Table 6 Serious Adverse Events in Cycles 1 or 2
|
RGB-02 (N = 121) n (%) |
Reference (N = 117) n (%) | |
|---|---|---|
| Any Serious Adverse Event in Cycle 1 or 2 | 10 (8.3) | 8 (6.8) |
| Blood and lymphatic system disorders | 5 (4.1) | 7 (6.0) |
| Febrile neutropenia | 5 (4.1) | 6 (5.1) |
| Neutropenia | 0 | 2 (1.7) |
| Infections and infestations | 2 (1.7) | 1 (0.9) |
| Cystitis | 0 | 1 (0.9) |
| Neutropenic infection | 1 (0.8) | 0 |
| Oesophageal candidiasis | 1 (0.8) | 0 |
| Vascular disorders | 2 (1.7) | 0 |
| Lymphorrhoea | 2 (1.7) | 0 |
| Gastrointestinal disorders | 1 (0.8) | 0 |
| Haemorrhagic duodenitis | 1 (0.8) | 0 |
| Erosive duodenitis | 1 (0.8) | 0 |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 1 (0.8) | 0 |
| Metastases to central nervous system | 1 (0.8) | 0 |