NESUG 2012
Coders' Corner
Kick It Old School - Creating Reports with the DATA _NULL_ Step
Sai Ma, PharmaNet/i3, Toronto, Ontario Canada
Suwen Li, Everest Clinical Research Services Inc., Markham, Ontario Canada
Minlan Li, Everest Clinical Research Services Inc., Markham, Ontario Canada
ABSTRACT
The powerful PROC REPORT can handle most of the clinical trial data reporting tasks. But when the report needs to be
customized to meet special requirements, PROC REPORT can sometimes be awkward. This is where the DATA
_NULL_ step comes to the rescue. It is old school. However, it allows you to have complete control in customizing your
reports. This paper illustrates when and how to generate study reports using DATA _NULL_ step by two examples.
KEY WORDS
DATA _NULL_, AE, Study Comments, PROC REPORT
INTRODUCTION
PROC REPORT is a dominating reporting tool to tabulate, display, and in some cases, analyze clinical data. It is
powerful, flexible and easy to use. But sometimes, we just wish it could do a little bit more. This extra bit can often make
us scratch our heads for days. DATA _NULL_ step can be a practical alternative in a situation like this. Using DATA
_NULL_ step to generate a report is like painting on a blank canvas. You can almost display anything anywhere on the
report. It also covers some blind spots of PROC REPORT so that the report-generating task is simplified and handled
more efficiently.
Two examples follow. The first example outlines how to make one SOC (system organ class) group of AE (adverse
event) terms continuously flow to the next page when multiple columns need to spread over more than one page, and
the second one elaborates on how to display long study comments in subject listings. Both examples show why DATA
_NULL_ step is preferred over PROC REPORT under certain circumstances. The main focus of this paper is not to give
a detailed tutorial on the usage of DATA _NULL_ step; rather, it is to show when and how DATA _NULL_ step can be
used as a supplement to PROC REPORT.
EXAMPLE 1: AE TABLE WITH THE SAME SOC TERMS CARRIED TO THE NEXT PAGE FOR
ALL TREATMENT GROUPS SPLIT OVER TWO PAGES
The table display requirements are as such:
1) The wrapped SOC term should be properly indented to enhance readability. For example,
Neoplasms benign, malignant and unspecified (incl cysts and
polyps)
4 ( 4.6)
4 ( 2.5)
......
4 ( 4.6)
4 ( 2.5)
......
should appear:
Neoplasms benign, malignant and unspecified (incl cysts and
���polyps)
2) If all the AE preferred terms under a SOC term cannot be printed on the same page, the SOC term should be
displayed at the top of the following page with text "(CONT.)" attached to indicate continuation. For example,
Infections and infestations
Upper respiratory tract infection
Urinary tract infection
4 ( 5.6)
2 ( 2.8)
1 ( 1.4)
2 ( 2.3)
1 ( 1.1)
1 ( 1.1)
......
......
......
1 ( 1.4)
0
......
with top of the next page:
Infections and infestations (CONT.)
Influenza
3) To present the data in the most sensible form for comparison given the page size limitation, we need to split the
desired treatment groups over 2 pages: Treatment group A, B, and C on the first page and D and E on the second.
Applying the indentation requirement is not substantially different between PROC REPORT and DATA _NULL_ step.
With proper data manipulation, both approaches can achieve this. It is the second and third requirements that deserve
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some thinking. By PROC REPORT, it does not seem feasible to get around the programming complexity of manually
calculating the total number of terms a page can contain. The calculation difficulty can easily be escalated when
considering indentation and counts for the insertion of blank lines after each group. If the total SOC groups, or the total
AE terms, per page are simply set to a fixed number to ensure same group of preferred terms do not cross pages, the
whole report loses its flexibility in displaying data and the output could become aesthetically unappealing.
DATA _NULL_ step can circumvent this issue well. As a first step, we wrap the AE term (both SOC and preferred terms).
