This report compares
distributions
of
adverse events
and demographic
variables
across treatment
arm.
Note
: Refer to
Distribution Reports
for a description of the general analysis performed by the JMP Clinical distribution reports.
Running AE Distribution with
Nicardipine
using
Actual
for
Trial Time Windows
generates the
Report
for
AE Distribution
as shown below. Differences with other processes are noted throughout this output description.
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: Panel enables analysis of various demographic groups by selected AE.
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: Panel enables analysis of various AEs by selected demographic group.
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This enables you to subset subjects based on demographic characteristics and other criteria. Refer to
Data Filter
for more information.
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Counts Graph
: Using a
Bar Chart
, this tab summarizes the
distributions
of terms based on
xxDECOD
or, if unavailable,
xxTERM
or
xxTRT
depending on
CDISC
domain type. Results are summarized by selected demographic grouping and can be displayed either as total counts or percentages.
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Counts Table
: If
AEBODSYS
is available, a Table summarizes the distribution of
adverse events,
body system
or
system organ class
. Results are summarized by
Trial Time Windows
. For
Interventions Distribution
,
xxCAT
is used (if available) and the tab name reflects the appropriate label. For example, for
CM
, the tab is
Category for Medication TreeMap
.
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Distributions (AE Distribution)
: Presents
Histogram
s
of event characteristics such as
Study Start Day
,
Causality
,
Outcome
,
Severity/Intensity
, and
Seriousness
.
Other Distribution processes
present term, classification, and study day
variables
.
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Profile Subjects
: Select subjects and click
to generate the patient profiles for subjects experiencing selected events. See
Profile Subjects
for additional information.
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Show Subjects
: Select subjects and click
to open the
ADSL
(or
DM
if
ADSL
is unavailable) of selected subjects for subjects experiencing selected events.
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Cluster Subjects
: Select subjects and click
to cluster subjects experiencing selected events based on available
covariates
. See
Cluster Subjects
for additional information.
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Adverse Events Narrative Generation
: Select subjects and click
to open the
AE Narrative
dialog. From this dialog, you can customize options and generate a narrative.
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Create Subject Filter
: Select subjects and click
to create a data set of
USUBJID
s for subjects experiencing selected events, which subsets all subsequently run processes to those selected subjects. The currently available filter data set can be applied by selecting
Apply Subject Filter
in any process
dialog
.
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(
AE Distribution
only): Select subjects and click
to launch
Interventions Distribution
to summarize the distribution of concomitant medications (
CM
) for subjects experiencing selected events.
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: Select subjects and click
to generate a stacked
Histogram
to show subjects experiencing selected events across study sites by
Trial Time Windows
. Not available for
Events Distribution
.
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: Select subjects and click
to launch
Findings Time Trends
to summarize laboratory results (
LB
) across time. See
Findings Time Trends
for more detail. Not available for
Events Distribution
.
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: Select subjects and click
to launch
Findings Time Trends
to summarize vitals signs (
VS
) across time for subjects experiencing selected events,. See
Findings Time Trends
for more detail. Not available for
Events Distribution
.
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: Select subjects and click
to launch
Findings Time Trends
to summarize ECG measurements (
EG
) across time for subjects experiencing selected events. See
Findings Time Trends
for more detail. Not available for
Findings Time Trends
.
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(
Interventions Distribution
only): Select subjects taking selected medications and click
to launch
AE Distribution
to summarize the distribution of
adverse events
(
AE
).
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Uniques Occurrence Subject Counts
: Select individual records and click
consider the selected/filtered AE records only and take the FIRST OCCURRENCE for each subject per each adverse event.
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Click
to view the associated data tables. Refer to
View Data
for more information.
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Click
to generate a standardized
pdf
- or
rtf
-formatted report containing the plots and charts of selected sections.
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Click
to take notes, and store them in a central location. Refer to
Add Notes
for more information.
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Click
to read user-generated notes. Refer to
View Notes
for more information.
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Click the
arrow to reopen the completed process dialog used to generate this output.
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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
.