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 group_rows() 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(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
 

Parameter
Statistic
Placebo
N=86
Drug 50
N=96
Drug 100
N=72
Total
N=254
Age (years)
n
86          
96          
72          
254          
Age (years)
Mean (SD)
75.2 ( 8.59)
76.0 ( 8.11)
73.8 ( 7.94)
 75.1 ( 8.25)
Age (years)
Median
76.0        
78.0        
75.5        
 77.0        
Age (years)
Q1, Q3
69.2, 81.8  
71.0, 82.0  
70.5, 79.0  
 70.0, 81.0  
Age (years)
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 )
Sex, n (%)
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 )
Race, n (%)
BLACK OR AFRICAN AMERICAN
 8   ( 9.3 )
 6   ( 6.2 )
 9   (12.5 )
 23   ( 9.1 )
Race, n (%)
ASIAN
 0          
 0          
 0          
  0          
Race, n (%)
AMERICAN INDIAN OR ALASKA NATIVE
 0          
 0          
 1   ( 1.4 )
  1   ( 0.4 )