/*------------------------------------------------------------* 
* program:     cdsic67a.sas                                    * 
* Description: Case #67. Treatment Emergent AE For AE domains, this identifies a Sponsor-provided Flag Variable *
*              for 'Treatment emergent AE' where the derivation can't be executed.* 
* By:          Sy Truong, 10/14/2009                          *
*-------------------------------------------------------------*/

libname templib '../data';

proc format library=work;
   value $chtoch 'F' = 'Female'
                  'M' = 'Male'
                  ;
run;
data templib.ae(label="Adverse Events");
attrib STUDYID length=$7 label="Study Identifier";
attrib DOMAIN length=$2 label="Domain Abbreviation";
attrib USUBJID length=$14 label="Unique Subject Identifier";

attrib AETERM length=$25 label="Reported Term for the Adverse Event";
attrib AEMODIFY length=$9 label="Modified Reported Term";
attrib AEDECOD length=$18 label="Dictionary-Derived Term";
attrib AEBODSYS length=$52 label="Body System or Organ Class";
attrib AESEQ length=8 label="Sequence Number";
attrib AESER length=$1 label="Serious Event";
attrib AEACN length=$30 label="Action Taken with Study Treatment";
attrib AEREL length=$16 label="Causality";
attrib AECONTRT length=$1 label="Concomitant or Additional Trtmnt Given";
attrib AESTDTC length=$10 label="Start Date/Time of Adverse Event";
attrib AEENDTC length=$10 label="End Date/Time of Adverse Event";
attrib AESTDY length=8 label="Study Day of Start of Adverse Event";
attrib AEENDY length=8 label="Study Day of End of Adverse Event";
attrib AEENRF length=$5 label="End Relative to Reference Period";
attrib AETOXGR label="Standard Toxicity Grade" length=$30;
attrib AETRTEM label="Treatment Emergent AE" length=$30 ;

STUDYID="CDISC01";
DOMAIN="AE";
USUBJID="CDISC01.100008";
AESEQ=1;
AETERM="AGITATED";
AEMODIFY="AGITATION";
AEDECOD="Agitation";
AEBODSYS="Psychiatric disorders";

AESER="N";
AEACN="DOSE NOT CHANGED";
AEREL="POSSIBLY RELATED";
AECONTRT="";
AESTDTC="2003-05";
AEENDTC="";
AESTDY=3;
AEENDY=.;
AEENRF="AFTER";
AETOXGR='1';
AETRTEM="F";
output;
STUDYID="CDISC01";
DOMAIN="AE";
USUBJID="CDISC01.100008";

AETERM="ANXIETY";
AEMODIFY="";
AEDECOD="Anxiety";
AEBODSYS="Psychiatric disorders";
AESEQ=1;
AESER="N";
AEACN="DOSE NOT CHANGED";
AEREL="POSSIBLY RELATED";
AECONTRT="";
AESTDTC="2003-05-13";
AEENDTC="";
AESTDY=15;
AEENDY=.;
AEENRF="AFTER";
AETOXGR='1';
output;
STUDYID="CDISC01";
DOMAIN="AE";
USUBJID="CDISC01.100008";

AETERM="DECREASED APPETITE";
AEMODIFY="";
AEDECOD="Decreased appetite";
AEBODSYS="Metabolism and nutrition disorders";
AESEQ=1;
AESER="N";
AEACN="DOSE NOT CHANGED";
AEREL="POSSIBLY RELATED";
AECONTRT="";
AESTDTC="2003-08-19";
AEENDTC="2003-09-15";
AESTDY=113;
AEENDY=140;
AEENRF="";
AETOXGR='';
output;
STUDYID="CDISC01";
DOMAIN="AE";
USUBJID="CDISC01.100014";

AETERM="DIARRHEA";
AEMODIFY="";
AEDECOD="Diarrhoea";
AEBODSYS="Gastrointestinal disorders";
AESEQ=1;
AESER="N";
AEACN="DOSE NOT CHANGED";
AEREL="NOT RELATED";
AECONTRT="";
AESTDTC="2004-01-06";
AEENDTC="";
AESTDY=84;
AEENDY=.;
AEENRF="AFTER";
AETOXGR='1';
output;
run;
%cdisc(datlib=templib,datname=ae);