Adverse Events Narratives

Data Sets Generated by the AE Narrative Report

This chapter

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:.

Variable	Contents
USUBJID	Unique Subject Identifier
SITEID	Study Site Identifier
ARM	Description of Planned Arm
ACTARM	Description of Actual Arm (if available)
INVHEAD	Either Investigator Name (precedence), Investigator Identifier, or Study Site Identifier depending on variable available (INVNAM, INVID or SITEID, respectively)
RACETXT	Formatted version of RACE
AESTDAYTXT	Formatted version of the start day for the adverse event
AEENDAYTXT	Formatted version of the end day for the adverse event
DSSTDAYTXT	Formatted version of the completion or discontinuation day from (DSSTDTC, if DS available)
EXSTDAYTXT	Formatted version of study day of minimum Start Date/Time of Treatment (EXSTDTC, if EX available)
AESEVTXT	Formatted version of the event severity. Either from Standard Toxicity Grade (AETOXGR, precedence) or Severity/Intensity (AESEV) (if available)
AERELTXT	Formatted version of the event causality (AEREL, 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 • Else lowercase of AEREL
AEACNTXT	Formatted version of action taken with study treatment (AEACN, if available) • If AEACN either N, No, Not, None, AEACNTXT = no • If AEACN either Y, Yes, AEACNTXT = yes • Otherwise, lowercase of AEACN
EXSTDY_MINTXT	Formatted version of minimum Start Date/Time of Treatment (EXSTDTC, if EX available)
SAETEXT	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)
AGE	Age
AGEU	Formatted version of AGEU or "year" if AGEU not available
SEX	Sex
RFSTDTC	Subject Reference Start Date/Time. Used to calculate study days if study days not available
AESEQ	Unique number within subject defined from AESEQ or created by JMP Clinical
AESTDTCP	Formatted Start Date/Time of Adverse Event. Asterisk (*) present if partial date for AESTDTC
AEENDTCP	Formatted End Date/Time of Adverse Event. Asterisk (*) present if partial date for AEENDTC
AETERM	Asterisk (*) present if partial date available for RFSTDTC, which means all study days are questionable unless individual study days provided in domain data sets.
NEARAETEXT	Formatted list of adverse events occurring within the specified by the dialog (default = 3). Contains severities based on AETOXGR or AESEV, if available. Contains only unique instances of event/severity within the . Asterisks (*) imply a partial start date for the particular event.
FLAG	Values are "No Treatment", "On Treatment" (on or after first dose and on or before last dose of any study drug), "Pre Treatment" (before any study drug) or "Post Treatment" (after any study drug)
FLAGTXT	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.
DRUGATFIRSTDOSE	Formatted text of all drugs from EX that are taken on the first date of any study drug (EXTRT, EXDOS, and EXDOSU).
AEDAYSFROMFIRSTDOSE	Number of days from first dose of any study drug (only if EX available)
AEDAYSFROMLASTDOSE	Number of days from last dose of any study drug (only if EX available)
DRUGATEVENT	Formatted text of all drugs from EX that are taken on the day on which the event occurs (EXTRT, EXDOS, and EXDOSU). Available only if all study treatments are taken at least once per day (from dialog).
NUMDAYSDRUGATTIME	List for the number of days the patient has been on each drug from DRUGATEVENT.
CMTEXT	Formatted list of concomitant medications that patient is on when 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)
MHTEXT	Formatted list of medical history with year from MHSTDTC (if MH available)
DSSTDTCP	Formatted Start Date/Time of Disposition Event for completion/ discontinuation. Asterisk present if partial date for AESTDTC.
TOTALCMCNT	Total concomitant records available for subject
HOTEXT	Formatted list of health-care encounters if all are requested from dialog. Asterisks imply a partial start or end date. (only if HO available)
NEARHOTEXT	Formatted list of health-care encounters occurring within the specified by the dialog (default = 3). Asterisks imply a partial start date. (only if HO available).
PREDATATXT_A	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.
POSTDATATXT_A	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.
BASETEXTA	String of baseline findings, limited to abnormal lab tests. Results apply to Findings B and Findings C with equivalent variables.
PRETEXTA	String of findings just prior to event, limited to abnormal lab tests with a normal baseline or those different from baseline. Results apply to Findings B and Findings C with equivalent variables.
POSTTEXTA	String of findings just subsequent to event, limited to abnormal lab tests with a normal baseline or those different from baseline. Results apply to Findings B and Findings C with equivalent variables.

Variables in the narrmeta_XXX.sas7bdat data set are as follows:.

Variable	Contents
CM	Y if CM domain available (with requirements met), N if not.
DS	Y if DS domain available (with requirements met), N if not.
EX	Y if EX domain available (with requirements met), N if not.
MH	Y if MH domain available (with requirements met), N if not.
HO	Y if HO domain available (with requirements met), N if not.
EXDaily	Y or N according to selected option in dialog as to whether all drugs are taken daily. If EX not available, this is missing.
HO	The HO 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.
AECONTRT	Y or N depending on whether variable is available.
AEOUT	Y or N depending on whether variable is available.
AEREL	Y or N depending on whether variable is available.
AESER	Y or N depending on whether variable is available.
CMINDC	Y or N depending on whether variable is available.
ACTARM	Y or N depending on whether variable is available.
AE	Based on dialog preference, default of 3 days.
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
NumEvents	Number of summarized events (rows of narrtext_XXX.sas7bdat). Each row is a separate narrative.

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1

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

Note: Completion-Discontinuation status is selected from the 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.