Table, Filename (.xls)

Description

Phoenix Table Template

*Demographics

Subject baseline demographics (age, weight) values for individu­als with summary statistics sorted by treatment. Crossover study designs create one table with all subjects included. Parallel study designs create a unique table per treatment.

Table 3

*Actual_Times

Actual sample times for individuals with summary statistics sorted by treatment.

Table 6

*Trough_Actual_­Times_Trt

Actual sample times (Trough only) for individuals with summary statistics sorted by treatment.

Table 6

*Actual_Times_Dev

Actual sample time deviations (difference of actual time and nom­inal time) for individuals sorted by treatment.

Table 6

*Concentration

Concentration values for individuals with summary statistics sorted by treatment.

Table 6

*Concentra­tion_Strat-<Var>

Concentration values for individuals with summary statistics sorted by treatment along with user-specified stratification vari­able.

Table 6

*Trough_Concentra­tion_Trt

Concentration (Trough only) values for individuals with summary statistics sorted by treatment.

Table 3

*Trough_Concentra­tion_Strat-<Var>_Trt

Concentration (Trough only) values for individuals with summary statistics sorted by treatment along with user-specified stratifica­tion variable.

Table 3

*Urine_ Amount^a 

Urine amount excreted over discrete collection intervals, or over the midpoints of discrete collection intervals, for individuals with summary statistics sorted by treatment.

Table 6

Urine_Amount_Strat-<Var>^a 

Urine amount excreted over discrete collection intervals of sum­mary statistics sorted by treatment along with stratification vari­able selected in the interface.

Table 6

*Urine_Cumul_ Amount^a 

Urine amount excreted over cumulative collection intervals for individuals with summary statistics sorted by treatment.

Table 6

*Urine_Cu­mul_Amount_Strat-<Var>^a 

Urine amount excreted over cumulative collection intervals for summary statistics sorted by treatment along with user-specified stratification variable.

Table 6

*Urine_Actual_­Times

Actual time intervals for urine collection. Derived from actual time/nominal time.

Table 6

*Lambda_Z

Individual values for selected regression fits by treatment with summary statistics. If Phoenix cannot create a regression line (for instance, when concentration increases over time), AutoPilot Toolkit cannot generate any table based on regression values like Lambda_Z. To force a regression line, set the start and stop times in Phoenix larger than t_last.

Table 3

*Cumul_AUC

Individual AUC values by RNT by treatment with summary statis­tics.

Table 6

*PK_Parameter_{a-z}^b 

PK parameters values for individuals with summary statistics sorted by treatment. The PK parameters displayed depend upon interface selections (NCA model selected and output specifica­tions).

Table 3

*PK_Parameter_{a-z}_Strat-<Var>^b 

PK parameters summary statistics sorted by treatment along with stratification variable selected in the interface. The PK parame­ters displayed depend upon interface selections (NCA model selected and output specifications).

Table 3

Urine_PK_Parame­ter^b 

Urine PK parameters values for individuals with summary statis­tics sorted by treatment. The PK parameters displayed depend upon interface selections (NCA model selected and output speci­fications).

Table 3

Urine_PK_Parame­ter_Strat-<Var>^b 

Urine PK parameters summary statistics sorted by treatment along with user-specified stratification variable. The PK parame­ters displayed depend upon interface selections (NCA Model selected and output specifications).

Table 3

*Intext_PK__Param­eter_{a-z}^b 

PK parameter summary statistics values are displayed by treat­ment. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geo­metric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

Special template

*Intext_PK_Parame­ter_{a-z}_Strat-<Var>^b 

PK parameter summary statistics values are displayed by treat­ment along with user-specified stratification variable. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geometric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

Special template

Urine_Intext_P­K_Parameter_Ana­lyte^b 

Urine PK parameter summary statistics values are displayed by treatment. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geo­metric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

Special template

Urine_Intext_P­K_Parameter_Strat-<Var>^b 

Urine PK parameter summary statistics values are displayed by treatment along with user-specified stratification variable. The PK parameters displayed depend upon interface selections (NCA model selected and output specifications). The summary term (e.g., Mean, Median, Harmonic Mean, and Geometric Mean) and error term (e.g., SD, SE, and Variance) can be selected.

Special template

*PK_Ratios

PK parameter ratio values for individuals with summary statistics sorted by a pair-wise treatment comparison. The table is only pro­duced for a Crossover study type and with interface selections for PK Ratios and Reference.

Table 3

Urine_PK_Ratios

Urine PK parameter ratio values for individuals with summary sta­tistics sorted by a pair-wise treatment comparison. The table is only produced for a Crossover study type and with interface selections for PK Ratios and Reference.

Table 3

*PK_Stats
PK Stats (Random­ized Crossover)
PK Stats (Non-Ran­domized Crossover)
PK Stats (Parallel)

Inferential statistics on user-specified subset of PK parameters. Tables are only produced when selecting Calculate Inferential Statistics and a Reference.

