Common use of Endpoints Clause in Contracts

Endpoints. The incidence and course (timing, location of pain and duration) of myalgia after conditioning were the primary endpoints. Secondary endpoint was pain severity according to the WHO pain relief ladder. Other variables noted above were collected to evaluate potential predisposing factors. Descriptive statistics, such as median and frequency, were used to summarize baseline characteristics and outcomes. Odds ratios (OR) were estimated by means of logistic regression to examine the association between conditioning regimen (TREO-based vs. BU-based) and myalgia and adjusted for possible confounding (hemoglobinopathies versus other indications). In the TREO cohort, univariable and multivariable logistic regression was performed to assess whether baseline- or transplant characteristics (age, underlying disease, conditioning regimen, treosulfan exposure) were prognostic for the development of myalgia. All P-values were 2-tailed and considered significant when P<0.05. Statistical 5 analyses were performed using R version 3.6.1 and RStudio version 1.2.5019.

Appears in 2 contracts

Sources: Pharmacokinetics and Dynamics Study, Doctoral Thesis