Table 1.

Patients with grade 3 or higher adverse events in the LyMa-101 trial

Patients treated, n = 85Grade 3Grade 4Grade 5
Patients
n = 6
Patients
n = 74
Patients
n = 2
Patients with at least 1 AE 6 (7.1%) 74 (87.1%) 2 (2.4%) 
Blood and lymphatic system disorders 4 (4.7%) 65 (76.5%) 0 (0.0%) 
Anemia 2 (2.4%) 43 (50.6%) 0 (0.0%) 
Neutropenia 1 (1.2%) 43 (50.6%) 0 (0.0%) 
Thrombocytopenia 1 (1.2%) 40 (47.1%) 0 (0.0%) 
Leukopenia 0 (0.0%) 16 (18.8%) 0 (0.0%) 
Febrile neutropenia 0 (0.0%) 15 (17.6%) 0 (0.0%) 
Lymphopenia 0 (0.0%) 14 (16.5%) 0 (0.0%) 
Febrile BM aplasia 2 (2.4%) 7 (8.2%) 0 (0.0%) 
Infections and infestations 2 (2.4%) 45 (52.9%) 1 (1.2%) 
Pneumonia 0 (0.0%) 6 (7.1%) 0 (0.0%) 
COVID-19 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Escherichia sepsis 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Human herpesvirus 6 infection 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Sinusitis 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Bronchitis 0 (0.0%) 3 (3.5%) 0 (0.0%) 
COVID-19 pneumonia 0 (0.0%) 2 (2.4%) 1 (1.2%) 
Sepsis 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Device-related infection 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hepatitis E 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Influenza 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Haemophilus pneumonia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Post–acute COVID-19 syndrome 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Staphylococcal infection 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Staphylococcal sepsis 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Gastrointestinal disorders 2 (2.4%) 38 (44.7%) 0 (0.0%) 
Stomatitis 1 (1.2%) 23 (27.1%) 0 (0.0%) 
Diarrhea 1 (1.2%) 9 (10.6%) 0 (0.0%) 
Colitis 1 (1.2%) 7 (8.2%) 0 (0.0%) 
Nausea 0 (0.0%) 6 (7.1%) 0 (0.0%) 
Vomiting 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Rectal hemorrhage 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Investigations 1 (1.2%) 39 (45.9%) 0 (0.0%) 
Platelet count decreased 1 (1.2%) 28 (32.9%) 0 (0.0%) 
Neutrophil count decreased 1 (1.2%) 21 (24.7%) 0 (0.0%) 
Lymphocyte count decreased 0 (0.0%) 16 (18.8%) 0 (0.0%) 
White blood cell count decreased 0 (0.0%) 14 (16.5%) 0 (0.0%) 
Gamma-glutamyl transferase increased 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Respiratory, thoracic, and mediastinal disorders 1 (1.2%) 11 (12.9%) 0 (0.0%) 
Lung disorder 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Pleural effusion 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Metabolism and nutrition disorders 0 (0.0%) 11 (12.9%) 0 (0.0%) 
Hypokalemia 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Tumor lysis syndrome 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Decreased appetite 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hyperglycemia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hyponatremia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
General disorders and administration site conditions 1 (1.2%) 9 (10.6%) 0 (0.0%) 
Pyrexia 0 (0.0%) 7 (8.2%) 0 (0.0%) 
General physical health deterioration 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hepatobiliary disorders 1 (1.2%) 6 (7.1%) 0 (0.0%) 
Hepatic cytolysis 1 (1.2%) 5 (5.9%) 0 (0.0%) 
Cholestasis 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Neoplasms, benign, malignant, and unspecified (cysts and polyps) 0 (0.0%) 7 (8.2%) 0 (0.0%) 
Prostate cancer 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Cardiac disorders 0 (0.0%) 4 (4.7%) 1 (1.2%) 
Myocardial infarction 0 (0.0%) 0 (0.0%) 1 (1.2%) 
Nervous system disorders 0 (0.0%) 5 (5.9%) 0 (0.0%) 
Presyncope 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Renal and urinary disorders 1 (1.2%) 4 (4.7%) 0 (0.0%) 
Renal failure 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Injury, poisoning, and procedural complications 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Infusion-related reaction 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Immune system disorders 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Hypogammaglobulinemia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Psychiatric disorders 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Skin and subcutaneous tissue disorders 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Vascular disorders 1 (1.2%) 2 (2.4%) 0 (0.0%) 
