Stage 4: analysis (executed output)
Table 14.1.2 Demographics
Synthetic data only: simulated for this worked example; not real trial data and not a regulatory deliverable.
Table 14.1.2 Demographic and Baseline Characteristics
Safety set
Study SIMBE01 (synthetic)
| TR | RT | Total | |
|---|---|---|---|
| (N=20) | (N=20) | (N=40) | |
| Age (years) | |||
| n | 20 | 20 | 40 |
| Mean (SD) | 43.8 (7.6) | 43.8 (7.6) | 43.8 (7.5) |
| Median | 44.5 | 43.0 | 44.0 |
| Min - Max | 32.0 - 59.0 | 34.0 - 58.0 | 32.0 - 59.0 |
| Height (cm) | |||
| n | 20 | 20 | 40 |
| Mean (SD) | 168.3 (9.6) | 172.3 (7.6) | 170.3 (8.8) |
| Median | 166.7 | 174.8 | 171.9 |
| Min - Max | 151.9 - 186.5 | 156.7 - 182.1 | 151.9 - 186.5 |
| Weight (kg) | |||
| n | 20 | 20 | 40 |
| Mean (SD) | 72.3 (15.0) | 73.2 (12.1) | 72.7 (13.5) |
| Median | 68.2 | 74.7 | 71.6 |
| Min - Max | 51.3 - 106.6 | 54.3 - 92.7 | 51.3 - 106.6 |
| BMI (kg/m2) | |||
| n | 20 | 20 | 40 |
| Mean (SD) | 25.7 (5.7) | 24.8 (4.9) | 25.2 (5.2) |
| Median | 24.6 | 24.0 | 24.6 |
| Min - Max | 18.0 - 35.4 | 18.9 - 36.2 | 18.0 - 36.2 |
| Sex, n (%) | |||
| n | 20 | 20 | 40 |
| Female | 12 (60.0%) | 9 (45.0%) | 21 (52.5%) |
| Male | 8 (40.0%) | 11 (55.0%) | 19 (47.5%) |
| Race, n (%) | |||
| n | 20 | 20 | 40 |
| Asian | 1 (5.0%) | 4 (20.0%) | 5 (12.5%) |
| Black or African American | 7 (35.0%) | 4 (20.0%) | 11 (27.5%) |
| Multiple | 1 (5.0%) | 0 (0.0%) | 1 (2.5%) |
| White | 11 (55.0%) | 12 (60.0%) | 23 (57.5%) |
| Ethnicity, n (%) | |||
| n | 20 | 20 | 40 |
| Hispanic or Latino | 5 (25.0%) | 2 (10.0%) | 7 (17.5%) |
| Not Hispanic or Latino | 15 (75.0%) | 18 (90.0%) | 33 (82.5%) |
| Not reported | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Files: t_14_1_2.rtf (RTF from formatters::export_as_rtf()), t_14_1_2.csv (the displayed cells). Program: study/04_analysis/03_tlf.R.