14-1.01

Summary of Populations

Made 2026-10-17 from uploaded data.

Program t-14-1-01.sas

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

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Output  : Table 14-1.01 / Summary of Populations / Intent-to-Treat Analysis Set
  Program : t-14-1-01.sas   Reporting effort : CSR
  ADaM    : /work/adam (ADSL, ADADAS, ADCIBC, ADLBC, ADLBH, ADNPIX, ADTTE, ADVS, ADAE, ADCM, ADMH, ADEX)
  The header and the report step follow from the shell. The sections between
  them make WORK.FINAL, one record per row of the table, in order:
    _page     the page (1 unless the output is paged); _pagelbl its heading or empty
    _ord      the row's order; _indent the label's indentation (0 = flush left)
    _rowid    the uuid of the shell row it shows (WORK._SHELL); one shell row may
              have several (a category per value); a blank row's is blank-<n>
    _kind     label | stat | blank
    rowlabel  the row's label, as text
    col1      Placebo|(N=xx)
    col2      Xanomeline Low Dose|(N=xx)
    col3      Xanomeline High Dose|(N=xx)
    col4      Total|(N=xx)
  and set the big N of the column headers:
    &_bign1    Placebo|(N=xx)
    &_bign2    Xanomeline Low Dose|(N=xx)
    &_bign3    Xanomeline High Dose|(N=xx)
    &_bign4    Total|(N=xx)
  /work/_lib/clinwright.sas has %ls_bign, %ls_count, %ls_stats, %ls_npct, %ls_num.
----------------------------------------------------------------------------*/
libname adam "/work/adam" access=readonly;
%include "/work/_lib/clinwright.sas";
%ls_setup;

/* The shell's rows, in order, with each column's value pattern (_xx1-_xx4). */
data work._shell;
  length _page 8 _pagelbl $200 _ord 8 _indent 8 _rowid $36 _kind $5 _var $32 rowlabel $200 _xx1 $40 _xx2 $40 _xx3 $40 _xx4 $40;
  _page = 1; _pagelbl = '';
  _ord=1; _indent=0; _rowid='e04fa2cf-a29e-45c6-95ef-a14b2abb5f98'; _kind='stat'; _var=''; rowlabel='Intent-To-Treat (ITT)'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; _xx4='xx (xx%)'; output;
  _ord=2; _indent=0; _rowid='blank-2'; _kind='blank'; _var=''; rowlabel=''; _xx1=''; _xx2=''; _xx3=''; _xx4=''; output;
  _ord=3; _indent=0; _rowid='33cd3552-edd9-4be2-aa2d-c1a5086f4868'; _kind='stat'; _var=''; rowlabel='Safety'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; _xx4='xx (xx%)'; output;
  _ord=4; _indent=0; _rowid='blank-4'; _kind='blank'; _var=''; rowlabel=''; _xx1=''; _xx2=''; _xx3=''; _xx4=''; output;
  _ord=5; _indent=0; _rowid='1c567caf-c3bc-405c-a49e-9e8616003ebc'; _kind='stat'; _var=''; rowlabel='Efficacy'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; _xx4='xx (xx%)'; output;
  _ord=6; _indent=0; _rowid='blank-6'; _kind='blank'; _var=''; rowlabel=''; _xx1=''; _xx2=''; _xx3=''; _xx4=''; output;
  _ord=7; _indent=0; _rowid='e95b1e49-f510-46a2-a46d-e2ea9ede4a5f'; _kind='stat'; _var=''; rowlabel='Complete Week 24'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; _xx4='xx (xx%)'; output;
  _ord=8; _indent=0; _rowid='blank-8'; _kind='blank'; _var=''; rowlabel=''; _xx1=''; _xx2=''; _xx3=''; _xx4=''; output;
  _ord=9; _indent=0; _rowid='117cfd1e-753c-4200-9fef-70d5cdbf0cc5'; _kind='stat'; _var=''; rowlabel='Complete Study'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; _xx4='xx (xx%)'; output;
run;

