Primary endpoint: Combination of complete reversal of HRS according to the Ascites-Club-criteria (2007) within 14d AND survival without renal replacement therapy (RRT) AND without liver transplantation for ≥28d.
Hazard ratios (HRs) and 95% confidence intervals (95% CIs) for each individual SNP and endpoint combination were estimated by fitting the Cox proportional hazard model while adjusting for age, gender, clinical stage, pack years of smoking, pre-treatment performance status, treatment regimen (radiotherapy or chemoradiotherapy), radiation type, and radiation dosage.
Methods used to test whether no-interaction can be assumed usually require dose-response-algorithms, which are not available for many substance-endpoint combinations.
How can we make practical use of an improved understanding of dose-response for assessing risk, developing regulatory standards, designing nutrition programs, etc.? Initial discussions by the group considered a range of agent-endpoint combinations (e.g., chloroform and liver carcinogenicity, Listeria monocytogenes and fetal death), focusing on what is known about the fundamental biology.
Secondary endpoint combining all-cause mortality and appropriate ICD shocks: The combination of all-cause mortality and appropriate ICD shocks is defined as a composite secondary endpoint.
The trial has as a primary efficacy endpoint the combination of all-cause mortality and heart failure hospitalisation and intends to enrol 650 patients.
Let ([a,b]subset mathbb{R}) be a closed interval, and let (alpha a+beta b) be the endpoints convex combination whose coefficients are positive.
Let (alpha a+beta b) be the unique endpoints convex combination such that sum_{i=1}^{n} kappa_{i}x_{i}=alpha a+beta b. (6).
Let (alpha a+beta b) be the unique endpoints convex combination such that frac{1}{mu([a,b])}int_{[a,b]}x,dmu=alpha a+ beta b. (9).
Small numerical differences in the primary and some secondary endpoints favoring combination therapy were not considered clinically meaningful.