This is accomplished by using an extra DATA step. Assuming the default delimiter that separates each individual word in
an AE term is a space ("�"), then we must consider the following three cases:
1)
The term breaks in the middle of a word.
e.g., xxxx�xxxxx|xxxxx
or xxxxxxx�xx|xxxx
2)
The term breaks in the middle of a word, but the first half of the term is in one piece (no word delimiters;
namely, a very long word).
e.g., xxxxxxxxxx|xxxx
3)
The term breaks between two words.
e.g., xxxxxxxxxx|�xxxx
or xxxxxxxxx�|xxxx
In all three scenarios, the piece that is cut from the original AE term will be saved separately and the remaining piece will
continue to loop this process until the whole term is exhausted. Further, in the second scenario, a bar ("-") will be
inserted at the end of the cut part to indicate word truncation. A counter variable (WRAPLINE) can tell how many pieces
the original AE term is cut into. Sample data on wrapped AE terms can be found in Output 1.
After this is done, DATA _NULL_ step can take care of the rest. Line size, page size, variable of number of lines
processed and the variable of number of remaining lines are all defined in FILE statement. The PRINT option makes
sure the output file contains carriage control characters.
data _null_;
set nesug12 end=lastrec;
file print ls=132 notitles line=lineno ll=lineleft ps=52;
Then we need a variable to flag new page (NEWPAGE) and a variable to keep track of the page number (PAGENO).
They are both updated under the HEADER statement label which is linked at the top of each page. The _PAGE_
modifier creates a page break at the beginning of each page. When the DATA step hits the dataset boundary or the
beginning of the spaces saved for footnotes, statements under label FOOTER will be linked. The contents of the
predefined footnote macro variables (&&FFOOT&J) will be loaded in the report. As a syntax note, we need two RETURN
statements for each statement label to prevent the statements being executed with each iteration of the DATA step.
if lineno eq 1 then link header;
......
if lastrec or lineleft le &footnum+1 then link footer;
return;
header:
put _page_;
pageno+1;
newpage=1;
......
return;
footer:
put @1 132*'_' ;
%do j=1 %to &footnum;
put @1 &&ffoot&j;
%end;
......
return;
To address the second table display requirement, we should carefully consider the circumstances that table headers and
footnotes need to be inserted. Apart from the beginning and the bottom part of the page, when a wrapped AE term (SOC
term or preferred term) requires more lines than what remains on the page (tested by comparing the values of variable
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LINELEFT and macro variable FOOTNUM), then both HEADER and FOOTER labels should be linked. Also, if a page
break is inserted in the middle of the same group of preferred terms, the corresponding SOC term will be carried forward
to the following page and the new page flag is reset to zero. Variable CONT is used to flag the AE term after which we
need to break the SOC group to flow to the next page and insert the text "(CONT.)". This is also necessary in order to
meet the third requirement. All the AE terms will populate the report through the adjustment of the column pointer control
(@). The exact number of spaces to be indented depends on the output column width and the study report requirements.
if not first.soc_term and newpage eq 1 then do;
put @1 soc_term "(CONT.)";
cont=1;
end;
newpage=0;
The variable PAGENO generated by DATA _NULL_ step counts the page numbers for us. This is a very useful feature
not only to allow treatment groups to flow over pages (i.e., the third requirement), but to support applications like
generating dynamic report footnotes (e.g., only on first/alternate/selected pages). To get this key information, all we need
is to run data through the DATA _NULL_ step one extra time before we use the DATA _NULL_ step to generate the final
output. The output dataset from the first pass of DATA _NULL_ step (FINAL) will be needed, hence saved, to determine
the desired page number, and the actual output can then be suppressed by ODS statements. With the page number in
place, we are now ready to split the data from each page into two parts: the first part is for the first three treatment
groups (Treatments A, B, and C), and the second part is for the remaining two groups (Treatments D and E).
data final;
set nesug12 end=lastrec;
file print ls=132 notitles line=lineno ll=lineleft ps=52;
......
