Table 4.
Treatment-emergent adverse events (N = 6)
| System organ class: MedDRA 16.0 preferred term | Patients, n (%) | |||
|---|---|---|---|---|
| Grade 1 AE | Grade 2 AE | Grade 3 AE | Grade 4 AE | |
| Blood and lymphatic system disorders | 0 | 0 | 1 (17) | 2 (33) |
| Anemia | 0 | 1 (17) | 2 (33) | 0 |
| Neutropenia | 0 | 0 | 0 | 1 (17) |
| Thrombocytopenia | 0 | 0 | 0 | 2 (33) |
| Cardiac disorders | 0 | 1 (17) | 0 | 0 |
| Atrial fibrillation | 0 | 1 (17) | 0 | 0 |
| Gastrointestinal disorders | 2 (33) | 3 (50) | 1 (17) | 0 |
| Abdominal pain | 1 (17) | 0 | 1 (17) | 0 |
| Abdominal pain upper | 1 (17) | 0 | 0 | 0 |
| Constipation | 0 | 2 (33) | 0 | 0 |
| Diarrhea | 1 (17) | 1 (17) | 0 | 0 |
| Nausea | 3 (50) | 0 | 0 | 0 |
| Vomiting | 1 (17) | 0 | 0 | 0 |
| General disorders and administration site conditions | 0 | 4 (67) | 1 (17) | 0 |
| Fatigue | 0 | 4 (67) | 1 (17) | 0 |
| Influenza-like illness | 1 (17) | 0 | 0 | 0 |
| Injection site rash | 1 (17) | 0 | 0 | 0 |
| Pyrexia | 1 (17) | 0 | 0 | 0 |
| Infections and infestations | 0 | 1 (17) | 0 | 0 |
| Cystitis | 0 | 1 (17) | 0 | 0 |
| Investigations | 0 | 0 | 0 | 1 (17) |
| Blood bilirubin increased | 0 | 1 (17) | 0 | 0 |
| Neutrophil count decreased | 0 | 0 | 0 | 1 (17) |
| Platelet count decreased | 0 | 0 | 1 (17) | 0 |
| White blood cell count decrease | 0 | 0 | 1 (17) | 0 |
| Metabolism and nutrition disorders | 1 (17) | 0 | 1 (17) | 0 |
| Hypocalcaemia | 1 (17) | 0 | 0 | 0 |
| Hypokalemia | 1 (17) | 0 | 0 | 0 |
| Hypophosphatemia | 0 | 0 | 1 (17) | 0 |
| Musculoskeletal and connective tissue disorders | 3 (50) | 2 (33) | 0 | 0 |
| Back pain | 1 (17) | 2 (33) | 0 | 0 |
| Myalgia | 2 (33) | 0 | 0 | 0 |
| Pain in extremity | 1 (17) | 0 | 0 | 0 |
| Psychiatric disorders | 0 | 1 (17) | 0 | 0 |
| Anxiety | 0 | 1 (17) | 0 | 0 |
| Reproductive system and breast disorders | 1 (17) | 0 | 0 | 0 |
| Pelvic pain | 1 (17) | 0 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | 0 | 2 (33) | 1 (17) | 0 |
| Cough | 0 | 1 (17) | 0 | 0 |
| Dyspnea | 0 | 1 (17) | 1 (17) | 0 |
| Skin and subcutaneous tissue disorders | 1 (17) | 0 | 0 | 0 |
| Erythema | 1 (17) | 0 | 0 | 0 |
| Vascular disorders | 1 (17) | 0 | 0 | 0 |
| Flushing | 1 (17) | 0 | 0 | 0 |
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities
If a patient reported an AE more than once, the greatest severity is presented for that AE. Patients were counted only once in each preferred term category and only once in each system organ class category, at the greatest severity for each