Output Overview Descriptions | Clinical | AE Narrative

AE Narrative
Running this process with the Nicardipine sample setting generates an rtf file containing narratives like the one below. Refer to the AE Narrative process description for more information. In general, a single narrative is included on each page. However, if Generate report by subject is selected, demographic and baseline findings (if requested) are presented with a summary of each event included. Generate Report by Subject is the default if narratives are requested from a patient profile.
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 had 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.
Based on the Number of days around AE start date (default ± 3) on the Options tab, 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 tabs) 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) 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.