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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).

When combining other filters with the GUID filter, please note the GUID filter should be added last. Otherwise, preselected data may be lost. For example, a predefined filter from Featured Datasets may select a subset of data available for a subject. When combined with a GUID filter for the same subject, the filter cart will contain all data available from that subject, data structure, and dataset; this may be more data than was selected in the predefined filter for that subject. Again, you should add the GUID Filter as the last filter to your cart. This ensures 'AND' logic between filters and will limit results to the subjects, data structures, and datasets already included in your filter cart.

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.

    When combining other filters with the GUID filter, please note the GUID filter should be added last. Otherwise, preselected data may be lost. For example, a predefined filter from Featured Datasets may select a subset of data available for a subject. When combined with a GUID filter for the same subject, the filter cart will contain all data available from that subject, data structure, and dataset; this may be more data than was selected in the predefined filter for that subject. Again, you should add the GUID Filter as the last filter to your cart. This ensures 'AND' logic between filters and will limit results to the subjects, data structures, and datasets already included in your filter cart.

  • 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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Change History For

Adverse Events

5,647 Shared Subjects

Adverse Events
Clinical Assessments
Adverse Events
01/29/2013
adev01
11/19/2021
View Data Structure
01
Element Name Change Description Before Now When
ae_dischdt NEW_MAP_ELEMENT Added data element 'ae_dischdt' to data structure 'adev01'. 11/19/2021 08:42 AM
ae_hospdt NEW_MAP_ELEMENT Added data element 'ae_hospdt' to data structure 'adev01'. 11/19/2021 08:42 AM
ae_lrnddt NEW_MAP_ELEMENT Added data element 'ae_lrnddt' to data structure 'adev01'. 11/19/2021 08:42 AM
ae_pidt NEW_MAP_ELEMENT Added data element 'ae_pidt' to data structure 'adev01'. 11/19/2021 08:42 AM
aeaction NEW_MAP_ELEMENT Added data element 'aeaction' to data structure 'adev01'. 11/19/2021 08:42 AM
aenci NEW_MAP_ELEMENT Added data element 'aenci' to data structure 'adev01'. 11/19/2021 08:42 AM
aerel_drug NEW_MAP_ELEMENT Added data element 'aerel_drug' to data structure 'adev01'. 11/19/2021 08:42 AM
aerel_part NEW_MAP_ELEMENT Added data element 'aerel_part' to data structure 'adev01'. 11/19/2021 08:42 AM
fdarprt NEW_MAP_ELEMENT Added data element 'fdarprt' to data structure 'adev01'. 11/19/2021 08:42 AM
fdarprtdt NEW_MAP_ELEMENT Added data element 'fdarprtdt' to data structure 'adev01'. 11/19/2021 08:42 AM
dsmbrprtdt NEW_MAP_ELEMENT Added data element 'dsmbrprtdt' to data structure 'adev01'. 11/19/2021 08:42 AM
ae_dischdt NEW_DATA_ELEMENT 11/19/2021 08:41 AM
ae_hospdt NEW_DATA_ELEMENT 11/19/2021 08:41 AM
ae_lrnddt NEW_DATA_ELEMENT 11/19/2021 08:41 AM
ae_pidt NEW_DATA_ELEMENT 11/19/2021 08:41 AM
aeaction NEW_DATA_ELEMENT 11/19/2021 08:41 AM
aenci NEW_DATA_ELEMENT 11/19/2021 08:41 AM
aerel_drug NEW_DATA_ELEMENT 11/19/2021 08:41 AM
aerel_part NEW_DATA_ELEMENT 11/19/2021 08:41 AM
fdarprt NEW_DATA_ELEMENT 11/19/2021 08:41 AM
fdarprtdt NEW_DATA_ELEMENT 11/19/2021 08:41 AM
dsmbrprtdt NEW_DATA_ELEMENT 11/19/2021 08:41 AM
sex DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Sex of subject at birth 07/09/2021 10:38 AM
ae_age NEW_MAP_ELEMENT Added data element 'ae_age' to data structure 'adev01'. 07/08/2021 15:38 PM
aefollowup_age NEW_MAP_ELEMENT Added data element 'aefollowup_age' to data structure 'adev01'. 07/08/2021 15:38 PM
aereport_age NEW_MAP_ELEMENT Added data element 'aereport_age' to data structure 'adev01'. 07/08/2021 15:38 PM
aeresolved_age NEW_MAP_ELEMENT Added data element 'aeresolved_age' to data structure 'adev01'. 07/08/2021 15:38 PM
primaryorsecondary NEW_MAP_ELEMENT Added data element 'primaryorsecondary' to data structure 'adev01'. 07/08/2021 15:38 PM
ae_age NEW_DATA_ELEMENT 07/08/2021 15:38 PM
aefollowup_age NEW_DATA_ELEMENT 07/08/2021 15:38 PM
aereport_age NEW_DATA_ELEMENT 07/08/2021 15:38 PM
aeresolved_age NEW_DATA_ELEMENT 07/08/2021 15:38 PM
primaryorsecondary NEW_DATA_ELEMENT 07/08/2021 15:38 PM