run;
data final;
set final (rename=(pageno=pagegrp) in=aaa drop=treat_d: treat_e:)
final (rename=(pageno=pagegrp) in=bbb drop=treat_a: treat_b: treat_c:)
;
if aaa then pagesub=1;
else if bbb then pagesub=2;
run;
proc sort data=final;
by pagesub soc_term pt_term wrapline;
run;
The new variables CONTSEQ1, CONTSEQ2, PAGESUB and PRESUB are used together to flag the page breaks and to
insert the headers and footnotes. Treatments will be displayed within each PAGESUB group (A, B, and C if PAGESUB is
1; D and E if PAGESUB is 2). All other steps follow what the first DATA _NULL_ step defines.
data final;
set final;
by pagegrp pagesub soc_term pt_term wrapline;
if first.soc_term and missing(cont) then contseq1+1;
if first.soc_term then contseq2+1;
presub=lag(pagesub);
run;
data _null_;
set final end=lastrec;
file print ls=132 notitles line=lineno ll=lineleft ps=52;
by contseq1 contseq2 soc_term pt_term wrapline;
if lineno eq 1 then link header;
if not missing(presub) and (pagesub ne presub) then do;
link footer;
link header;
end;
if not first.contseq1 and newpage eq 1 then put @1 soc_term "(CONT.)";
newpage=0;
if pagesub eq 1 then do;
......
end;
else if pagesub eq 2 then do;
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<Kick It Old School - Creating Reports with the DATA _NULL_ Step>, continued
......
end;
if lastrec then link footer;
return;
header:
......
return;
footer:
......
return;
run;
Although PROC REPORT can handle a situation where multiple treatment groups must flow over many pages (by
suppressing the WRAP option in the PROC REPORT statement and specifying ID option in the DEFINE statement for
the repeating variables), the insertion of page continuation text "XXXX XXX (CONT.)" still requires some additional
calculation on the report page capacity. As discussed above, for tables with standard outputs (i.e., all treatment groups
can be displayed within the same page), DATA _NULL_ step bypasses this need completely, whereas for tables with
special output requirements as in the example above, DATA _NULL_ step can automatically generate the page numbers
that takes all other requirements into consideration (wrapping long AE terms and breaking pages under the same SOC
term). This makes DATA _NULL_ step a very appealing and effective approach for this type of application. Sample data
is listed below in Output 1. Selected outputs are attached in the appendix (Output 5).
CONTSEQ1
CONTSEQ2
PAGEGRP
PAGESUB
19
19
19
22
22
22
22
22
25
25
25
25
25
25
25
25
28
28
28
28
28
28
21
21
21
24
24
24
25
25
28
28
28
28
28
28
29
29
32
32
32
32
32
32
3
3
3
3
3
3
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
4
1
1
1
2
2
2
1
1
1
1
1
1
1
1
2
2
2
2
2
2
2
2
PRESUB
SOC_NEW
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Respiratory, thoracic
mediastinal disorders
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Psychiatric disorders
Psychiatric disorders
Respiratory, thoracic
mediastinal disorders
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
1
1
1
2
2
2
2
1
1
1
1
1
1
1
1
2
2
2
2
2
2
2
CONT
SOC_TERM
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Psychiatric disorders
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Psychiatric disorders
Psychiatric disorders
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
Respiratory, thoracic
1
1
and
and
and
and
and
and
mediastinal
mediastinal
mediastinal
mediastinal
mediastinal
mediastinal
disorders
disorders
disorders
disorders
disorders
disorders
and
and
and
and
and
and
mediastinal
mediastinal
mediastinal
mediastinal
mediastinal
mediastinal
disorders
disorders
disorders
disorders
disorders
disorders
PT_TERM
PT_NEW
Abnormal dreams
Anxiety
Abnormal dreams
Anxiety
Abnormal dreams
Anxiety
Bruxism
Restlessness
Abnormal dreams
Anxiety
Bruxism
Restlessness
and
and
and
and
and
mediastinal
mediastinal
mediastinal
mediastinal
