Table 2.
Adverse events during induction phase with VPM1002BC graded according to common terminology criteria for adverse events (CTCAE) Version 4.0.
| CTCAE SOC | Term | Grade 1 n (%) | Grade 2 n (%) |
|---|---|---|---|
| Blood and lymphatic system disorders | Anemia | 2 (33.3%) | |
| Gastrointestinal disorders | Abdominal pain | 1 (16.7%) | |
| Infections and infestations | Asymptomatic bladder infection | 1 (16.7%) | |
| Prostate infection | 1 (16.7%) | ||
| Asymptomatic urinary enterococcus faecalis | 1 (16.7%) | ||
| Asymptomatic urinary tract infection | 1 (16.7%) | ||
| Investigations | Creatinine increased | 1 (16.7%) | |
| Nervous system disorders | Headache | 1 (16.7%) | |
| Renal and urinary disorders | Alguria | 2 (33.3%) | |
| Decreased GFR/Chronic kidney disease* | 1 (16.7%) | ||
| Hematuria | 1 (16.7%) | ||
| Nycturia | 1 (16.7%) | ||
| Skin and subcutaneous tissue disorders | Temporary redness of the skin | 1 (16.7%) | |
| Vascular disorders | Hematoma | 1 (16.7%) |
* grade 1 at baseline.