aae02 NEW_MAP_ELEMENT Added data element 'aae02' to data structure 'adev01'. 03/02/2021 10:28 AM
aae03 NEW_MAP_ELEMENT Added data element 'aae03' to data structure 'adev01'. 03/02/2021 10:28 AM
aae04 NEW_MAP_ELEMENT Added data element 'aae04' to data structure 'adev01'. 03/02/2021 10:28 AM
aae05 NEW_MAP_ELEMENT Added data element 'aae05' to data structure 'adev01'. 03/02/2021 10:28 AM
aae06 NEW_MAP_ELEMENT Added data element 'aae06' to data structure 'adev01'. 03/02/2021 10:28 AM
aae01 NEW_MAP_ELEMENT Added data element 'aae01' to data structure 'adev01'. 03/02/2021 10:28 AM
aae01 NEW_DATA_ELEMENT 03/02/2021 10:28 AM
aae02 NEW_DATA_ELEMENT 03/02/2021 10:28 AM
aae03 NEW_DATA_ELEMENT 03/02/2021 10:28 AM
aae04 NEW_DATA_ELEMENT 03/02/2021 10:28 AM
aae05 NEW_DATA_ELEMENT 03/02/2021 10:28 AM
aae06 NEW_DATA_ELEMENT 03/02/2021 10:28 AM
study DESCRIPTION DESCRIPTION: Study DESCRIPTION: Study; The code for each individual study 01/11/2021 08:51 AM
interview_date NOTES, NOTES: Required field NOTES: 01/08/2021 10:21 AM
ae33 NEW_TRANSLATION_RULE 2 = 0 09/29/2020 12:27 PM
ae17 NEW_TRANSLATION_RULE 2 = 0 09/29/2020 12:27 PM
ae21 NEW_TRANSLATION_RULE 2 = 0 09/29/2020 12:27 PM
ae25 NEW_TRANSLATION_RULE 2 = 0 09/29/2020 12:27 PM
ae29 NEW_TRANSLATION_RULE 2 = 0 09/29/2020 12:27 PM
ae13 NEW_TRANSLATION_RULE 2 = 0 09/29/2020 12:27 PM
aeout VALUE_RANGE, VALUE_RANGE: 1::18; -9 VALUE_RANGE: 1::19; -9 09/29/2020 12:23 PM
aeout NOTES, NOTES: 1 = 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 baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving NOTES: 1 = 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 baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving ; 19 = Worsened 09/29/2020 12:23 PM
aecat NOTES, NOTES: 1 = Cardiovascular;2 = Chest;3 = Ears / Eyes;4 = Gastrointestinal;5 = Genitourinary;6 = Head;7 = Hematological;8 = Mouth;9 = Musculskeletal;10 = Nose / Throat;11 = Other;12 = Other Psychological/Behavioral;13 = Skin NOTES: 1 = Cardiovascular;2 = Chest;3 = Ears / Eyes;4 = Gastrointestinal;5 = Genitourinary;6 = Head;7 = Hematological;8 = Mouth;9 = Musculoskeletal;10 = Nose / Throat;11 = Other;12 = Other Psychological/Behavioral;13 = Skin ; 14 = Congenital, Familial and Genetic Disorders ; 15 = Ear and Labyrinth Disorders ; 16 = Endocrine Disorders ; 17 = Eye Disorders ; 18 = Hepatobiliary Disorders ; 19 = Immune System Disorders ; 20 = Infections and Infestations ; 21 = Injury, Poisoning and Procedural Complications ; 22 = Investigations ; 23 = Metabolism and Nutrition Disorders ; 24 = Neoplasms Benign, Malignant and Unspecified (Including Cysts and Polyps) ; 25 = Nervous System Disorders ; 26 = Pregnancy, Puerperium and Perinatal Conditions ; 27 = Product Issues ; 28 = Renal and Urinary Disorders ; 29 = Reproductive System and Breast Disorders ; 30 = Respiratory, Thoracic and Mediastinal Disorders ; 31 = Social Circumstances ; 32 = Surgical and Medical Procedures ; 33 = Vascular Disorders 09/29/2020 12:23 PM
aecat VALUE_RANGE, VALUE_RANGE: 1::13 VALUE_RANGE: 1::33 09/29/2020 12:23 PM
ae13 NEW_MAP_ELEMENT Added data element 'ae13' to data structure 'adev01'. 09/29/2020 10:38 AM
ae14 NEW_MAP_ELEMENT Added data element 'ae14' to data structure 'adev01'. 09/29/2020 10:38 AM
ae15 NEW_MAP_ELEMENT Added data element 'ae15' to data structure 'adev01'. 09/29/2020 10:38 AM
ae16 NEW_MAP_ELEMENT Added data element 'ae16' to data structure 'adev01'. 09/29/2020 10:38 AM
ae17 NEW_MAP_ELEMENT Added data element 'ae17' to data structure 'adev01'. 09/29/2020 10:38 AM
ae18 NEW_MAP_ELEMENT Added data element 'ae18' to data structure 'adev01'. 09/29/2020 10:38 AM
ae19 NEW_MAP_ELEMENT Added data element 'ae19' to data structure 'adev01'. 09/29/2020 10:38 AM
ae30 NEW_MAP_ELEMENT Added data element 'ae30' to data structure 'adev01'. 09/29/2020 10:38 AM
ae31 NEW_MAP_ELEMENT Added data element 'ae31' to data structure 'adev01'. 09/29/2020 10:38 AM
ae32 NEW_MAP_ELEMENT Added data element 'ae32' to data structure 'adev01'. 09/29/2020 10:38 AM
ae33 NEW_MAP_ELEMENT Added data element 'ae33' to data structure 'adev01'. 09/29/2020 10:38 AM
ae20 NEW_MAP_ELEMENT Added data element 'ae20' to data structure 'adev01'. 09/29/2020 10:38 AM
ae21 NEW_MAP_ELEMENT Added data element 'ae21' to data structure 'adev01'. 09/29/2020 10:38 AM
ae22 NEW_MAP_ELEMENT Added data element 'ae22' to data structure 'adev01'. 09/29/2020 10:38 AM
ae23 NEW_MAP_ELEMENT Added data element 'ae23' to data structure 'adev01'. 09/29/2020 10:38 AM
ae24 NEW_MAP_ELEMENT Added data element 'ae24' to data structure 'adev01'. 09/29/2020 10:38 AM
