125.INPUT | FORMAT | PROC SORT | MERGE | BY | IF | PROC FREQ | TABLES | TITLE | ODS | PROC REPORT | CALL DEFINE | ODS LISTING | PROC COMPARE CHALLENGE

INPUT | FORMAT | PROC SORT | MERGE | BY | IF | PROC FREQ | TABLES | TITLE | ODS | PROC REPORT | CALL DEFINE | ODS LISTING | PROC COMPARE CHALLENGE  

/*CHALLENGE*/

/*1.Merge SDTM.DM and SDTM.AE to create a subject-level listing.*/

/*2.Summarize adverse events by severity and treatment (PROC FREQ).*/

/*3.Create a formatted TLF output (PROC REPORT, ODS PDF).*/

/*4.Validate using PROC COMPARE.*/

DATA SDTM_DM;

 INPUT USUBJID $ AGE SEX $ ARM $;

 DATALINES;

101 45 M Placebo

102 36 F DrugA

103 50 M DrugB

104 48 F Placebo

;

RUN;

PROC PRINT;RUN;

OUTPUT:

Obs	USUBJID	AGE	SEX	ARM
1	101	45	M	Placebo
2	102	36	F	DrugA
3	103	50	M	DrugB
4	104	48	F	Placebo

DATA SDTM_AE;

 INPUT USUBJID $ AEDECOD $ AESEV $ AESER $ AESTDTC : yymmdd10.;

 FORMAT AESTDTC DATE9.;

 DATALINES;

101 HEADACHE MILD N 2024-01-05

102 NAUSEA SEVERE Y 2024-01-06

103 VOMITING MODERATE N 2024-01-07

104 FATIGUE MILD N 2024-01-08

;

RUN;

PROC PRINT;RUN;

OUTPUT:

Obs	USUBJID	AEDECOD	AESEV	AESER	AESTDTC
1	101	HEADACHE	MILD	N	05JAN2024
2	102	NAUSEA	SEVERE	Y	06JAN2024
3	103	VOMITING	MODERATE	N	07JAN2024
4	104	FATIGUE	MILD	N	08JAN2024

PROC SORT DATA=SDTM_DM OUT=DM_SORT;BY USUBJID;RUN;

PROC SORT DATA=SDTM_AE OUT=AE_SORT;BY USUBJID;RUN;

/*1.Merge SDTM.DM and SDTM.AE to create a subject-level listing.*/

DATA DMAE;

 MERGE DM_SORT (IN=A)

       AE_SORT (IN=B); 

 BY USUBJID;

 IF A AND B;

RUN;

PROC PRINT;RUN;

OUTPUT:

Obs	USUBJID	AGE	SEX	ARM	AEDECOD	AESEV	AESER	AESTDTC
1	101	45	M	Placebo	HEADACHE	MILD	N	05JAN2024
2	102	36	F	DrugA	NAUSEA	SEVERE	Y	06JAN2024
3	103	50	M	DrugB	VOMITING	MODERATE	N	07JAN2024
4	104	48	F	Placebo	FATIGUE	MILD	N	08JAN2024

PROC FREQ DATA=DMAE;

 TABLES ARM*AESEV / MISSING NOROW NOPERCENT NOCOL;

 TITLE "Summary Adverse Events By Severity And Treatment";

RUN;

TITLE;

OUTPUT:

Summary Adverse Events By Severity And Treatment

                                                                        The FREQ Procedure

Frequency

Table of ARM by AESEV ARM AESEV MILD MODERATE SEVERE Total DrugA 0 0 1 1 DrugB 0 1 0 1 Placebo 2 0 0 2 Total 2 1 1 4

ODS PDF FILE = "C:\Users\Desktop\PDF\DMAE.PDF" STYLE=JOURNAL;

PROC REPORT DATA=DMAE NOWD;

 COLUMN USUBJID AGE SEX ARM AEDECOD AESEV AESER AESTDTC;

 DEFINE USUBJID / 'SUBJECT ID' ORDER;

 DEFINE AGE / 'AGE' DISPLAY;

 DEFINE SEX / 'SEX' DISPLAY;

 DEFINE AEDECOD / 'ADVERSE EVENT' DISPLAY;

 DEFINE ARM / 'TREATMENT GROUP' DISPLAY;

 DEFINE AESEV / 'SEVERITY' DISPLAY;

 DEFINE AESER / 'SERIOUS AE' DISPLAY;

 DEFINE AESTDTC / 'START DATE' DISPLAY FORMAT=DATE9.;

 COMPUTE AESER;

  IF AESER = 'Y' THEN CALL DEFINE(_ROW_ , "STYLE" , "STYLE=[FOREGROUND=RED]");

 ENDCOMP;

RUN;

ODS _ALL_ CLOSE;

PROC PRINT;RUN;

OUTPUT:

