Randomization for stratified unequal allocation ratio

[hagml]

I have 60 patients, 5 cohorts where in each there are 4 female and 8 male. In each cohort the allocation ratio for female is (3:1) so 3 treatment and 1 placebo. And for male is (6:2) so 6 treatment and 2 placebo.
Cohort 1 has the 150 mg dose
Cohort 2 has 200 mg
Cohort 3 has 250 mg
Cohort 4 is "optional treatment"
Cohort 5 is "optional treatment"

I need to create a randomization code in a way that the final output looks like below:

## Cohort 1 - 150 mg ##
## Female ##

| Randomization number | Treatment |
| -------- | -------------- |
| 101 | Treatment |
| 102 | Placebo |
| 103 | Treatment |
| 104 | Treatment |

## Cohort 1 - 150 mg ##
## Female ##

| Treatment | Count |
| -------- | -------------- |
| Treatment | 3 |
| Placebo | 1 |

Cohort 1 - 150 mg
## Male ##

| Randomization number | Treatment |
| -------- | -------------- |
| 105 | Treatment |
| 106 | Treatment |
| 107 | Treatment |
| 108 | Placebo |
| 109 | Treatment |
| 110 | Treatment |
| 111 | Treatment |
| 112 | Placebo |
## Cohort 1 - 150 mg ##
## Male ##

| Treatment | Count |
| -------- | -------------- |
| Treatment | 6 |
| Placebo | 2 |

## Cohort 2 - 200 mg ##
## Female ##

| Randomization number | Treatment |
| -------- | -------------- |
| 201 | Treatment |
| 202 | Treatment |
| 203 | Treatment |
| 204 | Placebo |

## Cohort 2 - 200 mg ##
## Female ##

| Treatment | Count |
| -------- | -------------- |
| Treatment | 3 |
| Placebo | 1 |

Cohort 2 - 200 mg
## Male ##

| Randomization number | Treatment |
| -------- | -------------- |
| 205 | Placebo |
| 206 | Treatment |
| 207 | Treatment |
| 208 | Placebo |
| 209 | Treatment |
| 210 | Treatment |
| 211 | Treatment |
| 212 | Treatment |

## Cohort 2 - 200 mg ##
## Male ##

| Treatment | Count |
| -------- | -------------- |
| Treatment | 6 |
| Placebo | 2 |

.
.
.
Up to cohort 5:

## Cohort 5 - Optional dose ##
## Female ##

| Randomization number | Treatment |
| -------- | -------------- |
| 501 | Treatment |
| 502 | Treatment |
| 503 | Placebo |
| 504 | Treatment |

## Cohort 5 - Optional dose ##
## Female ##

| Treatment | Count |
| -------- | -------------- |
| Treatment | 3 |
| Placebo | 1 |

Cohort 5 - Optional dose
## Male ##

| Randomization number | Treatment |
| -------- | -------------- |
| 505 | Treatment |
| 506 | Treatment |
| 507 | Treatment |
| 508 | Treatment |
| 509 | Treatment |
| 510 | Treatment |
| 511 | Placebo |
| 512 | Placebo |

## Cohort 1 - Optional dose ##
## Male ##

| Treatment | Count |
| -------- | -------------- |
| Treatment | 6 |
| Placebo | 2 |

then I need to create a pdf output, an excel output and the sas output. In addition, I want a pdf output in a way that each randomization number for each male and female and the allocated treatment/placebo be printed separately on each pdf page.

I also need the same exact output but with the following randomization number (where in the title for each page, a "replacement" will be added):

Female cohort 1: 181 182 183 184
Male cohort 1: 185 186 187 188 189 190 191 192

Female cohort 2: 281 282 283 284
Male Cohort 2: 285 286 287 288 289 290 292 292

up to cohort 5:
581,...,585 (female)
585,...,592 (male)

