Table 3.
Description of AEs (grade 3/4) leading to treatment changes by SOC classes and Preferred Terms (PT) per SOC in patients of set #1 (n=188)
| Grade 3/4 AE leading to | ||||||||
|---|---|---|---|---|---|---|---|---|
| Any change* | Dose reduction | Interruption | Discontinuation | |||||
| n | % | n | % | n | % | n | % | |
| Patients with AE of any SOC | 18 | 9.6 | 3 | 1.6 | 7 | 3.7 | 11 | 5.9 |
| Blood and lymphatic system disorders | 4 | 2.1 | 1 | 0.5 | 3 | 1.6 | 1 | 0.5 |
| Neutropenia | 3 | 1.6 | - | - | 3 | 1.6 | 1 | 0.5 |
| Haematotoxicity | 1 | 0.5 | 1 | 0.5 | - | - | - | - |
| Infections and infestations | 4 | 2.1 | - | - | 1 | 0.5 | 3 | 1.6 |
| Coronavirus infection | 2 | 1.1 | - | - | 1 | 0.5 | 1 | 0.5 |
| Brain abscess | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Septic shock | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Cardiac disorders | 2 | 1.1 | - | - | - | - | 2 | 1.1 |
| Angina pectoris | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Myocardial infarction | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Eye disorders | 1 | 0.5 | - | - | 1 | 0.5 | 1 | 0.5 |
| Diplopia | 1 | 0.5 | - | - | 1 | 0.5 | 1 | 0.5 |
| Gastrointestinal disorders | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Diarrhoea | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| General disorders and administration site conditions | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| General physical health deterioration | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Injury, poisoning and procedural complications | 1 | 0.5 | - | - | 1 | 0.5 | - | - |
| Post procedural haematoma | 1 | 0.5 | - | - | 1 | 0.5 | - | - |
| Metabolism and nutrition disorders | 1 | 0.5 | 1 | 0.5 | - | - | - | - |
| Hyponatraemia | 1 | 0.5 | 1 | 0.5 | - | - | - | - |
| Neoplasms benign, malignant and unspecified | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Lung adenocarcinoma | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Respiratory, thoracic and mediastinal disorders | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Acute respiratory failure | 1 | 0.5 | - | - | - | - | 1 | 0.5 |
| Not specified** | 2 | 1.1 | 1 | 0.5 | 1 | 0.5 | 1 | 0.5 |
*Any change includes change or interruption or discontinuation - one AE can lead to different changes
**No more information at the time of the interim analysis - SOC: System Organ Class according to MedDRA V25.0