Synthetic CDISC ADaM Adverse Events (ADAE) dataset from study TFRM-2024-001. Contains one row per subject per adverse event. Used for:
AE by SOC/PT table (Table 14.3.1): incidence by body system and preferred term, within treatment arm
Overall AE summary: subjects with TEAEs by seriousness, relatedness, severity, and action taken
All adverse events in this dataset are treatment-emergent (TRTEMFL = "Y").
Gastrointestinal and nervous system events are dose-related, reflecting the
cholinergic class effect of Zomerane.
Format
A data frame with approximately 750 rows and 27 variables:
- STUDYID
Study identifier
- USUBJID
Unique subject identifier
- ARM
Planned treatment arm
- TRTA
Actual treatment arm
- TRTAN
Actual treatment numeric code
- AGE
Subject age at time of event
- SEX
Subject sex
- RACE
Subject race
- SAFFL
Safety population flag
- AEBODSYS
MedDRA System Organ Class (SOC), e.g.
"Gastrointestinal disorders","Nervous system disorders"- AEDECOD
MedDRA Preferred Term (PT), e.g.
"Nausea","Dizziness"- AESEV
Severity:
"MILD","MODERATE", or"SEVERE"- AETOXGR
CTCAE toxicity grade:
"1","2","3", or"4". Derived from AESEV: MILD maps to 1–2, MODERATE to 2–3, SEVERE to 3–4- AESER
Serious adverse event flag:
"Y"or"N"- AEREL
Relationship to study drug:
"PROBABLE","POSSIBLE","REMOTE", or"NONE"- AEACN
Action taken with study treatment:
"DOSE NOT CHANGED","DRUG INTERRUPTED","DRUG WITHDRAWN","DOSE REDUCED", or"NOT APPLICABLE"- AEOUT
Outcome:
"RECOVERED/RESOLVED"or"NOT RECOVERED/NOT RESOLVED"- ASTDT
AE start date
- AENDT
AE end date
- ASTDY
AE start day relative to treatment start
- AENDY
AE end day relative to treatment start
- ADURN
AE duration in days
- TRTEMFL
Treatment-emergent flag (
"Y"for all records)- AESEQ
AE sequence number within subject
- AOCCFL
First-occurrence flag (any AE, per subject):
"Y"orNA- AOCCSFL
First SOC occurrence flag (per subject per SOC):
"Y"orNA- AOCCPFL
First PT occurrence flag (per subject per PT):
"Y"orNA
Examples
# Subjects with at least one treatment-emergent AE
te_aes <- subset(adae, TRTEMFL == "Y" & !is.na(AOCCFL))
table(te_aes$ARM)
#>
#> Placebo Zomerane 100mg Zomerane 50mg
#> 44 45 44
# AEs by body system
sort(table(adae$AEBODSYS), decreasing = TRUE)
#>
#> Gastrointestinal disorders
#> 96
#> Nervous system disorders
#> 80
#> Infections and infestations
#> 61
#> General disorders and administration site conditions
#> 53
#> Respiratory, thoracic and mediastinal disorders
#> 47
#> Musculoskeletal and connective tissue disorders
#> 45
#> Vascular disorders
#> 45
#> Skin and subcutaneous tissue disorders
#> 43
#> Psychiatric disorders
#> 42
#> Cardiac disorders
#> 41
#> Metabolism and nutrition disorders
#> 38
#> Investigations
#> 27
#> Renal and urinary disorders
#> 27
#> Reproductive system and breast disorders
#> 27
#> Eye disorders
#> 26
#> Ear and labyrinth disorders
#> 22
#> Blood and lymphatic system disorders
#> 19
#> Hepatobiliary disorders
#> 19
# Serious AEs only
subset(adae, AESER == "Y", select = c(USUBJID, ARM, AEDECOD, AESEV))
#> USUBJID ARM AEDECOD AESEV
#> 37 TFR-001-0042 Placebo Anxiety SEVERE
#> 82 TFR-001-0068 Zomerane 50mg Epistaxis SEVERE
#> 145 TFR-001-0131 Zomerane 100mg Hot flush SEVERE
#> 154 TFR-002-0026 Placebo Hypertension SEVERE
#> 186 TFR-002-0043 Placebo Anxiety SEVERE
#> 209 TFR-002-0071 Zomerane 50mg Oropharyngeal pain SEVERE
#> 215 TFR-002-0075 Zomerane 50mg Anxiety SEVERE
#> 220 TFR-002-0080 Zomerane 50mg Nocturia SEVERE
#> 255 TFR-002-0090 Zomerane 50mg Weight decreased SEVERE
#> 257 TFR-002-0090 Zomerane 50mg Dry eye SEVERE
#> 259 TFR-002-0091 Zomerane 100mg Rash SEVERE
#> 264 TFR-002-0093 Zomerane 100mg Asthenia SEVERE
#> 272 TFR-002-0093 Zomerane 100mg Hypertension SEVERE
#> 289 TFR-002-0099 Zomerane 100mg Asthenia SEVERE
#> 369 TFR-003-0050 Zomerane 50mg Vomiting SEVERE
#> 416 TFR-003-0092 Zomerane 100mg Cough SEVERE
#> 418 TFR-003-0092 Zomerane 100mg Bradycardia SEVERE
#> 458 TFR-003-0116 Zomerane 100mg Oropharyngeal pain SEVERE
#> 481 TFR-003-0130 Zomerane 100mg Tremor SEVERE
#> 482 TFR-003-0130 Zomerane 100mg Cough SEVERE
#> 545 TFR-004-0059 Zomerane 50mg Somnolence SEVERE
#> 586 TFR-004-0102 Zomerane 100mg Hypokalaemia SEVERE
#> 589 TFR-004-0102 Zomerane 100mg Rash SEVERE
#> 593 TFR-004-0111 Zomerane 100mg Urinary tract infection SEVERE
#> 599 TFR-004-0113 Zomerane 100mg Rash SEVERE
#> 622 TFR-005-0004 Placebo Blood creatinine increased SEVERE
#> 639 TFR-005-0020 Placebo Rhinorrhoea SEVERE
#> 666 TFR-005-0079 Zomerane 50mg Diarrhoea SEVERE
#> 699 TFR-005-0100 Zomerane 100mg Hypokalaemia SEVERE
#> 704 TFR-005-0103 Zomerane 100mg Somnolence SEVERE
#> 707 TFR-005-0103 Zomerane 100mg Confusional state SEVERE
#> 709 TFR-005-0103 Zomerane 100mg Hepatic enzyme increased SEVERE
#> 715 TFR-005-0105 Zomerane 100mg Atrial fibrillation SEVERE
#> 730 TFR-005-0122 Zomerane 100mg Dysuria SEVERE
#> 733 TFR-005-0124 Zomerane 100mg Flatulence SEVERE
#> 755 TFR-005-0133 Zomerane 100mg Dyspepsia SEVERE
# Action taken distribution
table(adae$AEACN)
#>
#> DOSE NOT CHANGED DOSE REDUCED DRUG INTERRUPTED DRUG WITHDRAWN
#> 503 72 74 23
#> NOT APPLICABLE
#> 86