ADTTE

AE Time To 1st Derm. Event Analysis

BASIC DATA STRUCTURE · one record per subject per parameter · keys USUBJID, PARAMCD

Variables

Program adtte.sas

Version 1, written from Clinwright's patterns, 2026-10-17, checks passed.

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Data set : ADTTE (AE Time To 1st Derm. Event Analysis)
  Reporting effort : CSR
  ADaM     : ADAE, ADSL
  The header and the finalize step follow from the specification.
----------------------------------------------------------------------------*/
libname sdtm "/work/sdtm" access=readonly;
libname adam "/work/adam";
options validvarname=upcase nofmterr msglevel=i;

/*==== 10-inputs ====*/
/* The subjects of ADSL, with ADSL's variables. */
data work._ds;
  set adam.adsl;
  trtdur = trtdurd;
  trtp = trt01p;
  trta = trt01a;
  trtan = trt01an;
run;
/* STARTDT (a copy of ADTTE.STARTDT): merge it on. */

/*==== 25-derived-parameters ====*/
/* AVAL[TTDE] (Time to Derm. Event or End of Study): ADT-STARTDT+1 -- to write. */

/*==== 30-timing ====*/
/* ADT: ADSL.RFENDTC as a SAS date. */
data work._ds;
  set work._ds;
  length _dtc $10;
  _dtc = rfendtc; /* (its first 10 characters: SUBSTR would complain of a shorter variable) */
  if length(_dtc) = 10 then adt = input(_dtc, ?? yymmdd10.);

  format adt date9.;
  drop _dtc;
run;

/*==== 70-other ====*/
/* Time to event TTDE: the first ADAE record where TRTEMFL ="Y" on or after TRTSDT is the event (CNSR = 0); */
/* a subject without one is censored (CNSR = 1) at RFENDT. AVAL: days from TRTSDT, +1.                                   */
proc sort data=adam.adae(where=((TRTEMFL ="Y") and not missing(astdt))) out=work._tte(keep=usubjid astdt aeseq);
  by usubjid astdt aeseq;
run;
data work._tte;
  merge work._tte(in=_e) work._ds(keep=usubjid trtsdt);
  by usubjid;
  if _e and astdt >= trtsdt > .;
run;
data work._tte(keep=usubjid _evdt _evseq);
  set work._tte;
  by usubjid;
  if first.usubjid;
  _evdt = astdt;

  _evseq = aeseq;

run;
data work._ds;
  merge work._ds(in=_in) work._tte(in=_ev);
  by usubjid;
  if _in;
  length paramcd $8 param evntdesc srcdom srcvar $200;
  paramcd = "TTDE";
  param = 'Time to First Dermatologic Event';
  startdt = trtsdt;
  if _ev then do;
    adt = _evdt; cnsr = 0; evntdesc = 'Dematologic Event Occured'; srcdom = "ADAE"; srcvar = "ASTDT";

    srcseq = _evseq;

  end;
  else do;
    adt = rfendt; cnsr = 1; evntdesc = 'Study Completion Date'; srcdom = "ADSL"; srcvar = "RFENDT"; call missing(srcseq);
  end;
  if nmiss(adt, startdt) = 0 then aval = adt - startdt + 1;
  format adt startdt date9.;
  drop _evdt _evseq;
run;

/*==== 89-final ====*/
/* The data set as derived; the finalize step keeps the specification's variables. */
data work._final;
  set work._ds;
run;

