Primary Endpoints Clause Samples
Primary Endpoints. Safety provided by the evaluation of peri-procedural device related adverse events produced by the ANET device used to ablate a target pulmonary nodule/tumor.
Primary Endpoints. Primary safety endpoints include: · occurrence of all adverse events including but not limited to · all MIs · cardiovascular hospitalization · serious ventricular arrhythmias sustained · VT (symptomatic or sustained VT [duration longer than 30 seconds or 100 beats, or associated with hemodynamic collapse]) · VF · symptomatic bradycardia, pauses of longer than 3.0 seconds, complete atrioventricular block, Mobitz II atrioventricular block · symptomatic heart failure (NYHA criteria + physical examination OR hospitalization because of heart failure) · renal failure · stroke · death
Primary Endpoints. The following PK parameters will be calculated whenever possible, based on the plasma concentrations of LOXO-305: • Cmax • tmax • area under the concentration-time curve (AUC) from hour 0 to the last measurable concentration (AUC0-t) • AUC from hour 0 extrapolated to infinity (AUC0-inf) • percentage extrapolation for AUC0-inf (%AUCextrap) • apparent terminal elimination rate constant (λz) • apparent plasma terminal elimination half-life (t½) • apparent systemic clearance (CL/F) • apparent volume of distribution during the terminal phase (Vz/F) • mean residence time (MRT). In addition, a single blood sample will be collected predose to determine the fraction unbound (fu) of LOXO-305 in plasma and, whenever possible, the following PK parameters will be calculated for unbound LOXO-305 using fu: unbound Cmax (Cmax,u), unbound AUC0-t (AUC0-t,u), unbound AUC0-inf (AUC0-inf,u), unbound CL/F (CL/F,u), and unbound Vz/F (Vz/F,u).
Primary Endpoints. Safety Adverse event -information will be collected daily and ▇▇▇▇▇ ▇▇▇▇▇ will be measured before and after each infusion. Blood and urine sample for clinical laboratory analysis will be collected periodically throughout the study and there will be [*]. Pharmacokinetic Blood and urine samples will be collected at predetermined times throughout the study for pharmacokinetic analysis. [ ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Primary Endpoints. The following PK parameters will be calculated whenever possible, based on the plasma concentrations of LOXO-305: • Cmax • tmax • AUC from hour 0 to the last measurable concentration (AUC0-t) • AUC from hour 0 extrapolated to infinity (AUC0-inf) • percentage extrapolation for AUC0-inf (%AUCextrap) • apparent terminal elimination rate constant (λz) • apparent plasma terminal elimination half-life (t½) • apparent systemic clearance (CL/F) • apparent volume of distribution during the terminal phase (Vz/F) • mean residence time (MRT). In addition, a single blood sample will be collected predose to determine the unbound fraction (fu) of LOXO-305 in plasma and, whenever possible, the following PK parameters will be calculated for unbound LOXO-305 using fu: unbound Cmax (Cmax,u), unbound AUC0-t (AUC0-t,u), unbound AUC0-inf (AUC0-inf,u), unbound CL/F (CL/F,u), and unbound Vz/F (Vz/F,u).
Primary Endpoints. The percent of patients with radiographic disease progression according to RECIST 1.1 at 6 months.
Primary Endpoints. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.