disorders
disorders
disorders
disorders
Paranasal sinus hypersecretion
Paranasal sinus hypersecretion
Rhinorrhoea
Sinus congestion
Bruxism
Restlessness
Paranasal sinus
hypersecretion
Rhinorrhoea
Sinus congestion
Bruxism
Restlessness
mediastinal
mediastinal
mediastinal
mediastinal
disorders
disorders
disorders
disorders
Paranasal sinus hypersecretion
Paranasal sinus hypersecretion
Rhinorrhoea
Sinus congestion
Paranasal sinus
hypersecretion
Rhinorrhoea
Sinus congestion
and
and
and
and
and
Output 1. Sample Data - Page Break Flags and Wrapped AE Terms
4
WRAPLINE
1
1
1
1
1
1
1
1
1
2
1
2
1
1
1
1
1
2
1
2
1
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EXAMPLE 2: LISTING WITH EXCESSIVELY LONG COMMENTS
Comment variables are typically lengthy (up to 200 characters) in the context of clinical trial studies. For certain data
panels, for example, ECG, Questionnaire, or Overall Study Comments, there can be more than one comment variable
collected. A typical method to display all the comments in the relevant subject data listing is to stack them vertically, and
to squeeze other fields into the report as much as possible to make room for this column. However, such a listing is
prone to have a disproportionally slim comment field. Our goal when incorporating study comments within subject data
listings is to ensure that the reviewer sees complete subject information without having to flip pages, as presented in
Display 1.
AABBCC PHARMACEUTICALS
Protocol XXXXXX123
COMPOUND ##
Page xxx of yyy
Listing - Subject Disposition and Evaluability
_______________________________________________________________________________________________________________________________________
Site # (Inv. Name) /
Subject Treatment
#
Group
Date
Consented
(yyyy-mm-dd)
Disposition
Date (yyyy-mm-dd)
Last Duration (days)
Reason for Treatment
ITT EPP
-----------------Dose --------------Discontinued
Study
Last
(tabs) Study Treatment
Completed/
Dose
Discontinued
_______________________________________________________________________________________________________________________________________
XXX (XXXXXXXXXXXX)
001
Placebo
XXXX-XX-XX
Completed/
XXXX-XX-XX
XXXX-XX-XX
X
XXX
XXX
Discontinued study/
......
Comment: XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
Completed/
Yes/ Yes/
Withdrawal of consent/ No
No
Adverse Events/......
......
_______________________________________________________________________________________________________________________________________
Display 1. Listing Shell
To this end, we first concatenate all the original comment variables into a new variable (CMNT). Similar to what is done
in Example 1, we then decompose this new comment variable into pieces and assign them to individual variables
(CMNT1 - CMNT4). The variable length for each piece can be as long as the full line size of the report. However, a
reasonably large number is usually sufficient (e.g., 100) for a better layout. Once the length is decided, the actual
"cutting" part is fairly straightforward.
j=0;
i=100;
do while (compress(cmnt) ne '');
temp=substr(cmnt,1,i);
cutoff=substr(temp,i,1);
i=i-1;
do while (cutoff ne ' ');
cutoff=substr(temp,i,1);
i=i-1;
end;
j=j+1;
if j=1 then cmnt1=substr(temp,1,i);
else if j=2 then cmnt2=substr(temp,1,i);
else if j=3 then cmnt3=substr(temp,1,i);
else if j=4 then cmnt4=substr(temp,1,i);
cmnt=substr(cmnt,i+2);
end;
Output 2 has the sample data.
cmnt1
Comment: SUBJECT INDEPENDENTLY D/C'ED STUDY MED (PRECIPITATED BY AES) 99XXX2099 AND MADE SITE AWARE
cmnt2
OF THIS ON 99XXX99. SHE WAS SCHEDULED FOR HER TERM VISIT ON 99XXX99 BUT DID NOT KEEP THAT APPT.
cmnt3
AFTER NUMEROUS ATTEMPTS TO CONTACT HER (PHONE CALLS AND CERT. MAIL) SHE WAS, ON 99XXX2099
cmnt4
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CONSIDERED LOST TO FOLLOW-UP SECONDARY TO "NO SHOWS" AT NUMEROUS TERM. APPTS.
