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| Definexmltable |
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| Multiple | true |
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| Extra | User Notes |
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| Dataset | ADGDSSF |
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| Level | Variable |
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| Purpose | Analysis |
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Variable Name | Variable Label | Type | Controlled Terms | Source | Derivation | User Notes |
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STUDYID | Study Identifier | Char |
| RS.STUDYID |
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| USUBJID | Unique Subject Identifier | Char |
| RS.USUBJID |
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| | SITEID | Site Identifier | Char |
| ADSL.SITEID |
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| 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 |
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| 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 | |
| RS.RSTEST for responses to individual questions copied from SDTM. Set PARAM to "GDS02- Total Score - Analysis" for the derived total score. |
| | PARAMCD | Parameter Code | Char | |
| 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 |
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| AVISIT represents the analysis visit for the record. Refer to the SAP for additional details. | AVISITN | Analysis Visit (N) | Num |
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| A numeric representation of AVISIT. |
| RSDTC | Date/Time of Finding | Char |
| RS.RSDTC |
| RS.RSDTC included for traceability. | ADT | Analysis Date | Num |
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| 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 |
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| RSORRESU | Original Units | Char |
| RS.RSORRESU |
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| AVAL | Analysis Value | Num |
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| See Parameter Value Level List - ADGDSSF table. |
| BASE | Baseline Value | Num | BASE=AVAL where ABLFL ="Y". | Only the derived total score records where PARAMCD="GDS02TS" should have BASE populated in this example. | CHG | Change from Baseline | Num | CHG=AVAL-BASE | Only populate for post-baseline total score records in this example (where PARAMCD="GDS02TS" and ADY>1). | 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 total score records (PARAMCD="GDS02TS") 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. |
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The following SDTM variables can be copied into the corresponding equivalent ADaM variables. Note that the SDTM variable values can be converted to mixed case as needed for analysis purposes. The Action column shown in the table below is optional, and can be removed if all values for these variables are simply copied over from SDTM. For supplements where the SDTM values are modified, please provide a description of what was done. For example, in the CHART-SF supplement, PARAM/PARAMCD are modified by replacing the version number with 'A', so that action is described here as "Harmonizing the two methods of administration (Paper and Interview) for individual items. Fragment representing version number is changed to an 'A'."for analysis purposes.
| Metadataspec |
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SDTM Variable | ADaM Variable | Action | RSTESTCD | PARAMCD | Copy directly in from SDTM on individual items | RSTEST | PARAM | Copy directly in from SDTM on individual items | RSCAT | PARCAT1 | Copy directly in from SDTM on individual items and retain on total scores | RSSTRESN | AVAL | Copy directly in from SDTM on individual items |
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All controlled terminology for instruments in both SDTM and ADaM is associated with a specific version of the instrument. When integrating responses from an instrument across studies, it is important to know which version of the instrument was used for each study. When multiple versions of the same instrument exist in an integration, a pooled analysis of responses across different versions can only be performed if determined to be clinically and statistically acceptable. In that case, sponsor-defined terminology, similar to CDISC Controlled Terminology but without the reference to a specific version, should be used for PARAMCD, PARAM and PARCATy.
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APACHE II score was measured on Day 15 or on the day of discharge (whichever was earlier). Participants As per the SAP, participants who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants at any time during the trial (worst case imputation for deaths). Missing data values of the parameters required for the derivation of the APACHE II score were replaced by the last available assessment. Item level imputation, in this example, is handled by the investigators and/or clinicians at the site and is considered source data, already captured in SDTM. The --LNKID variable can be used to determine the source or input record used to assess that particular physiological item on APACHE II at that time point. SOC included a variety of supportive therapies that ranged from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral treatment, convalescent plasma, corticosteroids, antibiotics or other agents.
The baseline measurement is defined as the last non-missing value collected at or prior to the start of treatment; change from the last non-missing post-baseline value to baseline is used to construct an endpoint. The SAP specifies that planned collected visits, including baseline measurements, are to be used in analyses and displays of results, whereas unscheduled visits appear only in listings. The total score records for 1 subject were collected at 3 visits, plus a derived last observed value (LOV) endpoint record for the APACHE II. Visit 1 is remapped to AVISIT = "BASELINE". There are 2 visits at AVISIT = "VISIT 2". However, because 1 visit was unscheduled, it is not used in the analysis and the ANL01FL value is null. Visits 5 and 6 are missing because the subject discontinued early due to an adverse event unrelated to treatment.
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