/*==== 90-finalize ====*/
/* 90-finalize: from the specification; the variables, their order and attributes are not changed here. */
/* The text variables the specification gives no length: as long as their longest value (at least 1). */
%let _len1 = 1; %let _len2 = 1; %let _len3 = 1; %let _len4 = 1; %let _len5 = 1; %let _len6 = 1; %let _len7 = 1; %let _len8 = 1; %let _len9 = 1; %let _len10 = 1; %let _len11 = 1; %let _len12 = 1; %let _len13 = 1; %let _len14 = 1;
data _null_;
  length _ren _asg _siz $32767;
  _dsid = open('work._final');
  if varnum(_dsid, 'STUDYID') > 0 then do; _ren = catx(' ', _ren, 'STUDYID=_rz1'); _asg = catx(' ', _asg, 'STUDYID = _rz1;');
    _siz = catx(' ', _siz, '_len1 = max(_len1, lengthn(STUDYID));'); end;
  if varnum(_dsid, 'SITEID') > 0 then do; _ren = catx(' ', _ren, 'SITEID=_rz2'); _asg = catx(' ', _asg, 'SITEID = _rz2;');
    _siz = catx(' ', _siz, '_len2 = max(_len2, lengthn(SITEID));'); end;
  if varnum(_dsid, 'USUBJID') > 0 then do; _ren = catx(' ', _ren, 'USUBJID=_rz3'); _asg = catx(' ', _asg, 'USUBJID = _rz3;');
    _siz = catx(' ', _siz, '_len3 = max(_len3, lengthn(USUBJID));'); end;
  if varnum(_dsid, 'AGEGR1') > 0 then do; _ren = catx(' ', _ren, 'AGEGR1=_rz4'); _asg = catx(' ', _asg, 'AGEGR1 = _rz4;');
    _siz = catx(' ', _siz, '_len4 = max(_len4, lengthn(AGEGR1));'); end;
  if varnum(_dsid, 'RACE') > 0 then do; _ren = catx(' ', _ren, 'RACE=_rz5'); _asg = catx(' ', _asg, 'RACE = _rz5;');
    _siz = catx(' ', _siz, '_len5 = max(_len5, lengthn(RACE));'); end;
  if varnum(_dsid, 'SEX') > 0 then do; _ren = catx(' ', _ren, 'SEX=_rz6'); _asg = catx(' ', _asg, 'SEX = _rz6;');
    _siz = catx(' ', _siz, '_len6 = max(_len6, lengthn(SEX));'); end;
  if varnum(_dsid, 'TRTP') > 0 then do; _ren = catx(' ', _ren, 'TRTP=_rz7'); _asg = catx(' ', _asg, 'TRTP = _rz7;');
    _siz = catx(' ', _siz, '_len7 = max(_len7, lengthn(TRTP));'); end;
  if varnum(_dsid, 'TRTA') > 0 then do; _ren = catx(' ', _ren, 'TRTA=_rz8'); _asg = catx(' ', _asg, 'TRTA = _rz8;');
    _siz = catx(' ', _siz, '_len8 = max(_len8, lengthn(TRTA));'); end;
  if varnum(_dsid, 'PARAM') > 0 then do; _ren = catx(' ', _ren, 'PARAM=_rz9'); _asg = catx(' ', _asg, 'PARAM = _rz9;');
    _siz = catx(' ', _siz, '_len9 = max(_len9, lengthn(PARAM));'); end;
  if varnum(_dsid, 'PARAMCD') > 0 then do; _ren = catx(' ', _ren, 'PARAMCD=_rz10'); _asg = catx(' ', _asg, 'PARAMCD = _rz10;');
    _siz = catx(' ', _siz, '_len10 = max(_len10, lengthn(PARAMCD));'); end;
  if varnum(_dsid, 'EVNTDESC') > 0 then do; _ren = catx(' ', _ren, 'EVNTDESC=_rz11'); _asg = catx(' ', _asg, 'EVNTDESC = _rz11;');
    _siz = catx(' ', _siz, '_len11 = max(_len11, lengthn(EVNTDESC));'); end;
  if varnum(_dsid, 'SRCDOM') > 0 then do; _ren = catx(' ', _ren, 'SRCDOM=_rz12'); _asg = catx(' ', _asg, 'SRCDOM = _rz12;');
    _siz = catx(' ', _siz, '_len12 = max(_len12, lengthn(SRCDOM));'); end;
  if varnum(_dsid, 'SRCVAR') > 0 then do; _ren = catx(' ', _ren, 'SRCVAR=_rz13'); _asg = catx(' ', _asg, 'SRCVAR = _rz13;');