Output 2. Sample Data - Comment Variable Decomposition
BY PROC REPORT
The first attempt to generate the listing is handled by PROC REPORT. Four comment variables are stacked together
(CMNTV) for the use of COMPUTE block within PROC REPORT, as shown in Output 3.
compute after cmntv;
line @13 cmntv $100.;
endcomp;
subnum
cmntv
......
777
777
777
777
Comment: SUBJECT INDEPENDENTLY D/C'ED STUDY MED (PRECIPITATED BY AES) 99XXX2099 AND MADE SITE AWARE
OF THIS ON 99XXX99. SHE WAS SCHEDULED FOR HER TERM VISIT ON 99XXX99 BUT DID NOT KEEP THAT APPT.
AFTER NUMEROUS ATTEMPTS TO CONTACT HER (PHONE CALLS AND CERT. MAIL) SHE WAS, ON 99XXX99
CONSIDERED LOST TO FOLLOW-UP SECONDARY TO "NO SHOWS" AT NUMEROUS TERM. APPTS.
......
Output 3. Sample Data - Prepared for PROC REPORT
The output created by PROC REPORT looks fine for short records (i.e., only CMNT1 is non-missing), but is problematic
for longer records. The data are not grouped properly by the COMPUTE block. Blank lines are automatically inserted
after the comment text. Furthermore, when the page break happens to lie among multiple comment lines for the same
subject, subject data are not the first row at the top of next page as expected. Instead, they are embedded between
comments (Output 4). All of these issues call for an alternative - DATA _NULL_ step.
AABBCC PHARMACEUTICALS
Protocol XXXXXX123
COMPOUND ##
Page xx1 of yyy
Listing - Subject Disposition and Evaluability
_______________________________________________________________________________________________________________________________________
Site # (Inv. Name) /
Subject Treatment
#
Group
Date
Consented
(yyyy-mm-dd)
Disposition
Date (yyyy-mm-dd)
Last Duration (days)
Reason for Treatment
ITT EPP
-----------------Dose --------------Discontinued
Study
Last
(tabs) Study Treatment
Completed/
Dose
Discontinued
_______________________________________________________________________________________________________________________________________
999 (Cccccc C. Ccccccc, M.D.)
......
555
Placebo
2099-99-99 Discontinued study 2099-99-99
2099
9
999
999
Other: lost to follow-up
Comment: SUBJECT NEVER CAME IN FOR WK 34 CLINIC VISIT, SEVERAL ATTEMPTS WERE MADE TO CONTACT
Yes No
SUBJECT, LAST CONFIRMED DOSE SUBJECT TOOK WAS 9/99/2099 AND WAS TABS.
......
777
Placebo
2099-99-99 Discontinued study 2099-99-99
2099-99-99
9
999
999
Investigator's decision
Comment: SUBJECT INDEPENDENTLY D/C'ED STUDY MED (PRECIPITATED BY AES) 99XXX2099 AND MADE SITE AWARE
Yes No
_______________________________________________________________________________________________________________________________________
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<Kick It Old School - Creating Reports with the DATA _NULL_ Step>, continued
AABBCC PHARMACEUTICALS
Protocol XXXXXX123
COMPOUND ##
Page xx2 of yyy
Listing - Subject Disposition and Evaluability
_______________________________________________________________________________________________________________________________________
Site # (Inv. Name) /
Subject Treatment
#
Group
Date (yyyy-mm-dd)
Last Duration (days)
Reason for Treatment
ITT EPP
-----------------Dose --------------Discontinued
Study
Last
(tabs) Study Treatment
Completed/
Dose
Discontinued
_______________________________________________________________________________________________________________________________________
777
888
......
