Pre-summarised vital-signs stats partitioned by sex (F / M)
across four visits (Baseline, Week 8, Week 16,
End of Treatment). Two parameters (Systolic BP, Diastolic BP)
emit four statistic rows each (n, Mean (SD), Median,
Min, Max). A partition-constant sex_n BigN column rides
alongside so banners can inline the denominator via
subgroup(label = "Sex: {sex} (N = {sex_n})") without reaching for
a separate lookup.
Format
A data frame with 64 rows and 10 columns:
sexFactor (
F/M).sex_nInteger BigN — number of subjects in the partition row's sex (partition-constant; rides into the banner via
{sex_n}template tokens).paramcdCDISC parameter code (
SYSBP/DIABP).paramDecoded parameter name (
"Systolic BP (mmHg)","Diastolic BP (mmHg)").visitAnalysis visit (
Baseline,Week 8,Week 16,End of Treatment).stat_labelStatistic label (
n,Mean (SD),Median,Min, Max).placebo,drug_50,drug_100,TotalPer-arm cell text.
Source
Derived in data-raw/bundle-demo.R from
pharmaverseadam::advs filtered to SAFFL == "Y", the three
CDISCPILOT01 arms, the SYSBP / DIABP parameters, and the four
scheduled visits.
Details
Designed for subgroup() and as_grid() examples: partition by
sex (one page set per sex) and nest parameter then visit inside each
page for the canonical by-visit CSR shape, or cross sex with visit
for a multi-variable partition.
See also
cdisc_saf_n for BigN denominators; subgroup() for the verb
this dataset is designed for.
Examples
# 95% pattern: subgroup partition by sex with inline BigN, parameter
# nesting visit inside each sex page. `sex` and `sex_n` auto-hide
# from the body: `sex` because it is the partition `by` column;
# `sex_n` because the banner template references it. No explicit
# `col_spec(visible = FALSE)` needed.
tabular(cdisc_saf_subgroup, titles = "Vital Signs by Visit") |>
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", align = "decimal"),
drug_50 = col_spec(label = "Drug 50", align = "decimal"),
drug_100 = col_spec(label = "Drug 100", align = "decimal"),
Total = col_spec(label = "Total", align = "decimal")
) |>
subgroup(by = "sex", label = "Sex: {sex} (N = {sex_n})")
Vital Signs by Visit
Parameter Visit Statistic Placebo Drug 50 Drug 100 Total Sex: F (N = 143) Diastolic BP (mmHg) Baseline n 208 220 140 568 Diastolic BP (mmHg) Baseline Mean (SD) 77.1 (11.2) 76.3 (10.5) 78.0 (10.8) 77.0 (10.8) Diastolic BP (mmHg) Baseline Median 78.0 77.3 78.3 78.0 Diastolic BP (mmHg) Baseline Min, Max 40 , 110 48 , 100 51 , 108 40 , 110 Diastolic BP (mmHg) Week 8 n 168 148 104 420 Diastolic BP (mmHg) Week 8 Mean (SD) 75.1 ( 9.4) 77.1 (11.0) 76.0 (10.0) 76.0 (10.1) Diastolic BP (mmHg) Week 8 Median 76.0 79.7 78.0 78.0 Diastolic BP (mmHg) Week 8 Min, Max 49 , 98 55 , 98 54 , 98 49 , 98 Diastolic BP (mmHg) Week 16 n 156 100 68 324 Diastolic BP (mmHg) Week 16 Mean (SD) 74.9 (11.1) 75.6 (10.8) 77.8 ( 8.9) 75.8 (10.6) Diastolic BP (mmHg) Week 16 Median 77.7 76.0 79.0 78.0 Diastolic BP (mmHg) Week 16 Min, Max 49 , 98 55 , 98 56 , 92 49 , 98 Diastolic BP (mmHg) End of Treatment n 129 108 81 318 Diastolic BP (mmHg) End of Treatment Mean (SD) 74.0 (10.7) 77.2 (11.9) 76.5 (11.7) 75.7 (11.5) Diastolic BP (mmHg) End of Treatment Median 74.0 79.5 80.0 78.0 Diastolic BP (mmHg) End of Treatment Min, Max 49 , 100 50 , 100 56 , 98 49 , 100 