Reported treatment-emergent AEs according to MedDRA, all grades, >5% safety population, or of clinical significance
| System organ class (MedDRA) . | TEAEs, n . | Patients . | |
|---|---|---|---|
| n . | % . | ||
| Infections and infestations | 28 | 22 | 55.0 |
| Bronchitis | 9 | 9 | 22.5 |
| Pneumonia | 4 | 4 | 10.0 |
| Urinary tract infection | 3 | 3 | 7.5 |
| Rhinitis | 3 | 3 | 7.5 |
| Skin infection | 3 | 2 | 5.0 |
| General disorders and administration site conditions | 39 | 21 | 52.5 |
| Asthenia | 10 | 10 | 25.0 |
| Edema | 10 | 8 | 20.0 |
| Fever | 6 | 6 | 15.0 |
| Inflammation | 3 | 3 | 7.5 |
| Chills | 3 | 3 | 7.5 |
| Chest pain | 4 | 3 | 7.5 |
| Gastrointestinal disorders | 31 | 17 | 42.5 |
| Diarrhea | 11 | 9 | 22.5 |
| Constipation | 6 | 6 | 15.0 |
| Nausea | 5 | 5 | 12.5 |
| Vomiting | 4 | 4 | 10.0 |
| Abdominal pain | 3 | 3 | 7.5 |
| Respiratory, thoracic, and mediastinal disorders | 17 | 12 | 30.0 |
| Cough | 8 | 7 | 17.5 |
| Dyspnea | 6 | 4 | 10.0 |
| Rhinorrhea | 2 | 2 | 5.0 |
| Pleural effusion | 1 | 1 | 2.5 |
| Bronchospasm (IRR) | 1 | 1 | 2.5 |
| Nervous system disorders | 14 | 11 | 27.5 |
| Neuropathy peripheral | 5 | 5 | 12.5 |
| Headache | 4 | 4 | 10.0 |
| Tremor | 2 | 2 | 5.0 |
| Ruptured cerebral aneurysm | 1 | 1 | 2.5 |
| Vascular disorders | 13 | 11 | 27.5 |
| Hypertension | 5 | 4 | 10.0 |
| Hypotension | 2 | 2 | 5.0 |
| Orthostatic hypotension | 3 | 2 | 5.0 |
| Injury, poisoning, and procedural complications | 8 | 7 | 17.5 |
| Infusion-related reaction | 5 | 5 | 12.5 |
| Fall | 2 | 2 | 5.0 |
| Musculoskeletal and connective tissue disorders | 10 | 6 | 15.0 |
| Pain | 6 | 4 | 10.0 |
| Cardiac disorders | 10 | 6 | 15.0 |
| Arrhythmia | 6 | 3 | 7.5 |
| Heart failure | 2 | 1 | 2.5 |
| Angina pectoris | 1 | 1 | 2.5 |
| Cardiac arrest | 1 | 1 | 2.5 |
| Investigations | 10 | 4 | 10.0 |
| Blood creatinine increased | 3 | 1 | 2.5 |
| Metabolism and nutrition disorders | 7 | 6 | 15.0 |
| Hyperkalemia | 3 | 3 | 7.5 |
| Psychiatric disorders | 6 | 5 | 12.5 |
| Skin and subcutaneous tissue disorders | 5 | 5 | 12.5 |
| Blood and lymphatic system disorders | 5 | 4 | 10.0 |
| Anemia | 2 | 2 | 5.0 |
| Eye disorders | 4 | 4 | 10.0 |
| Blurred vision | 2 | 2 | 5.0 |
| Congenital, familial, and genetic disorders | 2 | 2 | 5.0 |
| Macroglossia | 2 | 2 | 5.0 |
| Neoplasms: benign, malignant, and unspecified (including cysts and polyps) | 2 | 2 | 5.0 |
| Lung adenocarcinoma | 1 | 1 | 2.5 |
| Colon cancer | 1 | 1 | 2.5 |
| Ear and labyrinth disorders | 2 | 2 | 5.0 |
| Renal and urinary disorders | 1 | 1 | 2.5 |
| Renal failure | 1 | 1 | 2.5 |
| Surgical and medical procedures | 1 | 1 | 2.5 |
| Cardiac pacemaker insertion | 1 | 1 | 2.5 |