ae25 NEW_MAP_ELEMENT Added data element 'ae25' to data structure 'adev01'. 09/29/2020 10:38 AM
ae26 NEW_MAP_ELEMENT Added data element 'ae26' to data structure 'adev01'. 09/29/2020 10:38 AM
ae27 NEW_MAP_ELEMENT Added data element 'ae27' to data structure 'adev01'. 09/29/2020 10:38 AM
ae28 NEW_MAP_ELEMENT Added data element 'ae28' to data structure 'adev01'. 09/29/2020 10:38 AM
ae29 NEW_MAP_ELEMENT Added data element 'ae29' to data structure 'adev01'. 09/29/2020 10:38 AM
ae13 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae14 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae15 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae16 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae17 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae18 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae19 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae20 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae21 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae22 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae23 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae24 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae25 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae26 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae27 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae28 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae29 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae30 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae31 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae32 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
ae33 NEW_DATA_ELEMENT 09/29/2020 10:38 AM
bkgrnd_diag ELEMENT_SIZE, ELEMENT_SIZE: 255 ELEMENT_SIZE: 1020 09/22/2020 12:13 PM
description_of_sae ELEMENT_SIZE, ELEMENT_SIZE: 300 ELEMENT_SIZE: 800 06/25/2020 15:06 PM
visit ELEMENT_SIZE, ELEMENT_SIZE: 50 ELEMENT_SIZE: 60 06/25/2020 10:25 AM
resp_source NEW_MAP_ELEMENT Added data element 'resp_source' to data structure 'adev01'. 03/26/2020 12:05 PM
version_form ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 121 03/25/2020 12:57 PM
resp_source NEW_DATA_ELEMENT 03/23/2020 15:13 PM
aef008 NOTES, NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); -9=unknown NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); 7= Physiotherapy; 8= Hospitalization and medicine; 9= Physiotherapy and medicine; 10= Hospitalization and physio; 11= Hospitalization, medicine, and physio; -9=unknown 03/02/2020 16:33 PM
aef008 VALUE_RANGE, VALUE_RANGE: 1::6; -9 VALUE_RANGE: 1::11;-9 03/02/2020 16:31 PM
ae_flareup NEW_MAP_ELEMENT Added data element 'ae_flareup' to data structure 'adev01'. 03/02/2020 16:26 PM
ae_flareup NEW_DATA_ELEMENT 03/02/2020 16:26 PM
sex NEW_TRANSLATION_RULE 1 = F 03/02/2020 13:29 PM
sex NEW_TRANSLATION_RULE 0 = M 03/02/2020 13:29 PM
sex VALUE_RANGE, , NOTES, VALUE_RANGE: M;F NOTES: M = Male; F = Female VALUE_RANGE: M;F; O; NR NOTES: M = Male; F = Female; O=Other; NR = Not reported 02/21/2020 13:02 PM
update NOTES, NOTES: 1=Updated NOTES: 1= yes; 0= no 01/08/2020 19:28 PM
validity NEW_MAP_ELEMENT Added data element 'validity' to data structure 'adev01'. 12/03/2019 17:17 PM
validity NEW_DATA_ELEMENT 11/22/2019 11:47 AM
bkgrnd_diag DESCRIPTION DESCRIPTION: Diagnosis DESCRIPTION: Diagnosis. Provided by parent 09/11/2019 15:06 PM
sped3_11 NOTES, NOTES: NOTES: 999=NA/NK/missing 07/11/2019 12:45 PM
gender PERMANENTLY ALIASED gender sex 04/22/2019 00:00 AM
site ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 101 01/30/2019 17:56 PM
aeexp NEW_TRANSLATION_RULE 2 = 0 01/09/2019 12:00 PM
aeser NEW_TRANSLATION_RULE 2 = 0 01/09/2019 12:00 PM
gender DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Sex of the subject 08/22/2018 10:43 AM
gender DESCRIPTION DESCRIPTION: Block Brief 2000: Sex of the subject DESCRIPTION: Sex of the subject 08/20/2018 10:21 AM
gender DESCRIPTION DESCRIPTION: Sex of the subject DESCRIPTION: Block Brief 2000: Sex of the subject 08/14/2018 16:18 PM
visit NOTES, NOTES: Character description of each type of visit NOTES: 07/18/2018 13:11 PM
