!LANDSCAPE #* Table 2.1 Summary statistics for PK concentrations !BLOCKSTART[keepNext](table1_1) **Table 2.1-1 Summary statistics for PK concentrations of Plasma Drug B (Drug B) - Single IV Infusion Dose (SD) (1 of 2)** !TABINLINE[size:8,ignoreCaption:true,valueTable:false] | | | Nominal Time [h] | | | | | | | | | | | ------------- | ------------ | ------------------------- | ----- | ----- | ----- | ----- | ----- | ----- | ----- | ----- | ----- | | | | 0 | 0.5 | 2 | 8 | 24 | 48 | 72 | 168 | 240 | 336 | | **Treatment** | **Stats** | **Concentration [ug/mL]** | | | | | | | | | | | 300mg/m2 | N | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 3 | | | Mean | 2.5 | 25.73 | 108.3 | 85.53 | 76.2 | 68.17 | 61.63 | 48.97 | 39.6 | 33.83 | | | SD | 0 | 7.81 | 43.18 | 18.7 | 19.71 | 21.65 | 18.87 | 18.74 | 12.73 | 11.18 | | | Min | 2.5 | 17.7 | 75.4 | 64 | 55.2 | 49.1 | 42.3 | 27.5 | 27.4 | 21.3 | | | Median | 2.5 | 26.2 | 92.3 | 94.9 | 79.1 | 63.7 | 62.6 | 57.3 | 38.6 | 37.4 | | | Geo-mean | 2.5 | 24.9 | 103 | 84.03 | 74.39 | 65.95 | 59.61 | 46.08 | 38.22 | 32.43 | | | Max | 2.5 | 33.3 | 157.2 | 97.7 | 94.3 | 91.7 | 80 | 62.1 | 52.8 | 42.8 | | | CV% mean | 0 | 30.35 | 39.87 | 21.86 | 25.87 | 31.76 | 30.61 | 38.28 | 32.15 | 33.06 | | | CV% geo-mean | 0 | 32.73 | 39.36 | 23.96 | 27.81 | 32.17 | 32.99 | 47.25 | 33.71 | 38.32 | {NC: Not calculated.
Geo-mean: Geometric mean.
CV%% mean = coefficient of variation (%%)=SD/mean * 100.
CV%% geo-mean=(sqrt (exp (variance for log transformed data)-1)) * 100.
Lower limit of quantitation: 5 ug/mL. Pre-first dose =LLOQ values were handled as: asis. First = LLOQ was handled as: 0. Second to last First = LLOQ was handled as: 0.
Values in table are reported with 4 significant digits.
IQnca version: 1.3.1.9000
Script: compliance
Output: output/tables/summary_table_conc.rmd
Execution date: 2023-12-04 14:25:57.72934} !BLOCKEND(table1_1) !NEWPAGE !BLOCKSTART[keepNext](table1_1) **Table 2.1-1 Summary statistics for PK concentrations of Plasma Drug B (Drug B) - Single IV Infusion Dose (SD) (2 of 2)** !TABINLINE[size:8,ignoreCaption:true,valueTable:false] | | | Nominal Time [h] | | | ------------- | ------------ | ------------------------- | ----- | | | | 672 | 1008 | | **Treatment** | **Stats** | **Concentration [ug/mL]** | | | 300mg/m2 | N | 3 | 3 | | | Mean | 18.3 | 9.467 | | | SD | 7.269 | 2.899 | | | Min | 10.3 | 7.1 | | | Median | 20.1 | 8.6 | | | Geo-mean | 17.18 | 9.187 | | | Max | 24.5 | 12.7 | | | CV% mean | 39.72 | 30.62 | | | CV% geo-mean | 47.85 | 30.3 | {NC: Not calculated.
Geo-mean: Geometric mean.
CV%% mean = coefficient of variation (%%)=SD/mean * 100.
CV%% geo-mean=(sqrt (exp (variance for log transformed data)-1)) * 100.
Lower limit of quantitation: 5 ug/mL. Pre-first dose =LLOQ values were handled as: asis. First = LLOQ was handled as: 0. Second to last First = LLOQ was handled as: 0.
Values in table are reported with 4 significant digits.
