Page History
| 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 | |
| LBDTC |
STUDYID | USUBJID | TRTP | TRT01P | TRTA | TRT01A | ADT | ADY | AVISIT | AVISITN | LBSEQ | PARAM | PARAMCD | PARAMN | PARCAT1 |
|---|
| AVAL |
|---|
AVALC | LBSTNRC | ANRLO | ANRHI | ANRIND | LBLOINC | LBSPEC | ABLFL | LBCLSIG | VISITNUM | LBDTC |
|---|
| A123 |
| A2001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 1 | Leukocytes (10^9/L) | WBC | 6 | HEMATOLOGY | 11.0 |
| 4.5 | 11.0 | 26464-8 | BLOOD | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 | 001-001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 2 | RBC (10^12/L) | RBC | 8 | HEMATOLOGY | 5.4 |
| 4.7 | 6.1 | 33051-4 | BLOOD | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 |
| A2001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 3 | Platelets (10^9/L) | PLAT | 7 | HEMATOLOGY | 158 |
| 150 | 400 | 49497-1 | BLOOD | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 |
| A2001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 4 | Hemoglobin (g/dL) | HGB | 5 | HEMATOLOGY | 14.5 |
| 14 | 18 | 718-7 | BLOOD | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 |
| A2001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 5 | Cholesterol (mg/dL) | CHOL | 2 | CLINICAL CHEMISTRY | 229 |
| 200 | 2093-3 | BLOOD | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 |
| A2001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 6 | Albumin (g/L) | ALB | 1 | CLINICAL CHEMISTRY | 4.0 |
| 3.4 | 5.4 | 2862-1 | BLOOD | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 |
| A2001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 7 | Creatinine (mg/dL) | CREAT | 3 | CLINICAL CHEMISTRY | 0.8 |
| 0.7 | 1.3 | 2160-0 | BLOOD | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 |
| A2001 | Product A | Product A | Product A | Product A |
| 02JAN2021 | -6 | SCREENING | 1 | 8 | Urine Specific Gravity | USPGRAV | 9 | URINALYSIS | 1.005 | 1.030 | 2965-2 | URINE | Y | 1 |
| 2021- |
| 01- |
| 02 |
| A123 |
| A2001 | Product A | Product A | Product A | Product A | 02JAN2021 | -6 | SCREENING | 1 | 9 | Cannabinoids | CANNAB | 4 | DRUG TOXICITY | POSITIVE |
| NEGATIVE | ABNORMAL | 18282-4 | URINE | Y | Y | 1 |
| 2021- |
| 01- |
| 02 |
Overview
Content Tools