ae_action_taken_7 NEW_MAP_ELEMENT Added data element 'ae_action_taken_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_8 NEW_MAP_ELEMENT Added data element 'ae_action_taken_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_9 NEW_MAP_ELEMENT Added data element 'ae_action_taken_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_event_8 NEW_MAP_ELEMENT Added data element 'ae_event_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_event_9 NEW_MAP_ELEMENT Added data element 'ae_event_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_7 NEW_MAP_ELEMENT Added data element 'ae_expected_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_8 NEW_MAP_ELEMENT Added data element 'ae_expected_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_9 NEW_MAP_ELEMENT Added data element 'ae_expected_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_7 NEW_MAP_ELEMENT Added data element 'ae_outcome_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_8 NEW_MAP_ELEMENT Added data element 'ae_outcome_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_9 NEW_MAP_ELEMENT Added data element 'ae_outcome_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_7 NEW_MAP_ELEMENT Added data element 'ae_relation_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_8 NEW_MAP_ELEMENT Added data element 'ae_relation_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_9 NEW_MAP_ELEMENT Added data element 'ae_relation_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_7 NEW_MAP_ELEMENT Added data element 'ae_sae_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_8 NEW_MAP_ELEMENT Added data element 'ae_sae_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_9 NEW_MAP_ELEMENT Added data element 'ae_sae_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_severity_7 NEW_MAP_ELEMENT Added data element 'ae_severity_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_severity_8 NEW_MAP_ELEMENT Added data element 'ae_severity_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_severity_9 NEW_MAP_ELEMENT Added data element 'ae_severity_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_start_date_7 NEW_MAP_ELEMENT Added data element 'ae_start_date_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_start_date_8 NEW_MAP_ELEMENT Added data element 'ae_start_date_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_start_date_9 NEW_MAP_ELEMENT Added data element 'ae_start_date_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_7 NEW_MAP_ELEMENT Added data element 'ae_stop_date_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_8 NEW_MAP_ELEMENT Added data element 'ae_stop_date_8' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_9 NEW_MAP_ELEMENT Added data element 'ae_stop_date_9' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_3 NEW_MAP_ELEMENT Added data element 'ae_action_taken_3' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_4 NEW_MAP_ELEMENT Added data element 'ae_action_taken_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_5 NEW_MAP_ELEMENT Added data element 'ae_action_taken_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_6 NEW_MAP_ELEMENT Added data element 'ae_action_taken_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_event_5 NEW_MAP_ELEMENT Added data element 'ae_event_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_event_6 NEW_MAP_ELEMENT Added data element 'ae_event_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_event_7 NEW_MAP_ELEMENT Added data element 'ae_event_7' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_2 NEW_MAP_ELEMENT Added data element 'ae_expected_2' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_3 NEW_MAP_ELEMENT Added data element 'ae_expected_3' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_4 NEW_MAP_ELEMENT Added data element 'ae_expected_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_5 NEW_MAP_ELEMENT Added data element 'ae_expected_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_expected_6 NEW_MAP_ELEMENT Added data element 'ae_expected_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_2 NEW_MAP_ELEMENT Added data element 'ae_outcome_2' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_3 NEW_MAP_ELEMENT Added data element 'ae_outcome_3' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_4 NEW_MAP_ELEMENT Added data element 'ae_outcome_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_5 NEW_MAP_ELEMENT Added data element 'ae_outcome_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_outcome_6 NEW_MAP_ELEMENT Added data element 'ae_outcome_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_3 NEW_MAP_ELEMENT Added data element 'ae_relation_3' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_4 NEW_MAP_ELEMENT Added data element 'ae_relation_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_5 NEW_MAP_ELEMENT Added data element 