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Table 4 Efficacy

From: A phase II trial evaluating the efficacy and safety of perioperative pirfenidone for prevention of acute exacerbation of idiopathic pulmonary fibrosis in lung cancer patients undergoing pulmonary resection: West Japan Oncology Group 6711 L (PEOPLE Study)

Group

N

AE-IPF occurred within the 30th POD

Non–AE rate within the 30th POD

95 % CI

p-value

FAS

39

2

94.90 %

82.7–99.4

p = 0.010

PPS

36

1

97.20 %

85.5–99.9

p = 0.004

PPS-IPF

32

1

96.90 %

83.8–99.9

p = 0.008

  1. AE-IPF acute exacerbation of idiopathic pulmonary fibrosis, POD postoperative day, FAS full analysis set, PPS per protocol set, PPS-IPF PPS excluding non-IPF cases diagnosed by the central review committee