TABLE 2

Treatment-emergent adverse events at 1 year#

PirfenidonePlacebo
Subjects n623624
Nausea35.515.1
Cough23.124.0
Diarrhoea24.618.8
Upper respiratory tract infection22.620.2
Fatigue23.016.8
Headache20.518.1
Rash29.29.0
Nasopharyngitis15.115.9
Dyspnoea13.216.0
Dizziness16.710.1
Dyspepsia17.86.7
Bronchitis11.113.1
Idiopathic pulmonary fibrosis8.514.4
Vomiting12.76.1
Anorexia12.44.3
Gastro-oesophageal reflux disease10.35.6
  • Data are presented as % unless otherwise stated. #: occurring in ≥10% of patients in either treatment group (sorted by total incidence across treatment groups).