7 research outputs found
Enrollment, Randomization, Follow-Up and Analysis.
<p>Enrollment, Randomization, Follow-Up and Analysis.</p
Effect of Drug Holiday on CSF Drug Levels.
<p>Predictive illustration of the effect of “drug holidays” at steady-state. Drug holiday began at the arrow (24 hours). Dosing then resumed as usual at 72 hours. Despite the holiday, CSF levels remained above 1 micromolar in the 4 gm/day group, and fell slightly below 1 micromolar in the 2 gm/day group.</p
Time to Discontinuation of Study Drug by Treatment Arm (until 20 weeks).
<p>Kaplan-Meyer curve showing time to discontinuation of study drug within the first 20 weeks for patients who discontinued study drug within this time frame. Time to discontinuation of study drug was not significantly different between treatment arms (p = 0.90; Log-Rank). LD – Low Dose Ceftriaxone Arm; HD - High Dose Ceftriaxone Arm.</p
Demographics.
<p>VC – Vital Capacity; HHD - Hand-Held Dynamometry; ALSFRS-R – Revised ALS Functional Rating Scale; ALSQOL – ALS Quality of Life Questionnaire; V<sub>d</sub> – Volume of Distribution; T<sub>1/2</sub>– Half-life; mL – milliliters; min – minutes; kg - kilograms.</p
Reasons for Drug Discontinuation in Stages 1 and 2.
*<p>Pseudomembranous colitis, Pruritis, Neutropenia.</p>**<p>Pulmonary edema, Cholelithiasis.</p
Cholelithiasis and Biliary Sludging by Treatment Arm.
<p>(a) Biliary sludging and cholelithiasis were more common in the low dose (LD) and high dose (HD) treatment arms than in the placebo treatment arm (p<0.01; Jonckheere-Terpstra). (b) Treatment with ursodiol significantly shortened event duration when used to treat cholelithiasis and biliary sludging (p,0.001; Log-Rank).</p