This is an example of the ADSL dataset and associated metadata.
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| Dataset2 |
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| Row | 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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| 1 | A123 | A2008 | 2008 | 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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| 2021-01-08 |
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| 2 | 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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| 2021-02-08 |
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| 3 | A123 | A3008 | 3008 | 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 |
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| | AGEU | Age Units | Char | (AGEU) | Req | DM.AGEU |
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| 1 | Char |
| Perm | Character description of a grouping or pooling of the subject's age for analysis purposes. |
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| | | SEX | Sex | Char | (SEX) | Req | DM.SEX | | RACE | Race | Char | (RACE) | Req | DM.RACE |
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| ETHNIC | Ethnicity | Char |
| Perm | DM.ETHNIC | | SAFFL | Safety Population Flag | Char | Y; N | Cond | Y if ADSL. |
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| TRTSDT is not null, otherwise N |
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| 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 |
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| DM.ARM | | TRT01PN | Planned Product for Period 01 |
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| Assigned based on the ARM value | | TRT01A | Actual Product for Period 01 |
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| DM.ACTARM | | TRT01AN | Actual Product for Period 01 |
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Numeric representation of TRTxxA. There must be a one-to-one relationship between TRTxxAN and TRTxxA within a study.
TRTxxAN cannot be present unless TRTxxA is also present. When TRTxxA and TRTxxAN are present, then on a given record, either both must be populated or both must be null.
Assigned based on the ACTARM value | | TRTSDT | Date of First Exposure to |
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| Numeric version of RFXSTDTC |
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| TRTEDT | Date of Last Exposure to |
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| Numeric version of RFXENDTC |
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| 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 |
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| Product Status | Char | (SBJTSTAT) | Perm | The subject's status as of the end of |
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| product or data cutoff. Examples: COMPLETED, DISCONTINUED, ONGOING. | | DCTREAS | Reason for Discontinuation of |
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| Product | Char |
| Perm | If a subject discontinued |
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| product in the study, then this variable indicates the reason for discontinuation. This is for discontinuation of |
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| product in the overall study and not to be used for discontinuation reason within individual |
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| Rowcaps |
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| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | Notes |
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| STUDYID | Study Identifier | text | ABC123 | Req | DM.STUDYID |
USUBJID | Unique Subject Identifier | text | Req | DM.USUBJID | SUBJID | Subject Identifier for the Study | text | Req | DM.SUBJID | | SITEID | Study Site Identifier | text | 01;02 | Req | DM.SITEID |
| Dataset2 |
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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 |
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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| product periods. |
| RANDDT | Date of Randomization | Num |
| Cond |
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| DS.DSSTDTC where DSDECOD=RANDOMIZED |
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