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Description
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Data Structures with shared data
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Adverse Events - Spontaneously Reported/Systematic Inquiry

aesposys

01

Adverse Events -Spontaneously Reported/Systematic Inquiry

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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/projectCATIEID
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
visitidIntegerRecommendedMetaTrial Visit IDSystem variable: unique code for each type of visit -use to merge files
copyidIntegerRecommendedCopy ID for multi-copy formsThe case report form used to create this file is a multi- copy form, meaning more than one copy of it can be completed at any one visit. For example, a patient with three adverse events to report at a single visit would have 3 copies of the form at that visit, one for each adverse event. The data file will have three unique records for this patient at this visit. COPYID identifies the order in which the forms were completed at a visit.
prf_termString100RecommendedPreferred TermCoded variable: MedDRA dictionary, version 4.0: Preferred Term This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit
visitString50RecommendedVisit nameCharacter description of each type of visit
truncvisIntegerRecommendedTruncated Visit NumberCreated variable: provides a numeric visit number for all visits, including unscheduled and end of phase
phase_ctString20RecommendedCurrent Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase.Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1
aeString250RecommendedAdverse event Description
visdayIntegerRecommendedNumber of days from study baseline to date of visit
protocolString50RecommendedProtocol [Study] name
anygenaeIntegerRecommendedAny general adverse events (AE)0;10=No; 1=Yes
reportidIntegerRecommendedNumber of AE Report by PatientThe case report form used to create this file is a ¿multi- copy¿ form, meaning more than one copy of it can be completed at any one visit. For example, a patient with three adverse events to report at a single visit would have 3 copies of the form at that visit, one for each adverse event. The data file will have three unique records for this patient at this visit. COPYID identifies the order in which the forms were completed at a visit.
socString100RecommendedSOC System Organ ClassCoded variable: MedDRA dictionary, version 4.0: System Organ Class This file contains the MedDRA coded terms for any AEs/side effects that were reported spontaneously by the patient at a visit
mdsevIntegerRecommendedPhysicians assessment of the severity of the AE0::40 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4= NA- Male or postmenopausal female
ptsevIntegerRecommendedPatients assessment of the severity of the AE0::40 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4= NA- Male or postmenopausal female
adh_impIntegerRecommendedImpact of AE on patients adherence to study medication dose regimen0::30 = Unrelated to antipsychotic medication; 1 = Pt thinks SE caused by med - no impact; 2 = Pt thinks SE caused by med and SE affe; 3 = Pt thinks SE caused by med and is not
ptaeIntegerRecommendedPatient Reported AE0;10=No; 1=Yes
mdsev_cIntegerRecommendedMD Severity - Created0::30= Absent; 1= Mild; 2= Moderate; 3= Severe
mdaeIntegerRecommendedMD Reported AE0;10=No; 1=Yes
bl1_visIntegerRecommendedBaseline Visit for Phase 1/1A0;10=No; 1=Yes
bl1b_visIntegerRecommendedBaseline Visit for Phase 1B0;10=No; 1=Yes
bl3_visIntegerRecommendedBaseline Visit for Phase 30;10=No; 1=Yes
bl2_visIntegerRecommendedBaseline Visit for Phase 20;10=No; 1=Yes
bl1_sevIntegerRecommendedBaseline Severity for Phase 1/1A0::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
bl1b_sevIntegerRecommendedBaseline Severity for Phase 1B0::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
bl2_sevIntegerRecommendedBaseline Severity for Phase 20::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
bl3_sevIntegerRecommendedBaseline Severity for Phase 30::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
bl1_psvIntegerRecommendedBaseline Patient Severity for Phase 1/1A0::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
bl1b_psvIntegerRecommendedBaseline Patient Severity for Phase 1B0::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
bl2_psvIntegerRecommendedBaseline Patient Severity for Phase 20::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
bl3_psvIntegerRecommendedBaseline Patient Severity for Phase 30::40= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
te1IntegerRecommendedTE Phase 1/1A1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
te1bIntegerRecommendedTE Phase 1B1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
te2IntegerRecommendedTE Phase 21= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
te3IntegerRecommendedTE Phase 31= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
pte1IntegerRecommendedPatient TE Phase 1/1A1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
pte1bIntegerRecommendedPatient TE Phase 1B1= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
pte2IntegerRecommendedPatient TE Phase 21= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
pte3IntegerRecommendedPatient TE Phase 31= if AE is treatment emergent in phase (meaning the AE was reported, either during the phase or within 30 days of ending the phase, at a higher (created) physicians assessment of severity than the (created) physicians assessment of severity at baseline for that phase and AE) = missing otherwise
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:

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  • Download a copy of this definition in CSV format
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Please email the The NDA Help Desk with any questions.

Distribution for DataStructure: aesposys01 and Element:
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Filters for multiple data elements within a structure are supported. Selections across multiple data structures will be supported in a future version of NDA.