Common use of Safety Analysis Clause in Contracts

Safety Analysis. All safety assessments, including AEs, SAEs, vital sign measurements, clinical laboratory results, physical examination results, concomitant medications, and 12-lead ECGs, will be tabulated, and summarized where possible, using descriptive methodology by renal function group and, as needed, by timepoint. Unless otherwise specified, baseline value is defined as the last non-missing measurement before administration of LOXO-305. No formal statistical analyses are planned for the safety data. All safety data will be listed by subject. Concomitant medications will be coded using the World Health Organization (WHO) Drug Dictionary (WHO Drug Global B3, September 2019). Adverse events will be coded using Medical Dictionary for Regulatory Activities Version (MedDRA) 22.1 (or higher). The incidence of AEs for each renal function group (matched control healthy subjects, mild, moderate, and severe) will be presented by severity and by relationship to study drug as determined by the Investigator or designee (Appendix 1 for AE reporting). All TEAEs will be summarized by system organ class and preferred term, with a breakdown by renal function group.

Safety Analysis. All safety assessments, including AEs, AEs and SAEs, vital sign measurements, clinical laboratory results, physical examination results, concomitant medications, and 12-lead ECGs, will be tabulated, tabulated and summarized where possible, using descriptive methodology by renal hepatic function group and, as needed, by timepoint. Unless otherwise specified, baseline value is defined as the last non-missing measurement before administration of LOXO-305. No formal statistical analyses are planned for the safety data. All safety data will be listed by subject. Concomitant medications will be coded using the World Health Organization (WHO) Drug Dictionary (WHO Drug Global B3, September 2019). Adverse events will be coded using Medical Dictionary for Regulatory Activities Version (MedDRA) 22.1 (or higher). The incidence of AEs for each renal hepatic function group (matched matched-control healthy subjects, mild, moderate, and severe) will be presented by severity and by relationship to study drug as determined by the Investigator or designee (Appendix 1 for AE reporting). All TEAEs will be summarized by system system-organ class and preferred term, with a breakdown by renal function grouphepatic function.