'ae_relation_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_6 NEW_MAP_ELEMENT Added data element 'ae_relation_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_2 NEW_MAP_ELEMENT Added data element 'ae_sae_2' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_3 NEW_MAP_ELEMENT Added data element 'ae_sae_3' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_4 NEW_MAP_ELEMENT Added data element 'ae_sae_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_5 NEW_MAP_ELEMENT Added data element 'ae_sae_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_sae_6 NEW_MAP_ELEMENT Added data element 'ae_sae_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_severity_4 NEW_MAP_ELEMENT Added data element 'ae_severity_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_severity_5 NEW_MAP_ELEMENT Added data element 'ae_severity_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_severity_6 NEW_MAP_ELEMENT Added data element 'ae_severity_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_start_date_4 NEW_MAP_ELEMENT Added data element 'ae_start_date_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_start_date_5 NEW_MAP_ELEMENT Added data element 'ae_start_date_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_start_date_6 NEW_MAP_ELEMENT Added data element 'ae_start_date_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_3 NEW_MAP_ELEMENT Added data element 'ae_stop_date_3' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_4 NEW_MAP_ELEMENT Added data element 'ae_stop_date_4' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_5 NEW_MAP_ELEMENT Added data element 'ae_stop_date_5' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_6 NEW_MAP_ELEMENT Added data element 'ae_stop_date_6' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_2 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_action_taken_2 NEW_MAP_ELEMENT Added data element 'ae_action_taken_2' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_action_taken_3 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_action_taken_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_action_taken_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_action_taken_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_action_taken_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_action_taken_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_action_taken_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_event_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_event_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_event_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_event_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_event_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_2 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_3 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_expected_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_2 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_3 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_outcome_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_2 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_2 NEW_MAP_ELEMENT Added data element 'ae_relation_2' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_relation_3 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_relation_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_2 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_3 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_sae_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_severity_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_severity_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_severity_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_severity_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_severity_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_severity_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_start_date_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_start_date_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_start_date_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_start_date_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_start_date_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_start_date_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_2 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_2 NEW_MAP_ELEMENT Added data element 'ae_stop_date_2' to data structure 'adev01'. 07/06/2018 10:50 AM