| System organ class (MedDRA) . | TEAEs, n . | Patients . | |
|---|---|---|---|
| n . | % . | ||
| Infections and infestations | 28 | 22 | 55.0 |
| Bronchitis | 9 | 9 | 22.5 |
| Pneumonia | 4 | 4 | 10.0 |
| Urinary tract infection | 3 | 3 | 7.5 |
| Rhinitis | 3 | 3 | 7.5 |
| Skin infection | 3 | 2 | 5.0 |
| General disorders and administration site conditions | 39 | 21 | 52.5 |
| Asthenia | 10 | 10 | 25.0 |
| Edema | 10 | 8 | 20.0 |
| Fever | 6 | 6 | 15.0 |
| Inflammation | 3 | 3 | 7.5 |
| Chills | 3 | 3 | 7.5 |
| Chest pain | 4 | 3 | 7.5 |
| Gastrointestinal disorders | 31 | 17 | 42.5 |
| Diarrhea | 11 | 9 | 22.5 |
| Constipation | 6 | 6 | 15.0 |
| Nausea | 5 | 5 | 12.5 |
| Vomiting | 4 | 4 | 10.0 |
| Abdominal pain | 3 | 3 | 7.5 |
| Respiratory, thoracic, and mediastinal disorders | 17 | 12 | 30.0 |
| Cough | 8 | 7 | 17.5 |
| Dyspnea | 6 | 4 | 10.0 |
| Rhinorrhea | 2 | 2 | 5.0 |
| Pleural effusion | 1 | 1 | 2.5 |
| Bronchospasm (IRR) | 1 | 1 | 2.5 |
| Nervous system disorders | 14 | 11 | 27.5 |
| Neuropathy peripheral | 5 | 5 | 12.5 |
| Headache | 4 | 4 | 10.0 |
| Tremor | 2 | 2 | 5.0 |
| Ruptured cerebral aneurysm | 1 | 1 | 2.5 |
| Vascular disorders | 13 | 11 | 27.5 |
| Hypertension | 5 | 4 | 10.0 |
| Hypotension | 2 | 2 | 5.0 |
| Orthostatic hypotension | 3 | 2 | 5.0 |
| Injury, poisoning, and procedural complications | 8 | 7 | 17.5 |
| Infusion-related reaction | 5 | 5 | 12.5 |
| Fall | 2 | 2 | 5.0 |
| Musculoskeletal and connective tissue disorders | 10 | 6 | 15.0 |
| Pain | 6 | 4 | 10.0 |
| Cardiac disorders | 10 | 6 | 15.0 |
| Arrhythmia | 6 | 3 | 7.5 |
| Heart failure | 2 | 1 | 2.5 |
| Angina pectoris | 1 | 1 | 2.5 |
| Cardiac arrest | 1 | 1 | 2.5 |
| Investigations | 10 | 4 | 10.0 |
| Blood creatinine increased | 3 | 1 | 2.5 |
| Metabolism and nutrition disorders | 7 | 6 | 15.0 |
| Hyperkalemia | 3 | 3 | 7.5 |
| Psychiatric disorders | 6 | 5 | 12.5 |
| Skin and subcutaneous tissue disorders | 5 | 5 | 12.5 |
| Blood and lymphatic system disorders | 5 | 4 | 10.0 |
| Anemia | 2 | 2 | 5.0 |
| Eye disorders | 4 | 4 | 10.0 |
| Blurred vision | 2 | 2 | 5.0 |
| Congenital, familial, and genetic disorders | 2 | 2 | 5.0 |
| Macroglossia | 2 | 2 | 5.0 |
| Neoplasms: benign, malignant, and unspecified (including cysts and polyps) | 2 | 2 | 5.0 |
| Lung adenocarcinoma | 1 | 1 | 2.5 |
| Colon cancer | 1 | 1 | 2.5 |
| Ear and labyrinth disorders | 2 | 2 | 5.0 |
| Renal and urinary disorders | 1 | 1 | 2.5 |
| Renal failure | 1 | 1 | 2.5 |
| Surgical and medical procedures | 1 | 1 | 2.5 |
| Cardiac pacemaker insertion | 1 | 1 | 2.5 |
IRR, infusion related reaction; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent AE.