Demographics summary, Safety Population

Pre-summarised wide-format demographics suitable for direct passing into tabular(). One row per displayed statistic. Three parameter blocks — a deliberately minimal set covering both summary shapes:

Usage

cdisc_saf_demo

Format

A data frame with 11 rows and 6 columns:

variable

Display-block label ("Age (years)", "Sex, n (%)", "Race, n (%)"). Driven by cols(usage = "group") to collapse repeat values at render.

stat_label

Statistic or level label ("n", "Mean (SD)", "Median", "M", "WHITE", ...).

placebo

Placebo arm cell text.

drug_50

Xanomeline Low Dose (50 mg) arm cell text.

drug_100

Xanomeline High Dose (100 mg) arm cell text.

Total

Pooled-across-arms cell text.

Source

Derived in data-raw/bundle-demo.R from pharmaverseadam::adsl filtered to SAFFL == "Y" and the three CDISCPILOT01 treatment arms.

Details

• continuous: Age (years) — emitted as n, Mean (SD), Median, Q1, Q3, Min, Max

• categorical: Sex, Race — each level rendered as n (%)

Shaped for the display-only contract: every cell is the final string that will appear in the rendered table.

See also

cdisc_saf_demo_ard for the long-format ARD companion; cdisc_saf_n for the matching BigN denominators.

Examples

# 95% safety pattern: demographics table with BigN-embedded
# column labels and CDISC-canonical statistic order.
n <- stats::setNames(cdisc_saf_n$n, cdisc_saf_n$arm_short)
tabular(
  cdisc_saf_demo,
  titles = c(
    "Table 14.1.1",
    "Demographics and Baseline Characteristics",
    "Safety Population"
  )
) |>
  cols(
    variable   = col_spec(usage = "group", label = "Parameter"),
    stat_label = col_spec(label = "Statistic"),
    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 14.1.1
Demographics and Baseline Characteristics
Safety Population
 

Statistic
Placebo
N=86
Drug 50
N=96
Drug 100
N=72
Total
N=254
Age (years)
n
86         
96         
72         
254         
Mean (SD)
75.2 (8.59)
76.0 (8.11)
73.8 (7.94)
 75.1 (8.25)
Median
76.0       
78.0       
75.5       
 77.0       
Q1, Q3
69.2, 81.8 
71.0, 82.0 
70.5, 79.0 
 70.0, 81.0 
Min, Max
52  , 89   
51  , 88   
56  , 88   
 51  , 89   
 
Sex, n (%)
F
53 (61.6)  
55 (57.3)  
35 (48.6)  
143 (56.3)  
M
33 (38.4)  
41 (42.7)  
37 (51.4)  
111 (43.7)  
 
Race, n (%)
WHITE
78 (90.7)  
90 (93.8)  
62 (86.1)  
230 (90.6)  
BLACK OR AFRICAN AMERICAN
 8 ( 9.3)  
 6 ( 6.2)  
 9 (12.5)  
 23 ( 9.1)  
ASIAN
 0         
 0         
 0         
  0         
AMERICAN INDIAN OR ALASKA NATIVE
 0         
 0         
 1 ( 1.4)  
  1 ( 0.4)