| 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 |
| RANDFL | Randomized Population Flag | Char | Y;N | Cond | ADSL.RANDFL |
| SAFFL | Safety Population Flag | Char | Y;N | Cond | ADSL.SAFFL |
| 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 | |
| VISITNUM | Visit Number | Num | Perm | LB.VISITNUM | |
| LBDTC | Date/Time of Specimen Collection | Char | Perm | LB.LBDTC |
STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | ADT | ADY | AVISIT | AVISITN | PARAM | PARAMCD | PARAMN | PARCAT1 | AVAL | AVALC | BASE | CHG | PCHG | ABLFL | ANL01FL | LBSTNRC | ANRLO | ANRHI | ANRIND | LBLOINC | LBSPEC | RANDFL | SAFFL | LBCLSIG | LBSEQ | VISITNUM | LBDTC | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Leukocytes (10^9/L) | WBC | 6 | HEMATOLOGY | 11.0 | 11.0 | Y | Y | 4.5 | 11.0 | 26464-8 | BLOOD | Y | Y | 1 | 1 | 2021-01-02 | |||||||
| A123 | 001-001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | RBC (10^12/L) | RBC | 8 | HEMATOLOGY | 5.4 | 5.4 | Y | Y | 4.7 | 6.1 | 33051-4 | BLOOD | Y | Y | 2 | 1 | 2021-01-02 | |||||||
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Platelets (10^9/L) | PLAT | 7 | HEMATOLOGY | 158 | 158 | Y | Y | 150 | 400 | 49497-1 | BLOOD | Y | Y | 3 | 1 | 2021-01-02 | |||||||
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Hemoglobin (g/dL) | HGB | 5 | HEMATOLOGY | 14.5 | 14.5 | Y | Y | 14 | 18 | 718-7 | BLOOD | Y | Y | 4 | 1 | 2021-01-02 | |||||||
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Cholesterol (mg/dL) | CHOL | 2 | CLINICAL CHEMISTRY | 229 | 229 | Y | Y | 200 | 2093-3 | BLOOD | Y | Y | 5 | 1 | 2021-01-02 | ||||||||
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Albumin (g/L) | ALB | 1 | CLINICAL CHEMISTRY | 4.0 | 4.0 | Y | Y | 3.4 | 5.4 | 2862-1 | BLOOD | Y | Y | 6 | 1 | 2021-01-02 | |||||||
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Creatinine (mg/dL) | CREAT | 3 | CLINICAL CHEMISTRY | 0.8 | 0.8 | Y | Y | 0.7 | 1.3 | 2160-0 | BLOOD | Y | Y | 7 | 1 | 2021-01-02 | |||||||
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Urine Specific Gravity | USPGRAV | 9 | URINALYSIS | Y | Y | 1.005 | 1.030 | 2965-2 | URINE | Y | Y | 8 | 1 | 2021-01-02 | |||||||||
| A123 | A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | Cannabinoids | CANNAB | 4 | DRUG TOXICITY | POSITIVE | NEGATIVE | ABNORMAL | 18282-4 | URINE | Y | Y | Y | 9 | 1 | 2021-01-02 |
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