Tables
- TABLE 1
Risk or rate ratio of acute investigator-reported exacerbation and of adjudicated exacerbation for the two INPULSIS trials comparing nintedanib with placebo
Nintedanib Placebo Risk or rate ratio (95% CI) p-value INPULSIS-1 Patients n 309 204 Patients with at least one investigator-reported acute exacerbation 19 (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) INPULSIS-2 Patients n 329 219 Patients with at least one investigator-reported acute exacerbation 12 (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.
Vol 47 Issue 1
Table of Contents
The INPULSIS trials of idiopathic pulmonary fibrosis treatment: explaining further discrepancies on exacerbations