Placebo
Treatment
Date
Consented
(yyyy-mm-dd)
Disposition
OF THIS ON 99XXX99. SHE WAS SCHEDULED FOR HER TERM VISIT ON 99XXX99 BUT DID NOT KEEP THAT APPT.
2099-99-99 Discontinued study 2099-99-99
2099-99-99
9
999
999
Investigator's decision
AFTER NUMEROUS ATTEMPTS TO CONTACT HER (PHONE CALLS AND CERT. MAIL) SHE WAS, ON 99XXX99
CONSIDERED LOST TO FOLLOW-UP SECONDARY TO "NO SHOWS" AT NUMEROUS TERM. APPTS.
2099-99-99 Completed
2099-99-99
2099-99-99
9
999
999
Completed
Yes No
Yes Yes
_______________________________________________________________________________________________________________________________________
Output 4. Sample Output - Generated by PROC REPORT
BY DATA _NULL_ STEP
Because the comment variables have already been reconciled into the ready-to-output form, DATA _NULL_ step can
just write the data out to the report. Everything is controlled by querying the variable containing the number of remaining
lines (REMAIN). Actions are taken when the number of remaining lines drops below the threshold in different testing
situations. Again, as the following program shows, no complex calculation is needed and everything flows logically to
create the final output (Output 6, Appendix).
data _null_;
set pharma12;
by inv subnum;
file print footnote header=newpage linesleft=remain;
if first.inv then do;
if remain eq 2 and missing(cmnt1) or remain lt 5 and not missing(cmnt1) or
remain lt 6 and not missing(cmnt2) or remain lt 7 and not missing(cmnt3) or
remain lt 8 and not missing(cmnt4) then put _page_ / inv;
else put / inv;
end;
if not missing(cmnt4) then do;
if remain lt 6 then put _page_
/ &listvar / @14 cmnt1 / @23 cmnt2 / @23 cmnt3 / @23 cmnt4;
else put / &listvar / @14 cmnt1 / @23 cmnt2 / @23 cmnt3 / @23 cmnt4;
end;
else if not missing(cmnt3) then do;
if remain lt 5 then put _page_
/ &listvar / @14 cmnt1 / @23 cmnt2 / @23 cmnt3;
else put / &listvar / @14 cmnt1 / @23 cmnt2 / @23 cmnt3;
end;
else if not missing(cmnt2) then do;
if remain lt 4 then put _page_
/ &listvar / @14 cmnt1 / @23 cmnt2;
else put / &listvar / @14 cmnt1 / @23 cmnt2;
end;
else if not missing(cmnt1) then do;
if remain lt 3 then put _page_ / &listvar / @10 cmnt1;
else put / &listvar / @14 cmnt1;
end;
else if missing(cmnt1) then put
/ &listvar;
return;
newpage:
put "%sysfunc(repeat(%str(_),132))" /
"Site # (Inv. Name) /" //
"
Subject Treatment
Date
Disposition
Date (yyyy-mm-dd)"
"
Last Duration (days)
Reason for Treatment
ITT EPP"/
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<Kick It Old School - Creating Reports with the DATA _NULL_ Step>, continued
"
#
Group
Consented
"
Dose --------------Discontinued"/
"
(yyyy-mm-dd)
"
(tabs) Study Treatment"/
"
"
"/
"
"%sysfunc(repeat(%str(_),132))";
if not first.inv then do;
if first.subnum then put / inv '(CONT.)';
end;
return;
run;
------------------"
Study
Last"
Completed/
Dose"
Discontinued"/
CONCLUSION
DATA _NULL_ step is not out of the picture as a reporting tool, although people do tend to choose the more wellrounded PROC REPORT. It is still an ideal technique to consider for reports that have special requirements, or, are too
complicated to be created by PROC REPORT. There are a number of other nice features that DATA _NULL_ step can
offer when used to create study reports, for example, routing report output, executing special functions or call routines
[1]
available within the DATA step, interacting with ODS, and creating flat files for other programs and databases .