/*==== 10-data ====*/
/* Made from the output's analysis: the subjects of ADSL with ITTFL = 'Y', by TRT01P. */
data work._an;
  set adam.adsl(where=(ittfl = 'Y'));
  if trt01p in ('Placebo') then do; _col = 1; output; end;
  if trt01p in ('Xanomeline Low Dose') then do; _col = 2; output; end;
  if trt01p in ('Xanomeline High Dose') then do; _col = 3; output; end;
  _col = 4; output;
run;
data work._popc; set work._an(keep=usubjid _col); run;
data work._cols; do _col = 1 to 4; output; end; run;
%ls_bign(data=work._popc, trt=_col, values=1|2|3|4|1|2|3|4, names=_lsn1 _lsn2 _lsn3 _lsn4 _bign1 _bign2 _bign3 _bign4);

/* Subjects and records per column. */
proc sort data=work._an(keep=usubjid _col) out=work._u; by _col usubjid; run;
data work._c;
  set work._u;
  by _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; id _col; var _e; run;
data work._z; _z = 1; run;
data work._g0;
  merge work._z work._tn work._te;
  array _nn{4} _n1-_n4;
  array _ee{4} _e1-_e4;
  do _i = 1 to 4; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = _n4;
  drop _i _z;
run;
/* Intent-To-Treat (ITT): npct of ITTFL = Y. */
data work._f; set work._g0; do _col = 1 to 4; output; end; run;
proc sort data=work._an(keep=usubjid _col ittfl where=(ittfl = 'Y')) out=work._v; by _col usubjid; run;
data work._v;
  set work._v;
  by _col usubjid;
  retain _vn _ve;
  if first._col then do; _vn = 0; _ve = 0; end;
  _ve = _ve + 1;
  if first.usubjid then _vn = _vn + 1;
  if last._col then output;
  keep _col _vn _ve;
run;
proc sort data=work._an(keep=usubjid _col ittfl where=(not missing(ittfl))) out=work._d; by _col usubjid; run;
data work._d;
  set work._d;
  by _col usubjid;
  retain _dn _de;
  if first._col then do; _dn = 0; _de = 0; end;
  _de = _de + 1;
  if first.usubjid then _dn = _dn + 1;
  if last._col then output;
  keep _col _dn _de;
run;
data work._k1;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._v work._d;
  by _col;
  if _in;
  array _nn{4} _n1-_n4;
  array _ee{4} _e1-_e4;
  _rowid = 'e04fa2cf-a29e-45c6-95ef-a14b2abb5f98';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _label = '';
  _v = strip(ifc(missing(sum(_vn, 0)), '-', %ls_num(sum(_vn, 0), 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
  keep _rowid _label _page _pagelbl _k0 _col _v;
run;
/* Safety: npct of SAFFL = Y. */
data work._f; set work._g0; do _col = 1 to 4; output; end; run;
proc sort data=work._an(keep=usubjid _col saffl where=(saffl = 'Y')) out=work._v; by _col usubjid; run;
data work._v;
  set work._v;
  by _col usubjid;
  retain _vn _ve;
  if first._col then do; _vn = 0; _ve = 0; end;
  _ve = _ve + 1;
  if first.usubjid then _vn = _vn + 1;
  if last._col then output;
  keep _col _vn _ve;
run;
proc sort data=work._an(keep=usubjid _col saffl where=(not missing(saffl))) out=work._d; by _col usubjid; run;
data work._d;
  set work._d;
  by _col usubjid;
  retain _dn _de;
  if first._col then do; _dn = 0; _de = 0; end;
  _de = _de + 1;
  if first.usubjid then _dn = _dn + 1;
  if last._col then output;
  keep _col _dn _de;
run;
data work._k2;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._v work._d;
  by _col;
  if _in;
  array _nn{4} _n1-_n4;
  array _ee{4} _e1-_e4;
  _rowid = '33cd3552-edd9-4be2-aa2d-c1a5086f4868';
  _page = 1;
  _pagelbl = '';
  _k0 = 3;
  _label = '';
  _v = strip(ifc(missing(sum(_vn, 0)), '-', %ls_num(sum(_vn, 0), 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
  keep _rowid _label _page _pagelbl _k0 _col _v;
run;
/* Efficacy: npct of EFFFL = Y. */
data work._f; set work._g0; do _col = 1 to 4; output; end; run;