SUBJECT ID	AGE	SEX	TREATMENT GROUP	ADVERSE EVENT	SEVERITY	SERIOUS AE	START DATE
101	45	M	Placebo	HEADACHE	MILD	N	05JAN2024
102	36	F	DrugA	NAUSEA	SEVERE	Y	06JAN2024
103	50	M	DrugB	VOMITING	MODERATE	N	07JAN2024
104	48	F	Placebo	FATIGUE	MILD	N	08JAN2024

ODS LISTING;

PROC COMPARE BASE=SDTM_DM COMPARE=DMAE;

 BY USUBJID;

 TITLE "VALIDATION OF MERGED DATA";

RUN;

TITLE;

ODS LISTING CLOSE;

OTUPUT:

                                      VALIDATION OF MERGED DATA                                     12

                                                                                                            00:00 Monday, September 14, 2015

                                        The COMPARE Procedure

                              Comparison of WORK.SDTM_DM with WORK.DMAE

                                            (Method=EXACT)

                                          Data Set Summary

                    Dataset                Created          Modified  NVar    NObs

                    WORK.SDTM_DM  14SEP15:05:26:36  14SEP15:05:26:36     4       4

                    WORK.DMAE     14SEP15:05:28:21  14SEP15:05:28:21     8       4

                                          Variables Summary

                                Number of Variables in Common: 4.

                                Number of Variables in WORK.DMAE but not in WORK.SDTM_DM: 4.

                                Number of BY Variables: 1.

                                      VALIDATION OF MERGED DATA                                     13

                                                                                                      00:00 Monday, September 14, 2015

 

                                               The COMPARE Procedure

                              Comparison of WORK.SDTM_DM with WORK.DMAE

                                            (Method=EXACT)

-------------------------------------------- USUBJID=101 ---------------------------------------------

                                         Observation Summary

                                    Observation      Base  Compare

                                    First Obs           1        1

                                    Last  Obs           1        1

                   Number of Observations in Common: 1.

                   Total Number of Observations Read from WORK.SDTM_DM: 1.

                   Total Number of Observations Read from WORK.DMAE: 1.

                   Number of Observations with Some Compared Variables Unequal: 0.

                   Number of Observations with All Compared Variables Equal: 1.

                   NOTE: No unequal values were found. All values compared are exactly equal.



          

                                                                                                        00:00 Monday, September 14, 2015

                                        The COMPARE Procedure

                              Comparison of WORK.SDTM_DM with WORK.DMAE

                                            (Method=EXACT)

-------------------------------------------- USUBJID=102 ---------------------------------------------

                                         Observation Summary

                                    Observation      Base  Compare

                                    First Obs           2        2

                                    Last  Obs           2        2

                   Number of Observations in Common: 1.

                   Total Number of Observations Read from WORK.SDTM_DM: 1.

                   Total Number of Observations Read from WORK.DMAE: 1.

                   Number of Observations with Some Compared Variables Unequal: 0.

                   Number of Observations with All Compared Variables Equal: 1.

                   NOTE: No unequal values were found. All values compared are exactly equal.

                                   VALIDATION OF MERGED DATA                                     15

                                                                                                       00:00 Monday, September 14, 2015

                                        The COMPARE Procedure

                              Comparison of WORK.SDTM_DM with WORK.DMAE

                                            (Method=EXACT)

-------------------------------------------- USUBJID=103 ---------------------------------------------

                                         Observation Summary

                                    Observation      Base  Compare

                                    First Obs           3        3

                                    Last  Obs           3        3

                   Number of Observations in Common: 1.

                   Total Number of Observations Read from WORK.SDTM_DM: 1.

                   Total Number of Observations Read from WORK.DMAE: 1.

                   Number of Observations with Some Compared Variables Unequal: 0.

                   Number of Observations with All Compared Variables Equal: 1.

                   NOTE: No unequal values were found. All values compared are exactly equal.

                                                                                                        00:00 Monday, September 14, 2015

                                        The COMPARE Procedure

                              Comparison of WORK.SDTM_DM with WORK.DMAE

                                            (Method=EXACT)

-------------------------------------------- USUBJID=104 ---------------------------------------------

                                         Observation Summary

                                    Observation      Base  Compare

                                    First Obs           4        4

                                    Last  Obs           4        4

                   Number of Observations in Common: 1.

                   Total Number of Observations Read from WORK.SDTM_DM: 1.

                   Total Number of Observations Read from WORK.DMAE: 1.

                   Number of Observations with Some Compared Variables Unequal: 0.

                   Number of Observations with All Compared Variables Equal: 1.

                   NOTE: No unequal values were found. All values compared are exactly equal.

PRACTICE AND COMMENT YOUR CODE: 

-->PLEASE FOLLOW OUR BLOG FOR MORE UPDATES.

TO FOLLOW OUR TELEGRAM CHANNEL CLICK HERE