JMP Clinical Basics | Data Sets | Data Sets Generated by the AE Narrative Report

Data Sets Generated by the AE Narrative Report
A number of different SAS data sets are generated by the AE Narrative. These data sets and the variables that they contain are detailed in the tables below:
Variables in the narrtext_XXX.sas7bdat data set are as follows:.
Formatted version of the event severity. Either from Standard Toxicity Grade (AETOXGR, precedence) or Severity/Intensity (AESEV) (if available)
AEREL either Y, Yes = yes, AERELTXT = related
AEREL either N, No, Not, None, AERELTXT = no
AEREL either Probable, Probably, AERELTXT = probably related
AEREL either Possible, Possibly, AERELTXT = possibly related
AEREL either Definite, definitely, AERELTXT = definitely related
AEREL either Remote, remotely, AERELTXT = remotely related
If AEACN either N, No, Not, None, AEACNTXT = no
If AEACN either Y, Yes, AEACNTXT = yes
Formatted list of reasons for SAE status from Involves Cancer (AESCAN), Congenital Anomaly or Birth Defect (AESCONG), Persist or Sign if Disability/Incapacity (AESDISAB), Results in Death (AESDTH), Requires or Prolongs Hospitalization (AESHOSP) Is Life Threatening (AESLIFE), Occurred with Overdose (AESOD), Other Medically Important Serious Event (AESMIE)
Formatted version of AGEU or "year" if AGEU not available
Unique number within subject defined from AESEQ or created by JMP Clinical
Asterisk (*) present if partial date available for RFSTDTC, which means all study days are questionable unless individual study days provided in domain data sets.
Formatted list of adverse events occurring within the window specified by the dialog (default = 3). Contains severities based on AETOXGR or AESEV, if available. Contains only unique instances of event/severity within the window. Asterisks (*) imply a partial start date for the particular event.
The text of FLAG, with asterisk if any partial dates in EX. All dates/study days involving treatment should be reviewed. INEXDOSEIMP = 1 in these cases.
Formatted text of all drugs from EX that are taken on the first date of any study drug (EXTRT, EXDOS, and EXDOSU).
Formatted text of all drugs from EX that are taken on the day on which the event occurs (EXTRT, EXDOS and EXDOSU). Only available if all study treatments are taken at least once per day (from dialog).
Formatted list of concomitant medications that patient is on at the time the event starts. Can include indication (CMINDC) if requested from dialog. Contains only unique instances of medication/indication. Asterisks imply a partial or missing start or end date for the particular medication. (only if CM available)
Formatted version of the day/date with findings A prior to event. Made of PREDT_A and PRESTDY_A. Results apply to Findings B and Findings C with equivalent variables.
Formatted version of the day/date with findings A subsequent to event. Made of POSTDT_A and POSTSTDY_A. Results apply to Findings B and Findings C with equivalent variables.
Variables in the narrmeta_XXX.sas7bdat data set are as follows:.
Y if CM domain available (with requirements met), N if not.
Y if DS domain available (with requirements met), N if not.
Y if EX domain available (with requirements met), N if not.
Y if MH domain available (with requirements met), N if not.
Y if HO domain available (with requirements met), N if not.
The HOWindow value is nonmissing if nearby hospitalizations are requested from the dialog, and the value is based on user-selection (default = 3). This value is missing if all hospitalizations are reported or if the HO domain is not available.
Variables for Findings A1 ()
FDomA: 2 letter Findings domain code from Findings A tab if requirements are met. Missing otherwise.
FLabA: Label for findings domain A.
FBaseA: Y or N based on whether baseline findings A data is requested
FPreA: Y or N based on whether pre-event findings A data is requested
FPostA: Y or N based on whether post-event findings A data is requested
Number of summarized events (rows of narrtext_XXX.sas7bdat). Each row is a separate narrative.

1
Similar variables are present for Findings B and C, if specified

Note: Completion-Discontinuation status is selected from the records using the where statement provided for Filter to Choose Disposition Event for Completion Status. Otherwise, it is chosen from records where DSCAT = Disposition Event and EPOCH = Treatment (if either or available). If multiple records are available from this subsetting the last is chosen. Completers are those with COMPLETE in DSDECOD.