TABLE 1
Adverse eventsPirfenidoneNinetedanib
SubjectsGradeSubjectsGrade
1234512345
Gastrointestinal
 Diarrhoea1 (14)17 (100)61
 Nausea1 (14)12 (29)11
 Vomiting0 (0)1 (14)1
 Dyspepsia2 (28)115 (71)32
 Anorexia6 (86)4113 (43)12
 Weight loss2 (29)112 (29)2
Skin
 Pruritus2 (29)0 (0)
 Rash1 (14)0 (0)
 Photosensitivity reaction3 (43)30 (0)
Other
 Insomnia1 (14)0 (0)
 Dizziness3 (43)2 (29)
 Asthenia5 (71)3 (43)
 Arthralgia3 (43)210 (0)
 Pharyngolaryngeal pain0 (0)1 (14)
 Hot flush0 (0)0 (0)
 AST/ALT >3 times upper limit of normal0 (0)0 (0)
 Progression of IPF2 (29)2 (29)
 Acute exacerbation1 (14)2 (29)
Serious AE
 AE requiring hospitalisation2 (29)2 (29)
  Acute exacerbation2 (29)2 (29)
 AE leading to treatment discontinuation7 (100)2 (29)
  Gastrointestinal disorders0 (0)1 (14)
  Asthenia/fatigue4 (57)0
  Arthralgia1 (14)0
  Exacerbation/progression2 (29)1 (14)
  • Data are presented as n (%) or n. Grade refers to the Common Terminology Criteria for Adverse Events grading [8]. AST: aspartate transaminase; ALT: alanine transaminase; IPF: idiopathic pulmonary fibrosis: AE: adverse events.