Table 2.
Adverse events
| System organ class and preferred term (MedDRA 26.0) | Grade 1 | Grade 2 | Grade 3 | Total |
|---|---|---|---|---|
| Investigations, n (%) | 4 (40.0) | 2 (20.0) | 0 | 6 (60.0) |
| Blood glucose increased | 2 (20.0) | 0 | 0 | 2 (20.0) |
| Urinary occult blood positive | 2 (20.0) | 0 | 0 | 2 (20.0) |
| White blood cells urine positive | 2 (20.0) | 0 | 0 | 2 (20.0) |
| Bilirubin conjugated increased | 0 | 1 (10.0) | 0 | 1 (10.0) |
| Blood pressure increased | 0 | 1 (10.0) | 0 | 1 (10.0) |
| Glomerular filtration rate decreased | 1 (10.0) | 0 | 0 | 1 (10.0) |
| Glucose urine present | 1 (10.0) | 0 | 0 | 1 (10.0) |
| Neutrophil count decreased | 1 (10.0) | 0 | 0 | 1 (10.0) |
| Protein total decreased | 1 (10.0) | 0 | 0 | 1 (10.0) |
| Red blood cells urine positive | 1 (10.0) | 0 | 0 | 1 (10.0) |
| White blood cell count decreased | 1 (10.0) | 0 | 0 | 1 (10.0) |
| Blood and lymphatic system disorders, n (%) | 2 (20.0) | 0 | 1 (10.0) | 3 (30.0) |
| Anemia | 2 (20.0) | 0 | 1 (10.0) | 3 (30.0) |
| Cardiac disorders, n (%) | 2 (20.0) | 0 | 0 | 2 (20.0) |
| Atrioventricular block first degree | 2 (20.0) | 0 | 0 | 2 (20.0) |
| Injury, poisoning and procedural complications, n (%) | 2 (20.0) | 0 | 0 | 2 (20.0) |
| Post procedural inflammation | 2 (20.0) | 0 | 0 | 2 (20.0) |
| Metabolism and nutrition disorders, n (%) | 1 (10.0) | 1 (10.0) | 0 | 2 (20.0) |
| Hypoalbuminemia | 1 (10.0) | 0 | 0 | 1 (10.0) |
| Hypocalcaemia | 0 | 1 (10.0) | 0 | 1 (10.0) |
| Hyponatremia | 1 (10.0) | 0 | 0 | 1 (10.0) |
| Gastrointestinal disorders, n (%) | 0 | 1 (10.0) | 0 | 1 (10.0) |
| Vomiting | 0 | 1 (10.0) | 0 | 1 (10.0) |
The severity of adverse events was graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events version 5.0. Patients with multiple occurrences of adverse events in the same preferred term or system organ class are counted only once within that preferred term or system organ class. Percentages are based on the number of all included patients (N = 10). No adverse events were considered to be related to [89Zr]Zr-girentuximab