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Adverse Events - Spontaneously Reported/Systematic Inquiry

1,451 Shared Subjects

Adverse Events -Spontaneously Reported/Systematic Inquiry
Clinical Assessments
Adverse Events
05/07/2014
aesposys01
05/07/2014
View Change History
01
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project CATIEID
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0 :: 1260 Age 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.
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported
Query visitid Integer Recommended MetaTrial Visit ID System variable: unique code for each type of visit -use to merge files
Query copyid Integer Recommended Copy ID for multi-copy forms The 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_term String 100 Recommended Preferred Term Coded 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
Query visit String 60 Recommended Visit name
Query truncvis Integer Recommended Truncated Visit Number Created variable: provides a numeric visit number for all visits, including unscheduled and end of phase
Query phase_ct String 20 Recommended Current 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
Query ae String 250 Recommended Adverse event Description
Query visday Integer Recommended Number of days from study baseline to date of visit
protocol String 50 Recommended Protocol [Study] name
Query anygenae Integer Recommended Any general adverse events (AE) 0;1 0=No; 1=Yes
Query reportid Integer Recommended Number of AE Report by Patient The 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.
Query soc String 100 Recommended SOC System Organ Class Coded 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
Query mdsev Integer Recommended Physicians assessment of the severity of the AE 0::4 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4= NA- Male or postmenopausal female
Query ptsev Integer Recommended Patients assessment of the severity of the AE 0::4 0 = Absent; 1 = Mild; 2 = Moderate; 3 = Severe; 4= NA- Male or postmenopausal female
Query adh_imp Integer Recommended Impact of AE on patients adherence to study medication dose regimen 0::3 0 = 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
Query ptae Integer Recommended Patient Reported AE 0;1 0=No; 1=Yes
Query mdsev_c Integer Recommended MD Severity - Created 0::3 0= Absent; 1= Mild; 2= Moderate; 3= Severe
Query mdae Integer Recommended MD Reported AE 0;1 0=No; 1=Yes
Query bl1_vis Integer Recommended Baseline Visit for Phase 1/1A 0;1 0=No; 1=Yes
Query bl1b_vis Integer Recommended Baseline Visit for Phase 1B 0;1 0=No; 1=Yes
Query bl3_vis Integer Recommended Baseline Visit for Phase 3 0;1 0=No; 1=Yes
Query bl2_vis Integer Recommended Baseline Visit for Phase 2 0;1 0=No; 1=Yes
Query bl1_sev Integer Recommended Baseline Severity for Phase 1/1A 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query bl1b_sev Integer Recommended Baseline Severity for Phase 1B 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query bl2_sev Integer Recommended Baseline Severity for Phase 2 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query bl3_sev Integer Recommended Baseline Severity for Phase 3 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query bl1_psv Integer Recommended Baseline Patient Severity for Phase 1/1A 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query bl1b_psv Integer Recommended Baseline Patient Severity for Phase 1B 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query bl2_psv Integer Recommended Baseline Patient Severity for Phase 2 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query bl3_psv Integer Recommended Baseline Patient Severity for Phase 3 0::4 0= Absent; 1= Mild; 2= Moderate; 3= Severe; 4= NA- Male or postmenopausal female
Query te1 Integer Recommended TE Phase 1/1A 1= 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
Query te1b Integer Recommended TE Phase 1B 1= 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
Query te2 Integer Recommended TE Phase 2 1= 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
Query te3 Integer Recommended TE Phase 3 1= 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
Query pte1 Integer Recommended Patient TE Phase 1/1A 1= 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
Query pte1b Integer Recommended Patient TE Phase 1B 1= 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
Query pte2 Integer Recommended Patient TE Phase 2 1= 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
Query pte3 Integer Recommended Patient TE Phase 3 1= 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
  • Download a blank CSV submission template prepopulated with the correct structure header rows ready to fill with subject records and upload

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