Special template

Urine_PK_Stats
PK Stats (Random­ized Crossover)
PK Stats (Non-Ran­domized Crossover)
PK Stats (Parallel)

Inferential statistics on a subset of Urine PK parameters are dis­played in PK parameter tables. Provides p-value information for all tables. For a Crossover study design, additional values for Statistical Power, GLSM, and Confidence intervals are displayed. Only one table is created for all study designs. Tables are only produced when selecting Calculate Inferential Statistics and a Reference.

Special template

Profile_Exclusions

Listing of subjects with their profile data collection variables that were excluded using the Automation Exclusion feature. No sum­mary statistics.

Special template

Filename(.xls)

Study Design and Dosing/Matrix

Crossover^a

Parallel

SD

MD

TE

UR

SD

MD

TR

UR

Demographics Table

Demographics

X

X

X

X

X

X

Time-Concentration Tables

Actual_Times

X

X

X

X

Trough_Actual_Times_Trt

X

X

Actual_Times_Dev

X

X

X

X

Concentration

X

X

X

X

Concentration_Strat_-<Var>^b

X

X

X

X

Trough_Concentration_Trt

X

X

Trough_Concentration_Strat-<Var>_Trt^b 

X

X

Urine_Amount

X

X

Urine_Amount_Strat-<Var>^b 

X

X

Urine_Cumul_Amount

X

X

Urine_Cumul_Amount_-<Var>^b 

X

X

PK Parameter Tables

Cumul_AUC

X

X

X

X

Lambda_Z

X

X

X

X

PK_Parameter_A (applies to all six tables, A–F)

X

X

X

X

PK_Parameter_A_Strat_-<Var>^b(applies to all six tables, A–F)

X

X

X

X

Urine_PK_Parameter

X

X

Urine_PK_Parameter_Strat-<Var>^b 

X

X

Intext Table

Intext_PK_Parameter_I (applies to both tables, I–II)

X

X

X

X

Intext_PK_Parameter_I_Strat-<Var>^b (applies to both tables, I–II)

X

X

X

X

Urine_Intext_PK_Parameter

X

X

Urine_Intext_PK_Parameter_Strat-<Var>^b 

X

X

PK_Stats Tables^c

PK_Ratios^d

X

X

Urine_PK_Ratios^c 

X

X

PK_Stats^e specific to study design type, e.g., PK Stats (Randomized Crossover)

X

X

X

X

Urine_PK_Stats^d specific to study design type, e.g., PK Stats (Randomized Crossover)

X

X

Other Tables

Profile Exclusions^f

X

X

X

X

X

X

X

X

Filename (.xls)

Description

Phoenix Table
Template

*Comparison_Concen­tration_Ratios

Concentration ratio values for individuals with summary statis­tics. One table per treatment or period and day (if multiple dose) with the ratios based on analyte (parent vs. metabolite). Limited to Analyte-Plasma comparisons of automation runs using NCA models 200–202.

Table 6

Compari­son_Trough_Concen­tration_Ratios

Trough concentration ratio values for individuals with sum­mary statistics. One table per treatment or period and day (if multiple dose) with the ratios based on analyte (parent vs. metabolite). Limited to Analyte-Plasma comparisons for Trough (no NCA model) automations.

Table 6

*Comparison_PK_Pa­rameter_{a-z}_Ratios, for Analyte, Day, Abs Bioavail, and CLr^a 

PK parameter ratio values for individuals with summary statis­tics. Analyte Comp (Plasma): ratios based on analyte (parent vs. metabolite). Accumulation Comp: ratios based on day (multiple dose (test) vs. ref (SD)). Abs Bioavail Comp: ratios based on treatment (100 mg PO vs. 100 mg IV). Renal CLr Comp: ratios based on matrix (Plasma (test) vs. Ref (Ext)).
Note: In some instances, the table does not display the entire treatment description if table splitting is applied.

Table 3

*Comparison_Intext_P­K_Parameter for Ana­lyte, Day, Abs Bioavail, and CLr^a 

PK parameter summary statistic values. Analyte Comp (Plasma): separate columns for each analyte. Accumulation Comp: separate columns for each day. Abs Bioavail Comp: separate columns for each treatment. Renal CLr Comp: sepa­rate columns for plasma matrix data.

