Table 4.

Overview of TEAEs in the overall population

Overall, N = 103Any grade, n (%)Grade ≥3, n (%)
Any AE 103 (100.0) 97 (94.2) 
Serious AE 76 (73.8) 54 (52.4) 
AE leading to treatment discontinuation 36 (35.0) 30 (29.1) 
AEs in ≥15% of patients   
Hematologic AEs   
Thrombocytopenia  75 (72.8) 61 (59.2) 
Neutropenia  67 (65.0) 59 (57.3) 
Anemia  61 (59.2) 44 (42.7) 
Infections§  74 (71.8) 30 (29.1) 
COVID-19||  30 (29.1) 11 (10.7) 
CRS  54 (52.4) 1 (1.0) 
Diarrhea 48 (46.6) 5 (4.9) 
Nausea 41 (39.8) 2 (1.9) 
Fatigue 36 (35.0) 7 (6.8) 
Hypokalemia 32 (31.1) 9 (8.7) 
Pyrexia 30 (29.1) 
Increased alanine aminotransferase 29 (28.2) 10 (9.7) 
Increased aspartate aminotransferase 26 (25.2) 6 (5.8) 
Peripheral neuropathy 26 (25.2) 1 (1.0) 
Cough 21 (20.4) 
Hypomagnesemia 20 (19.4) 
Decreased appetite 19 (18.4) 3 (2.9) 
Increased lipase 19 (18.4) 6 (5.8) 
Injection-site reaction#  18 (17.5) 
Dyspnea 17 (16.5) 2 (1.9) 
Constipation 16 (15.5) 
AEs of special interest   
CRS  54 (52.4) 1 (1.0) 
ICANS 3 (2.9) 1 (1.0) 
Clinical tumor lysis syndrome 
Overall, N = 103Any grade, n (%)Grade ≥3, n (%)
Any AE 103 (100.0) 97 (94.2) 
Serious AE 76 (73.8) 54 (52.4) 
AE leading to treatment discontinuation 36 (35.0) 30 (29.1) 
AEs in ≥15% of patients   
Hematologic AEs   
Thrombocytopenia  75 (72.8) 61 (59.2) 
Neutropenia  67 (65.0) 59 (57.3) 
Anemia  61 (59.2) 44 (42.7) 
Infections§  74 (71.8) 30 (29.1) 
COVID-19||  30 (29.1) 11 (10.7) 
CRS  54 (52.4) 1 (1.0) 
Diarrhea 48 (46.6) 5 (4.9) 
Nausea 41 (39.8) 2 (1.9) 
Fatigue 36 (35.0) 7 (6.8) 
Hypokalemia 32 (31.1) 9 (8.7) 
Pyrexia 30 (29.1) 
Increased alanine aminotransferase 29 (28.2) 10 (9.7) 
Increased aspartate aminotransferase 26 (25.2) 6 (5.8) 
Peripheral neuropathy 26 (25.2) 1 (1.0) 
Cough 21 (20.4) 
Hypomagnesemia 20 (19.4) 
Decreased appetite 19 (18.4) 3 (2.9) 
Increased lipase 19 (18.4) 6 (5.8) 
Injection-site reaction#  18 (17.5) 
Dyspnea 17 (16.5) 2 (1.9) 
Constipation 16 (15.5) 
AEs of special interest   
CRS  54 (52.4) 1 (1.0) 
ICANS 3 (2.9) 1 (1.0) 
Clinical tumor lysis syndrome 

Thrombocytopenia includes hematopoietic thrombocytopenia using the Standardized Medical Dictionary for Regulatory Activities Query narrow search.

Neutropenia includes neutropenia and decreased neutrophil count.

Anemia includes anemia, decreased hematocrit, decreased hemoglobin, decreased red blood cell count, and decreased serum ferritin.

§

Infections and infestations by system organ class.

||

COVID-19 includes COVID-19, COVID-19 pneumonia, and post–acute COVID-19 syndrome.

CRS is shown twice (as an AE in ≥15% of patients and as an AE of special interest).

#

Injection-site reaction includes injection-site reactions as high-level group terms.

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