This is an example of an ADSL dataset and is based on input from the SDTM DM and DS datasets. 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.
These are example SDTM datasets used to create the ADSL dataset. Only variables needed for illustration are shown in the examples.
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| 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 |
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| 1 | A123 | DM | A2001 | 2001 | 2021-01-08 | 2021-01-28 | 2021-01-08 | 2021-01-28 | 2021-01-02 | 2021-02-04 |
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| 01 | JOHNSON, M | 1948-12-13 | 72 | | M | WHITE | NOT HISPANIC OR LATINO | Plac | Placebo | Plac | Placebo |
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| USA | | 2 | A123 | DM | A2008 | 2008 | 2021-02-08 | 2021-03-01 | 2021-02-08 | 2021-03-01 | 2021-02-02 | 2021-03-10 |
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| 02 | JAMES, A | 1955-03-22 | 65 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | A | Product A | A | Product A |
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| USA | | 3 | A123 | DM | A3009 | 3009 | 2021-06-09 | 2021-06-21 | 2021-06-09 | 2021-06-21 | 2021-06-01 | 2021-06-30 |
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| 03 | ADAMS, J | 1964-01-19 | 57 | YEARS | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | B | Product B | B | Product B |
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| USA |
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| Row | STUDYID | DOMAIN | USUBJID | DSSEQ | DSTERM | DSDECOD | DSCAT | DSSCAT | EPOCH | DSDTC | DSSTDTC |
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| 1 | A123 | DS | | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
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| 2021-01-02 | 2021-01-02 | | 2 | A123 | DS | A2001 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
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| 2021-01-08 | 2021-01-08 | | 3 | A123 | DS | A2001 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-01-08 | 2021-01-08 | | 4 | A123 | DS | A2001 | 4 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-01-28 | 2021-01-28 | | 5 | A123 | DS | A2001 | 5 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2021-02-04 | 2021-02-04 |
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| | 6 | A123 | DS | | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
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| 2021-02-02 | 2021-02-02 | | 7 | A123 | DS | A2008 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
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| 2021-02-08 | 2021-02-08 | | 3 | A123 | DS | A2008 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 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 | 2021-03-10 |
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| | 8 | A123 | DS | A3009 | 1 | INFORMED CONSENT OBTAINED | INFORMED CONSENT OBTAINED | PROTOCOL MILESTONE |
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| 2021-06-01 | 2021-06-01 | | 9 | A123 | DS | A3009 | 2 | RANDOMIZED | RANDOMIZED | PROTOCOL MILESTONE |
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| 2021-06-09 | 2021-06-09 | | 10 | A123 | DS | A3009 | 3 | COMPLETED | COMPLETED | DISPOSITION EVENT | STUDY PARTICIPATION | SCREENING | 2021-06-09 | 2003-06-09 | | 10 | A123 | DS | A3009 | 4 | FLU | ADVERSE EVENT | DISPOSITION EVENT | STUDY PARTICIPATION | PRODUCT EXPOSURE | 2021-06-21 | 2021-06-21 | | 11 | A123 | DS | A3009 | 5 | LOST TO FOLLOW-UP | LOST TO FOLLOW-UP | DISPOSITION EVENT | STUDY PARTICIPATION | FOLLOW-UP | 2021-06-30 | 2021-06-30 |
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This is an example of the ADSL dataset and associated metadata.