IQnca version: 1.3.1.9000
Script: compliance
Output: output/tables/summary_table_conc.rmd
Execution date: 2023-12-04 14:25:57.740035} !BLOCKEND(table1_1) !NEWPAGE !BLOCKSTART[keepNext](table1_2) **Table 2.1-2 Summary statistics for PK concentrations of Plasma Drug B (Drug B) - Single IV Infusion Dose (SD) (1 of 2)** !TABINLINE[size:8,ignoreCaption:true,valueTable:false] | | | Nominal Time [h] | | | | | | | | | | | ------------- | ------------ | ------------------------- | ------ | ------ | ------ | ------ | ------ | ------ | ------ | ------ | ------ | | | | 0.0 | 0.5 | 2.0 | 8.0 | 24.0 | 48.0 | 72.0 | 168.0 | 240.0 | 336.0 | | **Treatment** | **Stats** | **Concentration [ug/mL]** | | | | | | | | | | | 400mg/m2 | N | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 2 | | | Mean | 2.50 | 21.90 | 156.10 | 129.20 | 93.20 | 85.35 | 84.10 | 58.40 | 51.10 | 41.35 | | | SD | 0 | 0.9899 | 14.57 | 5.374 | 4.808 | 3.889 | 5.374 | 5.091 | NC | 9.405 | | | Min | 2.5 | 21.2 | 145.8 | 125.4 | 89.8 | 82.6 | 80.3 | 54.8 | 51.1 | 34.7 | | | Median | 2.50 | 21.90 | 156.10 | 129.20 | 93.20 | 85.35 | 84.10 | 58.40 | 51.10 | 41.35 | | | Geo-mean | 2.50 | 21.89 | 155.80 | 129.10 | 93.14 | 85.31 | 84.01 | 58.29 | 51.10 | 40.81 | | | Max | 2.5 | 22.6 | 166.4 | 133.0 | 96.6 | 88.1 | 87.9 | 62.0 | 51.1 | 48.0 | | | CV% mean | 0 | 4.52 | 9.331 | 4.159 | 5.159 | 4.557 | 6.39 | 8.718 | NC | 22.74 | | | CV% geo-mean | 0 | 4.524 | 9.365 | 4.162 | 5.165 | 4.561 | 6.401 | 8.745 | NC | 23.25 | {NC: Not calculated.
Geo-mean: Geometric mean.
CV%% mean = coefficient of variation (%%)=SD/mean * 100.
CV%% geo-mean=(sqrt (exp (variance for log transformed data)-1)) * 100.
Lower limit of quantitation: 5 ug/mL. Pre-first dose =LLOQ values were handled as: asis. First = LLOQ was handled as: 0. Second to last First = LLOQ was handled as: 0.
Values in table are reported with 4 significant digits.
IQnca version: 1.3.1.9000
Script: compliance
Output: output/tables/summary_table_conc.rmd
Execution date: 2023-12-04 14:25:57.763033} !BLOCKEND(table1_2) !NEWPAGE !BLOCKSTART[keepNext](table1_2) **Table 2.1-2 Summary statistics for PK concentrations of Plasma Drug B (Drug B) - Single IV Infusion Dose (SD) (2 of 2)** !TABINLINE[size:8,ignoreCaption:true,valueTable:false] | | | Nominal Time [h] | | | | ------------- | ------------ | ------------------------- | ----- | ----- | | | | 672 | 1008 | 1104 | | **Treatment** | **Stats** | **Concentration [ug/mL]** | | | | 400mg/m2 | N | 2 | 2 | 1 | | | Mean | 19.15 | 2.25 | 0.00 | | | SD | 7.99 | 3.182 | NC | | | Min | 13.5 | 0.0 | 0.0 | | | Median | 19.15 | 2.25 | 0.00 | | | Geo-mean | 18.3 | NC | NC | | | Max | 24.8 | 4.5 | 0.0 | | | CV% mean | 41.72 | 141.4 | NC | | | CV% geo-mean | 45.07 | NC | NC | {NC: Not calculated.
Geo-mean: Geometric mean.
CV%% mean = coefficient of variation (%%)=SD/mean * 100.
CV%% geo-mean=(sqrt (exp (variance for log transformed data)-1)) * 100.
Lower limit of quantitation: 5 ug/mL. Pre-first dose =LLOQ values were handled as: asis. First = LLOQ was handled as: 0. Second to last First = LLOQ was handled as: 0.
Values in table are reported with 4 significant digits.
IQnca version: 1.3.1.9000
Script: compliance
Output: output/tables/summary_table_conc.rmd
Execution date: 2023-12-04 14:25:57.7755} !BLOCKEND(table1_2)