14-7.04
Summary of Concomitant Medications (Number of Subjects)
Made 2026-10-17 from uploaded data.
CDISCPILOT01
Table 14-7.04
Summary of Concomitant Medications (Number of Subjects)
Safety Analysis Set
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | |
|---|---|---|---|
| Patients receiving at least one concomitant medication | 77 (90%) | 74 (88%) | 78 (93%) |
| ALIMENTARY TRACT AND METABOLISM | 12 (14%) | 11 (13%) | 9 (11%) |
| ALGELDRATE | 2 (2%) | 0 (0%) | 2 (2%) |
| CALCIUM | 7 (8%) | 6 (7%) | 3 (4%) |
| CALCIUM CARBONATE | 0 (0%) | 0 (0%) | 1 (1%) |
| CIMETIDINE | 0 (0%) | 1 (1%) | 0 (0%) |
| LOPERAMIDE HYDROCHLORIDE | 1 (1%) | 1 (1%) | 1 (1%) |
| METFORMIN HYDROCHLORIDE | 1 (1%) | 1 (1%) | 0 (0%) |
| NIZATIDINE | 1 (1%) | 1 (1%) | 4 (5%) |
| SIMETICONE | 0 (0%) | 2 (2%) | 0 (0%) |
| ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS | 1 (1%) | 0 (0%) | 1 (1%) |
| LEUPRORELIN ACETATE | 1 (1%) | 0 (0%) | 1 (1%) |
| BLOOD AND BLOOD FORMING ORGANS | 0 (0%) | 1 (1%) | 0 (0%) |
| FERROUS SULFATE | 0 (0%) | 1 (1%) | 0 (0%) |
| CARDIOVASCULAR SYSTEM | 12 (14%) | 12 (14%) | 7 (8%) |
| AMLODIPINE | 8 (9%) | 1 (1%) | 2 (2%) |
| DIGOXIN | 0 (0%) | 3 (4%) | 2 (2%) |
| DILTIAZEM HYDROCHLORIDE | 0 (0%) | 0 (0%) | 1 (1%) |
| DOXAZOSIN MESILATE | 1 (1%) | 2 (2%) | 1 (1%) |
| FELODIPINE | 0 (0%) | 1 (1%) | 0 (0%) |
| FLUVASTATIN | 0 (0%) | 2 (2%) | 0 (0%) |
| FUROSEMIDE | 2 (2%) | 2 (2%) | 1 (1%) |
| LOSARTAN POTASSIUM | 0 (0%) | 2 (2%) | 0 (0%) |
| NIFEDIPINE | 2 (2%) | 0 (0%) | 0 (0%) |
| DERMATOLOGICALS | 0 (0%) | 0 (0%) | 1 (1%) |
| CLOBETASOL PROPIONATE | 0 (0%) | 0 (0%) | 1 (1%) |
| GENITO URINARY SYSTEM AND SEX HORMONES | 6 (7%) | 10 (12%) | 5 (6%) |
| ESTROGENS CONJUGATED | 6 (7%) | 10 (12%) | 5 (6%) |
| NERVOUS SYSTEM | 23 (27%) | 14 (17%) | 8 (10%) |
| ACETYLSALICYLIC ACID | 21 (24%) | 11 (13%) | 6 (7%) |
| ALPRAZOLAM | 1 (1%) | 0 (0%) | 0 (0%) |
| DONEPEZIL HYDROCHLORIDE | 1 (1%) | 2 (2%) | 2 (2%) |
| HALOPERIDOL | 0 (0%) | 1 (1%) | 0 (0%) |
| PAROXETINE HYDROCHLORIDE | 0 (0%) | 1 (1%) | 0 (0%) |
| SUMATRIPTAN | 1 (1%) | 0 (0%) | 0 (0%) |
| RESPIRATORY SYSTEM | 4 (5%) | 1 (1%) | 4 (5%) |
| BUDESONIDE | 0 (0%) | 0 (0%) | 1 (1%) |
| GUAIFENESIN | 1 (1%) | 0 (0%) | 0 (0%) |
| IPRATROPIUM BROMIDE | 1 (1%) | 0 (0%) | 0 (0%) |
| NAPROXEN SODIUM | 1 (1%) | 0 (0%) | 3 (4%) |
| SALBUTAMOL SULFATE | 2 (2%) | 1 (1%) | 0 (0%) |
| SYSTEMIC HORMONAL PREPARATIONS, EXCL. | 2 (2%) | 13 (15%) | 8 (10%) |
| HYDROCORTISONE | 2 (2%) | 13 (15%) | 8 (10%) |
| UNCODED | 74 (86%) | 70 (83%) | 77 (92%) |
| UNCODED | 74 (86%) | 70 (83%) | 77 (92%) |
Note: Percentages are based on the number of subjects in the safety population within each treatment group.
