TABLE 2

Overall summary of adverse events

ParameterPBI-4050 alonePBI-4050+nintedanibPBI-4050+pirfenidone
Total patients91616
Patients with at least one AE8 (88.9)12 (75.0)14 (87.5)
Patients with at least one severe AE01 (6.3)2 (12.5)
Patients with at least one serious AE01 (6.3)0
Deaths000
AEs leading to permanent discontinuation of study drug001 (6.3)
AEs in >2 patients, by preferred term#
 Diarrhoea3 (33.3)7 (43.8)6 (37.5)
 Nausea004 (25.0)
 Headache2 (22.2)1 (6.3)1 (6.3)
 Fatigue01 (6.3)2 (12.5)
 Non-cardiac chest pain1 (11.1)02 (12.5)
 Cough003 (18.8)
 Dyspnoea003 (18.8)

Data are presented as n or n (%). Patients can be counted in more than one category. AE: adverse event. #: Medical Dictionary for Regulatory Activities [21].