topic Re: Difference between itt and safety populations in SAS Health and Life Sciences https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/Difference-between-itt-and-safety-populations/m-p/191627#M2420 <HTML><HEAD></HEAD><BODY><P>Hi Sam,</P><P></P><P>ITT analysis set and safety analysis set should be defined in the documents of&nbsp; Statistical Analysis Plan(SAP) or Data Presentation Specifications(DPS).</P><P>The definition may varies from different protocols but mainly the same:</P><P>Safety: any subject who receive at least 1 dose of study medication.</P><P>ITT: be classified according to the assigned treatment group, regardless of the actual treatment received. </P><P></P><P>Also, Safety is used for safety analysis, like AEs</P><P>ITT is often used for efficacy analysis, which is conservative for superiority trial. </P></BODY></HTML> Thu, 10 Apr 2014 01:31:36 GMT tonic 2014-04-10T01:31:36Z Difference between itt and safety populations https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/Difference-between-itt-and-safety-populations/m-p/191626#M2419 <HTML><HEAD></HEAD><BODY><P>Hello, I am a newbie here and needed your help. Can anyone please let me know the difference between "intent to treat" (itt) and safety populations?</P><P>I was in the process of flagging some data which I was working on, and got stuck not knowing the difference.</P><P>Thanks for your help.</P><P>-Sam</P></BODY></HTML> Sun, 02 Mar 2014 22:41:19 GMT https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/Difference-between-itt-and-safety-populations/m-p/191626#M2419 samchat 2014-03-02T22:41:19Z Re: Difference between itt and safety populations https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/Difference-between-itt-and-safety-populations/m-p/191627#M2420 <HTML><HEAD></HEAD><BODY><P>Hi Sam,</P><P></P><P>ITT analysis set and safety analysis set should be defined in the documents of&nbsp; Statistical Analysis Plan(SAP) or Data Presentation Specifications(DPS).</P><P>The definition may varies from different protocols but mainly the same:</P><P>Safety: any subject who receive at least 1 dose of study medication.</P><P>ITT: be classified according to the assigned treatment group, regardless of the actual treatment received. </P><P></P><P>Also, Safety is used for safety analysis, like AEs</P><P>ITT is often used for efficacy analysis, which is conservative for superiority trial. </P></BODY></HTML> Thu, 10 Apr 2014 01:31:36 GMT https://communities.sas.com/t5/SAS-Health-and-Life-Sciences/Difference-between-itt-and-safety-populations/m-p/191627#M2420 tonic 2014-04-10T01:31:36Z