Table 2 Signal strength of AEs of durvalumab at the SOC level in FAERS database
SOC | Cases (%) | Positive signal (%) |
|---|---|---|
General disorders and administration site conditions | 3372 (17.11) | 3 (4.92) |
Respiratory, thoracic and mediastinal disorders | 2418 (12.27) | 12 (19.67) |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1879 (9.53) | 18 (29.51) |
Investigations | 1422 (7.21) | 4 (6.56) |
Gastrointestinal disorders | 1374 (6.97) | 1 (1.64) |
Infections and infestations | 1281 (6.50) | 11 (18.03) |
Injury, poisoning and procedural complications | 1263 (6.41) | 3 (4.92) |
Nervous system disorders | 916 (4.65) | 1 (1.64) |
Blood and lymphatic system disorders | 852 (4.32) | 1 (1.64) |
Hepatobiliary disorders | 738 (3.74) | 2 (3.28) |
Skin and subcutaneous tissue disorders | 695 (3.53) | 0 |
Musculoskeletal and connective tissue disorders | 618 (3.14) | 0 |
Cardiac disorders | 590 (2.99) | 0 |
Metabolism and nutrition disorders | 535 (2.71) | 0 |
Endocrine disorders | 432 (2.19) | 0 |
Renal and urinary disorders | 331 (1.68) | 0 |
Vascular disorders | 313 (1.59) | 2 (3.28) |
Psychiatric disorders | 205 (1.04) | 0 |
Eye disorders | 174 (0.88) | 1 (1.64) |
Immune system disorders | 160 (0.81) | 2 (3.28) |
Ear and labyrinth disorders | 41 (0.21) | 0 |
Surgical and medical procedures | 27 (0.14) | 0 |
Reproductive system and breast disorders | 26 (0.13) | 0 |
Social circumstances | 20 (0.10) | 0 |
Congenital, familial and genetic disorders | 14 (0.07) | 0 |
Product issues | 12 (0.06) | 0 |
Pregnancy, puerperium and perinatal conditions | 1 (0.01) | 0 |
Total | 19,709 (100.00) | 61 (100.00) |