Special template

Filenames (*.xls)

Analyte

Accum

Abs Bio
Avail

Renal Cl

Plasma

Urine

Trough

Time-Concentration Tables

Comparison_Concentration_Ratios

X

Comparison_Trough_Concentration_Ratios

X

Comparison_Urine_Amount_Ratios

X

Comparison_Urine_Cumul_Amount_Ratios

X

PK Parameter Tables

Comparison_PK_Parameter_{a-z}_Ratios_Ana­lyte (applies to both tables, A and B)

X

Comparison_Urine_PK_Parameter_Ratios_Ana­lyte

X

X

Comparison_PK_Parameter_{a-z}_Ratios_Day (applies to both tables, A and B)

X

Comparison_PK_Parameter_{a-z}_Ra­tios_Abs_Bioavail

X

Comparison_PK_Parameter_{a-z}_Ra­tios_Renal_CLr

X

Intext Tables

Comparison_Intext_PK_Parameter_{a-z}_Analyte (applies to both tables, I–II)

X

Comparison_Urine_Intext_PK_Parameter_{a-z}_Analyte

X

Comparison_Intext_PK_Parameter_{a-z}_Day (applies to both tables, I–II)

X

Comparison_Intext_PK_Parameter_{a-z}_Abs_Bioavail (applies to both tables, I–II)

X

Comparison_Intext_PK_Parameter_{a-z}_Renal_­CLr (applies to both tables, I–II)

X

Graph

Description

Time Concentration Graphs — Plasma

*Conc_by_Subject

Individual time-concentration plot, one subject per graph. Activate Individual Time Concentration checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Time_Concentration.doc.

*Conc_Trt^a 

Spaghetti individual time-concentration plot, one graph per unique treatment or period. Can have variability data (e.g., mean, median, etc.).

*Conc_Trt_GroupBy-Strat-[Demog]^b 

Spaghetti individual time-concentration plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

*Summary_Conc_Trt^a 

Time-concentration summary, all treatments or periods on one graph.

*Summary_Conc_Trt_GroupBy-Strat-[Demog]^a 

Time-concentration summary, all treatments or periods on one graph with demographic variables in the legend (e.g., Treatment 1 Male, Treatment 1 Female).

Summary_Conc_Strat-[Demog][Value]

Time-concentration summary, one graph per demographic variable value (e.g., Male) with all treatments or periods in the legend (e.g., Treatment 1, Treatment 2).

Time Concentration Graphs — Urine

*Excretion_Rate_by_Subject_Lin/Log

Individual urine excretion rate, one subject per graph. Acti­vate Individual Excretion Rate checkbox in the Appendix list to incorporate these graphs into a Word file called Indi­vidual_Excretion_Rate.doc.

*Excretion_Rate_Trt_Lin/Log^a 

Spaghetti urine individual excretion rate plot, one graph per unique treatment or period, can have variability data (e.g., mean, median).

Excretion_Rate_Trt_GrouBy-Strat-[Demog]_Lin/Log^a 

Spaghetti individual urine excretion rate plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

*Summary_Excretion_Rate_Lin/Log^a 

Excretion rate summary, all treatments or periods on one graph.

Note: If one or more subjects in a data set have a negative relative actual time value, the mean values are not dis­played in the plots when the relative actual end time is used as the X-axis variable. If the default X-axis variable Midpoint Time is used, then the mean values in the table are plotted.

Summary_Excre­tion_Rate_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Excretion rate summary, all treatments or periods on one graph with demographic variables in the legend (e.g., Treatment 1 Male, Treatment 1 Female).

Summary_Excretion_Rate_Strat-[Demog][Value]_Lin/Log^a 

Excretion rate summary, one graph per demographic vari­able value (e.g., Male) with all treatments or periods in the legend (e.g., Treatment 1, Treatment 2).

Percent_Dose_Remaining_by_Sub­ject_Lin/Log^a 

Percent dose remaining to be excreted (%) one subject per graph. Activate Individual Percent Excreted checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Percent_Excreted.doc.

Percent_Dose_Remaining_Trt_Lin/Log^a 

Spaghetti percent dose remaining to be excreted individual (%) plot, one graph per unique treatment or period. Can have variability data (e.g., mean, median).

Percent_Dose_Remain­ing_Trt_GroupBy-Strat_[Demog]_Lin/Log^a 

Spaghetti individual percent dose remaining plot, one graph per unique treatment or period. Can contain variabil­ity data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

Summary_Percent_Dose_Remain­ing_Lin/Log^a 

Percent dose remaining to be excreted summary, all treat­ments or periods on one graph.

Summary_Percent_Dose_Remain­ing_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Percent dose remaining summary, all treatments or peri­ods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Percent_Dose_Remain­ing_Strat-[Demog][Value]_Lin/Log

Percent dose remaining summary, one graph per demo­graphic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

*Cumulative_Amount_Excreted_by_­Subject_Lin/Log

Individual line plot of the cumulative amount excreted by subject vs. midpoint or end time; linear and logarithmic scaling available. Activate Individual Cumulative Amount Excreted checkbox in the Appendix list to incor­porate these graphs into a Word file called Individual_Cu­mulative_Amount_Excreted.doc.

*Cumulative_Amount_Excret­ed_Trt_Lin/Log

Spaghetti plot of the cumulative amount excreted by treat­ment vs. midpoint or end time; linear and logarithmic scal­ing available.

