Overall adverse-event summary, Safety Population

Pre-summarised wide-format AE overview. Two clinical blocks: high-level flag rows (any TEAE, any SAE, any treatment-related, any AE leading to death, any AE recovered / resolved) and maximum-severity rows (mild / moderate / severe). Severity rows are indented with two leading spaces in the data, so a plain cols(stat_label = col_spec()) renders a flat overview with the severity rows nested under the flags, one row per category.

Usage

cdisc_saf_ae

Format

A data frame with 8 rows and 5 columns:

stat_label

Row label ("Any TEAE", "Any Serious AE (SAE)", "Any AE Related to Study Drug", "Any AE Leading to Death", "Any AE Recovered / Resolved", " Maximum severity: Mild", " Maximum severity: Moderate", " Maximum severity: Severe").

placebo

Placebo arm cell text ("n (pct)").

drug_50

Drug 50 arm cell text.

drug_100

Drug 100 arm cell text.

Total

Pooled-across-arms cell text.

Source

Derived in data-raw/bundle-demo.R from pharmaverseadam::adae filtered to SAFFL == "Y" and TRTEMFL == "Y".

See also

cdisc_saf_n for BigN denominators; cdisc_saf_aesocpt for the SOC / PT detail companion.

Examples

n <- stats::setNames(cdisc_saf_n$n, cdisc_saf_n$arm_short)
tabular(
  cdisc_saf_ae,
  titles = c(
    "Table 14.3.0",
    "Adverse Event Overview",
    "Safety Population"
  )
) |>
  cols(
    stat_label = col_spec(label = ""),
    placebo    = col_spec(
      label = "Placebo\nN={n['placebo']}",
      align = "decimal"
    ),
    drug_50    = col_spec(
      label = "Drug 50\nN={n['drug_50']}",
      align = "decimal"
    ),
    drug_100   = col_spec(
      label = "Drug 100\nN={n['drug_100']}",
      align = "decimal"
    ),
    Total      = col_spec(
      label = "Total\nN={n['Total']}",
      align = "decimal"
    )
  )
 
Table 14.3.0
Adverse Event Overview
Safety Population
 

Placebo
N=86
Drug 50
N=96
Drug 100
N=72
Total
N=254
Any TEAE
65 (75.6)
84 (87.5)
68 (94.4)
217 (85.4)
Any Serious AE (SAE)
 0       
 2 ( 2.1)
 1 ( 1.4)
  3 ( 1.2)
Any AE Related to Study Drug
43 (50.0)
77 (80.2)
64 (88.9)
184 (72.4)
Any AE Leading to Death
 2 ( 2.3)
 1 ( 1.0)
 0       
  3 ( 1.2)
Any AE Recovered / Resolved
47 (54.7)
61 (63.5)
49 (68.1)
157 (61.8)
  Maximum severity: Mild
36 (41.9)
21 (21.9)
20 (27.8)
 77 (30.3)
  Maximum severity: Moderate
24 (27.9)
47 (49.0)
40 (55.6)
111 (43.7)
  Maximum severity: Severe
 5 ( 5.8)
16 (16.7)
 8 (11.1)
 29 (11.4)