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.