Vital-signs summary

Pre-summarised vital-signs stats. Four parameters (SYSBP, DIABP, PULSE, TEMP) at four visits (Baseline, Week 8, Week 16, End of Treatment), each producing four statistic rows (n, Mean (SD), Median, Min, Max). The 4 x 4 x 4 grid makes this dataset a natural fit for paginate() examples — 64 rows comfortably exceed a single page under typical clinical row-per-page settings.

Usage

cdisc_saf_vital

Format

A data frame with 64 rows and 7 columns:

paramcd

CDISC parameter code (SYSBP / DIABP / PULSE / TEMP). Repeats across visit and statistic; use col_spec(usage = "group") to collapse.

param

Decoded parameter name.

visit

Analysis visit label ("Baseline" / "Week 8" / "Week 16" / "End of Treatment").

stat_label

Statistic label.

placebo, drug_50, drug_100

Per-arm cell text.

Source

Derived in data-raw/bundle-demo.R from pharmaverseadam::advs.

See also

cdisc_saf_n for BigN denominators.

Examples

n <- stats::setNames(cdisc_saf_n$n, cdisc_saf_n$arm_short)
tabular(
  cdisc_saf_vital,
  titles = c(
    "Table 14.4.1",
    "Vital Signs Summary at Baseline and End of Treatment",
    "Safety Population"
  )
) |>
  cols(
    paramcd    = col_spec(visible = FALSE),
    param      = col_spec(usage = "group", label = "Parameter"),
    visit      = col_spec(usage = "group", label = "Visit"),
    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"
    )
  )
 
Table 14.4.1
Vital Signs Summary at Baseline and End of Treatment
Safety Population
 

Statistic
Placebo
N=86
Drug 50
N=96
Drug 100
N=72
Diastolic Blood Pressure (mmHg)
Baseline
n
340         
384         
288         
Mean (SD)
 77.1 (10.7)
 76.6 (9.8) 
 78.2 (10.3)
Median
 77.7       
 76.7       
 78.8       
Min, Max
 40  , 110  
 48  , 108  
 51  , 108  
 
Week 8
n
292         
240         
224         
Mean (SD)
 75.2 (9.1) 
 75.4 (10.6)
 77.4 (9.1) 
Median
 76.0       
 74.0       
 78.3       
Min, Max
 49  , 101  
 52  , 100  
 54  , 98   
 
Week 16
n
272         
168         
148         
Mean (SD)
 75.1 (10.9)
 75.2 (10.0)
 76.0 (9.0) 
Median
 76.0       
 75.7       
 77.3       
Min, Max
 49  , 98   
 55  , 98   
 50  , 92   
 
End of Treatment
n
222         
177         
168         
Mean (SD)
 74.4 (10.7)
 76.0 (11.2)
 76.0 (9.9) 
Median
 73.5       
 76.0       
 78.0       
Min, Max
 49  , 104  
 50  , 100  
 56  , 98   
 
Pulse Rate (beats/min)
Baseline
n
340         
384         
288         
Mean (SD)
 73.5 (11.6)
 72.1 (10.8)
 72.4 (9.7) 
Median
 72.3       
 70.0       
 71.7       
Min, Max
 51  , 134  
 50  , 104  
 52  , 100  
 
Week 8
n
292         
240         
224         
Mean (SD)
 71.8 (9.0) 
 72.6 (11.1)
 74.0 (8.9) 
Median
 72.0       
 72.0       
 73.2       
Min, Max
 52  , 102  
 49  , 104  
 50  , 104  
 
Week 16
n
272         
168         
148         
Mean (SD)
 70.6 (8.8) 
 68.8 (9.4) 
 73.2 (9.5) 
Median
 70.2       
 68.0       
 72.0       
Min, Max
 50  , 90   
 48  , 104  
 51  , 96   
 
End of Treatment
n
222         
177         
168         
Mean (SD)
 75.2 (11.5)
 74.1 (9.4) 
 73.6 (9.6) 
Median
 74.0       
 75.0       
 73.0       
Min, Max
 51  , 106  
 50  , 94   
 50  , 98   
 
Systolic Blood Pressure (mmHg)
Baseline
n
340         
384         
288         
Mean (SD)
136.8 (17.6)
137.9 (18.5)
137.8 (17.2)
Median
136.3       
138.0       
138.0       
Min, Max
 80  , 184  
100  , 194  
100  , 192  
 
Week 8
n
292         
240         
224         
Mean (SD)
136.3 (17.0)
134.9 (17.8)
135.1 (15.5)
Median
136.5       
132.3       
134.0       
Min, Max
 90  , 189  
 92  , 200  
 91  , 198  
 
Week 16
n
272         
168         
148         
Mean (SD)
134.6 (18.3)
132.5 (14.3)
133.7 (16.0)
Median
134.0       
130.0       
132.0       
Min, Max
 76  , 190  
100  , 168  
 99  , 186  
 
End of Treatment
n
222         
177         
168         
Mean (SD)
132.7 (15.4)
133.0 (17.1)
132.3 (15.6)
Median
131.0       
130.0       
131.0       
Min, Max
 78  , 172  
 92  , 178  
100  , 177  
 
Temperature (C)
Baseline
n
172         
190         
144         
Mean (SD)
 36.6 (0.4) 
 36.5 (0.4) 
 36.6 (0.4) 
Median
 36.7       
 36.6       
 36.6       
Min, Max
 35  , 37   
 35  , 37   
 36  , 37   
 
Week 8
n
146         
118         
112         
Mean (SD)
 36.6 (0.4) 
 36.6 (0.4) 
 36.6 (0.4) 
Median
 36.6       
 36.7       
 36.7       
Min, Max
 36  , 37   
 36  , 37   
 36  , 37   
 
Week 16
n
136         
 82         
 74         
Mean (SD)
 36.7 (0.3) 
 36.6 (0.4) 
 36.6 (0.4) 
Median
 36.7       
 36.6       
 36.7       
Min, Max
 36  , 37   
 36  , 37   
 36  , 37   
End of Treatment
n
 74         
 59         
 56         
Mean (SD)
 36.7 (0.4) 
 36.6 (0.4) 
 36.6 (0.4) 
Median
 36.8       
 36.7       
 36.7       
Min, Max
 35  , 37   
 35  , 38   
 36  , 37