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| STUDYID | USUBJID | SUBJID | SITEID | AGE | AGEU | AGEGR1 | SEX | RACE | ETHNIC | SAFFL | RANDFL | ARM | ACTARM | TRT01P | TRT01PN | TRT01A | TRT01AN | TRTSDT | TRTEDT | EOSSTT | EOSDT | DCSREAS | EOTSTT | DCTREAS | RANDDT |
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| A123 | A2001 | 0001 | 01 | 72 | YEARS | >=65 Years | M | WHITE | NOT HISPANIC OR LATINO | Y | Y | Placebo | Placebo | Placebo | 1 | Placebo | 1 | 2021-01-08 | 2021-01-28 | COMPLETED | 2021-02-04 |
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| A123 | A2008 | 2008 | 02 | 65 | YEARS | >=65 Years | M | WHITE | NOT HISPANIC OR LATINO | Y | Y | Product A | Product A | Product A | 2 | Product A | 2 | 2021-02-08 | 2021-03-01 | COMPLETED | 2021-03-10 |
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| A123 | A3009 | 3009 | 03 | 57 | YEARS | <65 Years | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | Y | Y | Product B | Product B | Product B | 3 | Product B | 3 | 2021-06-09 | 2021-06-21 | COMPLETED | 2021-06-30 |
| DISCONTINUED | ADVERSE EVENT | 2021-06-09 |
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| Definexmltable |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADSL |
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| | Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADSL | Subject-Level Analysis Dataset | SUBJECT LEVEL ANALYSIS DATASET | One record per subject | Analysis | STUDYID, USUBJID | ADSL.xpt | ADSL.SAS/SAP | |
| Definexmltable |
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| Dataset | ADSL |
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| Level | Variable |
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| Purpose | Analysis |
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| | Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
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| STUDYID | Study Identifier | Char |
| Req | DM.STUDYID | | USUBJID | Unique Subject Identifier | Char |
| Req | DM.USUBJID | | SUBJID | Subject Identifier for the Study | Char |
| Req | DM.SUBJID | | SITEID | Study Site Identifier | Char |
| Req | DM.SITEID | | AGE | Age | Num |
| Req | DM.AGE | | AGEU | Age Units | Char | (AGEU) | Req | DM.AGEU | | AGEGR1 | Pooled Age Group 1 | Char |
| Perm | Character description of a grouping or pooling of the subject's age for analysis purposes. | | SEX | Sex | Char | (SEX) | Req | DM.SEX | | RACE | Race | Char | (RACE) | Req | DM.RACE | | ETHNIC | Ethnicity | Char |
| Perm | DM.ETHNIC | | SAFFL | Safety Population Flag | Char | Y; N | Cond | Y if ADSL.TRTSDT is not null, otherwise N | | RANDFL | Randomized Population Flag | Char | Y; N | Cond | Y if the subject was randomized, otherwise N | | ARM | Description of Planned Arm | Char |
| Req | DM.ARM | | ACTARM | Description of Actual Arm | Char |
| Perm | DM.ACTARM | | TRT01P | Planned Treatment for Period 01 | Char |
| Req | DM.ARM | | TRT01PN | Planned Treatment for Period 01 (N) | Num |
| Perm | Assigned based on the ARM value | | TRT01A | Actual Treatment for Period 01 | Char |
| Cond | DM.ACTARM | | TRT01AN | Actual Treatment for Period 01 (N) | Num |
| Perm | Assigned based on the ACTARM value | | TRTSDT | Date of First Exposure to Treatment | Num |
| Cond | Numeric version of RFXSTDTC | | TRTEDT | Date of Last Exposure to Treatment | Num |
| Cond | Numeric version of RFXENDTC | | EOSSTT | End of Study Status | Char | (SBJTSTAT) | Perm | The subject's status as of the end of study or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING. | | EOSDT | End of Study Date | Num |
| Perm | Date subject ended the study - either date of completion or date of discontinuation or data cutoff date for interim analyses. | | DCSREAS | Reason for Discontinuation from Study | Char |
| Perm | Reason for subject's discontinuation from study. The source would most likely be the SDTM DS dataset. Null for subjects who completed the study. | | EOTSTT | End of Treatment Status | Char | (SBJTSTAT) | Perm | The subject's status as of the end of treatment or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING. | | DCTREAS | Reason for Discontinuation of Treatment | Char |
| Perm | If a subject discontinued treatment in the study, then this variable indicates the reason for discontinuation. This is for discontinuation of treatment in the overall study and not to be used for discontinuation reason within individual treatment periods. | | RANDDT | Date of Randomization | Num |
| Cond | DS.DSSTDTC where DSDECOD=RANDOMIZED |
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