This is an example of an ADSL dataset and is based on the SDTM DM and DS domains. This is just an example and does not mean to indicate that ADSL must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study.
Below are example SDTM datasets the SDTM datset used to create the ADSL dataset.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | DTHDTC | DTHFL | SITEID | INVNAM | BRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
|---|
| 1 | A123 | DM | A0001 | 0001 | 2021-01-08 | 2021-01-28 | 2021-01-08 | 2021-01-0828 | 2021-01-02 | 2021-0102-0804 |
|
| 01 | JOHNSON, M | 1948-12-13 | 72 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | UB | Usual Brand | UB | Usual Brand |
|
| USA | | 2 | A123 | DM | A2008 | 00022008 | 20062021-0102-15082006 | 2021-0203-2801 | 20062021-0102-15082006 | 2021-0203-2801 | 20062021-0102-0402 | 20062021-03-2610 |
|
| 02 | JAMES,A | 1955-03-22 | 65 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | A | Product A | A | Product A |
|
| USA | | 3 | A123 | DM | A3009 | 00033009 | 20062021-0106-1609 | 2006-03-192006 | 2021-0106-1609 | 20062021-0306-19212006 | 2021-06-01-02 | 20062021-0306-1930 |
|
| 03 | ADAMS,J | 19381964-01-19 | 57 | YEARS | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | B | Product B | B | Product B |
|
| USA |
|
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | EPOCH | DSDTC | DSSTDTC |
|---|
| 1 | A123 | DS | A0001 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING |
|
| 2021-01-02 | 2021-01-02 | | 2 | A123 | DS | A0001A2001 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | SCREENING |
|
| 2021-01-07 | 2021-01-07 | | 3 | A123 | DS | A0001A2001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-01-07 | 20021-01-07 | | 4 | A123 | DS | A0001A2001 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-01-28 | 2021-01-28 | | 5 | A123 | DS | A0001A2001 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2021-02-04 | 2021-02-04 |
|
|
|
|
|
|
|
|
|
|
|
| | 6 | A123 | DS | A002 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING |
|
| 20032021-1102-21022003 | 2021-1102-2102 | | 7 | A123 | DS | A002A2008 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
|
| 2021-02-08 | 2021-02-08 | | 3 | A123 | DS | A2008 | 3 | COMPLETED | COMPLETED | SUBJECT DENIED ECG PROCEDURE | PROTOCOL VIOLATION | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2003-11-22 | | 2021-02-08 | 2021-02-08 | | 4 | A123 | DS | A2008 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-03-01 | 2021-03-01 | | 5 | A123 | DS | A2008 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2021-03-10 | 2021-03-102003-11-20 |
|
|
|
|
|
|
|
|
|
|
|
| | 8 | A123 | DS | A002A3009 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE | SCREENING |
|
| 20032021-0906-15012003 | 2021-0906-1501 | | 9 | A123 | DS | A002A3009 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE | SCREENING |
|
| 20032021-06-09 | 2021-30200306-09-30 | | 10 | A123 | DS | A002A3009 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-06-09 | 2003-06-09-302003-09-22 | | 10 | A123 | DS | A3009 | 4 | FLU | ADVERSE EVENT | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-06-21 | 2021-06-21 | | 11 | A123 | DS | A002A3009 | 45 | SUBJECT MOVEDCOMPLETED | LOST TO FOLLOW-UP | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 20032021-1006-31302003 | 2021-1006-31 |
|
|
| Definexmltable |
|---|
| Level | Dataset |
|---|
| Purpose | Analysis |
|---|
| Name | ADSL |
|---|
|
| Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
|---|
| ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | Analysis | STUDYID, USUBJID, PARQUAL, PARAMCD, AVISIT, | ADSL.xpt | ADSL.SAS/SAP | |
| Definexmltable |
|---|
| Dataset | ADSL |
|---|
| Level | Variable |
|---|
| Purpose | Analysis |
|---|
|
| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
|---|
| Study Identifier | text |
| Req | AE.STUDYID | | USUBJID | Unique Subject Identifier | text |
