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Filter Cart

Viewable at the top right of NDA pages, the Filter Cart is a temporary holder for filters and data they select. Filters are added to the Workspace first, before being submitted to The Filter Cart. Data selected by filters in the Filter Cart can be added to a Data Package or an NDA Study from the Data Packaging Page, by clicking the 'Create Data Package / Add Data to Study' button.

The filter cart supports combining multiple filters together, and depending on filter type will use "AND" or "OR"  when combining filters.

Multiple selections from the same filter type will result in those selections being applied with an ‘OR’ condition. For example, if you add an NDA Collection Filter with selections for both collections 2112 and 2563 to an empty Workspace, the subjects from NDA Collection 2112 ‘OR’ NDA Collection 2563 will be added to your Workspace even if a subject is in both NDA Collections. You can then add other NDA Collections to your Workspace which further extends the ‘OR’ condition.

If a different filter type is added to your Workspace, or a filter has already been submitted to the Filter Cart, the operation then performs a logical ‘AND’ operation. This means that given the subjects returned from the first filter, only those subjects that matched the first filter are returned by the second filter (i.e., subjects that satisfied both filters). Note that only the subjects specific to your filter will be added to your Filter Cart and only on data shared with the research community. Other data for those same subjects may exist (i.e., within another NDA Collection, associated with a data structure that was not requested in the query, etc.). So, users should select ‘Find all Subjects Data’ to identify all data for those specific subjects. 

Additional Tips:

  • You may query the data without an account, but to gain access you will need to create an NDA user account and apply for access.  Most data access requires that you or your lab are sponsored by an NIH recognized institution with Federal Wide Assurance (FWA).  Without access, you will not be able to obtain individual-level data. 

    Once you have selected data of interest you can:
  • Create a data package - This allows you to specify format for access/download
  • Assign to Study Cohort - Associate the data to an NDA Study allowing for a DOI to be generated and the data to be linked directly to a finding, publication, or data release. 
  • Find All Subject Data - Depending on filter types being used, not all data associated with a subject will be selected.  Data may be restricted by data structure, NDA Collection, or outcome variables (e.g., NDA Study). ‘Find All Data’ expands the fliter criteria by replacing all filters in your Filter Cart with a single Query by GUID filter for all subjects selected by those filters.

    Please Note:
  • When running a query, it may take a moment to populate the Filter Cart. Queries happen in the background so you can define other queries during this time. 
  • When you add your first filter, all data associated with your query will be added to the Filter Cart (e.g., a Concept, an NDA Collection, a Data Structure/Element, etc.). As you add additional filters, they will also display in the Filter Cart. Only the name of filter will be shown in the Filter Cart, not the underlying structures. 
  • Information about the contents of the Filter Cart can be seen by clicking "Edit”.
  • Once your results appear in the Filter Cart, you can create a data package or assign subjects to a study by selecting the 'Package/Assign to Study' option. You can also 'Edit' or 'Clear' filters.
     

Frequently Asked Questions

  • The Filter Cart currently employs basic AND/OR Boolean logic. A single filter may contain multiple selections for that filter type, e.g., a single NDA Study filter might contain NDA Study 1 and NDA Study 2. A subject that is in EITHER 1 OR 2 will be returned.  Adding multiple filters to the cart, regardless of type, will AND the result of each filter.  If NDA Study 1 and NDA Study 2 are added as individual filters, data for a subject will only be selected if the subject is included in  BOTH 1 AND 2.

  • Viewable at the top right of NDA pages, the Filter Cart is a temporary holder of data identified by the user, through querying or browsing, as being of some potential interest. The Filter Cart is where you send the data from your Workspace after it has been filtered.

  • After filters are added to the Filter Cart, users have options to ‘Create a Package’ for download, ‘Associate to Study Cohort’, or ‘Find All Subject Data’. Selecting ‘Find All Subject Data’ identifies and pulls all data for the subjects into the Filter Cart. Choosing ‘Create a Package’ allows users to package and name their query information for download. Choosing ‘Associate to Study Cohort’ gives users the opportunity to choose the Study Cohort they wish to associate this data.

Glossary

  • Once your filter cart contains the subjects of interest, select Create Data Package/Assign to Data Study which will provide options for accessing item level data and/or assigning to a study.  

  • Once queries have been added to your workspace, the next step is to Submit the Filters in the workspace to the Filter Cart.  This process runs the queries selected, saving the results within a filter cart attached to your account.  

  • The Workspace within the General Query Tool is a holding area where you can review your pending filters prior to adding them to Filter Cart. Therefore, the first step in accessing data is to select one or more items and move it into the Workspace. 

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NDA provides a single access to de-identified autism research data. For permission to download data, you will need an NDA account with approved access to NDA or a connected repository (AGRE, IAN, or the ATP). For NDA access, you need to be a research investigator sponsored by an NIH recognized institution with federal wide assurance. See Request Access for more information.

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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 Required field
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 the subject M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
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:

  • 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.