Note: If one or more subjects in a data set have a negative relative actual time value, the mean values are not dis­played in the plots when the relative actual end time is used as the X-axis variable. If the default X-axis variable Midpoint Time is used, then the mean values in the table are plotted.

Cumulative_Amount_Excret­ed_Trt_GroupBy-Strat_[Demog]_Lin/Log^a 

Spaghetti individual cumulative amount excreted plot, one graph per unique treatment or period. Can contain variabil­ity data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

Summary_Cumulative_Amount_Ex­creted_Lin/Log^a 

Cumulative amount excreted summary, all treatments or periods on one graph.

Summary_Cumulative_Amount_Ex­creted_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Cumulative amount excreted summary, all treatments or periods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Cumulative_Amount_Ex­creted_Strat-[Demog][Value]_Lin/Log

Cumulative amount excreted summary, one graph per demographic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

*Amount_Excreted_by_Subject_Lin/Log

Individual line plot of amount excreted by subject vs. mid­point or end time; linear and logarithmic scaling available. Activate Individual Amount Excreted checkbox in the Appendix list to incorporate these graphs into a Word file called Individual_Amount_Excreted.doc.

Note: In cases where there is more than one value in the Matrix column in the study data, the first Matrix value is the value displayed in the output. This can result in incorrect Y-axis labels for graphs. You may have to remove all of the rows for the first Matrix value in order to obtain the correct Y-axis labels.

*Amount_Excreted_Trt_Lin/Log

Spaghetti plot of amount excreted by treatment vs. mid­point or end time; linear and logarithmic scaling available.

Amount_Excreted_Trt_GroupBy-Strat_[Demog]_Lin/Log^a 

Spaghetti individual amount excreted plot, one graph per unique treatment or period. Can contain variability data, separated by All or demographic variables (e.g., All Mean, Male Mean, Female Mean).

*Summary_Amount_Excreted_Trt_Lin/Log

Line plot of the summary amount excreted by treatment vs. midpoint or end time; linear and logarithmic scaling avail­able, as are error bars.

Summary_Amount_Excreted_Lin/Log^a 

Amount excreted summary, all treatments or periods on one graph.

Summary_Amount_Excret­ed_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Amount excreted summary, all treatments or periods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Amount_Excreted_Strat-[Demog][Value]_Lin/Log

Amount excreted summary, one graph per demographic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

Time Concentration Graphs — Trough

Conc_by_Subject_Lin/Log

Individual trough time-concentration, one subject per graph. Activate Individual Trough Concentration check­box in the Appendix list to incorporate these graphs into a Word file called Individual_Trough_Concentration.doc.

Conc_Trt_Lin/Log^a 

Spaghetti trough individual time-concentration plot, one graph per unique treatment, period. Can have variability data (e.g. mean, median).

Conc_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Spaghetti trough individual time-concentration plot, one graph per unique treatment, period. Can contain variability data, separated by All or demographic variables (e.g. All Mean, Male Mean, Female Mean).

Summary_Conc_Trt_Lin/Log^a 

Trough time-concentration summary, all treatments or peri­ods on one graph.

Summary_Conc_Trt_GroupBy-Strat-[Demog]_Lin/Log^a 

Trough time-concentration summary, all treatments or peri­ods on one graph with demographic variables in the legend (e.g. Treatment 1 Male, Treatment 1 Female).

Summary_Conc_Strat-[Demog][Value]_Lin/Log^a 

Trough time-concentration summary, one graph per demo­graphic variable value (e.g. Male) with all treatments or periods in the legend (e.g. Treatment 1, Treatment 2).

PK Parameter Graphs — Plasma and Urine

*[PKParam]

PK parameter vs. categorical treatment or period.

[PKParam]_Norm-[Demog]

Normalized PK parameter vs. categorical treatment or period.

*[PKParam]_Trt_GroupBy-Strat-[Demog]^a 

PK parameter stratified by discrete demographic; categori­cal X-axis is demographic values with one graph per treat­ment or period.

[PKParam]_Strat-[Demog][Value]

PK parameter stratified by discrete demographic; categori­cal X-axis is treatment or period values with one graph per demographic value (e.g. Male, Female).

[PKParam]_Norm-[Demog]_Trt_GroupBy-Strat-[Demog]^a 

Normalized PK parameter stratified by discrete demo­graphic; categorical X-axis is demographic values with one graph per treatment or period.

[PKParam]_Norm-[Demog]_Strat-[Demog][Value]

Normalized PK parameter stratified by discrete demo­graphic; categorical X-axis is treatment or period values with one graph per demographic value (e.g. Male, Female).

*Box_[PKParam]

Box and whisker plot of PK parameter vs. categorical t

Box_[PKParam]_Norm-[Demog]

Box and whisker plot of normalized PK parameter vs. cate­gorical treatment or period.

