Problem Note 60237: JMP® Clinical 6.1 Adverse Event Narratives do not handle Supplemental Data
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This Hotfix allows supplemental data to be used in Adverse Events Narratives in JMP® Clinical 6.1.
One option is to specify the full path and name to the input SAS data set containing supplemental data for AE narratives. This data set merges events using USUBJID and AESEQ. If AESEQ is not available in the original SDTM or ADAM data, AESEQ is defined after sorting events by USUBJID, AESTDTC, and AETERM for events where AETERM is non-missing. This allows the merger on any data for each AE.
Additionally this HotFix handles AEOUT and AEACN in a multiple treatment study. In particular, these important grouping AE variables can be defined for each treatment making it much easier to evaluate in the AE Distribution report.
To use these enhancements apply the Hotfix specified in the Hotfix tab.
Operating System and Release Information
Product Family | Product | System | Product Release | SAS Release | ||
Reported | Fixed* | Reported | Fixed* | |||
JMP Software | JMP Clinical | Microsoft® Windows® for x64 | 6.1 | 9.4 TS1M4 | ||
Microsoft Windows 8 Enterprise 32-bit | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 8 Enterprise x64 | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 8 Pro 32-bit | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 8 Pro x64 | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 8.1 Enterprise 32-bit | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 8.1 Enterprise x64 | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 8.1 Pro 32-bit | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 8.1 Pro x64 | 6.1 | 9.4 TS1M4 | ||||
Microsoft Windows 10 | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Enterprise 32 bit | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Enterprise x64 | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Home Premium 32 bit | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Home Premium x64 | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Professional 32 bit | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Professional x64 | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Ultimate 32 bit | 6.1 | 9.4 TS1M4 | ||||
Windows 7 Ultimate x64 | 6.1 | 9.4 TS1M4 |
A fix for this issue for JMP Clinical 6.1 is available at:
https://tshf.sas.com/techsup/download/hotfix/HF2/A6M.html#60237
JMP® Clinical 6.1 Adverse Event Narratives do not handle supplemental data in the SUPPAE domain, or other SAS datasets containing supplemental data for Adverse Events.
Type: | Problem Note |
Priority: | high |
Date Modified: | 2017-04-03 15:07:14 |
Date Created: | 2017-04-03 14:45:59 |