proc sort data=work._an(keep=usubjid _col efffl where=(efffl = 'Y')) out=work._v; by _col usubjid; run;
data work._v;
  set work._v;
  by _col usubjid;
  retain _vn _ve;
  if first._col then do; _vn = 0; _ve = 0; end;
  _ve = _ve + 1;
  if first.usubjid then _vn = _vn + 1;
  if last._col then output;
  keep _col _vn _ve;
run;
proc sort data=work._an(keep=usubjid _col efffl where=(not missing(efffl))) out=work._d; by _col usubjid; run;
data work._d;
  set work._d;
  by _col usubjid;
  retain _dn _de;
  if first._col then do; _dn = 0; _de = 0; end;
  _de = _de + 1;
  if first.usubjid then _dn = _dn + 1;
  if last._col then output;
  keep _col _dn _de;
run;
data work._k3;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._v work._d;
  by _col;
  if _in;
  array _nn{4} _n1-_n4;
  array _ee{4} _e1-_e4;
  _rowid = '1c567caf-c3bc-405c-a49e-9e8616003ebc';
  _page = 1;
  _pagelbl = '';
  _k0 = 5;
  _label = '';
  _v = strip(ifc(missing(sum(_vn, 0)), '-', %ls_num(sum(_vn, 0), 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
  keep _rowid _label _page _pagelbl _k0 _col _v;
run;
/* Complete Week 24: npct of COMP24FL = Y. */
data work._f; set work._g0; do _col = 1 to 4; output; end; run;
proc sort data=work._an(keep=usubjid _col comp24fl where=(comp24fl = 'Y')) out=work._v; by _col usubjid; run;
data work._v;
  set work._v;
  by _col usubjid;
  retain _vn _ve;
  if first._col then do; _vn = 0; _ve = 0; end;
  _ve = _ve + 1;
  if first.usubjid then _vn = _vn + 1;
  if last._col then output;
  keep _col _vn _ve;
run;
proc sort data=work._an(keep=usubjid _col comp24fl where=(not missing(comp24fl))) out=work._d; by _col usubjid; run;
data work._d;
  set work._d;
  by _col usubjid;
  retain _dn _de;
  if first._col then do; _dn = 0; _de = 0; end;
  _de = _de + 1;
  if first.usubjid then _dn = _dn + 1;
  if last._col then output;
  keep _col _dn _de;
run;
data work._k4;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._v work._d;
  by _col;
  if _in;
  array _nn{4} _n1-_n4;
  array _ee{4} _e1-_e4;
  _rowid = 'e95b1e49-f510-46a2-a46d-e2ea9ede4a5f';
  _page = 1;
  _pagelbl = '';
  _k0 = 7;
  _label = '';
  _v = strip(ifc(missing(sum(_vn, 0)), '-', %ls_num(sum(_vn, 0), 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
  keep _rowid _label _page _pagelbl _k0 _col _v;
run;
/* Complete Study: npct of DCDECOD = COMPLETED. */
data work._f; set work._g0; do _col = 1 to 4; output; end; run;
proc sort data=work._an(keep=usubjid _col dcdecod where=(dcdecod = 'COMPLETED')) out=work._v; by _col usubjid; run;
data work._v;
  set work._v;
  by _col usubjid;
  retain _vn _ve;
  if first._col then do; _vn = 0; _ve = 0; end;
  _ve = _ve + 1;
  if first.usubjid then _vn = _vn + 1;
  if last._col then output;
  keep _col _vn _ve;
run;
proc sort data=work._an(keep=usubjid _col dcdecod where=(not missing(dcdecod))) out=work._d; by _col usubjid; run;
data work._d;
  set work._d;
  by _col usubjid;
  retain _dn _de;
  if first._col then do; _dn = 0; _de = 0; end;
  _de = _de + 1;
  if first.usubjid then _dn = _dn + 1;
  if last._col then output;
  keep _col _dn _de;
run;
data work._k5;
  length _rowid $36 _label _pagelbl $200 _v $200;
  merge work._f(in=_in) work._v work._d;
  by _col;
  if _in;
  array _nn{4} _n1-_n4;
  array _ee{4} _e1-_e4;
  _rowid = '117cfd1e-753c-4200-9fef-70d5cdbf0cc5';
  _page = 1;
  _pagelbl = '';
  _k0 = 9;
  _label = '';
  _v = strip(ifc(missing(sum(_vn, 0)), '-', %ls_num(sum(_vn, 0), 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * sum(_vn, 0) / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
  keep _rowid _label _page _pagelbl _k0 _col _v;
run;

