TABLE 3.

Serious adverse drug reactions (SADRs)^# in the overall population^¶

	Total events	Patients with event	Exposure-adjusted event rate+
Any SADR	78	55 (5.5)
Most common SADRs (≥2 patients)
Diarrhoea	6	6 (0.6)	4.8
Decreased weight	5	5 (0.5)	4.0
Nausea	4	4 (0.4)	3.2
IPF	3	3 (0.3)	2.4
Erythema	3	3 (0.3)	2.4
Decreased appetite	2	2 (0.2)	1.6
Dyspnoea	2	2 (0.2)	1.6
Pulmonary embolism	2	2 (0.2)	1.6
Photosensitivity reaction	2	2 (0.2)	1.6
Vomiting	2	2 (0.2)	1.6

Data are presented as n or n (%). IPF: idiopathic pulmonary fibrosis. ^#: an SADR was defined as an adverse drug reaction at any dose that resulted in death, disability or a congenital anomaly/birth defect, was life-threatening, required in-patient hospitalisation or prolonged an existing hospitalisation, but based upon appropriate medical judgement could have jeopardised the patient or may have required intervention to prevent one or more of the outcomes listed (the treating physician (investigator) made a clinical judgement to decide if the SADR 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).