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. Author manuscript; available in PMC: 2020 Jan 1.
Published in final edited form as: J Cyst Fibros. 2018 Aug 23;18(1):94–101. doi: 10.1016/j.jcf.2018.07.011

Table 2.

Mean Number of Days of PEx by Treatment With LUM 400 mg q12h/IVA 250 mg q12h or Placebo and Change in ppFEV1 Threshold Category*

LUM 400 mg q12h/IVA 250 mg q12h
Placebo
(n=371)		 Absolute
change ≤0
(n=146)		 Absolute
change >0
(n=223)		 Relative
change <5%
(n=228)		 Relative
change ≥5%
(n=141)
Mean days with PEx (SD) 15.7 (24.8) 11.5 (23.1) 5.9 (11.9) 8.9 (19.8) 6.9 (12.6)
  P value vs placebo — <0.0001 <0.0001 <0.0001 <0.0001
Mean days on IV antibiotics for PEx (SD) 10.1 (20.5) 5.4 (15.8) 2.8 (8.2) 3.8 (13.1) 3.7 (9.5)
  P value vs placebo — <0.0001 <0.0001 <0.0001 <0.0001
Mean days hospitalized for PEx (SD) 7.6 (18.8) 3.6 (13.7) 1.8 (6.3) 2.6 (11.3) 2.4 (7.2)
  P value vs placebo — <0.0001 <0.0001 <0.0001 0.0005

IV, intravenous; IVA, ivacaftor; LUM, lumacaftor; PEx, pulmonary exacerbation; ppFEV1, percent predicted forced expiratory volume in 1 second; q12h, every 12 hours; SD, standard deviation.

*

Change in ppFEV1 from baseline to day 15.