| Req | AE.USUBJID | | ASTDT | Analysis Start Date | integer |
| Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric date format | | ASTDTM | Analysis Start Date/Time | integer |
| Cond | Created from converting AE.AESTDTC from character ISO8601 format to numeric datetime format | | AENDT | Analysis End Date | integer |
| Cond | Created from converting AE.AEENDTC from character ISO8601 format to numeric date format | | AENDTM | Analysis End Date/Time | integer |
| Cond | Created from converting AE.AEENDTC from character ISO8601 format to numeric datetime format | | ASTDY | Analysis Start Relative Day | integer |
| Cond | ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT | | AENDY | Analysis End Relative Day | integer |
| Cond | AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT | | PREFL | Pre-treatment Flag | text | Y | Cond | If ASTDT < ADSL.TRTSDT then PREFL=’Y’ | | TRTEMFL | Treatment Emergent Analysis Flag | text | Y | Cond | If ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’ | | FUPFL | Follow-up Flag | text | Y | Cond | If ASTDT > ADSL.TRTEDT then FUPFL=’Y’
| | AETRTEM | Treatment Emergent Flag | text | (NY) | Perm | SUPPAE.QVAL where QNAM=’AETRTEM’. | | AOCCFL | 1st Occurrence within Subject Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each subject. | | AOCCPFL | 1st Occurrence of Preferred Term Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each AEDECOD for each subject. | | AOCCSFL | 1st Occurrence of SOC Flag | text | Y | Perm | Sort the data in the required order and flag the first treatment emergent record for each body system for each subject. | | AESER | Serious Event | text | (NY) | Req | AE.AESER | | AEREL | Causality | text |
| Perm | AE.AEREL | | RELGR1 | Pooled Causality Group y | text |
| Perm | set to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT) | | AEACN | Action Taken with Study Treatment | text | (ACN) | Perm | AE.AEACN | | TRTP | Planned Treatment | text |
| Cond | ADSL.TRT01P | | TRTA | Actual Treatment | text |
| Cond | ADSL.TRT01A | | SAFFL | Safety Population Flag | text |
| Cond | ADSL.SAFFL | | TRTSDT | Date of First Exposure to Treatment | integer |
| Perm | ADSL.TRTSDT | | TRTEDT | Date of Last Exposure to Treatment | integer |
| Perm | ADSL.TRTEDT | | AETERM | Reported Term for the Adverse Event | text |
| Req | AE.AETERM | | AEBODSYS | Body System or Organ Class | text |
| Req | AE.AEBODSYS | | AEDECOD | Dictionary-Derived Term | text |
| Req | AE.AEDECOD | | AEOUT | Outcome of Adverse Event | text |
| Perm | AE.AEOUT | | AESEQ | Sequence Number | integer |
| Perm | AE.AESEQ | | AESTDTC | Start Date/Time of
Adverse Event | text |
| Perm | AE.AESTDTC | | AEENDTC | End Date/Time of
Adverse Event | text |
| Perm | AE.AEENDTC | | AESTDY | Study Day of Start of
Adverse Event | text |
| Perm | AE.AESTDY | | AEENDY | Study Day of End of
Adverse Event | text |
| Perm | AE.AEENDY | | AEENRF | End Relative to
Reference Period | text |
| Perm | AE.AEENRF |
|
This is an example of the ADSL dataset.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | STUDYID | USUBJID | SUBJID | SITEID | AGE | AGEU | AGEGR1 | SEX | RACE | ETHNIC | SAFFL | RANDFL | ARM | ACTARM | TRT01P | TRT01PN | TRT01A | TRT01AN | TRTSDT | TRTEDT | EOSSTT | EOSDT | DCSREAS |
|---|
| A123 | A2001 | 0001 | 01 | 72 | YEARS | <65 | M | WHITE |
|---|
|
|
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| | 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 NATIVEB | Product B B2Product B22006020220060331ABC123ABC123020020200249F | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS
| M | WHITE | NOT HISPANIC OR LATINO | Y | Y | Product A | Product A | Product A |
|---|
1120060320060405DISCONTINUEDABC123 | ABC12302003 | 02003 | 02MULTIPLE| BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO |
N | N | DISCONTINUED | | Y | Y | Product B | Product B | Product B | 3 | Product B | 3 | 2021-06-09 | 2021-06-21 | DISCONTINUED |
|---|
SCREEN FAILURE |
|