Results

The results tab displays the simulated value and their post-processing as tables.

General display options

The tables generally contain many rows and are by default paginated. The page displayed and the number of records per page can be changed at the bottom (green highlight). The panel on the right (blue highlight) allows to switch the pagination off in order to show the entire table. The tables can also be all expanded and collapsed. When several groups and several output variables/outcomes/endpoints have been defined, the tables can be grouped by either simulation group or output/outcome/endpoint to easily compare the tables of interest. Finally it is possible to hide some of the simulation groups using the drop-down selection menu. The display panel can be hidden with the button at the top right. The buttonĀ  on the bottom left opens the result folder which contains the simulated values and their post-processing as text files. All tables can be copied to the clipboard using the buttonĀ  at the top left . Only the displayed page is copied. To copy the entire table, expand it first.

Result tables are organized into three sections:

Simulation

The simulation tab displays the simulated output values and the sampled individual parameters.

Outputs

Because the simulated output values are usually a very large table, the results are presented as percentiles for continuous simulations (minimum, 5th percentile, median, 95th percentile and maximum) and as percentage of survival and average number of events for time-to-event simulations. These statistics are calculated over time bins calculated automatically. When replicates are used, the statistics are calculated over all replicates merged together. Each simulation group is displayed as a separate table.

The full table of simulated values can be generated if the preference setting “Export simulation files” is true. It will then appear in the result folder > Simulation > simulation_xxx.txt with xxx the output variable name.

Individual parameters [Summary]

This tab displays the percentiles summarizing the distribution of individual parameters used for simulation for each of the groups. These parameters have been either directly defined by the user or sampled from the population parameters defined by the user. As for the simulated outputs, the statistics are calculated over all replicates merged together.

Individual parameters [Table]

This tab displays the full tables of individual parameters for all replicates and for all groups. The content of these tables can also be found in a table gathering all groups in the result folder>Simulation>individualParameters.txt .

 

Endpoints

The endpoints section appears if an outcome has been defined in the simulation tab, to post-process the simulation results.

Outcomes [Summary]

The summary shows one table per outcome, displaying the percentiles over individuals and replicates for each group if the outcome is continuous, and the number of true and false individuals if the outcome is a boolean.

Outcomes [Table]

The outcomes table shows the outcome values for all individuals. A table of all values for each outcome also appears the result folder/Endpoints.

Endpoints [Summary]

Endpoints summarize the outcome values over all individuals for a specific group and replicate. The endpoints summary shows percentiles for the calculated endpoint over replicates. These percentiles give the uncertainty of the endpoint value over several clinical trial simulations.

Endpoints [Table]

The endpoints table shows the value of the endpoint defined in the simulation tab for each group and each replicate. A table for each endpoint is also saved in the result folder/Endpoints.

Group Comparison

If several simulation groups are used, and if group comparison is checked in the simulation tab, the group comparison section appears in the results.

Group comparison Table

For each replicate study, a test comparing the groups is performed as defined in the group comparison section of the simulation tab. The statistics of the test, p-value and the resulting decision (success or failure) according to the defined criteria are reported for each group (compared to the reference group) and for each replicate. A table is also saved for each statistical test and for each decision criterion in the result folder/Endpoints.

Group comparison Summary

The summary of group comparison shows for each group the percentage of replicates that led to a successful test.

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