myCSG © |Area: ADaM| Concept: ADVS : Full ADVS - Vital Signs Analysis Dataset | Lesson: L1101 : ADVS dataset for a parallel arm study - statschoice-001 |
Complete program for ADVS of a parallel arm study
Includes paramcd, paramn, param, parcat1 and parcat1n derivation
Includes baseline flagging and dependent variables creation - ABLFL, BASE, CHG, PCHG
Includes creation of an analysis flag- ANL01FL - to select one record per analysis visit/parameter/subject
Includes creation of ANL02FL - to identify postbaseline records
| VARIABLE_NAME | VARIABLE_LABEL | TYPE | GENERAL_COMMENT |
|---|---|---|---|
| STUDYID | Study Identifier | _ | VS.STUDYID |
| USUBJID | Unique Subject Identifier | _ | VS.USUBJID |
| SUBJID | Subject Identifier for the Study | _ | ADSL.SUBJID |
| SITEID | Study Site Identifier | _ | ADSL.SITEID |
| AGE | Age | _ | ADSL.AGE |
| AGEU | Age Units | _ | ADSL.AGEU |
| SEX | Sex | _ | ADSL.SEX |
| RACE | Race | _ | ADSL.RACE |
| VSSEQ | Sequence Number | _ | VS.VSSEQ |
| ADT | Analysis Date | _ | Populate using VS.VSDTC |
| ADY | Analysis Relative Day | _ | Populate using ADSL.TRTSDT and ADVS.ADT. If ADT is on or after treatment start date then populate as the difference between ADT and TRTSDT and add one to the difference. Else if ADT is before TRTSDT then populate as the difference between ADT and TRTSDT. |
| EPOCH | Epoch | _ | VS.EPOCH |
| VISITNUM | Visit Number | _ | VS.VISITNUM |
| VISIT | Visit Name | _ | VS.VISIT |
| AVISIT | Analysis Visit | _ | 1) Populate with VS.VISIT for scheduled visits. Leave null for unscheduled visits. 2) Populate as "Baseline" on baseline records (ADVS.ABLFL="Y"). |
| AVISITN | Analysis Visit (N) | _ | 1) Populate with VS.VISITNUM for scheduled visits. Leave null for unscheduled visits. 2) Populate as 0 on baseline records (ADVS.ABLFL="Y"). |
| VSPOS | Vital Signs Position of Subject | _ | VS.VSPOS |
| PARAM | Parameter | _ | Populate as "Systolic Blood Pressure (mmHg)" when PARAMCD="SYSBP". Populate as "Diastolic Blood Pressure (mmHg)" when PARAMCD="DIABP". Populate as "Heart Rate (beats/min)" when PARAMCD="HR". Populate as "Respiratory Rate (breaths/min)" when PARAMCD="RESP". Populate as "Temperature (C)" when PARAMCD="TEMP". Populate as "Height (cm)" when PARAMCD="HEIGHT". Populate as "Weight (kg)" when PARAMCD="WEIGHT". |
| PARAMCD | Parameter Code | _ | Populate with values from VS.VSTESTCD. |
| PARAMN | Parameter (N) | _ | Populate as 1 when PARAMCD="SYSBP". Populate as 2 when PARAMCD="DIABP". Populate as 3 when PARAMCD="HR". Populate as 4 when PARAMCD="RESP". Populate as 5 when PARAMCD="TEMP". Populate as 6 when PARAMCD="HEIGHT". Populate as 7 when PARAMCD="WEIGHT". |
| PARCAT1 | Parameter Category 1 | _ | VS.VSCAT |
| PARCAT1N | Parameter Category 1 (N) | _ | Populate using VS.VSCAT. Populate as 1 when VSCAT="VITAL SIGNS". Populate as 2 when VSCAT="PHYSICAL MEASUREMENTS". |
| VSORRES | Result or Finding in Original Units | _ | VS.VSORRES |
| VSORRESU | Original Units | _ | VS.VSORRESU |
| AVAL | Analysis Value | _ | Populate using VS.VSSTRESN. |
| BASE | Baseline Value | _ | Populate using ADVS.AVAL on the record where ADVS.ABLFL="Y" of each parameter and subject on all records that subject and parameter. |
| CHG | Change from Baseline | _ | Populate as the difference between ADVS.AVAL and ADVS.BASE on postbaseline records (ADVS.ANL02FL="Y"). |
| PCHG | Percent Change from Baseline | _ | Populate using ADVS.CHG and ADVS.BASE, as CHG/BASE*100 when BASE is not null and is not 0. |
| ABLFL | Baseline Record Flag | _ | Populate as "Y" on the latest record with non-missing result on or prior to treatment start date (ADSL.TRTSDT) for each subject and parameter. |
| ANL01FL | Analysis Flag 01 | _ | Populate as "Y" on the latest record within each analysis visit (ADVS.AVISIT) per subject and parameter. |
| ANL02FL | Analysis Flag 02 | _ | Populate as "Y" on postbaseline records (ADVS.ADT>ADSL.TRTSDT). |
| SAFFL | Safety Population Flag | _ | ADSL.SAFFL |
| RANDFL | Randomized Population Flag | _ | ADSL.RANDFL |
| ENRLFL | Enrolled Population Flag | _ | ADSL.ENRLFL |
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