ae_stop_date_3 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_4 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_5 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_6 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_7 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_8 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
ae_stop_date_9 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
any_other_aes_to_report_1 NEW_DATA_ELEMENT 07/06/2018 10:50 AM
any_other_aes_to_report_1 NEW_MAP_ELEMENT Added data element 'any_other_aes_to_report_1' to data structure 'adev01'. 07/06/2018 10:50 AM
causedis NEW_TRANSLATION_RULE PRIMARY DISEASE UNDER STUDY = 1 05/31/2018 13:28 PM
ratrel ELEMENT_SIZE, ELEMENT_SIZE: 100 ELEMENT_SIZE: 250 05/30/2018 14:05 PM
sefgass16 VALUE_RANGE, , NOTES, VALUE_RANGE: 0::3; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown VALUE_RANGE: 0::3; -9; 9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 9 = Not Rated; 05/11/2018 14:05 PM
sefgens49 VALUE_RANGE, , NOTES, VALUE_RANGE: 0::3 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe VALUE_RANGE: 0::3; 9; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown 05/11/2018 14:05 PM
sefoths61 VALUE_RANGE, , NOTES, VALUE_RANGE: 0::3 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe VALUE_RANGE: 0::3; 9; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; 9 = Not Rated; -9 = Unknown 05/11/2018 14:05 PM
aef001 VALUE_RANGE, VALUE_RANGE: 1::99; -9 VALUE_RANGE: 05/04/2018 11:31 AM
aeacn NEW_TRANSLATION_RULE DRUG INTERRUPTED = 6 05/04/2018 11:05 AM
aeacn NEW_TRANSLATION_RULE DRUG PERMANENTLY DISCONTINUED = 2 05/04/2018 11:05 AM
ae_serious_signific NEW_TRANSLATION_RULE IMPORTANT MEDICAL EVENT = 1 05/03/2018 11:15 AM
defect NEW_TRANSLATION_RULE CONGENITAL ANOMALY OR BIRTH DEFECT = 1 05/03/2018 11:15 AM
dsabl NEW_TRANSLATION_RULE PERSISTENT OR SIGNIFICANT DISABILITY/INCAPACITY = 1 05/03/2018 11:15 AM
saedispd NEW_TRANSLATION_RULE UNK = NK 05/03/2018 11:15 AM
altnone NEW_TRANSLATION_RULE NONE = 1 05/03/2018 11:15 AM
altothr NEW_TRANSLATION_RULE OTHER KNOWN OR SUSPECTED CAUSE = 1 05/03/2018 11:15 AM
death NEW_TRANSLATION_RULE DEATH = 1 05/03/2018 11:15 AM
hsptl NEW_TRANSLATION_RULE REQUIRE INPATIENT HOSP OR PROLONGATION OF EXISTING HOSP = 1 05/03/2018 11:15 AM
lfthr NEW_TRANSLATION_RULE LIFE-THREATENING = 1 05/03/2018 11:15 AM
altillns NEW_TRANSLATION_RULE CONCOMITANT ILLNESS = 1 05/03/2018 11:15 AM
altproc NEW_TRANSLATION_RULE STUDY PROCEDURE = 1 05/03/2018 11:15 AM
causecon NEW_TRANSLATION_RULE CONCOMITANT MEDICATION = 1 05/03/2018 11:15 AM
causedis NEW_TRANSLATION_RULE PRIMARY DISEASE UNDER STUDY� = 1 05/03/2018 11:15 AM
aeser NEW_TRANSLATION_RULE Y = 1 05/03/2018 11:15 AM
aeser NEW_TRANSLATION_RULE N = 0 05/03/2018 11:15 AM
studyrelation_1 NEW_TRANSLATION_RULE POSSIBLY RELATED = 3 05/03/2018 11:15 AM
studyrelation_1 NEW_TRANSLATION_RULE DEFINITELY RELATED = 1 05/03/2018 11:15 AM
studyrelation_1 NEW_TRANSLATION_RULE PROBABLY RELATED = 2 05/03/2018 11:15 AM
aesev NEW_TRANSLATION_RULE MODERATE = 2 05/03/2018 11:15 AM
aesev NEW_TRANSLATION_RULE SEVERE = 3 05/03/2018 11:15 AM
studyrelation_1 NEW_TRANSLATION_RULE NOT RELATED = 5 05/03/2018 11:15 AM
studyrelation_1 NEW_TRANSLATION_RULE UNLIKELY RELATED = 4 05/03/2018 11:15 AM
aeout NEW_TRANSLATION_RULE NOT RECOVERED/NOT RESOLVED = 13 05/03/2018 11:15 AM
aeout NEW_TRANSLATION_RULE UNK = -9 05/03/2018 11:15 AM
aeout NEW_TRANSLATION_RULE FATAL = 4 05/03/2018 11:15 AM
aeout NEW_TRANSLATION_RULE RECOVERED/RESOLVED WITH SEQUELAE = 14 05/03/2018 11:15 AM
aesev NEW_TRANSLATION_RULE MILD = 1 05/03/2018 11:15 AM
aeongo NEW_TRANSLATION_RULE ONGOING = 1 05/03/2018 11:15 AM
aeout NEW_TRANSLATION_RULE RECOVERED/RESOLVED = 17 05/03/2018 11:15 AM
aeout NEW_TRANSLATION_RULE RECOVERING/RESOLVING = 18 05/03/2018 11:15 AM
aeout VALUE_RANGE, , NOTES, VALUE_RANGE: 1::17; -9 NOTES: 1 = 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 baseline VALUE_RANGE: 1::18; -9 NOTES: 1 = 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 baseline; 17 = Recovered/Resolved; 18 = Recovering/Resolving 05/02/2018 17:32 PM
saedispd VALUE_RANGE, VALUE_RANGE: Y;N VALUE_RANGE: Y;N; NK; NA 05/02/2018 17:31 PM
ae_serious_signific VALUE_RANGE, , NOTES, VALUE_RANGE: NOTES: VALUE_RANGE: 0;1 NOTES: 0 = No; 1 = Yes 05/02/2018 17:31 PM
none NEW_MAP_ELEMENT Added data element 'none' to data structure 'adev01'. 03/19/2018 15:44 PM
therapyp NEW_MAP_ELEMENT Added data element 'therapyp' to data structure 'adev01'. 03/19/2018 15:44 PM
