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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 | 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 | ABNORMAL | 18282-4 | URINE | Y | Y | 1 | 2020-12-01 |
| Definexmltable | |||||||||||||||||||||||||||
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| Variable Name | Variable Label | Type | Codelist/Controlled Terms | Core | CDISC Notes | STUDYID | 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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