Adverse Events Narrative

This report is used to generate adverse events narratives for clinical study reports.

Note: This report is considered to be Experimental in JMP Clinical v17.0. This report supports DM, ADSL, AE or ADE, EX start and end dates, and AE windows of 7 days only. There are no options available and the report uses the Default by Subject narrative template only. This report should not be used for submissions. We have included it to elicit user feedback and would appreciate any comments or suggestions you might care to offer. A fully functional version of this report will be available in JMP Clinical v17.1.

Report Results Description

Running this report with the Nicardipine sample setting generates an rtf file containing narratives like the one below.

The narrtext dataset output by the AE Narrative report contains variables that are used by the template to create the narrative. Refer to The Adverse Events Narrative NarrText Derivations Table for additional details about these variables and their derivations.

Click to create an RTF of the narratives.

A narrative, containing descriptions of all of the observed adverse events, is generated for each patient. The narrative for the Nicardipine example is 3134 pages long. In the example shown here, subject 101001 experienced 4 adverse events that are described over 2 pages.

Each narrative contains summary of patient demographics and the description of the adverse events experienced by that patient. Each description consists of the name and occurrence of the event. followed by three paragraphs of text.

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Paragraph 1 describes the particular AE of interest, such as the date of occurrence, whether it met the definition of serious or not and the particular criteria (all non-serious AEs are considered Other Significant Adverse Events) and the action taken with study medication as the result of the event. Other details include the dose of drug taken at the time of the event and how long the subject was at this dose. If the event occurred between the first and last day of dosing (inclusive), and a subject received a dose of 0 or no drug taken at the time, then this is considered a dose interruption. Events before the first day of dosing are considered "Pre-treatment", while those after the last day of dosing are considered "Post-treatment".

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Paragraph 2 reports on other adverse events that occur close to the start of the event of interest. The severity or toxgrade of these events are reported. Windowing is set to 7 days. Only unique instances based on AE term and severity are printed. For example, if a subject has two mild headaches in a six-day , this is printed only once. Any medications that are taken at the time of the event are reported.

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Paragraph 3 describes the causal effect of the study medication to the AE and whether the event was resolved.

Note: Microsoft Word is the only supported word processor for viewing Adverse Events narratives. You might need to set Microsoft Word as your default word processor to prevent other word processors from opening the narratives.

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?.

Note: The following notes: Multiple treatment periods have been detected and displayed. and Pre-treatment has been assigned to period=0. are inserted at the top of the report when these events are detected in your data.

In case of incomplete or missing dates:

Asterisks are placed in the text and can have the following meanings:

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When an incomplete/missing date is identified (xxDTC for LB, EG or VS), an asterisk (*) is appended to the end of the finding name or test code. You should review the findings for the appropriately reported set of observations.

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When the reference date (RFSTDTC) is incomplete/missing, an asterisk is appended to the AETERM. You should review all reported dates, study days, and contents for correctness.

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When the AE start date (AESTDTC) is incomplete/missing, an asterisk is appended to the date in the narrative. You should review all contents of the narrative.

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When the AE end date (AEENDTC) is incomplete/missing, an asterisk is appended to the date in the narrative. You should review the final outcome and narrative header information for correctness.

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When any of the dosing records have incomplete/missing dates for exstdtc or exendtc, an asterisk is placed in the drug header that explains dose at time of the event, or the pre- or post-dose status. All text related to the drug should be reviewed.

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When the date of completion or discontinuation (DSSTDTC) is incomplete/missing, an asterisk is appended to the date in the narrative. You should review these dates for correctness.

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When either or both of the start or stop dates (CMSTDTC or CMENDTC) for Concomitant medications are incomplete/missing, an asterisk is appended to the end of CMTERM or CMDECOD (based on the selected analysis option). You should review the data for this medication for correctness.