This is an example of an ADLB dataset and is based on input from the SDTM LB dataset. Other administrative data about the subjects are based on the ADSL dataset provided in Section x.x, Analysis Data Subject Level (ADSL).
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| SDTM EXAMPLE ADAM LB |
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| SDTM EXAMPLE ADAM LB |
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This is an example of the ADLB dataset and associated metadata. This is just an example and does not mean to indicate that ADLB must be used as the dataset name nor are the parameters described necessarily the ones that would be used in a particular study.
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| Dataset2 |
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STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | ADT | ADY | AVISIT | AVISITN | LBSEQ | PARAM | PARAMCD | PARAMN | PARCAT1 | AVALC | AVAL | LBSTRESU | LBSTNRC | ANRLO | ANRHI | ANRIND | LBLOINC | LBSPEC | ABLFL | LBCLSIG | VISITNUM | LBDTC |
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| A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 1 | Leukocytes (10^9/L) | WBC | 6 | HEMATOLOGY |
| 11.0 | 10^9/L |
| 4.5 | 11.0 |
| 26464-8 | BLOOD | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 2 | RBC (10^12/L) | RBC | 8 | HEMATOLOGY |
| 5.4 | 10^12/L |
| 4.7 | 6.1 |
| 33051-4 | BLOOD | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 3 | Platelets (10^9/L) | PLAT | 7 | HEMATOLOGY |
| 158 | 10^9/L |
| 150 | 400 |
| 49497-1 | BLOOD | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 4 | Hemoglobin (g/dL) | HGB | 5 | HEMATOLOGY |
| 14.5 | g/dL |
| 14 | 18 |
| 718-7 | BLOOD | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 5 | Cholesterol (mg/dL) | CHOL | 2 | CLINICAL CHEMISTRY |
| 229 | mg/dL |
| 200 |
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| 2093-3 | BLOOD | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 6 | Albumin (g/L) | ALB | 1 | CLINICAL CHEMISTRY |
| 4.0 | g/dL |
| 3.4 | 5.4 |
| 2862-1 | BLOOD | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 7 | Creatinine (mg/dL) | CREAT | 3 | CLINICAL CHEMISTRY |
| 0.8 | mg/dl |
| 0.7 | 1.3 |
| 2160-0 | BLOOD | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 8 | Urine Specific Gravity | USPGRAV | 9 | URINALYSIS |
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| 1.005 | 1.030 |
| 2965-2 | URINE | Y |
| 1 | 2020-12-01 | | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
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| 9 | Cannabinoids | CANNAB | 4 | DRUG TOXICITY | POSITIVE |
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| POSITIVE |
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| ABNORMAL | 18282-4 | URINE | Y | Y | 1 | 2020-12-01 |
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| Definexmltable |
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| Level | Dataset |
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| Purpose | Analysis |
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| Name | ADLB |
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| | Dataset | Description | Class | Structure | Purpose | Keys | Location | Documentation |
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| ADLB |
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| Analysis | , | ADSL.xpt | ADLB.SAS/SAP | |
| Definexmltable |
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| Dataset | ADLB |
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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 | CDISC Notes |
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| Study Identifier | Char |
| Req | LB.STUDYID | | USUBJID | Unique Subject Identifier | Char |
| Req | LB.USUBJID | | TRTP | Planned Treatment | Char |
| Cond | ADSL.TRT01P | | TRT01P | Planned Treatment for Period 01 | Char |
| Cond | ADSL.TRT01P | | TRTA | Actual Treatment | Char |
| Cond | ADSL.TRT01A | | TRTx01A | Actual Treatment for Period 01 | Char |
| Cond | ADSL.TRT01A | | ADT | Analysis Date | Num |
| Perm | LB.LBDTC captured in numeric format | | ADY | Analysis Relative Day | Num |
| Perm | LB.LBDY | | AVISIT | Analysis Visit | Char |
| Cond | LB.VISIT | | AVISITN | Analysis Visit (N) | Num |
| Perm | LB.VISITNUM | | PARAM | Parameter | Char |
| Req | LB.LBTEST concatenated with LB.LBSTRESU - if PARCAT1=URINALYSIS then preface with Urine | | PARAMCD | Parameter Code | text |
| Req | LB.LBTESTCD - if PARCAT1=URINALYSIS then preface with U | | PARAMN | Parameter (N) | Num |
| Perm | Numeric representation of PARAM. Sort by PARCAT! and PARAMCD and increment by 1 for each new LBTESTCD | | PARCAT1 | Parameter Category 1 | Char |
| Perm | LB.LBCAT | | AVAL | Analysis Value | Num |
| Cond | LB.LBSTRESN | | AVALC | Analysis Value (C) | Char |
| Cond | LB.LBSTRESC where LB.LBSTRESN is null | | BASE | Baseline Value | Num |
| Cond | AVAL where ABLFL=Y | | CHG | Change from Baseline | Num |
| Perm | AVAL-BASE - populated on ABLFL=Y records and post-baseline records | | PCHG | Percent Change from Baseline | Num |
| Perm | derived as ((AVAL-BASE)/BASE)*100 | | ABLFL | Baseline Record Flag | Char | Y | Cond | set to Y for last pre-treatment value within each PARAM | | ANL01FL | Analysis Flag 01 | Char | Y | Cond | set to Y for last value within PARAM and AVISIT | | COUNTRY | Country | Char |
| Perm | ADSL.COUNTRY | | AGE | Age | Num |
| Perm | ADSL.AGE | | SEX | Sex | Char |
| Perm | ADSL.SEX | | RACE | Race | Char |
| Perm | ADSL.RACE | | ETHNIC | Ethnicity | Char |
| Perm | ADSL.ETHNIC | | SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL | | RANDFL | Randomized Population Flag | Char | Y;N | Cond | ADSL.RANDFL | | TRTSDT | Date of First Exposure to Treatment | Num |
| Perm | ADSL.TRTSDT | | TRTEDT | Date of Last Exposure to Treatment | Num |
| Perm | ADSL.TRTEDT | | LBSEQ | Sequence Number | Num |
| Perm | LB.LBSEQ | | VISIT | Visit Name | Char |
| Perm | LB.VISIT | | VISITNUM | Visit Number | Num |
| Perm | LB.VISITNUM |
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