Systolic BP (mmHg) Baseline n 208 220 140 568 Systolic BP (mmHg) Baseline Mean (SD) 141.1 (16.9) 139.2 (18.2) 140.4 (19.5) 140.2 (18.0) Systolic BP (mmHg) Baseline Median 141.8 140.0 140.0 140.0 Systolic BP (mmHg) Baseline Min, Max 100 , 184 100 , 194 100 , 192 100 , 194 Systolic BP (mmHg) Week 8 n 168 148 104 420 Systolic BP (mmHg) Week 8 Mean (SD) 138.1 (16.5) 137.9 (17.8) 139.6 (19.0) 138.4 (17.6) Systolic BP (mmHg) Week 8 Median 139.5 135.7 140.0 138.7 Systolic BP (mmHg) Week 8 Min, Max 100 , 184 92 , 200 91 , 198 91 , 200 Systolic BP (mmHg) Week 16 n 156 100 68 324 Systolic BP (mmHg) Week 16 Mean (SD) 137.9 (17.4) 134.8 (15.0) 142.0 (15.3) 137.8 (16.4) Systolic BP (mmHg) Week 16 Median 139.5 130.5 140.0 138.0 Systolic BP (mmHg) Week 16 Min, Max 106 , 190 100 , 168 107 , 186 100 , 190 Systolic BP (mmHg) End of Treatment n 129 108 81 318 Systolic BP (mmHg) End of Treatment Mean (SD) 135.8 (15.3) 137.0 (16.1) 138.0 (17.4) 136.8 (16.1) Systolic BP (mmHg) End of Treatment Median 133.0 133.0 140.0 136.0 Systolic BP (mmHg) End of Treatment Min, Max 95 , 172 98 , 178 100 , 177 95 , 178 Sex: M (N = 111) Diastolic BP (mmHg) Baseline n 132 164 148 444 Diastolic BP (mmHg) Baseline Mean (SD) 77.1 (10.0) 77.1 ( 8.8) 78.5 ( 9.8) 77.6 ( 9.5) Diastolic BP (mmHg) Baseline Median 76.0 76.3 80.0 76.8 Diastolic BP (mmHg) Baseline Min, Max 54 , 102 58 , 108 58 , 100 54 , 108 Diastolic BP (mmHg) Week 8 n 124 92 120 336 Diastolic BP (mmHg) Week 8 Mean (SD) 75.4 ( 8.8) 72.7 ( 9.3) 78.5 ( 8.1) 75.8 ( 9.0) Diastolic BP (mmHg) Week 8 Median 76.0 72.0 79.7 76.0 Diastolic BP (mmHg) Week 8 Min, Max 50 , 101 52 , 100 57 , 94 50 , 101 Diastolic BP (mmHg) Week 16 n 116 68 80 264 Diastolic BP (mmHg) Week 16 Mean (SD) 75.4 (10.7) 74.6 ( 8.7) 74.5 ( 8.8) 74.9 ( 9.7) Diastolic BP (mmHg) Week 16 Median 76.0 73.7 75.5 75.3 Diastolic BP (mmHg) Week 16 Min, Max 50 , 98 59 , 94 50 , 90 50 , 98 Diastolic BP (mmHg) End of Treatment n 93 69 87 249 Diastolic BP (mmHg) End of Treatment Mean (SD) 75.1 (10.6) 74.0 ( 9.6) 75.6 ( 7.8) 75.0 ( 9.4) Diastolic BP (mmHg) End of Treatment Median 73.0 74.0 76.0 74.0 Diastolic BP (mmHg) End of Treatment Min, Max 58 , 104 52 , 94 57 , 90 52 , 104 Systolic BP (mmHg) Baseline n 132 164 148 444 Systolic BP (mmHg) Baseline Mean (SD) 130.0 (16.5) 136.1 (18.7) 135.3 (14.4) 134.0 (16.9) Systolic BP (mmHg) Baseline Median 130.3 134.0 137.2 132.0 Systolic BP (mmHg) Baseline Min, Max 80 , 170 100 , 188 104 , 170 80 , 188 Systolic BP (mmHg) Week 8 n 124 92 120 336 Systolic BP (mmHg) Week 8 Mean (SD) 133.7 (17.5) 130.1 (16.9) 131.2 (10.3) 131.8 (15.2) Systolic BP (mmHg) Week 8 Median 131.0 131.0 131.2 131.0 Systolic BP (mmHg) Week 8 Min, Max 90 , 189 98 , 180 110 , 158 90 , 189 Systolic BP (mmHg) Week 16 n 116 68 80 264 Systolic BP (mmHg) Week 16 Mean (SD) 130.2 (18.6) 129.0 (12.5) 126.5 (12.8) 128.8 (15.6) Systolic BP (mmHg) Week 16 Median 130.0 129.7 126.0 128.0 Systolic BP (mmHg) Week 16 Min, Max 76 , 178 100 , 158 99 , 154 76 , 178 Systolic BP (mmHg) End of Treatment n 93 69 87 249 Systolic BP (mmHg) End of Treatment Mean (SD) 128.5 (14.7) 126.8 (16.8) 127.0 (11.6) 127.5 (14.3) Systolic BP (mmHg) End of Treatment Median 130.0 124.0 130.0 130.0 Systolic BP (mmHg) End of Treatment Min, Max 78 , 164 92 , 162 100 , 156 78 , 164