Common use of Safety Analyses Clause in Contracts

Safety Analyses. Adverse events will be coded by preferred term and system organ class using the latest version of the Medical Dictionary for Regulatory Activities and summarized overall. All AE data will be presented in a data listing. Treatment-emergent AEs will be summarized overall, as well as by severity and relationship to study drug. Serious AEs and AEs leading to discontinuation of study drug will also be presented in the data listings and summarized overall. Actual values and changes from baseline for clinical laboratory test results, vital sign measurements, and 12-lead ECG results will be summarized at each time point using descriptive statistics (number of subjects, mean, SD, median, minimum, and maximum). Shift tables will be generated for clinical laboratory test results. Clinical laboratory data, vital sign measurements, 12-lead ECG results, and physical examination findings will be presented in data listings.

Safety Analyses. Adverse events will be coded by preferred term and system organ class using the latest version of the Medical Dictionary for Regulatory Activities and summarized overallActivities. All AE data will be presented in a data listing. Treatment-emergent AEs will be summarized by hepatic condition and overall, as well as by severity and relationship to study drug. Serious AEs and AEs leading to early discontinuation of study drug will also be presented in the data listings and summarized overalllistings. Actual values and changes from baseline for clinical laboratory test results, vital sign measurements, and 12-lead ECG results will be summarized by hepatic condition at each time point using descriptive statistics (number of subjects, mean, SD, minimum, median, minimum, and maximum). Shift tables will be generated for clinical laboratory test results. Clinical laboratory datatest results, vital sign measurements, 12-lead ECG results, and physical examination findings will be presented in data listings.