TABLE 4.

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

	Total events	Patients with event
Any ADRSI	1577	693 (68.7)
Gastrointestinal symptoms	591	386 (38.3)
Photosensitivity and skin rashes	388	293 (29.0)
Fatigue	257	244 (24.2)
Weight loss	173	162 (16.1)
Dizziness	79	72 (7.1)
Abnormal LFTs	54	36 (3.6)
Angioedema	10	9 (0.9)
Specific cardiac events	9	7 (0.7)
Falls	6	6 (0.6)
Blood dyscrasias	4	4 (0.4)
Severe skin infections	4	4 (0.4)
Drug interactions (including smoking)	2	2 (0.2)
Increased platelet count	0	0 (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.