Safety and Efficacy tables (not effecasy wake up!)
Safety tables provide the information as to how does the study drug affects OR what are the effects with regards to the overall health and safety of the patients. Safety measures can be Adverse events types, duration, serious or not, is it treatment emergent or not, , recovered from ae, survival/death, deaths withing 30days, etc.
Safety tables include group of TLFs produced on patients that are categorized as "Safety population". Protocol or statistical canalysis plan details the criteria of who is considered as safety population. For example, "any subject who has gone through at least one drug exposure" . The tables, listings, figures such as AE's, Sae's, TEAE's, Deaths, LabShifts to name a few.
Efficacy tables provide information as to how effective is the study drug, how much it alleviates the underlying symptoms of disease of interesthow beneficial are the benefits versus risks. The efficacy measures can be the overall remission rate, complete recovery, partial recovery, disease progress rate, how good are the effects compared to competetors one or placebo. These parameters can vary based on the area or the body organ system that are involved, and the extent of disease progression
Efficacy tables can include group of TLF's produced on Full analysis population(per SAP). It can include survival analysis such as Kaplan Meyer's.
Hope this helps!