3.3 Signal detection at SOC level
In the FAERS database, gastrointestinal disorders ranked first among 19
SOCs for pirfenidone (case number: 9,927; 30.63%), and also ranked
first among 23 SOCs for nintedanib (case number: 8,988; 35.88%) (Table
2,3). Additionally, in the VigiAccess database, gastrointestinal
disorders ranked second among 27 SOCs for pirfenidone (case number:
11,442, 15.75%), following general disorders and administration site
conditions (case number: 15,378, 21.17%) (Table 4). For nintedanib,
gastrointestinal disorders remained the top SOC (case number: 13,433,
22.77%), followed by general disorders and administration site
conditions (case number: 7,425, 12.59%) (Table 5).