AEL01 · Listing

Listing of Serious Adverse Events

Subject-level listing of serious adverse events with onset, severity, outcome and relationship.

Slug: l-ae-serious
Regulatory ID: AEL01
Type: Listing
E3 position: §14.3.2
Status: evidenced
Current iteration: v002
Datasets: adae
Evidence: 3/3 passing
Requirements: DSP-AE-001 DSP-AE-002 DSP-AE-003 DSP-AE-004 DSP-AE-005 DSP-ALL-001 DSP-ALL-002 DSP-DEMO-001 DSP-DEMO-002 DSP-DISP-001 DSP-DISP-002 DSP-EXP-001 DSP-EXP-002 DSP-SAE-001

RTFFull displayb351995

Generated by the same pipeline run that wrote the ARD and the HTML above, from the same rendered cells; the short hash is the manifest's record of the file.

l-ae-serious · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Subject	Treatment	Age	Sex	System organ class	Preferred term	Severity	Relationship	Start day	End day	Outcome
Listing of Serious Adverse Events
Study CDISCPILOT01 — Safety Analysis Set
1	01-709-1424	Xanomeline Low Dose	77	M	NERVOUS SYSTEM DISORDERS	SYNCOPE	MODERATE	POSSIBLE	5	5	RECOVERED/RESOLVED
2	01-718-1170	Xanomeline Low Dose	80	F	NERVOUS SYSTEM DISORDERS	SYNCOPE	SEVERE	PROBABLE	27	28	RECOVERED/RESOLVED
3	01-718-1371	Xanomeline High Dose	69	F	NERVOUS SYSTEM DISORDERS	PARTIAL SEIZURES WITH SECONDARY GENERALISATION	SEVERE	NONE	38	41	RECOVERED/RESOLVED
One row per serious adverse event record (AESER = 'Y').
Study day is relative to the first dose of study drug.
Source: adae (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display l-ae-serious (post_text variant); generated from the committed ARD.

Rendered from outputs/l-ae-serious/v002/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
sae_records	record	0001	—	—	USUBJID	—	listing	value	USUBJID	—	—	01-709-1424
sae_records	record	0002	—	—	USUBJID	—	listing	value	USUBJID	—	—	01-718-1170
sae_records	record	0003	—	—	USUBJID	—	listing	value	USUBJID	—	—	01-718-1371
sae_records	record	0001	—	—	TRT01A	—	listing	value	TRT01A	—	—	Xanomeline Low Dose
sae_records	record	0002	—	—	TRT01A	—	listing	value	TRT01A	—	—	Xanomeline Low Dose
sae_records	record	0003	—	—	TRT01A	—	listing	value	TRT01A	—	—	Xanomeline High Dose
sae_records	record	0001	—	—	AGE	—	listing	value	AGE	—	—	77
sae_records	record	0002	—	—	AGE	—	listing	value	AGE	—	—	80
sae_records	record	0003	—	—	AGE	—	listing	value	AGE	—	—	69
sae_records	record	0001	—	—	SEX	—	listing	value	SEX	—	—	M
sae_records	record	0002	—	—	SEX	—	listing	value	SEX	—	—	F
sae_records	record	0003	—	—	SEX	—	listing	value	SEX	—	—	F
sae_records	record	0001	—	—	AEBODSYS	—	listing	value	AEBODSYS	—	—	NERVOUS SYSTEM DISORDERS
sae_records	record	0002	—	—	AEBODSYS	—	listing	value	AEBODSYS	—	—	NERVOUS SYSTEM DISORDERS
sae_records	record	0003	—	—	AEBODSYS	—	listing	value	AEBODSYS	—	—	NERVOUS SYSTEM DISORDERS
sae_records	record	0001	—	—	AEDECOD	—	listing	value	AEDECOD	—	—	SYNCOPE
sae_records	record	0002	—	—	AEDECOD	—	listing	value	AEDECOD	—	—	SYNCOPE
sae_records	record	0003	—	—	AEDECOD	—	listing	value	AEDECOD	—	—	PARTIAL SEIZURES WITH SECONDARY GENERALISATION
sae_records	record	0001	—	—	AESEV	—	listing	value	AESEV	—	—	MODERATE
sae_records	record	0002	—	—	AESEV	—	listing	value	AESEV	—	—	SEVERE
sae_records	record	0003	—	—	AESEV	—	listing	value	AESEV	—	—	SEVERE
sae_records	record	0001	—	—	AEREL	—	listing	value	AEREL	—	—	POSSIBLE
sae_records	record	0002	—	—	AEREL	—	listing	value	AEREL	—	—	PROBABLE
sae_records	record	0003	—	—	AEREL	—	listing	value	AEREL	—	—	NONE
sae_records	record	0001	—	—	ASTDY	—	listing	value	ASTDY	—	—	5
sae_records	record	0002	—	—	ASTDY	—	listing	value	ASTDY	—	—	27
sae_records	record	0003	—	—	ASTDY	—	listing	value	ASTDY	—	—	38
sae_records	record	0001	—	—	AENDY	—	listing	value	AENDY	—	—	5
sae_records	record	0002	—	—	AENDY	—	listing	value	AENDY	—	—	28
sae_records	record	0003	—	—	AENDY	—	listing	value	AENDY	—	—	41
sae_records	record	0001	—	—	AEOUT	—	listing	value	AEOUT	—	—	RECOVERED/RESOLVED
sae_records	record	0002	—	—	AEOUT	—	listing	value	AEOUT	—	—	RECOVERED/RESOLVED
sae_records	record	0003	—	—	AEOUT	—	listing	value	AEOUT	—	—	RECOVERED/RESOLVED

