Table 3 Reports of durvalumab at the SOC level.
From: A pharmacovigilance analysis of post-marketing safety of durvalumab
System Organ Class (SOC) | Number of potential signals | number of cases | Proportion of AEs (%) |
|---|---|---|---|
General disorders and administration site conditions | 10 | 3615 | 17.1 |
Respiratory, thoracic and mediastinal disorders | 30 | 2532 | 12.0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 47 | 1996 | 9.4 |
Investigations | 24 | 1509 | 7.1 |
Gastrointestinal disorders | 20 | 1486 | 7.0 |
Infections and infestations | 24 | 1374 | 6.5 |
Injury, poisoning and procedural complications | 7 | 1357 | 6.4 |
Nervous system disorders | 16 | 969 | 4.6 |
Blood and lymphatic system disorders | 9 | 915 | 4.3 |
Hepatobiliary disorders | 22 | 823 | 3.9 |
Skin and subcutaneous tissue disorders | 7 | 770 | 3.6 |
Musculoskeletal and connective tissue disorders | 8 | 656 | 3.1 |
Cardiac disorders | 10 | 646 | 3.1 |
Metabolism and nutrition disorders | 4 | 587 | 2.8 |
Endocrine disorders | 20 | 484 | 2.3 |
Renal and urinary disorders | 3 | 366 | 1.7 |
Vascular disorders | 7 | 330 | 1.6 |
Immune system disorders | 3 | 195 | 0.9 |
Eye disorders | 2 | 188 | 0.9 |
Reproductive system and breast disorders | 1 | 27 | 0.1 |
Congenital, familial and genetic disorders | 2 | 18 | 0.1 |