wk6c11a NEW_MAP_ELEMENT Added data element 'wk6c11a' to data structure 'adev01'. 03/19/2018 15:44 PM
yr_treat1_ended NEW_MAP_ELEMENT Added data element 'yr_treat1_ended' to data structure 'adev01'. 03/19/2018 15:44 PM
completed VALUE_RANGE, , NOTES, VALUE_RANGE: 0::2 NOTES: 0=No; 1=Yes; 2=Yes, lost VALUE_RANGE: 0::3 NOTES: 0=No; 1=Yes; 2=Yes, lost; 3=Unverified 01/26/2018 12:16 PM
version_form DESCRIPTION DESCRIPTION: Form used DESCRIPTION: Form used/assessment name 11/24/2017 16:39 PM
interview_date DESCRIPTION DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY DESCRIPTION: Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY 08/28/2017 15:10 PM
ayen VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0 = No; 1 = Yes VALUE_RANGE: 0;1;-9 NOTES: 0 = No; 1 = Yes; -9 = Did not inquire 08/28/2017 12:15 PM
version_form NOTES NOTES: 0 NOTES: 08/01/2017 15:06 PM
version_form NOTES NOTES: NOTES: 0 08/01/2017 14:25 PM
saps_ad10 NOTES NOTES: 99 = Missing NOTES: 06/02/2017 11:32 AM
saps_ad10 NOTES NOTES: NOTES: 99 = Missing 06/02/2017 11:32 AM
completed DESCRIPTION DESCRIPTION: Checks if form is completed DESCRIPTION: Checks if completed 04/11/2017 12:29 PM
completed VALUE_RANGE VALUE_RANGE: 0:2 VALUE_RANGE: 0::2 03/16/2017 17:11 PM
completed VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0=No; 1=Yes VALUE_RANGE: 0:2 NOTES: 0=No; 1=Yes; 2=Yes, lost 03/16/2017 16:33 PM
yr_treat1_ended NEW_DATA_ELEMENT 03/14/2017 10:49 AM
sdatothr ELEMENT_SIZE ELEMENT_SIZE: 60 ELEMENT_SIZE: 250 02/10/2017 15:37 PM
ae ELEMENT_SIZE ELEMENT_SIZE: 100 ELEMENT_SIZE: 250 02/10/2017 15:37 PM
adverse_event_code VALUE_RANGE VALUE_RANGE: 1::26 VALUE_RANGE: 1::126 02/09/2017 16:22 PM
adverse_event_code VALUE_RANGE, NOTES VALUE_RANGE: 1::74 NOTES: 1 = Psychic Side Effects-UKU: Concentration; 2 = Psychic Side Effects-UKU: Asthenia/Lassitude/ Increased Fatigability; 3 = Psychic Side Effects-UKU: Sleepiness/Sedation; 4 = Psychic Side Effects-UKU: Failing Memory; 5 = Psychic Side Effects-UKU: Tension/Unrest; 6 = Psychic Side Effects-UKU: Increased Sleep; 7 = Psychic Side Effects-UKU: Decreased Sleep; 8 = Psychic Side Effects-UKU: Increased Dream Activity; 9 = Psychic Side Effects-UKU: Emotional Indifference "10 = Neurological-UKU: Dystonia; 11 = Neurological-UKU: Rigidity; 12 = Neurological-UKU: Hypokinesia/Akinesia; 13 = Neurological-UKU: Hyperkinesia; 14 = Neurological-UKU: Tremor; 15 = Neurological-UKU: Akathisia; 16 = Neurological-UKU: Seizures; 17 = Neurological-UKU: Paraesthesias; 18 = Neurological-UKU: Headache" "19 = Autonomic Side Effects-UKU: Accommodation Disturbances; 20 = Autonomic Side Effects-UKU: Increased Salivation; 21 = Autonomic Side Effects-UKU: Reduced Salivation (Dry Mouth); 22 = Autonomic Side Effects-UKU: Nausea/Vomiting; 23 = Autonomic Side Effects-UKU: Diarrhea; 24 = Autonomic Side Effects-UKU: Constipation; 25 = Autonomic Side Effects-UKU: Micturition Disturbances; 26 = Autonomic Side Effects-UKU: Polyuria/Polydipsia; 27 = Autonomic Side Effects-UKU: Orthostatic Dizziness; 28 = Autonomic Side Effects-UKU: Palpitations/Tachycardia; 29 = Autonomic Side Effects-UKU: Increased Tendency to sweat""30 = Skin -UKU: Rash; 31 = Skin -UKU: Pruritis; 32 = Skin -UKU: Photosensitivity; 33 = Skin -UKU: Increased Pigmentation; 34 = Weight-UKU: Weight Gain; 35 = Weight-UKU: Weight Loss""36 = Genitourinary-UKU: Menorrhagia; 37 = Genitourinary-UKU: Amenorrhea; 38 = Genitourinary-UKU: Galactorrhea; 39 = Genitourinary-UKU: Breast enlargement; 40 = Genitourinary-UKU: Increased Sexual Desire; 41 = Genitourinary-UKU: Decreased Sexual Desire; 42 = Genitourinary-UKU: Erectile Dysfunction; 43 = Genitourinary-UKU: Ejaculatory Dysfunction; 44 = Genitourinary-UKU: Orgastic Dysfunction; 45 = Genitourinary-UKU: Dry Vagina""46 = Psychological/Behavioral: Increased motor activity, including activation and hyperactivity; 47 = Psychological/Behavioral: Decreased motor activity; 48 = Psychological/Behavioral: Slurred speech; 49 = Psychological/Behavioral: Confusion; 50 = Psychological/Behavioral: Significant worsening of anxiety or development of anxiety not present at baseline; 51 = Psychological/Behavioral: Suicide gesture/attempt; 52 = Psychological/Behavioral: Suicide completion; 53 = Psychological/Behavioral: Aggression; 54 = Psychological/Behavioral: Development of hallucinations""55 = Other: Fever; 56 = Other: Psychiatric hospitalization due to worsening condition; 57 = Other: Death (not due to suicide); 58 = Other: Fall; 59 = Other: Accidental Injury; 60 = Other: Pedal edema/edema; 