Page History

This an example of the SDTM datset used to create the ALDS.

Dataset wrap

Name	dm

Dataset2

Row	STUDYID	DOMAIN	USUBJID	SUBJID	RFSTDTC	RFENDTC	RFXSTDTC	RFXENDTC	RFICDTC	RFPENDTC	SITEID	INVNAM	BRTHDTC	SEX	RACE	ETHNIC	ARMCD	ARM	ACTARMCD	ACTARM	COUNTRY
1	AD123	DM	ABC123-0001	0001	2021-10-07	2007-01-28	2021-10-07	2021-10-07	2021-10-01	2007-02-01	01	JOHNSON, M	1948-12-13	M	WHITE	NOT HISPANIC OR LATINO	A	Product A	A	Product A	USA
2	A123	DM	ABC123-0002	0002	2006-01-15	2006-02-28	2006-01-15	2006-02-28	2006-01-04	2006-03-26	01	JOHNSON, M	1955-03-22	M	WHITE	NOT HISPANIC OR LATINO	B	Product B	B	Product B	USA
3	A123	DM	ABC123-0003	0003	2006-01-16	2006-03-19	2006-01-16	2006-03-19	2006-01-02	2006-03-19	01	JOHNSON, M	1938-01-19	F	BLACK OR AFRICAN AMERICAN	NOT HISPANIC OR LATINO	B	Product B	B	Product B	USA

Dataset wrap

Name	ds

Dataset2

Row	STUDYID	DOMAIN	USUBJID	DSSEQ	DSTERM	DSDECOD	DSCAT	DSSCAT	EPOCH	DSDTC	DSSTDTC
1	A123	DS	A123-0001	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-21	2003-09-21
2	A123	DS	A123-0001	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
3	A123	DS	A123-0001	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-29
4	A123	DS	A123-0001	4	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	PRODUCT EXPOSURE	2003-10-31	2003-10-31
5	A123	DS	A123-0001	5	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	FOLLOW-UP	2003-11-15	2003-11-15
6	A123	DS	A123-0002	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-11-21	2003-11-21
7	A123	DS	A123-0002	2	SUBJECT DENIED ECG PROCEDURE	PROTOCOL VIOLATION	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-11-22	2003-11-20
8	A123	DS	A123-0002	1	INFORMED CONSENT OBTAINED	INFORMED CONSENT OBTAINED	PROTOCOL MILESTONE		SCREENING	2003-09-15	2003-09-15
9	A123	DS	A123-0003	2	RANDOMIZED	RANDOMIZED	PROTOCOL MILESTONE		SCREENING	2003-09-30	2003-09-30
10	A123	DS	A123-0003	3	COMPLETED	COMPLETED	DISPOSITION EVENT	STUDY PARTICIPATION	SCREENING	2003-09-30	2003-09-22
11	A123	DS	A123-0003	4	SUBJECT MOVED	LOST TO FOLLOW-UP	DISPOSITION EVENT	STUDY PARTICIPATION	PRODUCT EXPOSURE	2003-10-31	2003-10-31

Dataset wrap

Name	adsl

Dataset2

tableid	adsl

STUDYID	USUBJID	SUBJID	SITEID	AGE	AGEU	AGEGR1	SEX	RACE	ETHNIC	SAFFL	RANDFL	ARM	ACTARM	TRT01P	TRT01PN	TRT01A	TRT01AN	TRTSDT	TRTEDT	EOSSTT	EOSDT	DCSREAS
ABC123	ABC12301001	01001	01	57	YEARS	<65	M	WHITE	NOT HISPANIC OR LATINO	Y	Y	Product A	Product A	Product A	1	Product A	1	2006-01-12	2006-03-10	COMPLETED	2003-09-29
ABC123	ABC12301002	01002	01	50	YEARS		M	WHITE	NOT HISPANIC OR LATINO	Y	Y	B	Product B	Product B	2	Product B	2	2006-01-15	2006-02-28	DISCONTINUED		LOST TO FOLLOW-UP
ABC123	ABC12301003	01003	01	68	YEARS		F	BLACK OR AFRICAN AMERICAN	NOT HISPANIC OR LATINO	Y	Y	B	Product B	Product B	2	Product B	2	2006-01-16	2006-03-19	COMPLETED
ABC123	ABC12301004	01004	01				M	ASIAN	NOT HISPANIC OR LATINO	N	N									DISCONTINUED		SCREEN FAILURE
ABC123	ABC12302001	02001	02	55	YEARS		F	AMERICAN INDIAN OR ALASKA NATIVE	NOT HISPANIC OR LATINO	Y	Y	B	Product B	Product B	2	Product B	2	2006-02-02	2006-03-31	COMPLETED
ABC123	ABC12302002	02002	02	49	YEARS		F	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS	NOT HISPANIC OR LATINO	Y	Y	A	Product A	Product A	1	Product A	1	2006-02-03	2006-04-05	DISCONTINUED		ADVERSE EVENT
ABC123	ABC12302003	02003	02				F	MULTIPLE	NOT HISPANIC OR LATINO	N	N									DISCONTINUED		SCREEN FAILURE

Page tree