Data Guidelines

AE Timelines 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 with placeholder rows added 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 columns are expected in a data file used to create an instance of AE Timelines. A sample chart using this configuration is found here.

Data Specification

Settings Variable	Description	Default	Required?
id_col	Unique Subject Identifier	USUBJID	Y
seq_col	Sequence Number	AESEQ	Y
stdy_col	Analysis Start Relative Day	ASTDY	Y
endy_col	Analysis End Relative Day	AENDY	Y
term_col	Reported Term	AETERM	Y
color.value_col	Severity/Intensity	AESEV	Y *
highlight.value_col	Serious Event	AESER
* a coloring variable of some sort is required but it does not have to be AESEV

Settings

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: aeTimelines('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. The chart also highlights severe AEs and events under query. A sample chart using this configuration is found here.

Data Specification

Settings Variable	Description	Default	Required?
id_col	Unique Subject Identifier	USUBJID	Y
seq_col	Sequence Number	AESEQ	Y
stdy_col	Analysis Start Relative Day	ASTDY	Y
endy_col	Analysis End Relative Day	AENDY	Y
term_col	Reported Term	AETERM	Y
color.value_col	Severity/Intensity	AESEV	Y *
highlight.value_col	Serious Event	AESER
filter	AE Seriousness	AESER	Y
filter	AE Severity	AESEV	Y
filter	AE Relationship	AEREL	Y
filter	AE Outcome	AEOUT	Y
filter	Site ID	SITEID	Y
filter	Treatment Arm	ARM	Y
filter	Sex	SEX	Y
filter	Race	RACE	Y
filter	Query Flag ("Y" for yes)	QUERYFL	Y
* a coloring variable of some sort is required but it does not have to be AESEV

Settings Object

     var settings =
        {color:
            {value_col: 'AEREL'
            ,label: 'Relationship'
            ,values:
                ['NOT RELATED'
                ,'UNLIKELY RELATED'
                ,'POSSIBLY RELATED'
                ,'PROBABLY RELATED'
                ,'DEFINITELY RELATED']}
        ,highlight:
            {value_col: 'QUERYFL'
            ,label: 'Open Query'
            ,value: 'Y'
            ,detail_col: 'QUERY'
            ,attributes:
                {'stroke': 'black'
                ,'stroke-width': '8'
                ,'fill': 'none'
                ,'stroke-opacity':"0.2"}}
        ,custom_marks:
            [
                {type: 'circle'
                ,per: ['USUBJID', 'AESEQ', 'wc_value']
                ,tooltip: 'Serious Adverse Event'
                ,radius: 6
                ,attributes:
                    {'fill-opacity': .5
                    ,'fill': 'None'
                    ,'stroke': 'Red'}
                ,values: {"AESER": ['Y'] ,"wc_category":["ASTDY"]}}
            ]
        ,filters:
            [   {value_col: 'AESER', label: 'Serious Event'}
            ,   {value_col: 'AEREL', label: 'Relationship'}
            ,   {value_col: 'AESEV', label: 'Severity/Intensity'}
            ,   {value_col: 'USUBJID', label: 'Subject Identifier'}
            ,   {value_col: 'ARM', label: 'Arm'}
            ,   {value_col: 'SITEID', label: 'Site ID'}
            ,   {value_col: 'SEX', label: 'Sex'}
            ,   {value_col: 'RACE', label: 'Race'}
            ,   {value_col: 'QUERYFL', label: 'Has query?'}

            ]};