Abstract P13 Table 1

Treatment emergent adverse events in the integrated population compared with the pooled pirfenidone 2403 mg/d and placebo groups in the Phase 3 trials*

Integrated population (N = 1299)† OE = treatment emergent adverse event ment emergent adverse events d sun exposure during treatment with pirfenidone. the skin du
Median (range) duration of exposure, yr1.7 (>0, 9.9)
Treatment emergent adverse event,%
Nausea37.6
Cough35.1
Dyspnea30.9
Upper respiratory tract infection30.6
Idiopathic pulmonary fibrosis29.3
Fatigue28.2
Diarrhoea28.1
Rash25.0
Bronchitis23.8
Headache21.6
Nasopharyngitis21.3
Dizziness21.2
Dyspepsia18.4
Vomiting15.9
Weight decreased15.6
Back pain15.4
Anorexia15.2

  • ↵*Occurring in ≥15% of patients in the cumulative clinical database.

    †Includes 2 patients in Study 002 with a diagnosis of “pulmonary fibrosis.”