This process is used to generate
AE
narratives for clinical study reports.
Running this process with the
Nicardipine
sample setting generates an
rtf
file containing narratives like the one below.
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
) 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
Determining If 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?
.