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: v003
Datasets: adae 4ffe4e4
Evidence: 18/18 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-INTXT-001 DSP-INTXT-002 DSP-INTXT-003 DSP-SAE-001 STD-GATE-001 STD-GATE-002 STD-GATE-003 STD-GATE-004 STD-GATE-005 STD-MODEL-001 STD-MODEL-002 STD-MODEL-003 STD-MODEL-004 STD-MODEL-005 STD-SRC-001 STD-SRC-002
Used in: Clinical Study Report Listing 14.3.2.1
Study Synopsis Listing 13.6
Post-Text Display Package Listing 14.3.2.1
Abbreviated Clinical Study Report (ICH E3) Listing 14.3.2.1
Study model: Safety Analysis Set SAFFL
Specification: 3 iterations
Environment: R 4.3.3 Darwin 23.6.0
Bound by: No text block binds it
Values: No value is sourced from it

Inputs

adsl254 rows · 70c7278
adae1191 rows · 4ffe4e4
analysis.yamlwhat to compute
display.yamlhow to show it
study modelSafety Analysis Set

Function

prepare_data()regenerate('l-ae-serious')
build_ard()one row per statistic
render_display()every variant
render_rtf()the same cells

Outputs

ard.jsonv003 · 33 rows · cde8256
table.htmlthe rendered display
table.rtfsha256 1371cd5
manifest.jsonwho, why, every hash

RTFFull display1371cd5

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 High 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 (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). 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/v003/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 High 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: 2026-09-02T15:19:13Z
Spec hash: sha256:a046fb1cdc11ed10d586284efeb97e30ab743f4ad394869bd83ae1bfb401d140
Display hash: sha256:11a00d098fef3df8b121fb620738945ccf9e734b004c50eac13702efc5dfd705
ARD file: outputs/l-ae-serious/v003/ard.json
ARD hash: sha256:cde82561c80104b90b6cd633c27d62bdfbfd1e835fa8b6b761af9cc1d9142276

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:70c7278e83e571a7d4a94fd864c98bf8ca243c7c2cc9eec8b99a40fa7bc98e35
adae	1191	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:4ffe4e4c90c8a531e95e4931b601c258ed0b83638d4b346e66635d79e78a7bf1

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 (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). 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.