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. Author manuscript; available in PMC: 2013 Aug 6.
Published in final edited form as: Ann Intern Med. 2010 Sep 21;153(6):400–406. doi: 10.7326/0003-4819-153-6-201009210-00008

Table 3.

Survival Data in the GIPF-001 Trial for Actimmune Versus Placebo in Idiopathic Pulmonary Fibrosis*

Treatment Group Overall Study Group
Mild-to-Moderate Disease Subgroup
Participants, n Deaths, n Participants, n Deaths, n
Actimmune 162 16 126 6
Placebo 168 28 128 21
 Hazard ratio 0.59 0.29
 2-sided P value 0.084 0.004
*

Results of the GIPF-001 trial when a clinical cutoff date (15 June 2002) was used. Deaths occurred by the cutoff date and corresponded with the prespecified time for primary analysis of death or progression primary end point. The hazard ratio was derived by using a Cox regression analysis of time-to-event data. The mild-to-moderate disease subgroup is defined as FVC of 55% or more at baseline. Twelve deaths from the Actimmune subgroup (10 in patients with advanced disease and 2 occurring from 15 June 2002 to 19 August 2002) and 7 deaths from the placebo group (all in patients with advanced disease) were excluded. Actimmune is manufactured by InterMune (Brisbane, California).