Cards hierarchical ARD for AEs by SOC and PT

Long-format companion to cdisc_saf_aesocpt. Produced by cards::ard_stack_hierarchical() over (AEBODSYS, AEDECOD) with adsl-level denominators, sorted by descending overall incidence via cards::sort_ard_hierarchical(). Limited to the same top-10 SOC, top-5 PT subset as cdisc_saf_aesocpt so the two datasets describe the same slice of the data.

Usage

cdisc_saf_aesocpt_ard

Format

A card-classed tibble. Carries a hierarchical "overall" row (cards' internal ..ard_hierarchical_overall.. marker) that pivot_across() relabels to "Overall" (overridable via its label argument) and emits as the table's top row_type = "overall" row.

Source

Derived in data-raw/bundle-demo.R via cards::ard_stack_hierarchical() over pharmaverseadam::adae filtered to the top SOC / PT subset.

Details

This is the package's canonical hierarchical ARD demo (two grouping variables nested SOC -> PT). Its flat counterpart is cdisc_saf_demo_ard; together they cover both shapes pivot_across() must handle.

See also

pivot_across() for the long-to-wide bridge; cdisc_saf_aesocpt for the wide companion.

Examples

# Hierarchical ARD pivot. pivot_across() recognises the
# ard_stack_hierarchical shape and emits soc / label / row_type.
n <- stats::setNames(cdisc_saf_n$n, cdisc_saf_n$arm_short)
cdisc_saf_aesocpt_ard |>
  pivot_across(statistic = "{n} ({p}%)") |>
  tabular(
    titles = c(
      "Table 14.3.1",
      "Adverse Events by SOC and PT",
      "Safety Population"
    )
  ) |>
  cols(
    label    = col_spec(label = "SOC / PT", align = "left"),
    soc      = col_spec(visible = FALSE),
    row_type = col_spec(visible = FALSE),
    `Placebo`              = col_spec(align = "decimal"),
    `Xanomeline Low Dose`  = col_spec(align = "decimal"),
    `Xanomeline High Dose` = col_spec(align = "decimal")
  )
 
