Adverse Events Narratives

This chapter

Data Sets Generated by the Adverse Events Narrative Report

A number of different SAS data sets are generated by the Adverse Events 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:.

Table 1.1 

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:.

Table 1.2 

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.

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.