    _siz = catx(' ', _siz, '_len13 = max(_len13, lengthn(SRCVAR));'); end;
  if varnum(_dsid, 'SAFFL') > 0 then do; _ren = catx(' ', _ren, 'SAFFL=_rz14'); _asg = catx(' ', _asg, 'SAFFL = _rz14;');
    _siz = catx(' ', _siz, '_len14 = max(_len14, lengthn(SAFFL));'); end;
  _rc = close(_dsid);
  if _ren ne '' then _ren = cats('(rename=(', _ren, '))');
  call symputx('_ren', _ren);
  call symputx('_asg', _asg);
  call symputx('_siz', _siz);
run;
data _null_;
  set work._final end=_end;
  retain _len1 1 _len2 1 _len3 1 _len4 1 _len5 1 _len6 1 _len7 1 _len8 1 _len9 1 _len10 1 _len11 1 _len12 1 _len13 1 _len14 1;
  &_siz
  if _end then do;
    call symputx('_len1', _len1);
    call symputx('_len2', _len2);
    call symputx('_len3', _len3);
    call symputx('_len4', _len4);
    call symputx('_len5', _len5);
    call symputx('_len6', _len6);
    call symputx('_len7', _len7);
    call symputx('_len8', _len8);
    call symputx('_len9', _len9);
    call symputx('_len10', _len10);
    call symputx('_len11', _len11);
    call symputx('_len12', _len12);
    call symputx('_len13', _len13);
    call symputx('_len14', _len14);
  end;
run;
data adam.adtte(label="AE Time To 1st Derm. Event Analysis");
  attrib
    STUDYID  length=$&_len1 label="Study Identifier"
    SITEID   length=$&_len2 label="Study Site Identifier"
    USUBJID  length=$&_len3 label="Unique Subject Identifier"
    AGE      length=8 label="Age"
    AGEGR1   length=$&_len4 label="Pooled Age Group 1"
    AGEGR1N  length=8 label="Pooled Age Group 1 (N)"
    RACE     length=$&_len5 label="Race"
    RACEN    length=8 label="Race (N)"
    SEX      length=$&_len6 label="Sex"
    TRTSDT   length=8 label="Date of First Exposure to Treatment" format=DATE9.
    TRTEDT   length=8 label="Date of Last Exposure to Treatment" format=DATE9.
    TRTDUR   length=8 label="Duration of treatment (days)"
    TRTP     length=$&_len7 label="Planned Treatment"
    TRTA     length=$&_len8 label="Actual Treatment"
    TRTAN    length=8 label="Actual Treatment (N)"
    PARAM    length=$&_len9 label="Parameter"
    PARAMCD  length=$&_len10 label="Parameter Code"
    AVAL     length=8 label="Analysis Value"
    STARTDT  length=8 label="Time to Event Origin Date for Subject" format=DATE9.
    ADT      length=8 label="Analysis Date" format=DATE9.
    CNSR     length=8 label="Censor"
    EVNTDESC length=$&_len11 label="Event or Censoring Description"
    SRCDOM   length=$&_len12 label="Source Domain"
    SRCVAR   length=$&_len13 label="Source Variable"
    SRCSEQ   length=8 label="Source Sequence Number"
    SAFFL    length=$&_len14 label="Safety Population Flag"
  ;
  set work._final&_ren;
  &_asg
  keep STUDYID SITEID USUBJID AGE AGEGR1 AGEGR1N RACE RACEN SEX TRTSDT TRTEDT TRTDUR TRTP TRTA TRTAN PARAM PARAMCD AVAL STARTDT ADT CNSR EVNTDESC SRCDOM SRCVAR SRCSEQ SAFFL;
run;
proc sort data=adam.adtte; by USUBJID PARAMCD; run;

Data (first 20 of 254 records, uploaded)