Table 14.3.1
Adverse Events by SOC and PT
Safety Population
 

SOC / PT
Placebo
Xanomeline High Dose
Xanomeline Low Dose
Overall
52 (60%)
66 (92%)
81 (84%)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
19 (22%)
35 (49%)
36 (38%)
PRURITUS
 8 ( 9%)
25 (35%)
21 (22%)
ERYTHEMA
 8 ( 9%)
14 (19%)
14 (15%)
RASH
 5 ( 6%)
 8 (11%)
13 (14%)
HYPERHIDROSIS
 2 ( 2%)
 8 (11%)
 4 ( 4%)
SKIN IRRITATION
 3 ( 3%)
 5 ( 7%)
 6 ( 6%)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
15 (17%)
30 (42%)
36 (38%)
APPLICATION SITE PRURITUS
 6 ( 7%)
21 (29%)
23 (24%)
APPLICATION SITE ERYTHEMA
 3 ( 3%)
14 (19%)
13 (14%)
APPLICATION SITE DERMATITIS
 5 ( 6%)
 7 (10%)
 9 ( 9%)
APPLICATION SITE IRRITATION
 3 ( 3%)
 9 (12%)
 9 ( 9%)
APPLICATION SITE VESICLES
 1 ( 1%)
 5 ( 7%)
 5 ( 5%)
GASTROINTESTINAL DISORDERS
13 (15%)
17 (24%)
12 (12%)
DIARRHOEA
 9 (10%)
 3 ( 4%)
 5 ( 5%)
VOMITING
 3 ( 3%)
 6 ( 8%)
 4 ( 4%)
NAUSEA
 3 ( 3%)
 6 ( 8%)
 3 ( 3%)
ABDOMINAL PAIN
 1 ( 1%)
 1 ( 1%)
 3 ( 3%)
SALIVARY HYPERSECRETION
 0      
 4 ( 6%)
 0      
NERVOUS SYSTEM DISORDERS
 6 ( 7%)
17 (24%)
18 (19%)
DIZZINESS
 2 ( 2%)
10 (14%)
 9 ( 9%)
HEADACHE
 3 ( 3%)
 5 ( 7%)
 3 ( 3%)
SYNCOPE
 0      
 2 ( 3%)
 5 ( 5%)
SOMNOLENCE
 2 ( 2%)
 1 ( 1%)
 3 ( 3%)
TRANSIENT ISCHAEMIC ATTACK
 0      
 1 ( 1%)
 2 ( 2%)
CARDIAC DISORDERS
 7 ( 8%)
14 (19%)
12 (12%)
SINUS BRADYCARDIA
 2 ( 2%)
 8 (11%)
 7 ( 7%)
MYOCARDIAL INFARCTION
 4 ( 5%)
 4 ( 6%)
 2 ( 2%)
ATRIAL FIBRILLATION
 1 ( 1%)
 2 ( 3%)
 2 ( 2%)
SUPRAVENTRICULAR EXTRASYSTOLES
 1 ( 1%)
 1 ( 1%)
 1 ( 1%)
VENTRICULAR EXTRASYSTOLES
 0      
 1 ( 1%)
 2 ( 2%)
INFECTIONS AND INFESTATIONS
12 (14%)
11 (15%)
 6 ( 6%)
NASOPHARYNGITIS
 2 ( 2%)
 6 ( 8%)
 4 ( 4%)
UPPER RESPIRATORY TRACT INFECTION
 6 ( 7%)
 3 ( 4%)
 1 ( 1%)
INFLUENZA
 1 ( 1%)
 1 ( 1%)
 1 ( 1%)
URINARY TRACT INFECTION
 2 ( 2%)
 1 ( 1%)
 0      
CYSTITIS
 1 ( 1%)
 1 ( 1%)
 0      
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
 5 ( 6%)
 9 (12%)
 8 ( 8%)
COUGH
 1 ( 1%)
 5 ( 7%)
 5 ( 5%)
NASAL CONGESTION
 3 ( 3%)
 3 ( 4%)
 1 ( 1%)
DYSPNOEA
 1 ( 1%)
 1 ( 1%)
 1 ( 1%)
EPISTAXIS
 0      
 2 ( 3%)
 1 ( 1%)
PHARYNGOLARYNGEAL PAIN
 0      
 1 ( 1%)
 1 ( 1%)
PSYCHIATRIC DISORDERS
 7 ( 8%)
 3 ( 4%)
 9 ( 9%)
CONFUSIONAL STATE
 2 ( 2%)
 1 ( 1%)
 3 ( 3%)
AGITATION
 2 ( 2%)
 0      
 3 ( 3%)
INSOMNIA
 2 ( 2%)
 2 ( 3%)
 0      
ANXIETY
 0      
 0      
 3 ( 3%)
DELUSION
 1 ( 1%)
 1 ( 1%)
 0      
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
 3 ( 3%)
 5 ( 7%)
 6 ( 6%)
BACK PAIN
 1 ( 1%)
 3 ( 4%)
 1 ( 1%)
ARTHRALGIA
 1 ( 1%)
 1 ( 1%)
 2 ( 2%)
SHOULDER PAIN
 1 ( 1%)
 0      
 2 ( 2%)
MUSCLE SPASMS
 0      
 1 ( 1%)
 1 ( 1%)
ARTHRITIS
 0      
 1 ( 1%)
 0      
INVESTIGATIONS
 5 ( 6%)
 3 ( 4%)
 4 ( 4%)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION
 4 ( 5%)
 0      
 1 ( 1%)
ELECTROCARDIOGRAM T WAVE INVERSION
 2 ( 2%)
 1 ( 1%)
 1 ( 1%)
BLOOD GLUCOSE INCREASED
 0      
 1 ( 1%)
 1 ( 1%)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED
 1 ( 1%)
 0      
 1 ( 1%)
BIOPSY
 0      
 1 ( 1%)
 0