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 group_rows() 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(label = "Parameter"),
    visit      = col_spec(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
 

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