Enhancements to JMP® Clinical 7.1

[#1]

The following is a list of enhancements to JMP Clinical 7.1, found in the JMP Clinical 7.1.1 hot fix.

1. Adverse Event Narrative: Use CMCAT/MHCAT to determine the subset of CM/MH records to use: 
   
   For the ByNarrativeCategoryDetails template, the following has been added:
   
   For prior and concomitant medications, JMP Clinical looks to see if CMCAT = "PRIOR AND CONCOMITANT MEDICATIONS" exists as a category in the CM data set. If it does exist, then use only records where CMCAT = "PRIOR AND CONCOMITANT MEDICATIONS" to populate the prior and concomitant sections of the table. Otherwise, if CMCAT exists, populate these sections with any records where CMCAT is not equal to "PRIOR THERAPY" and is not equal to "PRIOR RADIOTHERAPY" and does not contain "PRIOR SURGERY". If CMCAT does not exist, then use all records in CM.
   
   For medical history, JMP Clinical looks to see if MHCAT = "GENERAL MEDICAL HISTORY" exists as a category in the MH data set. If it does exist, then use only records where MHCAT = "GENERAL MEDICAL HISTORY" to populate the medical history section of the table. Otherwise, if MHCAT exists, populate this section with any records where MHCAT does not equal "CANCER HISTORY". If MHCAT does not exist, then use all records in MH.
    

2. Add a dose units column to the concomitant medications table in the Adverse Event Narrative:

   In the Adverse Event Narrative, the concomitant medications table, which appears when selecting the option from the Adverse Event Narrative dialog box, now enables you to see the dose units in a column next to the dose.

3. Include the medical history end date in Patient Profile tables:

   In JMP Clinical 7.1, if a medical history end date is present, it is not included in the Medical History table within a Patient Profile. The hot fix now adds this variable to the table.

4. Additional enhancements are added for the medical history in Patient Narratives. The Patient Narrative can now display the following:

   • The complete date of the medical history, and also the date relative to the study start date 

   • The Preferred Term + Verbatim naming conventions

5. A new option for Adverse Event Narratives enables you to select from the available domains which ones you want to go to the output folder. This enables you to use any variable from the original SDTM or ADaM data sets in the templates. A new option has been added called "Select Domains". You can add any SDTM or ADaM domain with the exception of SUPP domains, RELREC, and trial design domains. Any data set selected in this new option will now go to the output folder so it can be used by the template.  

6. New validation reports are added.  

   There is now a set of validation programs and associated files for JMP Clinical 7.1. This add-in was created and put into the installation (the default path is C:\Program Files\SASHome\JMPClinical\14\Clinical\Add-in). You can simply apply this add-in to a JMP Clinical installation and run it from the Add-in menu. There is an add-in now called JMP Clinical Validation. Running this add-in enables you to run the validation programs, see the validation code, run the JMP Clinical templates, choose an output location, and explore the validation package shipped with the product.

The following is a list of enhancements to JMP Clinical 7.1, found in the JMP Clinical 7.1.2 hot fix.

1. Addition to the Incidence Screen

This hot fix adds 95% confidence intervals to the data table for incidence screens. Confidence intervals are for incidence screens in Adverse Events, Events, Interventions, and SMQ.   

2. New options for Adverse Events Incidence Rates

1. Currently, in Adverse Events incidence rates, when a subject is missing either TRTEDT or RFENDTC, then they and their Adverse Events records are removed from any result. In this hot fix, the following improvements are made. 

In this hot fix, a new option "Use last modification date for ongoing subjects" is added.

When this new check-box option is selected, the last modification date/time stamp of the Adverse Events study data set is used as the end date for subjects that are ongoing in a clinical trial and therefore missing values for the Study or Exposure End Date Variable. For example, if RFENDTC is missing in DM for a patient record because that patient is still ongoing in the clinical trial, the date of the last modification to the AE or ADAE table in the study data directory is used as the end date value.

When this option is not selected, subjects ongoing (missing End Date values) are excluded from the incidence rate analysis.

2. There is now a new dialog option to add the number of offset days. The option reads "Offset (in Days) to Include with End Date Variable". This option is enabled when a user is using Date Variables to estimate Patient Time at risk and adverse event inclusion for incidence rates. It will be a strict addition of x number of days to the period for calculating time at risk and Adverse Event inclusion. For example, if you select 30 days, 30 days will be added to the end date day to calculate risk. It will NOT consider other disposition events such as death/lost to FU/withdrawn.

3. Updated Adverse Event Incidence Rates to consistently show date/time information

Previously, the StartDY and EndDY information displayed differently when you chose Patient Years of Exposure versus Patient Years on Study. One selection shows days while the other shows dates. This hot fix now displays the results in a consistent manner, showing the dates.

4. Allow Date/Time to be used in the calculation of events for the Adverse Event Time to Event report

Currently Adverse Event (AE) Time to Event calculates time to AE in whole days and does not consider the time component of when the AE occurred. This hot fix will allow date/time values in order to calculate the time to event.

5. New Sort options for tables in Distribution Reports

This hot fix adds a new sort option, to sort by count or to sort alphabetically. The new sort option can be found in Adverse Events, Event, and Interventions distribution in the report options under the RESULTS section. Specifically the sort option can be applied to the adverse events table, the events table, and the interventions table. The sort order in the graphs is unchanged.

6. Allow longer offset to be specified for end of dosing

This hot fix allows for a greater number of days to be specified for offset for end of dosing. The slider has been extended to have a maximum of 60 (days) instead of 30 (days). This enhancement will apply to offset sliders in the following reports: AE Report, AE Distribution, AE Incidence, AE Resolution, AE Severity ANOVA, AE Time to Event, Event Distribution, Event Incidence, Intervention Distribution, Intervention Incidence, SMQ Distribution, and SMQ Incidence.

Click here to access the hot fix for this issue.

[Previously JMP Note 65481]