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)

The positive signal generation conditions were as follows: i) number of cases ≥ 3; ii) ROR 95% CI lower limit > 1; iii) PRR ≥ 2, χ²≥4; iv) IC025 > 0; v) EBGM05 > 2. SOC, system organ class