Reports | AE Time to Event

AE Time to Event
The AE Time to Event report screens all adverse events by performing log-rank and Wilcoxon tests between treatment groups. The time to first occurrence of the adverse event is used as the response.
Note : If you run this analysis using data from a blinded study or from a study that has only one ARM, you generate a different set of output. See AE Time to Event (One ARM) for a detailed description
The AE Time to Event report screens all adverse events by performing log-rank and Wilcoxon tests between treatment groups. The time to first occurrence of the adverse event is used as the response.
Report Results Description
Running this report with the Nicardipine sample setting generates the tabbed Results shown below.
Volcano Plots
Presents summary figures for two popular statistical tests for Kaplan-Meier analyses: the Log-Rank and Wilcoxon .
The Volcano Plots section contains the following elements:
Two Volcano Plots .
The Y axis represents the -log 10 (raw p-value ) from either the Log-Rank test ( left ) or the Wilcoxon test ( right ). In most instances, these two tests coincide. To interpret this axis, consider the following.
1. a p -value of 1 equals 0 on the -log 10 scale,
2. a p -value of 0.1 equals 1 on the -log 10 scale,
3. a p -value of 0.01 equals 2 on the -log 10 scale,
4. a p -value of 0.001 equals 3 on the -log 10 scale,
5. a p -value of 0.0001 equals 4 on the -log 10 scale.
The X axis represents the maximum computed distance between the two curves, and color indicates which treatment was likely to have the event sooner. For example, Phlebitis occurs at approximately 0.27 on the X axis and is green . This means that at least one time point in the Kaplan-Meier and Hazard Plots , the risk of having this particular event was 27% more likely for Nicardipine versus Placebo.
Events above the dotted red line are considered statistically significant after adjusting for multiple comparisons. Adjustment is applied using the linear step-up method of Benjamini and Hochberg (1995) to control the false discovery rate.
See Volcano Plot for more information.
Action Buttons
Action buttons, provide you with an easy way to drill down into your data. The following action buttons are generated by this report:
Kaplan-Meier and Hazard Plots : Click to generate individual Kaplan-Meier and hazard curves for selected events. This button is surfaced when Time to first event is specified as the Response Type .
Fit Incidence Density Model : Click to fit selected events to a generalized linear model. This button is surfaced when either Incidence density based on first event only or Incidence density based on all events is specified as the Response Type .
Click to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.
Click the Options arrow to reopen the completed report dialog used to generate this output.
Click the gray border to the left of the Options tab to open a dynamic report navigator that lists all of the reports in the review. Refer to Report Navigator for more information.
Note : For information about how treatment emergent adverse events (TEAEs) are defined in JMP Clinical, please refer to How does JMP Clinical determine whether an Event Is a Treatment Emergent Adverse Event? ..
Report Options
Report Option Descriptions
Specific documentation for each of the options can be viewed by clicking on the following links:
General Options
Term Level , Treatment or Comparison Variable to Use , Treatment or Comparison Variable
Include serious adverse events only , Event Type , Ignore available treatment emergent flags , Offset for End of Dosing , Response Type , Percent Occurrence Threshold
Subject Filter 1
Additional Filters
Additional Filter to Include Subjects 2 Merge supplemental domain , Filter to Include Adverse Events , Select the population to include in the analysis , By Variables
Treatment Control Level , Time Scale , Trial Time Windows
Incidence Density Modeling : Distribution , Class Variables , Fixed Effects , Random Effects , Gradient Convergence Criterion
Color Theme

Subject-specific filters must be created using the Create Subject Filter report prior to your analysis.

For more information about how to specify a filter using this option, see The SAS WHERE Expression .