Box_[PKParam]_Trt_GroupBy-Strat-[Demog]^a 

Box and whisker plot of PK parameter stratified by discrete demographic; categorical X-axis is demographic values with one graph per treatment or period.

Box_[PKParam]_Strat_[Demog][Value]

Box and whisker plot of PK parameter stratified by discrete demographic; categorical X-axis is treatment or period val­ues with one graph per demographic value (e.g. Male, Female).

Box_[PKParam]_Norm-[Demog]_Trt_GroupBy-Strat-[Demog]^a 

Box and whisker plot of normalized PK parameter stratified by discrete demographic; categorical X-axis is demo­graphic values with one graph per treatment or period.

Box[PKParam]_Norm-[Demog]_Strat-[Demog][Value]

Box and whisker plot of normalized PK parameter stratified by discrete demographic; categorical X-axis is treatment or period values with one graph per demographic value (e.g. Male, Female).

*[PKParam]_by-Dose

PK parameter vs. continuous dose X-variable.

[PKParam]_Norm-[Demog]_vs-Dose

Normalized PK parameter vs. continuous dose X-variable.

Box_[PKParam]_vs-Dose

Box and whisker plot of PK parameter vs. continuous dose X-variable.

Box_[PKParam]_Norm-[Demog]_vs-Dose

Box and whisker plot of normalized PK parameter vs. con­tinuous dose X-variable.

*[PKParam]_ vs-Cont-[Demog]

PK parameter vs. continuous demographic X-variable; all individual subjects for all treatments or periods are dis­played on same graph.

[PKParam]_Norm-[Demog]_vs-Cont-[Demog]

Normalized PK parameter vs. continuous demographic X-variable; all individual subjects for all treatments or periods are displayed on same graph.

*[PKParam]_ Trt_vs-Cont-[Demog]^a 

PK parameter vs. continuous demographic X-variable; a separate graph is created for each unique treatment or period.

[PKParam]_Norm-[Demog]_Trt_vs-Cont-[Demog]^a 

Normalized PK parameter vs. continuous demographic X-variables, where a separate graph is created for each unique treatment or period.

[PKParam]_Strat-[Demog]_vs-Cont-[Demog]

PK parameter vs. continuous demographic X-variables; all individual subjects for all treatments or periods are dis­played on same graph, legend includes stratified demo­graphic values (e.g. Male, Female).

[PKParam]_Norm-[Demog]_Strat-[Demog]_vs-Cont-[Demog]

Normalized PK Parameter vs. continuous demographic X-variables; all individual subjects for all treatments or peri­ods are displayed on same graph, legend includes strati­fied demographic values (e.g. Male, Female).

[PKParam]_Trt_GroupBy-Strat-[Demog]_vs-Cont-[Demog]^a 

PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique treatment or period, legend includes stratified demographic values (e.g. Male, Female).

[PKParam]_Norm-[Demog]_Trt_GroupBy-Strat-[Demog]_vs-Cont-[Demog]^a 

Normalized PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique treatment or period, legend includes stratified demographic values (e.g. Male, Female).

[PKParam]_Strat-[Demog][Value]_vs-Cont-[Demog]

PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique demographic variable value (e.g. Male or Female), legend includes treat­ments or periods.

[PKParam]_Norm-[Demog]_Strat-[Demog][Value]_vs-Cont-[Demog]

Normalized PK parameter vs. continuous demographic X-variables; a separate graph is created for each unique demographic variable value (e.g. Male or Female), legend includes treatments or periods.

