Data Expectations

ADSL

This is a subject level data set with one record per subject and includes any variables that are intended to be used for plot splitting

• For example if it is the intention to be able to split the line plot by some outcome variable then that outcome variable must be in ADSL.
  • e.g. ABCWK24 which represents a two level outcome variable with values of “Y” and “N” at Week 24.
    
    

ADLB

This is a Basic Data Structure (BDS) data set meaning multiple records per subject per assay (PARAM) across unique time points. Additional variables that are intended to be used for plot splitting should be joined to ADLB.

• See ADSL example above where ABCWK24 would need to be joined to ADLB
  
  

Other Basic Data Structures

Other BDS data sets could be provisioned to teal.goshawk like ADQS which contains multiple records per subject per question (PARAM) across unique time points. However with all cases other than ADLB there are likely workarounds needed.

• For example the concept of assay units, stored in AVALU, is not really relevant to a BDS like ADQS which contains questionnaire data. Given teal.goshawk expects an AVALU variable and uses the values in the plot title and y-axis label, AVALU would need to be added to ADQS with some appropriate value: Perhaps “Q”. If a value is not provided the the “()” portion of the title and y-axis label will be empty.

TRTORD

Definition: This variable orders treatment values in the legend

Rationale: Allows for congruent ordering as compared to other outputs being generated by a study team

Alternative: Variable is required

AVISITCD

Definition: This variable contains abbreviated values of AVISIT values

Rationale: Many AVISIT values are long and contain arguably superfluous information in some cases. Using these long values as x-axis tick labels can really chew into the real estate area available for the plot. Using thoughtful abbreviations conveys chronology with no substantive loss of information and maximizes the area available for the plot.

Alternative: If in cases creating abbreviations is not helpful then simply set AVISITCD <- AVISIT

AVISITCDN

Definition: This variable contains the numeric portion of AVISITCD values

Rationale: Often AVISITN contains values that are not particularly helpful to reflect the proportional chronology of visits. Once AVISITCD is created then it is helpful to create the numeric values from AVISITCD values that can be seen as intuitively reflecting the visit chronology. For example: 0, 2, 4, 12, 24, 56, 84 etc. for weeks or 0, 14, 28, 84, 168, 392, 588 etc. for days. Using these, the longitudinal visualization x-axis will nicely reflect proportional distances between visits.

Alternative: If in cases creating a more intuitive numeric chronology is not helpful then simply set AVISITCDN <- AVISITN

AVALU

Definition: Analysis Value Unit

Rationale: Used in the plot title and y-axis labels. Please see “Other BDS data sets” comments above

Alternative: Variable is required.

LBSTRESC

Definition: From SDTM Character Result/Finding in Std Format

Rationale: As a character type variable, this variable contains values that include those below or above limits of quantitation (LOQ). These might look like “2.1<” or “>20.7”. When this is the case then AVAL is often missing. It is important to be able to still capture these values so the following derivation is used to do so and when this is needed the LOQFL variable should be set to “Y”. This signifies that the AVAL value for this record has been derived. - For values below the limit of quantitation, AVAL is set to the numeric portion of LBSTRESC divided by 2. - For values above the limit of quantitation, AVAL is set to the numeric portion of LBSTRESC.

Alternative: Variable is required

LOQFL

Definition: This is not an ADaM standard variable but represents the Limit of Quantitation Flag

Rationale: Set to “Y” when LBSTRESC value is used to populate AVAL and LBSTRESC value is either below a limit of quantitation for the assay or above the limit of quantitation for the assay. Derivations for AVAL and LOQFL could look like the following in a mutate() statement. - AVAL = if_else(grepl("<|>", LBSTRESC), as.numeric(gsub("[^0-9, .]+", "", LBSTRESC)), AVAL) - LOQFL = if_else(grepl("<|>", LBSTRESC), "Y", "N")

Alternative: If the limit of quantitation concept is not relevant then please set LOQFL <- "N"

BASE2

Definition: This is not an ADaM standard variable but represents the assay value at Screening

Rationale: When change from Screening visit analyses are needed then this variable contains the assay value at Screening

Alternative: If Screening visit analyses are not relevant then please set BASE2 <- NA

CHG2

Definition: This is not an ADaM standard variable but represents the change from Screening assay value

Rationale: When change from Screening visit analyses are needed then this variable contains the assay value change between Screening and subsequent visit

Alternative: If Screening visit analyses are not relevant then please set CHG2 <- NA

PCHG2

Definition: This is not an ADaM standard variable but represents the percent change from Screening assay value

Rationale: When percent change from Screening visit analyses are needed then this variable contains the assay value percent change between Screening and subsequent visit

Alternative: If Screening visit analyses are not relevant then please set PCHG2 <- NA

AVALL2, BASEL2, BASE2L2

Description: Log 2 of AVAL, BASE and BASE2 respectively

Rationale: This transformation addresses data variance to improve the interpretability or appearance of plots.