Table 4:

Pulmonary exacerbation events through week 24 by ppFEV₁ subgroup and treatment group

Rate ratio vs placebo (95% CI)	LUM 600 mg qd/IVA 250 mg q12h		LUM 400 mg q12h/IVA 250 mg q12h
	ppFEV1 at baseline
	<40 (n=24)*	≥40 (n=342)	<40 (n=29)*	≥40 (n=336)
Pulmonary exacerbation events	0∙47 (0∙24–0∙93)	0∙73 (0∙58–0∙92)	0∙59 (0∙33–1∙05)	0∙61 (0∙48–0∙77)
p value	0∙030	0∙007	0∙074	<0∙001
Events requiring IV antibiotic therapy	0∙41 (0∙17–0∙98)	0∙57 (0∙43–0∙77)	0∙56 (0∙27–1∙17)	0∙42 (0∙30–0∙58)
p value	0∙046	<0∙001	0∙122	<0∙001
Events requiring hospitalisation	0∙43 (0∙14–1∙33)	0∙63 (0∙44–0∙89)	0∙67 (0∙27–1∙65)	0∙36 (0∙23–0∙54)
p value	0∙142	0∙009	0∙382	<0∙001
	ppFEV1 at screening
	<70 (n=241)	≥70 (n=119)	<70 (n=245)	≥70 (n=114)
Pulmonary exacerbation events	0∙74 (0∙57–0∙95)	0∙55 (0∙35–0∙85)	0∙65 (0∙50–0∙84)	0∙51 (0∙32–0∙80)
p value	0∙018	0∙007	0∙001	0∙003
Events requiring IV antibiotic therapy	0∙53 (0∙39–0∙73)	0∙53 (0∙27–1∙01)	0∙49 (0∙36–0∙68)	0∙22 (0∙09–0∙55)
p value	<0∙001	0∙052	<0∙001	0∙001
Events requiring hospitalisation	0∙59 (0∙40–0∙85)	0∙53 (0∙27–1∙06)	0∙48 (0∙32–0∙71)	0∙09 (0∙02–0∙37)
p value	0∙005	0∙072	<0∙001	0∙001

^*Eighty-one patients had ppFEV₁ that decreased to <40 between screening and baseline.

CI=confidence interval; IV=intravenous; IVA=ivacaftor; LUM=lumacaftor; q12h=every 12 hours; qd=every day.