Serious Drug-Related TEAEs (Safety Population)
| System organ class, preferred term | 6.0 GBq (n = 23) | 7.4 GBq (n = 41) | Overall (n = 64) |
|---|---|---|---|
| Any Serious Drug Related TEAE | 1 (4.3) | 4 (9.8) | 5 (7.8) |
| Blood and lymphatic system disorders | |||
| Anemia (grade 3, possibly related) | 0 | 1 (2.4) | 1 (1.6) |
| Thrombocytopenia (grade 4, possibly related) | 0 | 1 (2.4) | 1 (1.6) |
| Gastrointestinal disorders | |||
| Gastrointestinal hemorrhage (grade 3, possibly related) | 0 | 1 (2.4) | 1 (1.6) |
| General disorders | |||
| Death (grade 5, possibly related) | 0 | 1 (2.4) | 1 (1.6) |
| Injury complications | |||
| Subdural hematoma (grade 4 possibly related) | 1 (4.3) | 0 | 1 (1.6) |
| Renal and urinary disorders | |||
| Acute kidney injury (grade 3, possibly related) | 0 | 1 (2.4) | 1 (1.6) |
| Respiratory, thoracic and mediastinal disorders | |||
| Pleural effusion (grade 3, possibly related) | 0 | 1 (2.4) | 1 (1.6) |
Results given as xx (xx.x) where xx = number of patients with serious, drug-related TEAEs, (xx.x) = percentage of patients. Every patient was counted a single time for each applicable specific serious, drug-related AE with highest severity. A patient with multiple serious, drug-related TEAEs within a system organ class (SOC) was counted a single time for that SOC with the highest severity. None of the Serious drug-related TEAEs were considered as probably or definitely related to treatment by the investigators and all were reported as possibly related to treatment. Data in parentheses are percentages.