AEL02 [Spec Added]

[barnett11]

Table Name

AEL02

Description

Listing of Adverse Events

Analysis dataset

ADAE

Analysis filtering

ANL01FL = "Y"

Analysis population

SE

Column Variable

SITEID SUBJID AGE SEX RACE (concatenated) TRTSDTM AEDECOD ASTDY ADURN AESER ASEV AREL AEOUT AECONTRT AEACN

Study Withdrawal option - ASTDISFL

Multiple Drug Options - AEREL1-n, AEACN1-n

Analysis variables

Default is to sort the listing by center and patient ID within treatment group, by AE day of onset within patient and by MedDRA preferred term within day of onset. Provide an option to sort the listing by center/patient ID within treatment group, by MedDRA preferred term within each patient and AE day of onset within MedDRA preferred term.

If same term on same day repeated, order by AESEQ

Analysis concept

Statistics

Include variables shown in mock-up as default. Adverse event variables are from the Adverse Event eCRF. Provide options for AE onset date and end date. Date of study drug administration is from the Study Drug Administration eCRF.
For studies which assess severity NCI CTCAE grade, “Most Extreme Intensity” field may be replaced by “Most Extreme NCI CTCAE Grade”.

For studies where the question “Was the subject discontinued from study due to AE?” is implemented on the AE eCRF:
• Include the text “Withdrawal = withdrawal from study” in the footnote for Action Taken
• If an AE leads to study drug discontinuation AND withdrawal from study, for efficiency capture only "Withdrawal" under Action Taken. (In this case, "withdrawal from study" implies “drug withdrawn.”)
• If an AE (e.g., headache) leads to study drug discontinuation but the patient remains in the study to complete assessments as specified in the protocol, then display that AE (in this case "headache") in the listing with drug withdrawn as action taken. If, subsequently, another AE (e.g., neutropenia) is entered on the eCRF and it leads to discontinuation from the study, then display that AE (in this case "neutropenia") in the listing with withdrawal from study as action taken.

For trials with multiple study drugs:
• For “Caused by Study Drug” indicate the name of the drug where the answer is “yes” as shown in the mockup (add a line for each drug with answer=“yes”)
• Add a separate row for each study drug within a patient, for “Action Taken.” Concatenate drug name with action taken in the format of “drug name: action code.”
• The column “Center/Patient ID Adverse Event MedDRA Preferred Term” can span the width of the “Age/Sex/Race” column. “Study Day of Onset” is calculated as “Onset date – Date of first study drug administration + 1”. “AE Duration in Days” is calculated as “End Date – Onset Date + 1”.

Default treatment of zero count rows

None

Additional comments

All outputs must be left-justified
Replace missing AEDECOD with No Coding Available