Become familiar with the basic syntax and study some interesting examples, so that you can give DATA _NULL_ step a
shot next time you struggle with a fancy-looking report.
REFERENCES
[1]. Bahler, Caroline; Brinsfield, Eric (2002), "Report Creation Using Data _NULL_", SUGI 27 Proceedings, April 1417, 2002, Orlando, Florida.
[2]. Carpenter, Arthur L., "Creating Customized Reports Using the DATA _NULL_ Step".
ACKNOWLEDGMENTS
The author wants to thank Beizhen Lei and Kathy Colucci for their invaluable comments on this paper.
CONTACT INFORMATION
Your comments and questions are valued and encouraged. Contact the author at:
Name:
Enterprise:
City, State:
Work Phone:
Fax:
E-mail:
Web:
Sai Ma
PharmaNet/i3
Toronto, Ontario Canada
(905) 707-0469
(905) 707-7632
sma@pharmanet-i3.com
www.pharmanet-i3.com
SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute
Inc. in the USA and other countries. ® indicates USA registration.
Other brand and product names are trademarks of their respective companies.
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<Kick It Old School - Creating Reports with the DATA _NULL_ Step>, continued
APPENDIX
Page 1
Table: Incidence of Adverse Events by Treatment Group, System Organ Class, Preferred Term, and Severity
____________________________________________________________________________________________________________________________________
System Organ Class/
Treatment A
Treatment B
Treatment C
Preferred Term
(N=XX)
(N=XX)
(N=XX)
____________________________________________________________________________________________________________________________________
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
___________________________________ ___________________________________ ___________________________________
......
Psychiatric disorders
5 (16.7)
0
0
2 (7.4)
0
0
5 (20.8)
0
0
Abnormal dreams
4 (13.3)
0
0
0
0
0
3 (12.5)
0
0
Anxiety
3 (10.0)
0
0
0
0
0
0
0
0
____________________________________________________________________________________________________________________________________
Page 2
Table: Incidence of Adverse Events by Treatment Group, System Organ Class, Preferred Term, and Severity
____________________________________________________________________________________________________________________________________
System Organ Class/
Treatment D
Treatment E
Preferred Term
(N=XX)
(N=XX)
____________________________________________________________________________________________________________________________________
Mild
Moderate
Severe
Mild
Moderate
Severe
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
___________________________________
___________________________________
......
Psychiatric disorders
0
0
0
12 (40.0)
0
0
Abnormal dreams
0
0
0
7 (23.3)
0
0
Anxiety
0
0
0
3 (10.0)
0
0
____________________________________________________________________________________________________________________________________
Page 3
Table: Incidence of Adverse Events by Treatment Group, System Organ Class, Preferred Term, and Severity
____________________________________________________________________________________________________________________________________
System Organ Class/
Treatment A
Treatment B
Treatment C
Preferred Term
(N=XX)
(N=XX)
(N=XX)
____________________________________________________________________________________________________________________________________
Mild
Moderate
Severe
Mild
Moderate
Severe
Mild
Moderate
Severe
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
___________________________________ ___________________________________ ___________________________________
Psychiatric disorders (CONT.)
Bruxism
0
0
0
0
0
0
1 (4.2)
0
0
Restlessness
0
0
0
0
0
0
2 (8.3)
0
0
......
Respiratory, thoracic and 1 (3.3)
0
0
2 (7.4)
0
0
2 (8.3)
0
0
�mediastinal disorders
Paranasal sinus
0
0
0
1 (3.7)
0
0
1 (4.2)
0
0
�hypersecretion
......
