STUDYID | Study Identifier | Char |
| RS.STUDYID |
|
|
USUBJID | Unique Subject Identifier | Char |
| RS.USUBJID |
|
|
| SITEID | Site Identifier | Char |
| ADSL.SITEID |
|
|
RSSEQ | Sequence Number | Num |
| RS.RSSEQ |
| RSSEQ is included to provide traceability back to SDTM. |
| ASEQ | Analysis Sequence Number | Num |
| | After sorting by key variables, renumber all the records from 1 to n within a subject. | Provides a sequence number to derived rows which are not present in RSSEQ. |
ITTFL | Intent-to-Treat Population Flag | Char | “Y”, “N” | ADSL.ITTFL |
| Conditional; must include at least 1 population flag. |
TRTP | Planned Treatment | Char | "DRUG A + SOC", "SOC" |
|
| Derivation should be defined by sponsor according to analysis needs. Conditional; should include at least 1 treatment variable (e.g., TRTP, TRTA, TRTSEQP, TRT01P). |
PARAM | Parameter | Char | GDS02TNAPCH1TN, GDS02PNAPCH1PN |
| RS.RSTEST for responses to individual questions copied from SDTM. Set PARAM to "APCH1-A: Total Acute Physiology Score - Analysis" for the derived total acute physiology score. Set PARAM to "GDS02APCH1-Total APACHE II Score - Analysis" for the derived total score. |
|
| PARAMCD | Parameter Code | Char | GDS02TCAPCH1TC, GDS02PCAPCH1PC |
| RS.RSTESTCD for responses to individual questions copied from SDTM. Set PARAMCD to "GDS02TS" for the derived total score. |
|
PARAMN | Parameter Number | Num |
| | Number of the item in the order it appears on the form; assign a higher value to the derived total score record. |
|
PARCAT1 | Parameter Category 1 | Char | "APACHE II" | | Set to RS.RSCAT for records that come directly from SDTM and "APACHE II" for any derived records such as total scores. |
|
VISIT | Visit Name | Char |
| RS.VISIT |
| RS.VISIT included for traceability. |
VISITNUM | Visit Number | Num |
| RS.VISITNUM |
| RS.VISITNUM included for traceability. |
AVISIT | Analysis Visit | Char |
|
|
| AVISIT represents the analysis visit for the record. Refer to the SAP for additional details. |
AVISITN | Analysis Visit (N) | Num |
|
| A numeric representation of AVISIT. |
|
RSDTC | Date/Time of Finding | Char |
| RS.RSDTC |
| RS.RSDTC included for traceability. |
ADT | Analysis Date | Num |
|
| Date portion of RS.RSDTC converted to numeric and displayed in a format such as DATE9. For derived total score records where PARAMCD="GDS02TS", this information will be copied from the individual records that comprise that instrument. |
|
ADY | Analysis Relative Day | Num |
| | ADT-ADSL.TRTSDT+1 if ADT≥TRTSDT; else, ADT-ADSL.TRTSDT if ADT<TRTSDT. | This derivation is for example only. |
RSORRES | Finding in Original Units | Char |
| RS.RSORRES |
|
|
RSORRESU | Original Units | Char |
| RS.RSORRESU |
|
|
AVAL | Analysis Value | Num |
|
| See Parameter Value Level List - ADAPCH table. |
|
DTYPE | Derivation Type | Char | "WOC" | |
|
|
ABLFL | Baseline Record Flag | Char | “Y” | | Set ABLFL="Y" on the record defined as the baseline value. This flag will only be populated on the derived acute physiology and APACHE II total score records (PARAMCD in("APCH1TPS" "APCH1TS")) in this example. |
|
| COUNTRY | Country | Char |
| ADSL.COUNTRY |
| Permissible if needed for analysis. Generally represented using ISO 3166-1 Alpha-3. Note that regulatory agency specific requirements (e.g., US FDA) may require other terminologies; in such cases, follow regulatory requirements. |
REGION1 | Geographic Region 1 | Char |
| ADSL.REGION1 |
| Permissible if needed for analysis. |
REGION1N | Geographic Region 1 (N) | Num |
| ADSL.REGION1N |
| Permissible if needed for analysis. |