Table 6.
Summary of SAEs by NCI CTCAE toxicity grade, system organ class, and preferred term
| System organ class/adverse event | Severity (NCI CTCAE v4.0 toxicity grade) | |||||
|---|---|---|---|---|---|---|
| Gr1 | Gr2 | Gr3 | Gr4 | Gr5 | Total | |
| All system organ class | 2 | 7 | 2 | 0 | 0 | 11 |
| Gastrointestinal disorders | 0 | 1 | 0 | 0 | 0 | 1 |
| Haematemesis, oesophageal and duodenal ulcer | 0 | 1 | 0 | 0 | 0 | 1 |
| General disorders and administration site conditions | 0 | 2 | 0 | 0 | 0 | 2 |
| Necrosis | 0 | 2 | 0 | 0 | 0 | 2 |
| Infections and infestations | 0 | 0 | 1 | 0 | 0 | 1 |
| Orchitis | 0 | 0 | 1 | 0 | 0 | 1 |
| Renal and urinary disorders | 0 | 2 | 1 | 0 | 0 | 3 |
| Urethral stenosis | 0 | 0 | 1 | 0 | 0 | 1 |
| Dysuria | 0 | 1 | 0 | 0 | 0 | 1 |
| Haematuria | 0 | 1 | 0 | 0 | 0 | 1 |
| Reproductive system and breast disorders | 2 | 1 | 0 | 0 | 0 | 3 |
| Pelvic pain | 1 | 0 | 0 | 0 | 0 | 1 |
| Prostatitis | 1 | 1 | 0 | 0 | 0 | 2 |
| Vascular disorders | 0 | 1 | 0 | 0 | 0 | 1 |
| Deep vein thrombosis | 0 | 1 | 0 | 0 | 0 | 1 |