33 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-07-27T03:23:31Z
Spec hash: sha256:a046fb1cdc11ed10d586284efeb97e30ab743f4ad394869bd83ae1bfb401d140
Display hash: sha256:b865356eb33a50fb5cabae395251d60df06c7607485231ce1ae9516804af6523
ARD file: outputs/l-ae-serious/v002/ard.json
ARD hash: sha256:0395149df9ea9e04395bc28a568415b8cec29d736acb92dce4613453f72728b0

Source datasets

Dataset	Rows	Package	Hash
adsl	254	pharmaverseadam 1.1.0	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
adae	1191	pharmaverseadam 1.1.0	sha256:7d4237afdbf934742091e6b7e0a756fcba6a0e79fc9f35b578f86574baf8f7d4

Environment

R 4.3.3 · Darwin 23.6.0 · cards 0.6.1 · cardx 0.2.5 · gtsummary 2.3.0 · gt 1.0.0 · dplyr 1.1.4 · pharmaverseadam 1.1.0 · jsonlite 2.0.0 · yaml 2.3.10 · digest 0.6.37

library/tfl/l-ae-serious/analysis.yaml

id: l-ae-serious
title: "Listing of Serious Adverse Events"
regulatory_id: AEL01
type: listing
dataset: adae
analysis_set: safety
denominator: adsl
group: []
total: false
analyses:
  - name: sae_records
    method: listing
    label: "Serious adverse events"
    filter: "AESER == 'Y'"
    sort: [USUBJID, ASTDY]
    variables:
      - USUBJID
      - TRT01A
      - AGE
      - SEX
      - AEBODSYS
      - AEDECOD
      - AESEV
      - AEREL
      - ASTDY
      - AENDY
      - AEOUT

library/tfl/l-ae-serious/display.yaml

id: l-ae-serious
title: "Listing of Serious Adverse Events"
study: CDISCPILOT01
population_label: "Safety Analysis Set"
cutoff: "2014-07-01"
source: "Source: adae (pharmaverseadam). Data cut-off: 2014-07-01."
footnotes:
  - "One row per serious adverse event record (AESER = 'Y')."
  - "Study day is relative to the first dose of study drug."
columns:
  order:
    - USUBJID
    - TRT01A
    - AGE
    - SEX
    - AEBODSYS
    - AEDECOD
    - AESEV
    - AEREL
    - ASTDY
    - AENDY
    - AEOUT
  labels:
    USUBJID: "Subject"
    TRT01A: "Treatment"
    AGE: "Age"
    SEX: "Sex"
    AEBODSYS: "System organ class"
    AEDECOD: "Preferred term"
    AESEV: "Severity"
    AEREL: "Relationship"
    ASTDY: "Start day"
    AENDY: "End day"
    AEOUT: "Outcome"
format:
  digits: {}
variants:
  post_text: {}

Every iteration is kept: outputs/l-ae-serious/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.