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Description
Value Range
Notes
Data Structures with shared data
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Multiple Adverse Events

mae

01

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Element NameData TypeSizeRequiredDescriptionValue RangeNotesAliases
subjectkeyGUIDRequiredThe NDAR Global Unique Identifier (GUID) for research subjectNDAR*
src_subject_idString20RequiredSubject ID how it's defined in lab/project
interview_dateDateRequiredDate on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYYRequired field
interview_ageIntegerRequiredAge in months at the time of the interview/test/sampling/imaging.0 :: 1260Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
genderString20RequiredSex of the subjectM;FM = Male; F = Female
aeString250RecommendedAdverse event Descriptionae1_name
aestddDateRecommendedAE start date MM/DD/YYYYae1_startdate
aeenddDateRecommendedAE end date MM/DD/YYYYae1_stopdate
aesevIntegerRecommendedSeverity1::4; -91 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; -9=unknownae1_severity
aerelIntegerRecommendedRelatedness1::31 = Not related; 2 = Possibly/Probably related; 3 = Definitely relatedae1_relation_inflix
aeoutIntegerRecommendedOutcome1::17; -91 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving; 16= returned to baselineae1_outcome
aeacnIntegerRecommendedAction taken1::11;991 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown;9 = Dose increased; 10 = Delayed;11=Change Administration Timeae1_action
aeserIntegerRecommendedSerious0;1; -90 = No; 1 = Yes; -9=unknownae1_serious
aes2String50RecommendedDescription of Adverse Event2ae2_name
aes2dateDateRecommendedAdverse Event2 Onset Dateae2_startdate
ae2_stopdateDateRecommendedAdverse Event 2 Stop Date
aes2svrtIntegerRecommendedSeverity of AE 21::31 = Mild; 2 = Moderate; 3 = Severeae2_severity
ae2_relationIntegerRecommendedAdverse Event 2 Relationship to study drug1::31= related; 2= not related; 3= possibly relatedae2_relation_inflix
ae2_outcomeIntegerRecommendedAdverse Event 2 Outcome1::151 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving
ae2_actionIntegerRecommendedAdverse Event 2 Action Taken1::81 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown
ae2_seriousIntegerRecommendedAdverse Event 2 Serious0;10=no; 1=yes
aes3String50RecommendedDescription of Adverse Event3ae3_name
aes3dateDateRecommendedAdverse Event3 Onset Dateae3_startdate
ae3_stopdateDateRecommendedAdverse Event 3 Stop Date
aes3svrtIntegerRecommendedSeverity of AE 30::31 = Mild; 2 = Moderate; 3 = Severe; 0=Absentae3_severity
ae3_relationIntegerRecommendedAdverse Event 3 Relationship to study drug1::31 = Not related; 2 = Possibly/Probably related; 3 = Definitely relatedae3_relation_inflix
ae3_outcomeIntegerRecommendedAdverse Event 3 Outcome1::151 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving
ae3_actionIntegerRecommendedAdverse Event 3 Action Taken1::81 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown
ae3_seriousIntegerRecommendedAdverse Event 3 Serious0;10=no; 1=yes
aesa21dString50RecommendedDescription of Adverse Event4ae4_name
ae4_startdateDateRecommendedAdverse Event 4 Start Date
ae4_stopdateDateRecommendedAdverse Event 4 Stop Date
ae4_severityIntegerRecommendedAdverse Event 4 Severity1::31= mild; 2= moderate; 3= severe
ae4_relationIntegerRecommendedAdverse Event 4 Relationship to study drug1::31 = Not related; 2 = Possibly/Probably related; 3 = Definitely relatedae4_relation_inflix
ae4_outcomeIntegerRecommendedAdverse Event 4 Outcome1::151 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving
ae4_actionIntegerRecommendedAdverse Event 4 Action Taken1::81 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown
ae4_seriousIntegerRecommendedAdverse Event 4 Serious0;10=no; 1=yes
ae5_nameString20RecommendedAdverse Event 5 Name
ae5_startdateDateRecommendedAdverse Event 5 Start Date
ae5_stopdateDateRecommendedAdverse Event 5 Stop Date
ae5_severityIntegerRecommendedAdverse Event 5 Severity1::31= mild; 2= moderate; 3= severe
ae5_relationIntegerRecommendedAdverse Event 5 Relationship to study drug1::31 = Not related; 2 = Possibly/Probably related; 3 = Definitely relatedae5_relation_inflix
ae5_outcomeIntegerRecommendedAdverse Event 5 Outcome1::151 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving
ae5_actionIntegerRecommendedAdverse Event 5 Action Taken1::81 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown
ae5_seriousIntegerRecommendedAdverse Event 5 Serious0;10=no; 1=yes
ae6_nameString20RecommendedAdverse Event 6 Name
ae6_startdateDateRecommendedAdverse Event 6 Start Date
ae6_stopdateDateRecommendedAdverse Event 6 Stop Date
ae6_severityIntegerRecommendedAdverse Event 6 Severity1::31= mild; 2= moderate; 3= severe
ae6_relationIntegerRecommendedAdverse Event 6 Relationship to study drug1::31 = Not related; 2 = Possibly/Probably related; 3 = Definitely relatedae6_relation_inflix
ae6_outcomeIntegerRecommendedAdverse Event 6 Outcome1::151 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving
ae6_actionIntegerRecommendedAdverse Event 6 Action Taken1::81 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown
ae6_seriousIntegerRecommendedAdverse Event 6 Serious0;10=no; 1=yes
ae7_nameString20RecommendedAdverse Event 7 Name
ae7_startdateDateRecommendedAdverse Event 7 Start Date
ae7_stopdateDateRecommendedAdverse Event 7 Stop Date
ae7_severityIntegerRecommendedAdverse Event 7 Severity1::31= mild; 2= moderate; 3= severe
ae7_relationIntegerRecommendedAdverse Event 7 Relationship to study drug1::31 = Not related; 2 = Possibly/Probably related; 3 = Definitely relatedae7_relation_inflix
ae7_outcomeIntegerRecommendedAdverse Event 7 Outcome1::151 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown; 6=AE Still Present-No Treatment; 7=AE Still Present-Being Treated; 8=Residual Effect(s) Present-No Treatment; 9=Residual Effect(s) Present-Being Treated; 10=Change in severity, status, or characteristic ; 11=Lost to follow up; 12=Other; -9=unknown;13= not recovered/not resolved; 14= recovered/resolved with sequelae; 15= recovered/resolving
ae7_actionIntegerRecommendedAdverse Event 7 Action Taken1::81 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown
ae7_seriousIntegerRecommendedAdverse Event 7 Serious0;10=no; 1=yes
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
  • For valid elements with shared data, on the far left is a Filter button you can use to view a summary of shared data for that element and apply a query filter to your Cart based on selected value ranges

At the top of this page you can also:

  • Use the search bar to filter the elements displayed. This will not filter on the Size of Required columns
  • Download a copy of this definition in CSV format
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

Please email the The NDA Help Desk with any questions.

Distribution for DataStructure: mae01 and Element:
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Filters enable researchers to view the data shared in NDA before applying for access or for selecting specific data for download or NDA Study assignment. For those with access to NDA shared data, you may select specific values to be included by selecting an individual bar chart item or by selecting a range of values (e.g. interview_age) using the "Add Range" button. Note that not all elements have appropriately distinct values like comments and subjectkey and are not available for filtering. Additionally, item level detail is not always provided by the research community as indicated by the number of null values given.

Filters for multiple data elements within a structure are supported. Selections across multiple data structures will be supported in a future version of NDA.