Stage 4: analysis (executed output)
Table 14.4.1.1 Concentrations by nominal time
Synthetic data only: simulated for this worked example; not real trial data and not a regulatory deliverable.
Table 14.4.1.1 Summary of Plasma SIMDRUG Concentrations (ng/mL) by Nominal Time
PK concentration set
Study SIMBE01 (synthetic)
| Test | Reference | |
|---|---|---|
| (N=39) | (N=39) | |
| Nominal time (h) | ||
| 0 (pre-dose) | ||
| n (n BLQ) | 39 (38) | 39 (39) |
| Mean (SD) | 0.05 (0.29) | 0.00 (0.00) |
| CV% | 624.5 | NE |
| Median | 0.00 | 0.00 |
| Min - Max | 0.00 - 1.84 | 0.00 - 0.00 |
| 0.25 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 73.58 (35.52) | 72.76 (35.81) |
| CV% | 48.3 | 49.2 |
| Median | 66.30 | 63.80 |
| Min - Max | 20.90 - 180.00 | 16.10 - 177.00 |
| 0.5 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 94.93 (41.29) | 93.58 (40.79) |
| CV% | 43.5 | 43.6 |
| Median | 83.10 | 87.20 |
| Min - Max | 30.90 - 211.00 | 27.50 - 217.00 |
| 1 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 101.25 (37.23) | 100.62 (37.04) |
| CV% | 36.8 | 36.8 |
| Median | 86.30 | 92.80 |
| Min - Max | 40.40 - 205.00 | 39.60 - 198.00 |
| 1.5 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 97.33 (33.41) | 99.15 (34.17) |
| CV% | 34.3 | 34.5 |
| Median | 90.60 | 94.10 |
| Min - Max | 45.70 - 194.00 | 40.40 - 183.00 |
| 2 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 96.10 (31.80) | 97.00 (36.28) |
| CV% | 33.1 | 37.4 |
| Median | 92.60 | 89.90 |
| Min - Max | 46.70 - 178.00 | 45.20 - 212.00 |
| 3 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 85.46 (24.31) | 82.97 (25.95) |
| CV% | 28.4 | 31.3 |
| Median | 83.10 | 80.10 |
| Min - Max | 44.90 - 152.00 | 42.50 - 176.00 |
| 4 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 77.39 (21.94) | 76.45 (22.61) |
| CV% | 28.3 | 29.6 |
| Median | 74.10 | 73.60 |
| Min - Max | 44.70 - 141.00 | 42.00 - 156.00 |
| 6 | ||
| n (n BLQ) | 39 (0) | 39 (1) |
| Mean (SD) | 63.49 (16.59) | 61.00 (21.01) |
| CV% | 26.1 | 34.4 |
| Median | 63.60 | 59.40 |
| Min - Max | 37.40 - 113.00 | 0.00 - 138.00 |
| 8 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 52.42 (17.22) | 51.84 (16.50) |
| CV% | 32.8 | 31.8 |
| Median | 47.00 | 48.40 |
| Min - Max | 29.20 - 104.00 | 28.80 - 116.00 |
| 12 | ||
| n (n BLQ) | 38 (0) | 39 (0) |
| Mean (SD) | 36.56 (12.98) | 36.75 (16.48) |
| CV% | 35.5 | 44.8 |
| Median | 36.35 | 34.50 |
| Min - Max | 16.10 - 60.70 | 11.30 - 96.40 |
| 16 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 27.93 (13.47) | 27.29 (13.49) |
| CV% | 48.2 | 49.4 |
| Median | 24.60 | 28.00 |
| Min - Max | 7.08 - 52.40 | 4.51 - 62.40 |
| 24 | ||
| n (n BLQ) | 39 (0) | 39 (0) |
| Mean (SD) | 15.06 (10.05) | 14.42 (9.90) |
| CV% | 66.7 | 68.7 |
| Median | 13.10 | 13.60 |
| Min - Max | 1.00 - 37.90 | 0.57 - 39.00 |
| 36 | ||
| n (n BLQ) | 39 (5) | 39 (6) |
| Mean (SD) | 6.90 (6.41) | 6.54 (5.93) |
| CV% | 92.9 | 90.8 |
| Median | 5.29 | 4.90 |
| Min - Max | 0.00 - 25.40 | 0.00 - 25.50 |
| 48 | ||
| n (n BLQ) | 39 (11) | 39 (12) |
| Mean (SD) | 3.45 (4.11) | 3.17 (3.90) |
| CV% | 119.1 | 123.0 |
| Median | 1.87 | 2.12 |
| Min - Max | 0.00 - 16.00 | 0.00 - 19.50 |
Files: t_14_4_1_1.rtf (RTF from formatters::export_as_rtf()), t_14_4_1_1.csv (the displayed cells). Program: study/04_analysis/03_tlf.R.