Program: t-14-7-04.sas
Program t-14-7-04.sas
Version 1, written from Clinwright's patterns, 2026-10-17, checks passed.
/*==== 00-header ====*/
/*----------------------------------------------------------------------------
Output : Table 14-7.04 / Summary of Concomitant Medications (Number of Subjects) / Safety Analysis Set
Program : t-14-7-04.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)
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)
/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-_xx3). */
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;
_page = 1; _pagelbl = '';
_ord=1; _indent=0; _rowid='35d8307b-0ce7-4b4f-a35d-49174ae0b5e6'; _kind='stat'; _var=''; rowlabel='Patients receiving at least one concomitant medication'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; output;
_ord=2; _indent=0; _rowid='blank-2'; _kind='blank'; _var=''; rowlabel=''; _xx1=''; _xx2=''; _xx3=''; output;
_ord=3; _indent=0; _rowid='f9c9f5dd-becf-4307-98d9-47fca5b465b5'; _kind='stat'; _var=''; rowlabel='[Therapeutic class]'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; output;
_ord=4; _indent=1; _rowid='b1b42188-0ffd-4cb0-9b00-ff4bc448003a'; _kind='stat'; _var=''; rowlabel='[Medication]'; _xx1='xx (xx%)'; _xx2='xx (xx%)'; _xx3='xx (xx%)'; output;
run;
/*==== 10-data ====*/
/* Made from the output's analysis: the records of ADCM of the subjects of ADSL with SAFFL = 'Y', by TRT01A. */
/* The population's subjects, in each column they count in. */
data work._popc;
set adam.adsl(where=(saffl = 'Y'));
if trt01a in ('Placebo') then do; _col = 1; output; end;
if trt01a in ('Xanomeline Low Dose') then do; _col = 2; output; end;
if trt01a in ('Xanomeline High Dose') then do; _col = 3; output; end;
keep usubjid _col;
run;
data work._pop1; set adam.adsl(where=(saffl = 'Y')); keep usubjid trt01a; run;
proc sort data=work._pop1; by usubjid; run;
/* The records of ADCM, of the population's subjects, in each column. */
proc sort data=adam.adcm(keep=usubjid saffl cmdecod cmclas) out=work._rec; by usubjid; run;
data work._an;
merge work._rec(in=_r) work._pop1(in=_p);
by usubjid;
if _r and _p;
if trt01a in ('Placebo') then do; _col = 1; output; end;
if trt01a in ('Xanomeline Low Dose') then do; _col = 2; output; end;
if trt01a in ('Xanomeline High Dose') then do; _col = 3; output; end;
run;
data work._cols; do _col = 1 to 3; output; end; run;
%ls_bign(data=work._popc, trt=_col, values=1|2|3|1|2|3, names=_lsn1 _lsn2 _lsn3 _bign1 _bign2 _bign3);
/* 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{3} _n1-_n3;
array _ee{3} _e1-_e3;
do _i = 1 to 3; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
_tot = sum(of _n1-_n3);
drop _i _z;
run;
/* Patients receiving at least one concomitant medication: any. */
data work._f; set work._g0; do _col = 1 to 3; output; end; run;
data work._k1;
length _rowid $36 _label _pagelbl $200 _v $200;
set work._f;
array _nn{3} _n1-_n3;
array _ee{3} _e1-_e3;
_rowid = '35d8307b-0ce7-4b4f-a35d-49174ae0b5e6';
_page = 1;
_pagelbl = '';
_k0 = 1;
_k1 = 0; _k2 = 0;
_k3 = 0; _k4 = 0;
_label = '';
_v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _col _v;
run;
/* Per value of cmclas: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col cmclas where=(not missing(cmclas))) out=work._u; by cmclas _col usubjid; run;
data work._c;
set work._u;
by cmclas _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 cmclas _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by cmclas; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by cmclas; id _col; var _e; run;
data work._g1;
merge work._tn work._te; by cmclas;
array _nn{3} _n1-_n3;
array _ee{3} _e1-_e3;
do _i = 1 to 3; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
_tot = sum(of _n1-_n3);
drop _i;
run;
proc sort data=work._g1; by cmclas; run;
data work._g1;
set work._g1;
_o1 = _n_;
run;
/* [Therapeutic class]: npct of CMCLAS. */
