Risk or rate ratio of acute investigator-reported exacerbation and of adjudicated exacerbation for the two INPULSIS trials comparing nintedanib with placebo

NintedanibPlaceboRisk or rate ratio (95% CI)p-value
 Patients n309204
 Patients with at least one investigator-reported   acute exacerbation19 (6.1)11 (5.4)1.14 (0.55–2.35)0.72
 Investigator-reported acute exacerbations#20 (6.5)13 (6.4)1.02 (0.52–2.00)0.96
 Confirmed or suspected acute exacerbations#7 (2.3)8 (3.9)0.58 (0.21–1.57)0.28
 “False” acute exacerbations#12 (3.9)5 (2.5)
 Patients n329219
 Patients with at least one investigator-reported   acute exacerbation12 (3.6)21 (9.6)0.38 (0.19–0.76)0.006
 Investigator-reported acute exacerbations#13 (3.9)24 (10.9)0.36 (0.19–0.69)0.002
 Confirmed or suspected acute exacerbations#5 (1.5)16 (7.3)0.21 (0.08–0.56)0.002
  “False” acute exacerbations#7 (2.1)7 (3.2)
  • Data are presented as n (%), unless otherwise stated. #: the numbers of patients were not provided in the paper for the breakdown of patients with confirmed exacerbation, so the number of events was also used. A total of three investigator-reported exacerbations did not have sufficient data for adjudication.