# AE Tables Documentation

## Table 14-4.01: Adverse Event Overview

### Header
- **Table ID**: 14-4.01
- **Title**: Overview of Adverse Events
- **Population**: Safety Population

### Columns
| Column | Label |
|--------|-------|
| Placebo | N=86 |
| Xanomeline Low Dose | N=84 |
| Xanomeline High Dose | N=84 |
| Total | N=254 |

### Row Categories
- Any Adverse Event: Subjects with at least one AE (n, %) / Number of events
- Treatment-Emergent AEs (TEAEs): TRTEMFL='Y' (n, %) / Number of events
- Serious AEs (SAEs): AESER='Y' and TRTEMFL='Y' (n, %) / Number of events
- AE Leading to Death: (n, %)
- AE Leading to Discontinuation: DSRAEFL='Y' (n, %)
- AE Leading to Dose Interruption: (n, %)

### Data Source
- **Dataset**: ADAE
- **Population filter**: SAFFL = 'Y'
- **TEAE filter**: TRTEMFL = 'Y'

## Table 14-4.02: AE by System Organ Class and Preferred Term

### Header
- **Table ID**: 14-4.02
- **Title**: Treatment-Emergent Adverse Events by SOC and PT (>=5% in Any Group)
- **Population**: Safety Population

### Display Rules
- Only TEAEs with >=5% incidence in any treatment group
- Sorted by SOC frequency (descending), then PT frequency within SOC
- Pre-listed SOCs with specific preferred terms

### Data Source
- **Dataset**: ADAE
- **MedDRA coding**: AEBODSYS (SOC), AEDECOD (PT)
- **Population filter**: SAFFL = 'Y'
- **TEAE filter**: TRTEMFL = 'Y'
- **Threshold**: >=5% in any treatment group

## Footnotes
1. Safety Population: Subjects who received at least one dose of study drug.
2. TEAE = Treatment-Emergent Adverse Event (onset >= first dose date).
3. n (%) = number (percentage) of subjects; multiple events per subject counted once.
