wiki:Hicdep_1.50/TableAe

tblAE - Adverse Events

holds type and date of adverse events including serious non-AIDS conditions

Core fields

Note: Fields marked bold form the unique identifier for a record of the table.

Field name

Format

Description

EVENT_ID

numeric

Unique Event Identifier (foreign key to the different event tables)

PATIENT

character (or numeric if possible)

Code to identify patient (Cohort Patient ID)

AE_D

yyyy-mm-dd

date of event

AE_ID

character. see coding table for valid codings.

identifies type of event

AE_SPEC

character. see coding table for valid codings.

further specification

SRCDOC_Y

numeric:

  • 1 = Yes
  • 0 = No

whether the source documentation is available

SRCDOC_D

yyyy-mm-dd

date for source documentation verification

VERIFY_Y

numeric:

  • 1 = Yes
  • 0 = No

Has the monitor verified the source documentation?

VERIFY_D

yyyy-mm-dd

date for monitor verification

APPROV_Y

numeric:

  • 1 = Yes
  • 0 = No

final verification/approval

APPROV_D

yyyy-mm-dd

final verification date

APPROV_S

character

signature for final verification

Additional fields

Field name

Format

Description

AE_Y

numeric:

  • 1 = Yes
  • 0 = No
  • 9 = Unknown

has the patient had an event?

AE_NAME

character

full name of the event

AE_DESCRIP

character

full description of the event

AE_R_Y

numeric:

  • 0 = not related
  • 1 = definitive
  • 2 = remote/unlikely
  • 3 = possible
  • 4 = probable

relation to treatment

QA Checks

Table Crosstable Error Code Description Study specific HICDEP?
AllTablesCrossTableATC001any date in database after DEATH_D in tblLTFUYES
AllTablesCrossTableATC002any date in database after DROP_D in tblLTFUYES
AllTablesCrossTableATC003any date in database before BIRTH_D in tblBASYES
AllTablesCrossTableATC004any date in database in the futureYES
AllTablesCrossTableATC005patients submitted previously who have been missed outYES
AllTablesCrossTableATC006Any fields not coded as coding lists on table definitionYES
Last modified 6 years ago Last modified on 09/13/11 06:31:00