Adverse drug reactions of special interest (ADRSI)# in the overall population

Total eventsPatients with event
Any ADRSI1577693 (68.7)
 Gastrointestinal symptoms591386 (38.3)
 Photosensitivity and skin rashes388293 (29.0)
 Fatigue257244 (24.2)
 Weight loss173162 (16.1)
 Dizziness7972 (7.1)
 Abnormal LFTs5436 (3.6)
 Angioedema109 (0.9)
 Specific cardiac events97 (0.7)
 Falls66 (0.6)
 Blood dyscrasias44 (0.4)
 Severe skin infections44 (0.4)
 Drug interactions (including smoking)22 (0.2)
 Increased platelet count00 (0.0)

Data are presented as n or n (%). LFT: liver function test; EMA: European Medicines Agency; CHMP: Committee for Medicinal Products for Human Use. #: ADRSI included any important identified/potential risks identified in the EMA's CHMP assessment report for pirfenidone (important identified risks: photosensitivity reactions/skin rashes, abnormal LFTs, dizziness, weight loss, gastrointestinal symptoms, fatigue and angioedema; important potential risks: falls, drug interactions (particularly cytochrome P450 CYP1A2 inducers/inhibitors such as cigarette smoke and ciprofloxacin), increased platelet counts, specific cardiac events (including supraventricular tachyarrhythmia, atrioventricular block and sick sinus syndrome, ventricular arrhythmia, bundle branch block and aortic or pulmonic valvular incompetence)) [12]; in addition to these ADRSI included in the EMA's CHMP, this study also included angioedema, blood dyscrasias (specifically agranulocytosis, leukopenia and neutropenia), severe skin reactions and warfarin interactions as important/potential risks (the treating physician (investigator) made a clinical judgement to decide if the ADRSI was related to pirfenidone); : n=1009.