Patients with grade 3 or higher adverse events in the LyMa-101 trial
| Patients treated, n = 85 . | Grade 3 . | Grade 4 . | Grade 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 = 85 . | Grade 3 . | Grade 4 . | Grade 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.