____________________________________________________________________________________________________________________________________
Page 4
Table: Incidence of Adverse Events by Treatment Group, System Organ Class, Preferred Term, and Severity
____________________________________________________________________________________________________________________________________
System Organ Class/
Treatment D
Treatment E
Preferred Term
(N=XX)
(N=XX)
____________________________________________________________________________________________________________________________________
Mild
Moderate
Severe
Mild
Moderate
Severe
n (%)
n (%)
n (%)
n (%)
n (%)
n (%)
___________________________________
___________________________________
Psychiatric disorders (CONT.)
Bruxism
0
0
0
1 (3.3)
0
0
Restlessness
0
0
0
2 (6.7)
0
0
......
Respiratory, thoracic and
0
0
0
4 (13.3)
0
0
�mediastinal disorders
Paranasal sinus
0
0
0
2 (6.7)
0
0
�hypersecretion
......
____________________________________________________________________________________________________________________________________
Output 5. Final Output - Example 1
9
NESUG 2012
Coders' Corner
<Kick It Old School - Creating Reports with the DATA _NULL_ Step>, continued
AABBCC PHARMACEUTICALS
Protocol XXXXXX123
COMPOUND ##
Page xx1 of yyy
Listing - Subject Disposition and Evaluability
_______________________________________________________________________________________________________________________________________
Site # (Inv. Name) /
Subject Treatment
#
Group
Date
Consented
(yyyy-mm-dd)
Disposition
Date (yyyy-mm-dd)
Last Duration (days)
Reason for Treatment
ITT EPP
-----------------Dose --------------Discontinued
Study
Last
(tabs) Study Treatment
Completed/
Dose
Discontinued
_______________________________________________________________________________________________________________________________________
999 (Cccccc C. Ccccccc, M.D.)
111
Placebo
2099-99-99
Discontinued study
2099-99-99
2099-99-99
9
999
999
Adverse event
Yes Yes
222
Treatment
2099-99-99
Completed
2099-99-99
2099-99-99
9
999
999
Completed
Yes Yes
333
Placebo
2099-99-99 Discontinued trt.
2099-99-99
2099-99-99
9
999
999
Other
Comment: PATIENT WANTED TO DISCONTINUE TREATMENT BECAUSE SHE BELIEVED IT WASN'T BENEFICIAL TO HER.
Yes No
444
Treatment
Yes No
555
Placebo
2099-99-99 Discontinued study 2099-99-99
2099
9
999
999
Other: lost to follow-up
Comment: SUBJECT NEVER CAME IN FOR WK 34 CLINIC VISIT, SEVERAL ATTEMPTS WERE MADE TO CONTACT
SUBJECT, LAST CONFIRMED DOSE SUBJECT TOOK WAS 9/99/2099 AND WAS TABS.
Yes No
666
Treatment
Yes Yes
777
Placebo
2099-99-99 Discontinued study 2099-99-99
2099-99-99
9
999
999
Investigator's decision
Comment: SUBJECT INDEPENDENTLY D/C'ED STUDY MED (PRECIPITATED BY AES) 99XXX2099 AND MADE SITE AWARE
OF THIS ON 99XXX99. SHE WAS SCHEDULED FOR HER TERM VISIT ON 99XXX99 BUT DID NOT KEEP THAT APPT.
AFTER NUMEROUS ATTEMPTS TO CONTACT HER (PHONE CALLS AND CERT. MAIL) SHE WAS, ON 99XXX2099
CONSIDERED LOST TO FOLLOW-UP SECONDARY TO "NO SHOWS" AT NUMEROUS TERM. APPTS.
2099-99-99
2099-99-99
Discontinued study
Completed
2099-99-99
2099-99-99
2099-99-99
2099-99-99
9
9
999
999
999
999
Withdrawal of consent
Completed
Yes No
......
_______________________________________________________________________________________________________________________________________
Output 6. Final Output - Example 2
10