Illustrates Data Structures
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.
|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.|
|25OCT2018||BLACK OR AFRICAN AMERICAN||1||FRA|
ADSL Dataset Metadata
Subject-Level Analysis Dataset
One record per subject
SUBJECT LEVEL ANALYSIS DATASET
ADSL Variable Metadata
Unique Subject Identifier
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|
|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|
Date of Birth
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.
Birth Date Imputation Flag
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|
Planned Treatment for Period 01
|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
Date/Time of Type 1 Diabetes Diagnosis
MH.MHSTDTC where MHTERM is "TYPE 1 DIABETES" and MHEVDTYP is "DIAGNOSIS"
Date of Type 1 Diabetes Diagnosis
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.
Date of Type 1 Diagnosis Imputation Flag
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|
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