Graph

Study Design and Dosing/Matrix

Crossover

Parallel

SD

MD

TR

UR

SD

MD

TR

UR

Time Concentration Graphs — Plasma

Conc_by_Subject_Lin/Log

X

X

X

X

Conc_by_Trt or _Per_Lin/Log

X

X

X

X

Conc_Strat_[Demog]_by_Trt or _Per_Lin/Log

X

X

X

X

Summary_Conc_Lin/Log

X

X

X

X

Summary_Conc_Strat_[Demog]_Lin/Log

X

X

X

X

Summary_Conc_Strat_by_[Demog](Value)_Lin/Log

X

X

X

X

Time Concentration Graphs — Urine

Excretion_Rate_by_Subject_Lin/Log

X

X

Excretion_Rate_by_Trt or _Per_Lin/Log

X

X

Excretion_Rate_Strat_[Demog]_by_Trt or _Per_Lin/Log

X

X

Summary_Excretion_Rate_Lin/Log

X

X

Summary_Excretion_Rate_Strat_[Demog]_Lin/Log

X

X

Summary_Excretion_Rate_Strat_by_[Demog](Value)_Lin/Log

X

X

Percent_Dose_Remaining_by_Subject_Lin/Log

X

X

Percent_Dose_Remaining_by_Trt or _Per_Lin/Log

X

X

Percent_Dose_Remaining_Strat_[Demog]_by_Trt or _Per_Lin/Log

X

X

Summary_Percent_Dose_Remaining_Lin/Log

X

X

Summary_Percent_Dose_Remaining_Strat_[Demog]_Lin/Log

X

X

Summary_Percent_Dose_Remain­ing_Strat_by[Demog]_(Value)_Lin/Log

X

X

Cumulative_Amount_Excreted_by_Subject_Lin/Log

X

X

Cumulative_Amount_Excreted_by_Treatment_Lin/Log

X

X

Summary_Cumulative_Amount_Excreted_Lin/Log

X

X

Individual_Cumulative_Amount_Excreted_Lin/Log

X

X

Amount_Excreted_by_Subject_Lin/Log

X

X

Amount_Excreted_by_Treatment_Lin/Log

X

X

Summary_Amount_Excreted_Lin/Log

X

X

Individual_Amount_Excreted_Lin/Log

X

X

Time Concentration Graphs — Trough

Conc_by_Subject_Lin/Log

X

X

Conc_by_Trt or _Per_Lin/Log

X

X

Conc_Strat_[Demog]_by_Trt or _Per_Lin/Log

X

X

Summary_Conc_Lin/Log

X

X

Summary_Conc_Strat_[Demog]_Lin/Log

X

X

Summary_Conc_Strat_by_[Demog]_[Value]_Lin/Log

X

X

PK Parameter Graphs — Plasma and Urine

[PKParam]

X

X

X

X

X

X

[PKParam]_Norm-[Demog]

X

X

X

X

X

X

[PKParam]_Trt or _Per_GroupBy-Strat-[Demog]

X

X

X

X

X

X

[PKParam]_Norm-[Demog]_Trt or _Per_GroupBy-Strat-[Demog]

X

X

X

X

X

X

[PKParam]_Strat-[Demog][Value]

X

X

X

X

X

X

[PKParam]_Norm-[Demog]_Strat-[Demog][Value]

X

X

X

X

X

X

Box_[PKParam]

X

X

X

X

X

X

Box_[PKParam]_Norm-[Demog]

X

X

X

X

X

X

Box_[PKParam]_Trt or _Per_GroupBy-Strat-[Demog]

X

X

X

X

X

X

Box_[PKParam]_Norm-[Demog]_Trt or _Per_GroupBy-Strat-[Demog]

X

X

X

X

X

X

Box_[PKParam]_Strat-[Demog][Value]

X

X

X

X

X

X

Box_[PKParam]_Norm-[Demog]_Strat-[Demog][Value]

X

X

X

X

X

X

[PKParam]_by-Dose

X

X

X

X

X

X

[PKParam]_Norm-[Demog]_vs_Dose

X

X

X

X

X

X

[PKParam]_Trt or _Per_GroupBy-Strat-[Demog]_by-Dose

X

X

X

X

X

X

[PKParam]_Norm-[Demog]_Trt or _Per_GroupBy-Strat-[Demog]_by-Dose

X

X

X

X

X

X

[PKParam]_Strat-[Demog][Value]_by-Dose

X

X

X

X

X

X

[PKParam]_Norm-[Demog]_Strat-[Demog][Value]_by-Dose

X

X

X

X

X

X

Box_[PKParam]_vs_Dose

X

X

X

X

X

X

Box_[PKParam]_Normalized_[Demog]_vs_Dose

X

X

X

X

X

X

Box_[PKParam]_Trt or _Per_GroupBy-Strat-[Demog]_by-Dose

X

X

X

X

X

X

Box_[PKParam]_Norm-[Demog]_Trt or _Per_GroupBy-Strat-[Demog]_by-Dose

X

X

X

X

X

X

Box_[PKParam]_Strat-[Demog][Value]_by-Dose

X

X

X

X

X

X

Box_[PKParam]_Norm-[Demog]_Strat-[Demog][Value]_by-Dose

X

X

X

X

X

X

[PKParam]_ vs_Cont_[Demog]

X

X

X

X

X

X

[PKParam]_ Norm-[Demog]_vs-Cont-[Demog]

X

X

X

X

X

X

PKParam]_Trt or _Per_GroupBy-Strat-[Demog]_vs-Cont-[Demog]

X

X

X

X

X

X

[PKParam]_Norm-[Demog]_Trt or _Per_GroupBy-Strat-[Demog]_vs-Cont-[Demog]

X

X

X

X

X

X

[PKParam]_Strat-[Demog][Value]_vs-Cont-[Demog]_vs-Cont-[Demog]

X

X

X

X

X

X

[PKParam]_Norm-[Demog]_Strat-[Demog][Value]_vs-Cont-[Demog]

X

X

X

X

X

X

Filename (*.jpg, *.emf, *.wmf)

Description

*Comp_Conc_by_Subject_Lin/Log

Overlay time-concentration graph of all treatment and period with all possible analyte combinations (e.g., Treat­ment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…) per subject. One graph per subject indepen­dent of number of treatments and analytes. Activate Com­parison Individual Time Conc checkbox in the Appendix list to incorporate these graphs into a Word file called Com­parison_Individual_Time_Conc.doc.

