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Table 1 Definition of infection of interest. MedDRA, Medical Dictionary for Regulatory Activities; PT, Preferred Term

From: Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database

Event of interest MedDRA PTa
Infection “Arthritis infective,” “Aspergillus infection,” “Atypical mycobacterial infection,” “Cytomegalovirus infection,” “Epstein-Barr virus infection,” “Fungal infection, Infection,” “Infectious pleural effusion,” “Infective myositis,” “Mycobacterial infection,” “Mycobacterium avium complex infection,” “Mycobacterium marinum infection,” “Post procedural infection,” “Postoperative wound infection,” “Respiratory tract infection,” “Severe invasive streptococcal infection,” “Staphylococcal infection,” “Streptococcal infection,” and “Urinary tract infection,” and “Wound infection”
Interstitial lung disease “Interstitial lung disease”
Pneumonia “Eosinophilic pneumonia,” “Pneumonia,” “Pneumonia influenzal,” “Pneumonia mycoplasmal,” “Pneumonia pneumococcal,” “Pneumonia streptococcal,” “Pneumonia bacterial,” “Organising pneumonia,” “Atypical mycobacterial pneumonia,” and “Pneumocystis jirovecii pneumonia”
Sepsis “Sepsis,” “Septic shock,” and “Listeria sepsis”
Tuberculosis “Disseminated tuberculosis,” “Intestinal tuberculosis,” “Lymph node tuberculosis,” “Peritoneal tuberculosis,” “Pulmonary tuberculosis,” “Tuberculosis,” and “Tuberculous pleurisy”