Table 4.
System Organ Class | Preferred term | Total patients | Total events | Incidence (%) |
---|---|---|---|---|
Gastrointestinal disorders | Hypoaesthesia oral | 1 | 1 | 0.2 |
Vomiting | 1 | 1 | 0.2 | |
Gastrointestinal disorders total | 2 | 2 | 0.2 | |
General disorders and administration site conditions | Pyrexia | 8 | 10 | 1.7 |
Chills | 1 | 1 | 0.2 | |
Fatigue | 1 | 1 | 0.2 | |
Infusion site inflammation | 1 | 1 | 0.2 | |
Local reaction | 2 | 2 | 0.4 | |
General disorders and administration site conditions total | 10 | 15 | 2.1 | |
Immune system disorders | Hypersensitivity | 1 | 2 | 0.2 |
Immune system disorders total | 1 | 2 | 0.2 | |
Musculoskeletal and connective tissue disorders | Myalgia | 1 | 1 | 0.2 |
Musculoskeletal and connective tissue disorders total | 1 | 1 | 0.2 | |
Nervous system disorders | Headache | 1 | 1 | 0.2 |
Paraesthesia | 1 | 1 | 0.2 | |
Nervous system disorders total | 2 | 2 | 0.2 | |
Skin and subcutaneous tissue disorders | Pruritus | 6 | 6 | 1.3 |
Rash | 1 | 1 | 0.2 | |
Urticaria | 3 | 3 | 0.6 | |
Skin and subcutaneous tissue disorders total | 10 | 10 | 2.1 | |
| ||||
Total | 22 | 32 | 4.6 |