Diabetes ADSL dataset

Illustrates Domains

ADEFF

Illustrates Variables

ABLFL

Illustrates Data Structures

ADSL

Content

The following is an example of an abbreviated ADSL dataset. The variables presented are those that may be of specific interest to the analysis of Type 1 Diabetes trials.

adsl.xpt

Rows 1-3:	Because the value of BRTHDTC included only the year, the value of BRTHDT was derived by setting the month to June (06) and the day of the month to 30, then converting the date character string to an integer. The BRTHDTF variable was set to "M" to indicate that the month and day were imputed.
Row 4:	Because the value of BRTHDTC included only the month and year, the value of BRTHDT was derived by setting the day of the month to 15, then converting the date character string to an integer. The BRTHDTF variable was set to "D" to indicate that the day was imputed.
Rows 5-7:	Because full dates were provided for both BRTHDTC and T1DDXDTC, BRTHDTF and T1DDXTF are null.
Row 8:	Because the value of T1DDXDTC included a year and a month, the value of T1DDXDT was derived by setting the day of the month to 15, then converting to a numeric date. The T1DDXTF variable was set to "D" to indicate that the day was imputed.

adsl.xpt

Row	STUDYID	USUBJID	SPDEVID	AGE	AGEU	AAGE	AAGEU	SEX	SEXN	BRTHDTC	BRTHDT	BRTHDTF	RFICDT	TRT01P	TRTSTDT	RANDDT	T1DDXDTC	T1DDXDT	T1DDXDTF	RACE	RACEN	COUNTRY
1	TD011	001-001	CGM-001			11.49	YEARS	M	1	2007	30JUN2007	M	27DEC2018	Drug A	27DEC2018	27DEC2018	2018-12-20	20DEC2018		WHITE	5	DEU
2	TD011	001-002	CGM-001			11.42	YEARS	F	2	2006	30JUN2006	M	30NOV2018	Drug B	30NOV2018	30NOV2018	2018-11-23	23NOV2018		WHITE	5	DEU
3	TD011	001-003	CGM-001			11.32	YEARS	M	1	2007	30JUN2007	M	23OCT2018	Drug B	23OCT2018	23OCT2018	2018-10-16	16OCT2018		ASIAN	2	DEU
4	TD011	001-004	CGM-001			11.93	YEARS	F	2	2007-02	15FEB2007	D	20JAN2019	Drug A	20JAN2019	20JAN2019	2019-01-13	13JAN2019		WHITE	5	DEU
5	TD011	002-001	CGM-001	13	YEARS	12.66	YEARS	F	2	2006-05-24	24MAY2006		20JAN2019	Drug A	20JAN2019	20JAN2019	2019-01-15	15JAN2019		OTHER	6	FRA
6	TD011	002-002	CGM-001	12	YEARS	11.71	YEARS	F	2	2007-01-15	15JAN2007		02OCT2018	Drug B	02OCT2018	02OCT2018	2018-09-24	24SEP2018		WHITE	5	FRA
7	TD011	002-003	CGM-001	12	YEARS	12.34	YEARS	F	2	2006-06-25	25JUN2006		27OCT2018	Drug B	27OCT2018	27OCT2018	2018-10-25	25OCT2018		BLACK OR AFRICAN AMERICAN	1	FRA
8	TD011	002-004	CGM-001	14	YEARS	14.22	YEARS	M	1	2004-02-11	11FEB2004		01MAY2018	Drug A	01MAY2018	01MAY2018	2018-03	15MAR2018	D	WHITE	5	FRA

ADSL Dataset Metadata

Dataset Name	Dataset Description	Dataset Location	Dataset Structure	Keys	Class	Documentation
ADSL	Subject-Level Analysis Dataset	adsl.xpt	One record per subject	STUDYID, USUBJID	SUBJECT LEVEL ANALYSIS DATASET	SAP

ADSL Variable Metadata

Variable Name	Variable Label	Type	Codelist/Controlled Terms	Source/Derivation/Comment
STUDYID	Study Identifier	text		DM.STUDYID
USUBJID	Unique Subject Identifier	text		DM.USUBJID
SPDEVID	Device Identifier	text		DI.SPDEVID
AGE	Age	integer		DM.AGE
AGEU	Age Units	text	YEARS	Assigned
AAGE	Analysis Age	float		Derived: Calculated as ROUND(((RFICDT – BRTHDT) / 365.25),0.01). In general, the (calculated) age is shown as an integer, but in pediatric diabetes studies the age is (often) calculated for analysis with 2 decimal places.
AAGEU	Analysis Age Units	text	YEARS	Assigned
SEX	Sex	text	M,F	DM.SEX
SEXN	Sex (N)	integer	1, 2	Numeric code for DM.SEX. Set to 1 if SEX = "M", 2 if SEX = "F"
BRTHDTC	Date/Time of Birth	text		DM.BRTHDTC
BRTHDT	Date of Birth	integer	date9.	Derived: Numeric version of date portion of BRTHDTC. If BRTHDTC does not include a day, set day to 15. If day and month are missing, set day to 30 and month to 6.
BRTHDTF	Birth Date Imputation Flag	text	M,D	Derived: When the BRTHDTC includes only a year, the value of BRTHDTF is "M", indicating that both the month and day are imputed. If BRTHDTC contains year and month, the value of BRTHDTF is "D", indicating that day is imputed.
RFICDT	Date of Informed Consent	integer		Numeric version of DM.RFICDTC
TRT01P	Planned Treatment for Period 01	text		DM.ARM
TRTSTDT	Date of First Exposure to Treatment	integer		Set to date part of DM.RFXSTDTC captured as a numeric variable
RANDDT	Date of Randomization	integer		Set to date part of DS.DSSTDTC where DS.DSTERM="RANDOMIZED" captured as a numeric variable
T1DDXDTC	Date/Time of Type 1 Diabetes Diagnosis	text		MH.MHSTDTC where MHTERM is "TYPE 1 DIABETES" and MHEVDTYP is "DIAGNOSIS"
T1DDXDT	Date of Type 1 Diabetes Diagnosis	integer	date9.	Derived: Numeric portion of T1DDXDTC . If the day of the month is missing, set it to 15. If the day and month are missing, set month to 6 and day to 30.
T1DDXDTF	Date of Type 1 Diagnosis Imputation Flag	text	M,D	Derived: When T1DDXDTC includes only a year, the value of T1DDXDTF is "M", indicating that both the month and day are imputed. If T1DDXDTC contains year and month, the value of T1DDXDTF is "D", indicating that day is imputed.
RACE	Race	text	ASIAN, BLACK OR AFRICAN AMERICAN, OTHER, WHITE	DM.RACE
RACEN	Race (N)	integer	1,2,5,6	Numeric code for DM.RACE. Set to 1 if RACE=BLACK OR AFRICAN AMERICAN, 2 if RACE=ASIAN, 5 if RACE=WHITE, 6 if RACE=OTHER
COUNTRY	Country	text		DM.COUNTRY