data work._cells; set work._k1 work._k2 work._k3 work._k4 work._k5; run;
proc sort data=work._cells; by _page _pagelbl _k0 _rowid _label _col; run;
proc transpose data=work._cells out=work._wide(drop=_name_) prefix=col;
  by _page _pagelbl _k0 _rowid _label;
  id _col;
  var _v;
run;
proc sort data=work._wide; by _rowid; run;
proc sort data=work._shell(drop=_page _pagelbl) out=work._rows; by _rowid; run;
data work._inst;
  merge work._wide(in=_w) work._rows(in=_s);
  by _rowid;
  if _w and _s;
  if _label ne '' then rowlabel = _label;
run;
data work._fixed;
  set work._shell;
  if _rowid not in ('e04fa2cf-a29e-45c6-95ef-a14b2abb5f98' '33cd3552-edd9-4be2-aa2d-c1a5086f4868' '1c567caf-c3bc-405c-a49e-9e8616003ebc' 'e95b1e49-f510-46a2-a46d-e2ea9ede4a5f' '117cfd1e-753c-4200-9fef-70d5cdbf0cc5');
  _k0 = _ord;
run;
data work.final;
  length col1 col2 col3 col4 $200 _pagelbl $200;
  set work._inst work._fixed;
run;
proc sort data=work.final; by _page _k0; run;
data work.final;
  set work.final;
  _ord = _n_;
  keep _page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4;
run;

/*==== 90-report ====*/
/* 90-report: from the shell; the titles, columns, headers and footnotes are not changed here. */
%ls_need(_bign1 _bign2 _bign3 _bign4);
%ls_final_check(columns=_page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4);
proc sort data=work.final out=work._report; by _page _ord; run;
data work._report;
  set work._report;
  /* Two spaces per step of indentation: the label column keeps leading spaces (asis=on). */
  if _indent > 0 then rowlabel = repeat(' ', 2 * _indent - 1) || rowlabel;
run;
%let _lspaged = 0;
proc sql noprint; select count(*) into :_lspaged trimmed from work._report where _pagelbl ne ''; quit;

options orientation=landscape;
ods listing close;
ods rtf file="/work/out/t-14-1-01.rtf" style=journal;
title1 j=l "CDISCPILOT01" j=r "Page ~{thispage} of ~{lastpage}";
title2 j=c "Table 14-1.01";
title3 j=c "Summary of Populations";
title4 j=c "Intent-to-Treat Analysis Set";
footnote1 j=l "NOTE: N in column headers represents number of subjects entered in study (i.e., signed informed consent).";
footnote2 j=l "The ITT population includes all subjects randomized. The Safety population includes all randomized subjects known to have taken at least one dose of randomized study drug. The Efficacy population includes all subjects in the safety population who also have at least one post-baseline ADAS-Cog and CIBIC+ assessment.";
footnote3 j=l "Program: t-14-1-01.sas";
%macro _ls_report;
proc report data=work._report nowd split='|' missing style(report)={width=100%};
  column _page _pagelbl _ord _indent _kind rowlabel col1 col2 col3 col4;
  define _page / order order=internal noprint;
  define _pagelbl / order noprint;
  define _ord / order order=internal noprint;
  define _indent / display noprint;
  define _kind / display noprint;
  define rowlabel / display "" style(column)={cellwidth=40% asis=on} style(header)={just=l};
  define col1 / display "Placebo|(N=&_bign1.)" style(column)={cellwidth=15% just=c} style(header)={just=c};
  define col2 / display "Xanomeline Low Dose|(N=&_bign2.)" style(column)={cellwidth=15% just=c} style(header)={just=c};
  define col3 / display "Xanomeline High Dose|(N=&_bign3.)" style(column)={cellwidth=15% just=c} style(header)={just=c};
  define col4 / display "Total|(N=&_bign4.)" style(column)={cellwidth=15% just=c} style(header)={just=c};
  %if &_lspaged > 0 %then %do;
  compute before _pagelbl / style={just=l};
    line _pagelbl $200.;
  endcomp;
  %end;
  break after _page / page;
run;
%mend _ls_report;
%_ls_report;
ods rtf close;
ods listing;
%ls_final_export;