TABLE 2.

The signals of AEs of pirfenidone at the SOC level in the FEARS database.

SOC name	Case number	PT	Percentage (%)
Gastrointestinal disorders	9,927	21	30.63
General disorders and administration site conditions	8,009	8	24.71
Respiratory, thoracic and mediastinal disorders	4,694	44	14.48
Metabolism and nutrition disorders	2,168	7	6.69
Skin and subcutaneous tissue disorders	1969	9	6.08
Investigations	1925	21	5.94
Cardiac disorders	1,343	6	4.14
Psychiatric disorders	759	5	2.34
Injury, poisoning and procedural complications	748	6	2.31
Nervous system disorders	406	4	1.25
Immune system disorders	228	2	0.70
Renal and urinary disorders	69	1	0.21
Vascular disorders	66	5	0.20
Surgical and medical procedures	66	5	0.20
Social circumstances	14	1	0.04
Musculoskeletal and connective tissue disorders	8	1	0.02
Reproductive system and breast disorders	6	2	0.02
Infections and infestations	3	1	0.01
Ear and labyrinth disorders	3	1	0.01

Abbreviations: AEs, adverse events; SOC, system organ class; FAERS, food and drug administration adverse event reporting system; PT, preferred term.