data work._f; set work._g1; do _col = 1 to 3; output; end; run;
proc sort data=work._f; by cmclas _col; run;
data work._k2;
length _rowid $36 _label _pagelbl $200 _v $200;
set work._f;
array _nn{3} _n1-_n3;
array _ee{3} _e1-_e3;
_rowid = 'f9c9f5dd-becf-4307-98d9-47fca5b465b5';
_page = 1;
_pagelbl = '';
_k0 = 3;
_k1 = _o1; _k2 = 0;
_k3 = 0; _k4 = 0;
_label = strip(cmclas);
_v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _col _v;
run;
/* Per value of cmclas and cmdecod: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col cmclas cmdecod where=(not missing(cmclas) and not missing(cmdecod))) out=work._u; by cmclas cmdecod _col usubjid; run;
data work._c;
set work._u;
by cmclas cmdecod _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 cmclas cmdecod _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by cmclas cmdecod; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by cmclas cmdecod; id _col; var _e; run;
data work._g2;
merge work._tn work._te; by cmclas cmdecod;
array _nn{3} _n1-_n3;
array _ee{3} _e1-_e3;
do _i = 1 to 3; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
_tot = sum(of _n1-_n3);
drop _i;
run;
proc sort data=work._g2; by cmclas cmdecod; run;
data work._g2;
set work._g2;
by cmclas;
retain _r;
if first.cmclas then _r = 0;
_r = _r + 1;
_o2 = _r;
drop _r;
run;
proc sort data=work._g2; by cmclas; run;
proc sort data=work._g1(keep=cmclas _o1) out=work._gp; by cmclas; run;
data work._g2; merge work._g2(in=_in) work._gp; by cmclas; if _in; run;
/* [Medication]: npct of CMDECOD. */
data work._f; set work._g2; do _col = 1 to 3; output; end; run;
proc sort data=work._f; by cmclas cmdecod _col; run;
data work._k3;
length _rowid $36 _label _pagelbl $200 _v $200;
set work._f;
array _nn{3} _n1-_n3;
array _ee{3} _e1-_e3;
_rowid = 'b1b42188-0ffd-4cb0-9b00-ff4bc448003a';
_page = 1;
_pagelbl = '';
_k0 = 3;
_k1 = _o1; _k2 = 4;
_k3 = _o2; _k4 = 0;
_label = strip(cmdecod);
_v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 0))) || '%)';
keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _col _v;
run;
data work._cells; set work._k1 work._k2 work._k3; run;
proc sort data=work._cells; by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _rowid _label _col; run;
proc transpose data=work._cells out=work._wide(drop=_name_) prefix=col;
by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _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 ('35d8307b-0ce7-4b4f-a35d-49174ae0b5e6' 'f9c9f5dd-becf-4307-98d9-47fca5b465b5' 'b1b42188-0ffd-4cb0-9b00-ff4bc448003a');
_k0 = _ord; _k1 = 0; _k2 = 0; _k3 = 0; _k4 = 0;
run;
data work.final;
length col1 col2 col3 $200 _pagelbl $200;
set work._inst work._fixed;
run;
proc sort data=work.final; by _page _k0 _k1 _k2 _k3 _k4; run;
data work.final;
set work.final;
_ord = _n_;
keep _page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3;
run;
/*==== 90-report ====*/
/* 90-report: from the shell; the titles, columns, headers and footnotes are not changed here. */
%ls_need(_bign1 _bign2 _bign3);
%ls_final_check(columns=_page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3);
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-14-7-04.rtf" style=journal;
title1 j=l "CDISCPILOT01" j=r "Page ~{thispage} of ~{lastpage}";
title2 j=c "Table 14-7.04";
title3 j=c "Summary of Concomitant Medications (Number of Subjects)";
title4 j=c "Safety Analysis Set";
footnote1 j=l "Note: Percentages are based on the number of subjects in the safety population within each treatment group.";
footnote2 j=l "Program: t-14-7-04.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;
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=20% just=c} style(header)={just=c};
define col2 / display "Xanomeline Low Dose|(N=&_bign2.)" style(column)={cellwidth=20% just=c} style(header)={just=c};
define col3 / display "Xanomeline High Dose|(N=&_bign3.)" style(column)={cellwidth=20% 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;