TABLE 2

Adverse drug reactions (ADRs)# in the overall population

Total eventsPatients with eventExposure-adjusted event rate+Patients with event in first 30 daysPatients with events resulting in permanent discontinuation of pirfenidone
Any ADR2167741 (73.4)379 (37.6)290 (28.7)
Most common ADRs (≥5% of patients)
 Nausea227208 (20.6)181.2113 (11.2)41 (4.1)
 Fatigue194187 (18.5)154.9101 (10.0)15 (1.5)
 Decreased appetite172163 (16.2)137.369 (6.8)17 (1.7)
 Decreased weight172161 (16.0)137.359 (5.8)32 (3.2)
 Rash135123 (12.2)107.815 (1.5)32 (3.2)
 Diarrhoea11196 (9.5)88.644 (4.4)21 (2.1)
 Dizziness6965 (6.4)55.130 (3.0)5 (0.5)
 Photosensitivity reaction6159 (5.8)48.75 (0.5)15 (1.5)

Data are presented as n or n (%). #: an ADR was defined as any safety event with a possible causal relationship to pirfenidone (the treating physician (investigator) made a clinical judgement to decide if the ADR was related to pirfenidone); : n=1009 (person-years of observation=1252.8); +: exposure-adjusted event rate per 1000 person-years of exposure is calculated as: 1000×(number of reported events/total person-years of exposure).