AET06[Spec Added]

### Table Name

AET06

### Description

Adverse Events by Baseline Characteristic

### Analysis dataset

ADAE

### Analysis filtering

`ANL01FL` = "Y"

### Analysis population

SE

### Column Variable

ACTARM

### Analysis variables

`AEBODSYS`, `AEDECOD` plus subgrouping by `ADSL` variable of choice

### Analysis concept


### Statistics

`nn (xx.x%)`

Percentages are of the number of patients in the specified analysis population within each treatment x baseline characteristics grouping. For example 1, the percentages in the Male column under Group 1 would be computed using the total number of males in that treatment group as the denominator. For example 2, the percentages in the Group 1 column under “2 - <6 years” would be computed using the total number of Group 1 patients in that age group as the denominator. For frequency counts by preferred term, multiple occurrences of the same AE in an individual are counted only once. For frequency counts of “Total number of events” rows, multiple occurrences of the same AE in an individual are counted separately.

### Default treatment of zero count rows

Remove

### Additional comments

AET06 summarizes AEs by MedDRA system organ class (SOC) and preferred term (PT). There is the option to summarize by MedDRA SOC, high-level term (HLT), and PT which includes an overall total row as well as total rows for each SOC and HLT (HLT module highlighted in grey in mockup).
HLT), and PT which includes an overall total row as well as total rows for each SOC and HLT (HLT module highlighted in grey in mockup).

AET06_SMQ summarizes AEs by standardized MedDRA query (SMQ). Unlike AET06, it is recommended not to include an “Overall total number of events” row in this template since SMQ event totals may not sum to overall total number of events.

Within each template, sort the data by total column frequency from most to least frequently reported SOC (regardless of whether or not total column is displayed). Within a SOC, sort by total column decreasing frequency of PT. For each SOC include a row summarizing total number of events in that SOC with option to present this row before (default) or after the summary of patients with events by preferred term.

Allow table to be generated for categorical baseline characteristics with 2-4 levels (e.g., sex, race).