*Comp_Summary_Conc_Lin/Log

Summary overlay time-concentration graph of all treat­ments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treat­ment 2 Analyte 1…). One graph per run independent of number of subjects, treatments, and analytes.

*Comp_Excretion_Rate_by_Sub­ject_Lin/Log

Overlay excretion rate graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…) per subject. One graph per subject independent of number of treatments and analytes. Activate Comparison Individual Excretion Rate by Subject checkbox in the Appendix list to incorporate these graphs into a Word file called Comparison_Individual_Excretion_Rate.doc.

*Comp_Summary_Excre­tion_Rate_Lin/Log

Summary overlay excretion rate graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…). One graph per run independent of number of subjects, treatments, and analytes.

*Comp_Cumulative_Amount_Excret­ed_by_Subject_Lin/Log

Overlay of the cumulative amount of urine excreted by sub­ject for all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…). One graph per sub­ject independent of number of treatments and analytes. Activate Comparison Individual Cumulative Amount Excreted by Subject checkbox in the Appendix list to incorporate these graphs into a Word file called Compari­son_Individual_Cumulative_Amount_Excreted.doc.

*Comp_Summary_Cumula­tive_Amount_Excreted_Lin/Log

Summary overlay line graph of the cumulative amount of urine excreted by treatment vs. midpoint or end time. Error bars are available.

*Comp_Amount_Excreted_by_Sub­ject_Lin/Log

Overlay line graph of the amount excreted by subject per treatment vs. midpoint or end time.

*Comp_Summary_Amount_Excret­ed_Lin/Log

Comparison overlay line graph of the summary amount excreted vs. the midpoint or end time. Error bars are avail­able.

*Comp_Percent_Dose_Remaining

_by_Subject_Lin/Log

Overlay line graph of the percent dose remaining by sub­ject per treatment vs. midpoint or end time.

*Comp_Summary_Percent_Dose_Re­maining_Lin/Log

Comparison overlay line graph of the summary percent dose remaining vs. the midpoint or end time. Error bars are available.

*Comp_Trough_Conc_by_Sub­ject_Lin/Log

Overlay trough time-concentration graph of all treatments and periods with all possible analyte combinations (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…) per subject. One graph per subject indepen­dent of number of treatments and analytes. Activate Com­parison Individual Trough Time checkbox in the Appendix list to incorporate these graphs into a Word file called Comparison_Individual_Trough_Time.doc.

*Comp_Summary_Conc_Lin/Log (Trough)

Summary overlay trough time-concentration graph of all treatments and periods with all possible analyte combina­tions (e.g., Treatment 1 Analyte 1, Treatment 1 Analyte 1, Treatment 2 Analyte 1…). One graph per run independent of number of subjects, treatments, and analytes.

*Comp_[PKParam]

Individual and summary overlay PK parameter graph of all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations dis­played on X-axis. One graph per PK parameter per run independent of number of treatments or periods, analytes, days, or subjects. All Comparison types included.

Comp_[PKParam]_Norm-[Demog]

Individual and summary overlay normalized PK parameter graph of all treatments and periods with all possible Ana­lyte (Analyte–Plasma/Urine), Day (Accumulation), Abso­lute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on X-axis. One graph per PK parameter per run independent of number of treatments or periods, analytes, days, or subjects.

*Comp_Box_[PKParam]

Box & whisker plot of PK parameter for all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clini­cal Renal (Treatment) combinations displayed on X-axis. One graph per PK parameter per run independent of num­ber of treatments or periods, analytes, days, or subjects. All Comparison types included. Requires at least three subjects in the study.

Comp_Box_[PKParam]_Norm-[Demog]

Box & whisker plot of normalized PK parameter for all treatments and periods with all possible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations dis­played on X-axis. One graph per PK parameter per run independent of number of treatments, periods, analytes, days, or subjects. Requires at least three subjects in the study.

*Comp_[PKParam]_vs-Cont-[Demog]

Individual scatter plot of PK parameter graph vs. continu­ous demographic of all treatments and periods with all pos­sible Analyte (Analyte–Plasma/Urine), Day (Accumulation), Absolute Bioavail (Treatment), Clinical Renal (Treatment) combinations displayed on legend. One graph per PK parameter per run independent of number of treatments periods, analytes, days, or subjects.

Comp_[PKParam]_Norm-[Demog]_vs-Cont-[Demog]

Individual scatter plot of PK parameter graph vs. continu­ous demographic all each treatment and period with all possible Analyte (Analyte–Plasma/Urine), Day (Accumula­tion), Absolute Bioavail (Treatment), Clinical Renal (Treat­ment) combinations displayed on legend. One graph per PK parameter per run independent of number of treat­ments, periods, analytes, days, or subjects.

