Table 3.
Summary of adverse events and causality.
| Adverse events | Number of patients | |||||
|---|---|---|---|---|---|---|
| Total | Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
| Injection-site mediated toxicities | Causality | |||||
| Injection-site immune reaction | 1 (5.6%) | 0 | 1 (5.6%) | 0 | 0 | Definite |
| Injection-site erythema | 7 (38.9%) | 7 (38.9%) | 0 | 0 | 0 | Definite |
| Abdominal wall bruising | 3 (16.7%) | 3 (16.7%) | 0 | 0 | 0 | Definite |
| Injection-site pain | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Definite |
| Pruritus | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Definite |
| Fatigue | 3 (16.7%) | 1 (5.6%) | 2 (11%) | 0 | 0 | Possible |
| Pedal oedema | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Possible |
| Arthralgia | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Possible |
| Hot flushes | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Possible |
| Thrombosis | ||||||
| Pulmonary embolus | 1 (5.6%) | 0 | 0 | 1 (5.6%) | 0 | Possible |
| Venous thrombus | 1 (5.6%) | 0 | 0 | 1 (5.6%) | 0 | Possible |
| Gastrointestinal toxicities | ||||||
| Diarrhoea | 2 (11%) | 2 (11%) | 0 | 0 | 0 | Possible |
| Nausea | 1 (5.6%) | 0 | 1 (5.6%) | 0 | 0 | Possible |
| Vomiting | 2 (11%) | 2 (11%) | 0 | 0 | 0 | Possible |
| Anorexia | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Possible |
| Infections | ||||||
| Pyrexia | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Possible |
| Oral candidiasis | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Possible |
| Urinary tract infection | 1 (5.6%) | 0 | 1 (5.6%) | 0 | 0 | Possible |
| Neurological toxicities | ||||||
| Blurred vision | 1 (5.6%) | 1 (5.6%) | 0 | 0 | 0 | Probable |
| Headache | 2 (11%) | 2 (11%) | 0 | 0 | 0 | Possible |
| Depression | 1 (5.6%) | 0 | 1 (5.6%) | 0 | 0 | Possible |
The number (percentage), type, and grade of adverse events are shown, along with an assessment of the likelihood of causality.