This report is used to generate AE narratives for clinical study reports.
Running this report with the Nicardipine sample setting generates an rtf file containing narratives like the one below.
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When a partial date 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 partial, 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 partial, 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 partial, 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 partial 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 partial, 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 partial, 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.
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Paragraph 1 summarizes demographic and medical history. You have the option to include reported or coded medical history terms. The first exposure to study drug is reported as well as the subject's completion status. The appropriate disposition term from DS should be provided on the General tab of the AE Narrative dialog.
Paragraph 2 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". If a subject has no records in EX with a dose > 0, then they are considered "Untreated". If more than one dose is taken on the day on which the event begins, the maximum is reported. Concomitant medications were used to treat the event are reported (based on AECONTRT). Should AECONTRT = Y, the narrative code attempts to identify these medications by looking for medications with indications that match the reported term of the event.
Paragraph 3 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. Only unique instances based on AE term and severity are printed. For example, if a subject has two mild headaches in a six-day window, this is printed only once. Any medications that are taken at the time of the event are reported. The Options tab enables you to include the indication for each medication. Similar to the reporting of nearby AEs, only unique concomitant medications (and indications, if requested) are reported.
Paragraphs 4-6 (if requested from the Labs, ECG, or Vital Signs sections) provide a brief description of findings results that provide further insight to the adverse event. Baseline findings can be included to understand how a subject began the study. Baseline flags reported in the data are considered for defining baseline. Otherwise, the program determines baseline (of all records, or those flagged as baseline from the data). For laboratory measurements, the last measurement on or before the start of dosing (day 1) is considered baseline. For ECG and Vital Signs, the last day of measurements on or before the start of dosing (day 1) is considered baseline. If multiple measurements are reported on this day, all measurements are reported. You also have the ability to report on post-baseline findings that occur on, before, or after the event. Findings reporting can be customized using WHERE statements (see The SAS WHERE Expression) or the option to subset those tests or results that are of interest.
The final paragraph 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: For information about how incomplete or missing date and time information is handled by JMP Clinical, please refer to How does JMP Clinical handle partial or incomplete date and time information?.