Table 3.
Incidence and grade of CTCAE v4.0 Serious Adverse Events (SAEs)
| System Organ Class | Preferred Term | Arm 1 (n=31) | Arm 2 (n=29) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade | Grade | ||||||||||
| 1 | 2 | 3 | 4 | 5 | 1 | 2 | 3 | 4 | 5 | ||
| Blood and lymphatic system disorders | Febrile neutropenia | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Cardiac disorders | Cardiac arrest | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Gastrointestinal disorders | Diarrhea | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dysphagia | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Vomiting | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| General disorders and administration site conditions | Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Product adhesion issue | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Pyrexia | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | |
| Systemic inflammatory response syndrome | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | |
| Infections and infestations | Bronchitis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Pneumonia | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Metabolism and nutrition disorders | Dehydration | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Psychiatric disorders | Depression | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Renal and urinary disorders | Renal failure acute | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | Hypoxia | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Vascular disorders | Embolism | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any SAE- Maximum Grade Seen (Total) | 0 | 0 | 9 | 0 | 2 | 0 | 0 | 6 | 1 | 0 | |
CTCAE: Common Toxicity Criteria for Adverse Events