Table 2.

Results of the GIPF-001 Trial Providing a Placebo-Controlled Evaluation of Actimmune in Idiopathic Pulmonary Fibrosis*

Treatment Group	Sample Size, n	Progression, n (%)	Progression or Death, n (%)	Death, n†
Actimmune	162	68 (42.0)	75 (46.3)	16 (18)
Placebo	168	75 (44.6)	87 (51.8)	28 (28)
Hazard ratio‡	–	0.942	0.894	–
2-sided P value	–	–	0.53	0.084 (0.15)

Safety Profile	Sample Size, n	Pulmonary SAEs	Pneumonia SAEs	Vascular Disorders
Actimmune	162	41	20	7
Placebo	168	34	8	1

SAE = serious adverse event.

^*The trial had 90% power to detect a difference of 40% versus 20% in the probability of progression or death at 1 y. Data are shown for events on Actimmune (InterMune, Brisbane, California) versus placebo occurring by 15 June 2002, the prespecified date for the primary analysis of the composite primary end point, progression or death.

^†Data are also shown in parentheses when including events that occur by 19 August 2002, the date of the last data monitoring committee meeting when results were released to the sponsor.

^‡Derived by using a Cox regression analysis of time-to-event data.