*Comp_[PKParam]_Trt or _Per_vs-Cont-[Demog]

Individual scatter plot PK parameter graph vs. continuous demographic of each treatment or period with all possible Analyte (Analyte–Plasma/Urine) or Day (Accumulation) combinations displayed on legend. One graph per PK parameter per treatment or period per run independent of number of analytes, days, or subjects.

Comp_[PKParam]_Norm-[Demog]_Trt or _Per_vs-Cont-[Demog]

Individual scatter plot PK parameter graph vs. continuous demographic of each treatment or period with all possible Analyte (Analyte–Plasma/Urine) or Day (Accumulation) combinations displayed on legend. One graph per PK parameter per treatment or period per run independent of number of analytes, days, or subjects.

Filename (*.jpg, *.emf, *.wmf)

Analyte

Accum

Abs Bio
Avail

Renal Cl

Plasma

Urine

Trough

Time-Concentration Graphs — Plasma

Comp_Conc_by_Subject_Lin/Log

X

X

X

Comp_Summary_Conc_Lin/Log

X

X

X

Time-Concentration Graphs — Urine

Comp_Excretion_Rate_by_Subject_Lin/Log

X

Comp_Summary_Excretion_Rate_Lin/Log

X

Comp_Cumulative_Amount_Excreted_by_Sub­ject_Lin/Log

X

Comp_Summary_Cumulative_Amount_Excret­ed_Lin/Log

X

Comp_Amount_Excreted_by_Subject_Lin/Log

X

Comp_Summary_Amount_Excreted_Lin/Log

X

Comp_Percent_Dose_Remaining_by_Sub­ject_Lin/Log

X

Comp_Summary_Percent_Dose_Remaining_Lin/Log

X

Time-Concentration Graphs — Trough

Comp_Trough_Conc_by_Subject_Lin/Log

X

Comp_Summary_Conc_Lin/Log (Trough)

X

PK Parameter Graphs — Plasma and Urine

Comp_[PKParam]

X

X

X

X

X^a

Comp_[PKParam]_Norm-[Demog]

X

X

X

X

X^a

Comp_Box_[PKParam]

X

X

X

X

X^a

Comp_Box_[PKParam]_Norm-[Demog]

X

X

X

X

X^a

Comp_[PKParam]_vs-Cont-[Demog]

X

X

X

X

X^a

Comp_[PKParam]_Norm-[Demog]_vs-Cont-[Demog]

X

X

X

X

X^a

Comp_[PKParam]_Trt or _Per_vs-Cont-[Demog]

X

X

X

Comp_[PKParam]_Norm-[Demog]_Trt or _Per_vs-Cont-[Demog]

X

X

X

Word Document

Description

Time-Concentration/Excretion Rate/Percent Dose Remaining

Individual_Time_Concentration.doc

Individual time-concentration, one subject per graph

Individual_Excretion_Rate.doc

Individual_Excretion_Rate, one subject per graph

Individual_Percent_Dose_Remaining.doc

Individual percent dose remaining, one subject per graph.

Individual_Cumulative_Amount_Excreted.doc

Individual_Cumulative_Amount_Excreted.doc

Individual_Amount_Excreted.doc

Individual_Amount_Excreted.doc

PK Parameter

Summary_PK_Text.doc

Individual regression fit, one subject per graph and listing of the individual PK parameter values selected for display in the tables.

•If Phoenix cannot create a regression line (for instance, when concentration increases over time), AutoPilot Toolkit cannot generate this document, since it is based. To force a regres­sion line, set the start and stop times in Phoenix larger than t_last.

•Any selections made to the X-axis scaling, including uniform vs. non-uniform scaling, user-defined tick mark settings, and any options to start the X-axis at time=0, are only applied to the JNB, WMF, and EMF output objects and not to the charts in this document.

Word Document

Study Design and Dosing/Matrix

Crossover

Parallel

SD

MD

TR

UR

SD

MD

TR

UR

Time-Concentration/Excretion Rate/Percent Dose Remaining

Individual_Time_Concentration.doc

X

X

X

X

X

X

Individual_Excretion_Rate.doc

X

X

Individual_Percent_Dose_Remaining.doc

X

X

Individual_Cumulative_Amount_Excreted.doc

X

Individual_Amount_Excreted.doc

X

PK Parameter

Summary_PK_Text.doc

X

X

X

X

X

X

Filenames (*.doc)

Analyte

Accum

Abs Bio
Avail

Renal Cl

Plasma

Urine

Trough

Time-Concentration Graphs

Comparison_Individual_Time_Conc.doc

X

X

X

Comparison_Individual_Trough_Time.doc

X

Comparison_Individual_Excretion_Rate.doc

X

Comparison_Individual_Cumulative_Amount_­Excreted.doc

X