Data Guidelines

Data Guidelines

AE Explorers are initialized using JSON data files that match the format created by d3.csv(). The chart requires a data set with one record per adverse event and optionally with placeholder rows for participants who didn't experience any adverse events over the course of the study. The chart uses column names from the ADAM data standard by default, but can be customized to work with any column names as long as the data structure is as expected.

Default Chart

The following table describes chart settings and data specifications required to create an AE Explorer. A sample chart using this configuration is found here.

Data Specification

Settings Variable	Variable	Default	Required?
variables.id	Participant ID	USUBJID	Y
variables.major	Major Category	AEBODSYS	Y
variables.minor	Minor Category	AEDECOD	Y
variables.group	Group Variable	ARM	Y

Settings Object

No customization is needed to initialize a chart when the data object contains all default variables above. Just pass an empty object ({}) for settings and initialize the chart like so: aeTable("body",{}).init(data)

Customized Chart with Queries

The following data specs and chart settings can be used to create a chart with several custom filters, including Sex, Race and Query Status. A sample chart using this configuration is found here.

Data Specification

Settings Variable	Variable	Default	Required?
variables.id	Participant ID	USUBJID	Y
variables.major	Major Category	AEBODYSYS	Y
variables.minor	Minor Category	AEDECOD	Y
variables.group	Group Variable	ARM	Y
variables.filters	AE Seriousness	AESER	Y
variables.filters	AE Severity	AESEV	Y
variables.filters	AE Relationship	AEREL	Y
variables.filters	AE Outcome	AEOUT	Y
variables.filters	Site ID	SITEID	Y
variables.filters	Treatment Arm	ARM	Y
variables.filters	Sex	SEX	Y
variables.filters	Race	RACE	Y
variables.filters	Query Flag ("Y" for yes)	QUERYFL	Y

Settings Object

const settings = {
        'variables': {
            'id': 'USUBJID',
            'major': 'AEBODSYS',
            'minor': 'AEDECOD',            
            'group': 'ARM',
            'filters': [
                { 'value_col': 'AESER', 'label': 'Serious?', 'type': 'event' }, 
                { 'value_col': 'AESEV', 'label': 'Severity','type': 'event' }, 
                { 'value_col': 'AEREL', 'label': 'Relationship','type': 'event' }, 
                { 'value_col': 'AEOUT','label': 'Outcome','type': 'event' }, 
                { 'value_col': 'SITEID', 'label': 'Site ID','type': 'participant' }, 
                { 'value_col': 'ARM', 'label': 'Arm','type': 'participant' },
                { 'value_col': 'SEX', 'label': 'Sex','type': 'participant' },
                { 'value_col': 'RACE', 'label': 'Race','type': 'participant' },
                { 'value_col': 'QUERYFL','label': 'Open Query?','type': 'event' }
            ]
        },
        'defaults': {
            'placeholderFlag': {'value_col': "AEBODSYS", 'values': [""] },
            'maxPrevalence': 10,
            'maxGroups': 7,
            'totalCol': true,
            'diffCol': true,
            'prefTerms': false 
        },
        'plotSettings': { 'h': 15,
            'w': 200,
            'margin': { 'left': 40, 'right': 40 },
            'diffMargin': { "left": 5, "right": 5 },
            'r': 7 }
        };