 3 (6.3) | 2 (4.2) |
Capillary leak syndrome | 1 (2.1) | 1 (2.1) |
CRS | 43 (89.6) | 9 (18.8) |
Hematologic AEs | ||
Neutropenia | 42 (87.5) | 34 (70.8) |
Lymphocytopenia | 40 (83.3) | 35 (72.9) |
Thrombocytopenia | 29 (60.4) | 16 (33.3) |
Hypoglobinemia | 32 (66.7) | 22 (45.8) |
Multisystem AEs | ||
Gastrointestinal bleeding | 1 (2.1) | 1 (2.1) |
Hemoptysis | 1 (2.1) | 1 (2.1) |
Intracranial hemorrhage | 1 (2.1) | 1 (2.1) |
Acute pancreatitis | 1 (2.1) | 1 (2.1) |
Heart failure | 3 (6.3) | 3 (6.3) |
Renal failure | 2 (4.2) | 2 (4.2) |
Multiple organ and system failure | 1 (2.1) | 1 (2.1) |
Laboratory abnormalities | ||
ALT/AST elevation | 28 (58.3) | 11 (22.9) |
Blood bilirubin elevation | 7 (14.6) | 5 (10.4) |
Creatintine elevation | 8 (16.7) | 2 (4.2) |
Electrolyte disturbance | 1 (2.1) | 1 (2.1) |
Myocardial enzyme/BNP elevation | 14 (29.2) | 4 (8.3) |
Fibrinogen decreased | 3 (6.3) | 3 (6.3) |
NEs | ||
Encephalopathy | 11 (22.9) | 4 (8.3) |
Disturbance in attention | 6 (12.5) | 1 (2.1) |
Cognitive disorder | 6 (12.5) | 2 (4.2) |
Mental status changes | 1 (2.1) | 0 |
Memory impairment | 2 (4.2) | 1 (2.1) |
Lethargy | 4 (8.3) | 1 (2.1) |
Depressed level of consciousness | 10 (20.8) | 3 (6.3) |
Headache/dizziness | 7 (14.6) | 2 (4.2) |
Tremor | 2 (4.2) | 1 (2.1) |
Aphasia | 1 (2.1) | 1 (2.1) |
Delirium | 8 (16.7) | 2 (4.2) |
Motor dysfunction | 1 (2.1) | 1 (2.1) |
Ataxia | 2 (4.2) | 0 |
Seizure | 4 (8.3) | 4 (8.3) |
Vision disorder | 3 (6.3) | 3 (6.3) |
Tinnitus | 1 (2.1) | 1 (2.1) |
Data are presented as n (%). AEs were captured for all treated patients within the first 30 d after CAR T-cell infusion.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BNP, brain natriuretic peptide.