Infection outcomes.
fever, pulmonary dysfunction, infections, infection, lung abnormalities
INFECTION, STERILE, BRONCHIECTASIS, INFECTIONS
The primary endpoint was the difference between the two 12-month treatment phases for total infection severity score (TISS), a weighted composite of predefined infection frequency and severity parameters (number of infections, presence or absence of fever, sterile versus nonsterile site of infection, route of administration of antibiotics, and level of care needed) that are relevant to the participants’ experience. TISS was variable on each drug and between the two 1-year treatments and was not significantly lower for plerixafor than for G-CSF (median TISS = 11 on G-CSF and 10 on plerixafor, Nonsterile barrier sites (skin/mucosa) accounted for 86% of 114 total infections occurring during the 2 treatment phases; 89% of all infections occurred in 5 sites: the upper respiratory tract (No patient died, consistent with low mortality reported in the literature (Although evaluation of lung function was not a prespecified study endpoint, all 19 patients had chest computerized tomography at baseline. Of 13 patients with lung abnormalities, 10 had mild-to-severe bronchiectasis, and 7 of the 10 had mild-to-severe pulmonary function test abnormalities, particularly diminished diffusion capacity of the lung for carbon monoxide; however, neither study drug significantly improved pulmonary dysfunction (