Patients treated, n = 85Grade 3Grade 4Grade 5
Patients
n = 6
Patients
n = 74
Patients
n = 2
Patients with at least 1 AE 6 (7.1%) 74 (87.1%) 2 (2.4%) 
Blood and lymphatic system disorders 4 (4.7%) 65 (76.5%) 0 (0.0%) 
Anemia 2 (2.4%) 43 (50.6%) 0 (0.0%) 
Neutropenia 1 (1.2%) 43 (50.6%) 0 (0.0%) 
Thrombocytopenia 1 (1.2%) 40 (47.1%) 0 (0.0%) 
Leukopenia 0 (0.0%) 16 (18.8%) 0 (0.0%) 
Febrile neutropenia 0 (0.0%) 15 (17.6%) 0 (0.0%) 
Lymphopenia 0 (0.0%) 14 (16.5%) 0 (0.0%) 
Febrile BM aplasia 2 (2.4%) 7 (8.2%) 0 (0.0%) 
Infections and infestations 2 (2.4%) 45 (52.9%) 1 (1.2%) 
Pneumonia 0 (0.0%) 6 (7.1%) 0 (0.0%) 
COVID-19 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Escherichia sepsis 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Human herpesvirus 6 infection 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Sinusitis 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Bronchitis 0 (0.0%) 3 (3.5%) 0 (0.0%) 
COVID-19 pneumonia 0 (0.0%) 2 (2.4%) 1 (1.2%) 
Sepsis 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Device-related infection 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hepatitis E 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Influenza 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Haemophilus pneumonia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Post–acute COVID-19 syndrome 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Staphylococcal infection 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Staphylococcal sepsis 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Gastrointestinal disorders 2 (2.4%) 38 (44.7%) 0 (0.0%) 
Stomatitis 1 (1.2%) 23 (27.1%) 0 (0.0%) 
Diarrhea 1 (1.2%) 9 (10.6%) 0 (0.0%) 
Colitis 1 (1.2%) 7 (8.2%) 0 (0.0%) 
Nausea 0 (0.0%) 6 (7.1%) 0 (0.0%) 
Vomiting 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Rectal hemorrhage 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Investigations 1 (1.2%) 39 (45.9%) 0 (0.0%) 
Platelet count decreased 1 (1.2%) 28 (32.9%) 0 (0.0%) 
Neutrophil count decreased 1 (1.2%) 21 (24.7%) 0 (0.0%) 
Lymphocyte count decreased 0 (0.0%) 16 (18.8%) 0 (0.0%) 
White blood cell count decreased 0 (0.0%) 14 (16.5%) 0 (0.0%) 
Gamma-glutamyl transferase increased 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Respiratory, thoracic, and mediastinal disorders 1 (1.2%) 11 (12.9%) 0 (0.0%) 
Lung disorder 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Pleural effusion 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Metabolism and nutrition disorders 0 (0.0%) 11 (12.9%) 0 (0.0%) 
Hypokalemia 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Tumor lysis syndrome 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Decreased appetite 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hyperglycemia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hyponatremia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
General disorders and administration site conditions 1 (1.2%) 9 (10.6%) 0 (0.0%) 
Pyrexia 0 (0.0%) 7 (8.2%) 0 (0.0%) 
General physical health deterioration 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Hepatobiliary disorders 1 (1.2%) 6 (7.1%) 0 (0.0%) 
Hepatic cytolysis 1 (1.2%) 5 (5.9%) 0 (0.0%) 
Cholestasis 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Neoplasms, benign, malignant, and unspecified (cysts and polyps) 0 (0.0%) 7 (8.2%) 0 (0.0%) 
Prostate cancer 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Cardiac disorders 0 (0.0%) 4 (4.7%) 1 (1.2%) 
Myocardial infarction 0 (0.0%) 0 (0.0%) 1 (1.2%) 
Nervous system disorders 0 (0.0%) 5 (5.9%) 0 (0.0%) 
Presyncope 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Renal and urinary disorders 1 (1.2%) 4 (4.7%) 0 (0.0%) 
Renal failure 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Injury, poisoning, and procedural complications 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Infusion-related reaction 0 (0.0%) 4 (4.7%) 0 (0.0%) 
Immune system disorders 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Hypogammaglobulinemia 0 (0.0%) 2 (2.4%) 0 (0.0%) 
Psychiatric disorders 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Skin and subcutaneous tissue disorders 0 (0.0%) 3 (3.5%) 0 (0.0%) 
Vascular disorders 1 (1.2%) 2 (2.4%) 0 (0.0%) 

Grade 3 or higher AEs with at least 2 instances are reported by worse grade for the 85 patients treated in LyMa-101 trial.

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