Which I am having hard time creating them as I am not familiar with SAS programming at all. This is what I worked on so far but the problem is I could only do it for the equal number of male and female in each cohort and I cannot separate them in a way that in one pdf page I get female and the next page male (like the above output) and also having hard time creating the randomization number as above.

```
options ls=132 ps=58 nodate nonumber; title1 "RANDOMIZATION SCHEDULE"; title2 "A Randomized, Double-Blind, Placebo-Controlled, MAD Study";
%let seed=9683473;
data rannum(keep=seed);
do i=1 to 5;
rannum=ranuni(&seed);
seed=int(rannum*1000000);
output;
end; run;
proc sql noprint;
select seed
into :seed1 - :seed5
from rannum;
quit;
proc format;

value sex 1='Female'
2='Male';
value treat 1='Placebo'
2='150 mg'
3='200 mg'
4='250 mg'
5='optional dose'
6='optional dose';
run;

proc plan seed=&seed1;
factors sex=2 treat=12 /noprint;
output out=data1
sex nvals=(1 2) random
treat nvals=(1 1 1 2 2 2 2 2 2 2 2)
random;
run;
proc plan seed=&seed2;
factors sex=2 treat=12 /noprint;
output out=data2
sex nvals=(1 2) random
treat nvals=(1 1 1 3 3 3 3 3 3 3 3)
random;
run;

proc plan seed=&seed3;
factors sex=2 treat=12 /noprint;
output out=data3
sex nvals=(1 2) random
treat nvals=(1 1 14 4 4 4 4 4 4 4)
random;
run;

proc plan seed=&seed4;
factors sex=2 treat=12 /noprint;
output out=data4
sex nvals=(1 2) random
treat nvals=(1 1 1 5 5 5 5 5 5 5 5)
random;
run;

proc plan seed=&seed5;
factors sex=2 treat=12 /noprint;
output out=data5
sex nvals=(1 2) random
treat nvals=(1 1 1 6 6 6 6 6 6 6 6)
random;
run;

%macro combine(dataset);
%do i=1 %to 5;
%let dataset=data&i;
proc sort data=&dataset; by sex;
data &dataset;
set &dataset;
cohort=&i;
subid=%eval(&i.00)+(_n_);
%end; %mend;
%combine
data combine;
set data1 data2 data3 data4 data5
run;

proc sort; by cohort sex;

print data=combine noobs double
proc
uniform split='*';
var sex subid treat;
id cohort;
by cohort;
label subid="Randomization number"
treat="TREATMENT";
format treat treat.;
run;
```

[Ksharp]

/*
You are asking too much questions.
I have no time to follow all your questions.
The following code could give you a start
*/

proc plan seed=123  ;
factors cohorts=5 ordered subject=4 random/noprint;
treatments treat=4;
output out=female;
run;
factors cohorts=5 ordered subject=8 random/noprint;
treatments treat=8;
output out=male;
run;
quit;

data female;
 set female;
 length sex  treatment $ 20;
 sex='female';
 treatment=ifc(treat in (1:3),'treatment ','placebo');
run;
data male;
 set male;
 length sex treatment $ 20;
 sex='male';
 treatment=ifc(treat in (1:6),'treatment ','placebo');
run;
proc format;
value fmt
1='150 mg'
2='200 mg'
3='250 mg'
4='optional treatment'
5='optional treatment2' 
;
run;
data want;
 set female male(in=inb);
 by cohorts;
 subjectid=100*cohorts+subject+ifn(inb,4,0);
 format cohorts fmt.;
 label subjectid='Randomization number' treatment='Treatment';
run;

%macro print(sex=,cohorts=);
title "##Cohort: %cmpres(%sysfunc(putn(&cohorts.,fmt.)))##";
title2 "## &sex. ##";
proc report data=want nowd;
where upcase(sex)="%upcase(&sex.)" and cohorts=&cohorts.;
column subjectid treatment ;
define subjectid/order;
run;
proc sql;
select treatment,count(*) as Count from want where upcase(sex)="%upcase(&sex.)" and cohorts=&cohorts. group by treatment;
quit;
%mend;

options nodate nonumber;
ods pdf file='c:\temp\want.pdf' style=journal startpage=no;
%print(sex=female,cohorts=1)
ods pdf startpage=now;
%print(sex=female,cohorts=2)
ods pdf startpage=now;
%print(sex=female,cohorts=3)
ods pdf startpage=now;
%print(sex=female,cohorts=4)
ods pdf startpage=now;
%print(sex=female,cohorts=5)
ods pdf startpage=now;

%print(sex=male,cohorts=1)
ods pdf startpage=now;
%print(sex=male,cohorts=2)
ods pdf startpage=now;
%print(sex=male,cohorts=3)
ods pdf startpage=now;
%print(sex=male,cohorts=4)
ods pdf startpage=now;
%print(sex=male,cohorts=5)
ods pdf close;