Date:         Wed, 23 Aug 2006 17:11:38 -0400
Reply-To:     Venky Chakravarthy <swovcc@HOTMAIL.COM>
Sender:       "SAS(r) Discussion" <SAS-L@LISTSERV.UGA.EDU>
From:         Venky Chakravarthy <swovcc@HOTMAIL.COM>
Subject:      Re: A Clinical SAS question - Adverse Event

On Wed, 23 Aug 2006 17:02:35 -0400, Venky Chakravarthy <swovcc@HOTMAIL.COM>
wrote:

>On Wed, 23 Aug 2006 16:37:40 -0400, Rathindronath <mehedisas@YAHOO.COM>
>wrote:
>
>>I am trying to do a summary table for the overview of adverse events
>>(analysis set: all patient ). Since I am new in Clinical Trial will any be
>>kind enough give me a brief idea what the following things mean:
>>
>>1) All treatment-emergent AEs
>
>Any AE that happened after the patient started taking study medication.
>Note that this can be an AE that was classified as "MILD" even before the
>patient took study med but became "MODERATE" or "SEVERE" any time after the
>patient took study med.
>
>>2) All treatment-related, treatment-emergent Aes
>>
>
>This is a subset of the above. The investigator usually makes a
>determination whether a particular AE may have been caused by the study
>medication. Typical classifications are "Likely", "Unlikely", "Definitely
>Not", "Unknown" etc.

I left this mid way. So relationship to study drug is determined based on
the investigators response. Usually "Unknown" is conservatively reported as
RELATED to study drug. To answer your question an AE is either related to
the study drug or Not related to the study drug. That is why I said it is a
subset of 1).

>
>>Thanks in advance
>
>Welcome.
>
>By the way, I am looking forward to your response about reverese
>engineering those output summary tables into SAS data sets.
>
>Venky Chakravarthy