Table 3 Nature of adverse drugs reactions
System organ class and preferred term | e | n (%) |
|---|---|---|
Ear and labyrinth disorders | ||
Ear pruritus | 1 | 1 (1.1) |
General disorders and administration site conditions | ||
Asthenia* | 1 | 1 (1.1) |
Chest discomfort | 1 | 1 (1.1) |
Injection site erythema | 1 | 1 (1.1) |
Injection site pain | 3 | 3 (3.2) |
Injection site pruritus | 25 | 12 (12.9) |
Injection site reaction | 52 | 22 (23.7) |
Injection site swelling | 4 | 3 (3.2) |
Respiratory, thoracic and mediastinal disorders | ||
Asthma | 4 | 1 (1.1) |
Throat irritation | 3 | 3 (3.2) |