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Dataset2 |
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ROW | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRC | LBSTNRLO | LBSTNRHI | LBNRIND | LBLOINC | LBSPEC | LBLOBXFL | LBCLSIG | VISITNUM | LBDTC |
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1 | A123 | LB | 2001 | 1 | WBC | Leukocytes | HEMATOLOGY | 11.0 | 10^9/L | 4.5 | 11.0 | 11.0 | 11.0 | 10^9/L |
| 4.5 | 11.0 |
| 26464-8 | BLOOD | Y |
| 1 | 2021-1-02 | 2 | A123 | LB | 2001 | 2 | RBC | RBC | HEMATOLOGY | 5.4 | 10^12/L | 4.7 | 6.1 | 5.4 | 5.4 | 10^12/L |
| 4.7 | 6.1 |
| 33051-4 | BLOOD | Y |
| 1 | 2021-1-02 | 3 | A123 | LB | 2001 | 3 | PLAT | Platelets | HEMATOLOGY | 158 | 10^9/L | 150 | 400 | 158 | 158 | 10^9/L |
| 150 | 400 |
| 49497-1 | BLOOD | Y |
| 1 | 2021-1-02 | 4 | A123 | LB | 2001 | 4 | HGB | Hemoglobin | HEMATOLOGY | 14.5 | g/dL | 14 | 18 | 14.5 | 14.5 | g/dL |
| 14 | 18 |
| 718-7 | BLOOD | Y |
| 1 | 2021-1-02 | 5 | A123 | LB | 2001 | 5 | CHOL | Cholesterol | CLINICAL CHEMISTRY | 229 | mg/dL | 200 |
| 229 | 229 | mg/dL |
| 200 |
|
| 2093-3 | BLOOD | Y |
| 1 | 2021-1-02 | 6 | A123 | LB | 2001 | 6 | ALB | Albumin | CLINICAL CHEMISTRY | 40.0 | g/L | 34 | 54 | 4.0 | 4.0 | g/dL |
| 3.4 | 5.4 |
| 2862-1 | BLOOD | Y |
| 1 | 2021-1-02 | 7 | A123 | LB | 2001 | 7 | CREAT | Creatinine | CLINICAL CHEMISTRY | 0.8 | mg/dL | 0.7 | 1.3 | 0.8 | 0.8 | mg/dl |
| 0.7 | 1.3 |
| 2160-0 | BLOOD | Y |
| 1 | 2021-1-02 | 8 | A123 | LB | 2001 | 8 | SPGRAV | Specific Gravity | URINALYSIS | 1.002 |
| 1.005 | 1.030 |
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|
|
| 1.005 | 1.030 |
| 2965-2 | URINE | Y |
| 1 | 2021-1-02 | 9 | A123 | LB | 2001 | 9 | CANNAB | Cannabinoids | DRUG TOXICITY | POSITIVE |
|
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| POSITIVE |
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| POSITIVE |
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| ABNORMAL | 18282-4 | URINE | Y | Y | 1 | 2021-1-02 |
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This is an example of the ADLB dataset and associated metadata.
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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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 5 | Cholesterol (mg/dL) | CHOL | 2 | CLINICAL CHEMISTRY |
| 229 | mg/dL |
| 200 |
|
| 2093-3 | BLOOD | Y |
| 1 | 2020-12-01 | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
|
| 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 |
|
| 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 |
|
| 8 | Urine Specific Gravity | USPGRAV | 9 | URINALYSIS |
|
|
|
| 1.005 | 1.030 |
| 2965-2 | URINE | Y |
| 1 | 2020-12-01 | A123 | 2001 | Placebo | Placebo | Placebo | Placebo | 02JAN2021 | -5 |
|
| 9 | Cannabinoids | CANNAB | 4 | DRUG TOXICITY | POSITIVE |
|
| 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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