AEs within 1 month that were potentially related to CAR T-cell infusion
AEs . | Any . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . |
---|---|---|---|---|---|
Any | 28 (100) | 2 (7) | 7 (25) | 10 (36) | 9 (32) |
CRS | 14 (50) | 8 (29) | 2 (7) | 4 (14) | |
CRES | 6 (21) | 4 (14) | 2 (7) | ||
General disorders and administration site conditions | |||||
Pyrexia | 25 (89) | 10 (36) | 5 (18) | 10 (36) | |
Fatigue | 27 (96) | 25 (89) | 2 (7) | ||
Skeletal joint pain | 10 (36) | 10 (36) | |||
Skin rash | 6 (21) | 6 (21) | |||
Edema | 8 (29) | 6 (21) | 1 (4) | 1 (4) | |
Headache | 7 (25) | 7 (25) | |||
Dizziness | 10 (36) | 10 (36) | |||
Rigor | 12 (43) | 9 (32) | 3 (11) | ||
Hyponoia | 3 (11) | 2 (7) | 1 (4) | ||
Laboratory tests | |||||
Increased alanine aminotransferase | 10 (36) | 8 (29) | 2 (7) | ||
Increased aspartate aminotransferase | 13 (47) | 10 (36) | 3 (11) | ||
Increased γ-glutamy ltransferase | 8 (29) | 3 (11) | 3 (11) | 2 (7) | |
Increased creatinine | 1 (4) | 1 (4) | |||
Increased total bilirubin | 3 (11) | 2 (7) | 1 (4) | ||
Decreased platelet count | 21 (75) | 10 (36) | 4 (14) | 3 (11) | 4 (14) |
Neutropenia | 22 (79) | 1 (4) | 4 (14) | 9 (32) | 8 (29) |
Disorders of the blood and lymphatic, respiratory, renal, and GI systems | |||||
Anemia | 4 (14) | 4 (14) | |||
Hypotension | 7 (25) | 3 (11) | 2 (7) | 2 (7) | |
Hypoalbuminemia | 8 (29) | 8 (29) | |||
Hypokalemia | 4 (14) | 3 (11) | 1 (4) | ||
Hyponatremia | 11 (39) | 9 (32) | 1 (4) | 1 (4) | |
Hypocalcemia | 1 (4) | 1 (4) | |||
Tachycardia | 12 (43) | 8 (29) | 3 (11) | 1 (4) | |
Dyspnea | 3 (11) | 1 (4) | 1 (4) | 1 (4) | |
Diarrhea | 7 (25) | 7 (25) | |||
Neurologic events | |||||
Anxiety | 3 (11) | 1 (4) | 1 (4) | 1 (4) | |
Somnolence | 1 (4) | 1 (4) | |||
Tremor | 5 (18) | 5 (18) | |||
Disturbance in attention | 3 (11) | 2 (7) | 1 (4) | ||
Speech disorder | 1 (4) | 1 (4) | |||
Abnormal thinking | 1 (4) | 1 (4) | |||
Infections | |||||
Herpes zoster | 15 (54) | 12 (43) | 2 (7) | 1 (4) | |
Viral infection | 3 (11) | 2 (7) | 1 (4) | ||
Bacterial infection | 6 (21) | 5 (18) | 1 (4) |
AEs . | Any . | Grade 1 . | Grade 2 . | Grade 3 . | Grade 4 . |
---|---|---|---|---|---|
Any | 28 (100) | 2 (7) | 7 (25) | 10 (36) | 9 (32) |
CRS | 14 (50) | 8 (29) | 2 (7) | 4 (14) | |
CRES | 6 (21) | 4 (14) | 2 (7) | ||
General disorders and administration site conditions | |||||
Pyrexia | 25 (89) | 10 (36) | 5 (18) | 10 (36) | |
Fatigue | 27 (96) | 25 (89) | 2 (7) | ||
Skeletal joint pain | 10 (36) | 10 (36) | |||
Skin rash | 6 (21) | 6 (21) | |||
Edema | 8 (29) | 6 (21) | 1 (4) | 1 (4) | |
Headache | 7 (25) | 7 (25) | |||
Dizziness | 10 (36) | 10 (36) | |||
Rigor | 12 (43) | 9 (32) | 3 (11) | ||
Hyponoia | 3 (11) | 2 (7) | 1 (4) | ||
Laboratory tests | |||||
Increased alanine aminotransferase | 10 (36) | 8 (29) | 2 (7) | ||
Increased aspartate aminotransferase | 13 (47) | 10 (36) | 3 (11) | ||
Increased γ-glutamy ltransferase | 8 (29) | 3 (11) | 3 (11) | 2 (7) | |
Increased creatinine | 1 (4) | 1 (4) | |||
Increased total bilirubin | 3 (11) | 2 (7) | 1 (4) | ||
Decreased platelet count | 21 (75) | 10 (36) | 4 (14) | 3 (11) | 4 (14) |
Neutropenia | 22 (79) | 1 (4) | 4 (14) | 9 (32) | 8 (29) |
Disorders of the blood and lymphatic, respiratory, renal, and GI systems | |||||
Anemia | 4 (14) | 4 (14) | |||
Hypotension | 7 (25) | 3 (11) | 2 (7) | 2 (7) | |
Hypoalbuminemia | 8 (29) | 8 (29) | |||
Hypokalemia | 4 (14) | 3 (11) | 1 (4) | ||
Hyponatremia | 11 (39) | 9 (32) | 1 (4) | 1 (4) | |
Hypocalcemia | 1 (4) | 1 (4) | |||
Tachycardia | 12 (43) | 8 (29) | 3 (11) | 1 (4) | |
Dyspnea | 3 (11) | 1 (4) | 1 (4) | 1 (4) | |
Diarrhea | 7 (25) | 7 (25) | |||
Neurologic events | |||||
Anxiety | 3 (11) | 1 (4) | 1 (4) | 1 (4) | |
Somnolence | 1 (4) | 1 (4) | |||
Tremor | 5 (18) | 5 (18) | |||
Disturbance in attention | 3 (11) | 2 (7) | 1 (4) | ||
Speech disorder | 1 (4) | 1 (4) | |||
Abnormal thinking | 1 (4) | 1 (4) | |||
Infections | |||||
Herpes zoster | 15 (54) | 12 (43) | 2 (7) | 1 (4) | |
Viral infection | 3 (11) | 2 (7) | 1 (4) | ||
Bacterial infection | 6 (21) | 5 (18) | 1 (4) |
All data are n (%). Individual symptoms of AEs were graded using CTCAE, version 4.0.
GI, gastrointestinal.