Table 3. AE and SAE Summary (SS).
| SS (N=32) | |||
|---|---|---|---|
| Type of adverse events | Patients with at least one event, n (%) | Severity by Grade | Number of events |
| Any AE | 30 (93.8%) | I, II, III, IV, V | 308 |
| Adverse drug reaction | 26 (81.3%) | 239 | |
| AE leading to drug withdrawal | 1 (3.1%) | 1 | |
| AE leading to death | 1 (3.1%) | 1 | |
| SAE | 5 (15.6%) | 6 | |
| Infection | 1 (3.1%) | III | 1 |
| Upper respiratory tract infection | 1 (3.1%) | III | 1 |
| Completed suicide | 1 (3.1%) | V | 1 |
| Leukopenia | 1 (3.1%) | IV | 1 |
| Neutropenia | 1 (3.1%) | IV | 1 |
| Cataract | 1 (3.1%) | III | 1 |
| AEs in at least 10% patients, by System Organ Class (SOC) | |||
| Investigations | |||
| Alanine aminotransferase increased | 4 (12.5%) | I, II | |
| Nervous System Disorders | |||
| Hypoaesthesia | 11 (34.4%) | I, II, III | |
| Injury, Poisoning and Procedural Complications | |||
| Neurotoxicity | 4 (12.5%) | I, II, III | |
| Respiratory, Thoracic and Mediastinal Disorders | |||
| Cough | 4 (12.5%) | I, II | |
| Skin and Subcutaneous Tissue Disorders | |||
| Alopecia | 7 (21.9%) | I, II | |
| Nail disorder | 5 (15.6%) | I, II | |
| General Disorders and Administration Site Reactions | |||
| Fever | 6 (18.8%) | I, II | |
| Asthenia | 7 (21.9%) | I, II, III | |
| Oedema peripheral | 5 (15.6%) | I, II | |
| Gastrointestinal Disorders | |||
| Diarrhea | 5 (15.6%) | I, II | |
| Vomiting | 4 (12.5%) | I, II | |
| Hypophagia | 5 (15.6%) | I, II | |
| Blood and Lymphatic System Disorders | |||
| Leukopenia | 19 (59.4%) | II, III, IV | |
| Granulocytopenia | 10 (31.3%) | II, III, IV | |
| Neutropenia | 18 (56.3%) | II, III, IV | |