1. SAS Macro for Summarizing Adverse Events
Julius Kirui, Sarah Cannon Research Institute, Nashville, TN
Rakesh Mucha, Sarah Cannon Research Institute, Nashville, TN
This presentation features a tool that can facilitate production of multiple
AE summary tables.
AE summaries are often grouped by System Organ Class and Preferred Term.
The groups above can be summarized based on:
1. Maximum CTCAE grade
2. Relatedness to study treatment
3. Seriousness
4. Relatedness and Seriousness criteria.
Further subsets may also occur by treatment emergent, AE outcome, cohort, etc.
The resulting combinations requires considerable programming effort which is
repetitive and error-prone. paper PO19

2. One time macro call set up
After the set up, simple manuplations are required to produces multiple table
%sumAE(
subjlabel=Subjects with Any TEAE, /*unique subject level summary label*/
condition=Any, /*Any = any AE, related, Serious, RS = related and serious*/
table=RTF.Extract1, /*unique table ID*/
subset=, /*AEOUT=‘FATAL’, AETOXGRD >=3, etc*/
type=H, /*H = CTCAE grades horizontally, V= CTCAE grade vertically*/
grtype=NO, /*grtype = YES display grade 1-5 and Total*/
ordertotal=-1, /*0= delete grade Totals 1=grade Totals after grade 5 per PTT*/
order=, /*0=delete SOC*/
time=TEAE, /*ALL any AE regardless of time, TEAE after dose*/
sfdt=dm, /*safety analysis datasets used*/
var2=arm+cohort+<>, /*arm=arm coded, cohort= arm description, <> arm grouping*/
var1=_ AETOXGR*subjid+soc+ptt, /*change variable name NOT ORDER*/
overall=YES, /*YES=all columns, NO=no Total column, TOTAL=total column only*/
path=<< output path>>) /*output path*/
paper PO19

3. Summary of any TEAE with CTCAE grades displayed horizontally
macro call manipulation
subjlabel=Subjects with Any TEAE, /*unique subject level summary label*/
condition=Any, /*Any = any AE, related, Serious, RS = related and serious*/
type=H, /*H = CTCAE grades horizontally, V= CTCAE grade vertically*/
time=TEAE, /*ALL any AE regardless of time, TEAE after dose*/
Note : Table excerpt provided below ….

4. Summary of treatment related AE -grade summaries displayed vertically
macro call manipulation
subjlabel=Subjects with related TEAE, /*unique subject level summary label*/
condition=related, /*Any = any AE, related, Serious, RS = related and serious*/
type=V, /*H = CTCAE grades horizontally, V= CTCAE grade vertically*/
grtype=YES, /*grtype = YES display grade 1-5 and Total*/
ordertotal=-1, /*0= delete Totals 1=grade Totals at the bottom per SOC ,PTT*/
time=ALL, /*ALL any AE regardless of time, TEAE after dose*/
Note : Table excerpt provided below ….

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Contact Information
Name: Julius Kirui
Enterprise: SCRI, Nashville, TN
julius.kirui@scresearch.net
juliuskr3@gmail.com
Contact Information
Name: Rakesh Mucha
Enterprise: SCRI, Nashville, TN
rakesh.mucha@scri-innovations.com
Conclusion
• With simple manipulation, this tool can produce multiple combinations of AE
summary tables (see appendix 1 of related paper)
• This tool reduces the need for repetitive manual programming, thus saving
time and reducing possible sources of error.
See related paper if interested in learning more about this tool (paper PO19)