Mortality Time to Event

Mortality Time-to-Event groups clinical mortality results by treatment arm and generates Kaplan-Meier survival curves with associated statistics.

Report Results Description

Running this report for Nicardipine using default settings generates the report shown below.

Mortality Time to Event

This plot is a Kaplan-Meier time-to-event analysis that compares the time until the last disposition record. Otherwise, subjects are censored at the reference end date (RFENDTC). See Survival Plot for more information.

The Number at Risk table, displayed at the bottom of the figure when All Patients is selected using the Number at Risk display option, communicates the number of patients who have yet to have an event or be censored. When Cumulative Events is selected using the Number at Risk display option, the total number of patients with events up to and including a particular time are presented in the risk table, which has now been renamed Cumulative Events. Numbers are presented every 30 days and at the last day of follow up.

Product-Limit Survival Fit

Contains a Kaplan-Meier time-to-event analysis and associated statistics.

•

One Survival Plot.

This analysis compares the time until the last disposition record. Otherwise, subjects are censored at the reference end date (RFENDTC).

See Survival Plot for more information.

•

Summary Statistics

Contains tables of summary statistics for the survival of the study subjects.

Hazard Ratio Plots

Displays Hazard Ratio Event Plots with 95% confidence intervals for each of the following demographic subgroups: overall, gender, race, country, study site identifier, high and low baseline lab tests, concomitant medications, medical history, and adverse events.

Options

Data

End Date Variable to Use for Censoring

Use the End Date Variable to Use for Censoring option for specifying the end date for censoring. Options include the reference end date (selected by default), the date of the last treatment, or the date of the last disposition record.

Number at Risk Interval (days)

Enter the number of days comprising the block of time between study days where the number of subjects remaining in the study are reported.

Color Risk Table by Treatment

Use this option to color the numbers in the Risk Table by treatment.

Display

Number at Risk

Use this option to specify whether to calculate risk for all subjects or just those experiencing cumulative events. All Patients, which is set by default, displays the number of patients currently at risk in the analysis (i.e., those who have yet to have an event or be censored). Cumulative Events displays the number of patients who have experienced an event by the given time point.

Add Intervals

Check this option to show the 95% pointwise confidence bands for the Kaplan-Meier survival functions in the Survival Plot and the Failure Plot. Meeker and Escobar (1998, ch. 3) discuss pointwise and simultaneous confidence intervals and the motivation for simultaneous confidence intervals in survival analysis.

Add Simultaneous Intervals

Check this option to show the 95% simultaneous confidence bands for the Kaplan-Meier survival functions in the Survival Plot and the Failure Plot. Meeker and Escobar (1998, ch. 3) discuss pointwise and simultaneous confidence intervals and the motivation for simultaneous confidence intervals in survival analysis.

Add Tests

Check this option to add the Wilcoxon and Log-rank test p-values when two or more treatments are present.

General and Drill Down Buttons

Action buttons provide you with an easy way to drill down into your data. The following action buttons are generated by this report:

•

Click to rerun the report using default settings.

•

Click to view the associated data tables. Refer to Show Tables for more information.

•

Click to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections.

•

Click to generate a JMP Live report. Refer to Create Live Report for more information.

•

Click to take notes, and store them in a central location. Refer to Add Notes for more information.

•

Click to read user-generated notes. Refer to View Notes for more information.

•

Select one or more subjects, then click to apply the Review Subject Filter and filter all reports in the review builder on the selected subjects.

•

Select a group of subjects and click to specify Derived Population Flags that enable you to distinguish the selected group of subjects from the general population based on their meeting specific criteria.

By default, time is measured in days. However, you can change the Time Scale to measure time in weeks. This option is useful for assessing report graphics for exceptionally long studies.

You can opt to assess interventions across the entire study (specified by default). Alternatively, you can specify an End Time to restrict the analysis to a specific time interval.

Default Settings

Refer to Set Study Preferences for default Subject Level settings.

Methodology

Deaths are determined using records from the disposition dataset where the term (DSDECOD) is either DEATH, DEAD, or DIED and the study day (DSSTDY) is greater than or equal to 1. Subjects with missing censor date information are removed from the analysis. Notes are displayed at the top of the report for what censor date variable is used and how many subjects were removed due to missing censor date information.

To produce the hazard ratios, the preference for control level must be set to a level other than None. Any subgroups in the hazard ratios that cause a convergence issue are removed from the analysis and a note is displayed under the plots for which subgroups were removed.

Note: xxOCCUR records are excluded from this analysis.