Table 4

Gastrointestinal and skin-related adverse events of interest

		Phase 3 multinational trials†
	Integrated population (N=1299)*	Pirfenidone (N=623)	Placebo (N=624)
Nausea, %
Grade 3 TEAE	1.9	1.8	0.5
Grade 4 TEAE	0	0	0
TE SAE	0	0.5	0
Treatment discontinuation	1.7	1.1	0
Diarrhoea, %
Grade 3 TEAE	1.1	0.6	0
Grade 4 TEAE	0	0	0
TE SAE	0	0	0.2
Treatment discontinuation	0.2	0	0.3
Dyspepsia, %
Grade 3 TEAE	0.5	0.3	0.3
Grade 4 TEAE	0	0	0
TE SAE	0	0	0
Treatment discontinuation	0.2	0	0
Vomiting, %
Grade 3 TEAE	0.6	0.5	0
Grade 4 TEAE	0	0	0
TE SAE	0.2	0.2	0
Treatment discontinuation	0.3	0.3	0.2
Rash, %
Grade 3 TEAE	0.5	0.6	0.2
Grade 4 TEAE	0	0	0
TE SAE	<0.1	0.2	0
Treatment discontinuation	2.2‡	1.4	0
Photosensitivity reaction, %
Grade 3 TEAE	0.5	0.8	0.2
Grade 4 TEAE	0	0	0
TE SAE	0	0.2	0
Treatment discontinuation	0.5	0.6	0.2

*Median duration of exposure, 1.7 years.
†Median duration of exposure, 1.1 years.
‡Includes rash (1.5%), erythematous rash (0.2%), generalised rash (0.3%), papular rash (0.2%), pruritic rash (<0.1%).
TEAE, treatment-emergent adverse event; TE SAE, treatment-emergent serious adverse event.