safety and effecasy table

[deleted_user]

what is different between safety table and effecasy table?

[Doc_Duke]

The needs of the consumer.

Safety is about whether a drug or device hurts people.

Efficacy is about whether it helps people.

[deleted_user]

hi Doc@duke;


i want more information about safety table and effecacy table ,like what type of table include in safety and effecacy.

[deleted_user]

Doc gave you the correct spelling, I'm sure a search on your favourite internet search engine will give you considerable material to consider.

[deleted_user]

The safety tables are generated mainly in Phase I studeis, they can include pharmacokinetics, pharmacodynamics. Safety TLFs basically figures out and establishes what amount of the drug is of best beneficial w.r.to risks versus benfits. (These different amounts of drugs are grouped as Cohorts.) So, the next phases could use that fixed amount for further phase studies. Safety also figures out how the demographic details (age, height, race, sex, county of rsidence) contribute to the drug dynamics.

Efficacy tables gather for the given treatment how much percentage of people benefitted 100%, 80%, 40% etc. Protocol defines what percentage of recovery (or # of subjects that recovered) is considered for the drug to be effective.

[Doc_Duke]

The contents of the tables are largely driven by the topic under consideration. Efficacy measures should be in the protocol. Safety measures always include death, but there is little else that is an 'always'. Items to consider in safety are also topic driven; the safety items for a statin might be quite different than those for a topical dermatitis agent.

[deleted_user]

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!

[pthakkar]

It is Kaplan-Meier (not Meyer wake up!)