61 = Other: Ecchymosis; 62 = Other: Dizziness/faintness; 63 = Other: Loss of consciousness; 64 = Other: Bradychardia""65 = Other: Muscle/bone/joint pain/condition; 66 = Other: Hair problems; 67 = Other: Medical or Surgical Procedure; 68 = Other: Chest Pain; 69 = Other: Heart attack; 70 = Other: Development or exacerbation of asthma; 71 = Other: Change in study lab values requiring medical intervention; 72 = Other: NMS; 73 = Other: Allergies, Not Otherwise Specified (elicit specific reaction and code using symptomatology. If no other code is applicable, use this code.); 74 = Other" VALUE_RANGE: 1::26 NOTES: 1 = Concentration; 2 = Asthenia/Lassitude/ Increased Fatigability; 3 = Sleepiness/Sedation; 4 = Failing Memory; 5 = Tension/Unrest; 6 = Increased Sleep; 7 = Decreased Sleep; 8 = Increased Dream Activity; 9 = Emotional Indifference; 10 = Dystonia; 11 = Rigidity; 12 = Hypokinesia/Akinesia; 13 = Hyperkinesia; 14 = Tremor; 15 = Akathisia; 16 = Seizures; 17 = Paraesthesias; 18 = Headache;19 = Accommodation Disturbances; 20 = Increased Salivation; 21 = Reduced Salivation (Dry Mouth); 22 = Nausea/Vomiting; 23 = Diarrhea; 24 = Constipation; 25 = Micturition Disturbances; 26 = Polyuria/Polydipsia; 27 = Orthostatic Dizziness; 28 = Palpitations/Tachycardia; 29 = Increased Tendency to sweat; 30 = Skin -UKU: Rash; 31 = Skin -UKU: Pruritis; 32 = Skin -UKU: Photosensitivity; 33 = Skin -UKU: Increased Pigmentation; 34 = Weight-UKU: Weight Gain; 35 = Weight-UKU: Weight Loss; 36 = Genitourinary-UKU: Menorrhagia; 37 = Genitourinary-UKU: Amenorrhea; 38 = Genitourinary-UKU: Galactorrhea; 39 = Genitourinary-UKU: Breast enlargement; 40 = Genitourinary-UKU: Increased Sexual Desire; 41 = Genitourinary-UKU: Decreased Sexual Desire; 42 = Genitourinary-UKU: Erectile Dysfunction; 43 = Genitourinary-UKU: Ejaculatory Dysfunction;44 = Genitourinary-UKU: Orgastic Dysfunction; 45 = Genitourinary-UKU: Dry Vagina;46 = Psychological/Behavioral: Increased motor activity, including activation and hyperactivity; 47 = Psychological/Behavioral: Decreased motor activity; 48 = Psychological/Behavioral: Slurred speech; 49 = Psychological/Behavioral: Confusion; 50 = Psychological/Behavioral: Significant worsening of anxiety or development of anxiety not present at baseline; 51 = Psychological/Behavioral: Suicide gesture/attempt; 52 = Psychological/Behavioral: Suicide completion; 53 = Psychological/Behavioral: Aggression; 54 = Psychological/Behavioral: Development of hallucinations; 55 = Fever; 56 = Psychiatric hospitalization due to worsening condition; 57 = Death (not due to suicide); 58 = Fall; 59 = Accidental Injury; 60 = Pedal edema/edema; 61 = Ecchymosis; 62 = Dizziness/faintness; 63 = Loss of consciousness; 64 = Bradychardia;65 = Muscle/bone/joint pain/condition; 66 = Hair problems; 67 = Medical or Surgical Procedure; 68 = Chest Pain; 69 = Heart attack; 70 = Development or exacerbation of asthma; 71 = Change in study lab values requiring medical intervention; 72 = NMS; 73 = Allergies, Not Otherwise Specified (elicit specific reaction and code using symptomatology. If no other code is applicable, use this code.); 74 = Other;75=Flu or Upper Respiratory Problems, including Bronchitis; 76=Stomach or abdominal discomfort, including "nervous stomach" and abdominal cramps, but not menstrual cramps; 77=Tiredness/fatigue; 78=Hallucinations; 79=Difficulty falling asleep; 80=Repetitive Behavior or Thoughts; 81=Nasal congestion or Cold; 82=Appetite decrease; 83=Tic movements; 84=Irritability; 85=Anxiety; 86=Emotional Outburst/Mood Lability; 87=Coughing; 88=Disinhibition, including behavioral disinhibition; 89=Epistaxis/nosebleed; 90=Abnormal Lab Result: includes anemia; 91=Painful urination; 92=Depression; 93=Dermatologic problems; 94=Not Otherwise Listed (or Unknown); 95=Enuresis; 96=Hypertension; 97=Oppositional Behavior; 98=Shortness of breath; 99=Fever; 100=Withdrawn/Spacey/"Zombie-like"; 101=Dental problems; 102=Difficulty swallowing; 103=Viral Syndrome, includes infectious diseases; 104=Dyskinesia; 105=Muscle/bone/joint pain/condition; 106=Aggression; 107=Early morning awakening; 108=Interrupted sleep/Other Sleep Problems; 110=Sore throat; 111=Tachycardia; 112=Over-Talkativeness; 113=Eye irritation; 114=Ear ache/Otitis, including ear fluid; 115=Mouth Ulcer; 116=Blurred vision; 117=Tinnitus; 118=Poor hearing; 119=Increased thirst; 120=Hyperacusis: sensory sensitivity or oversensitivity; 121=Over focused; 122=Stammering/Stuttering; verbal dysfluency; 123=Medication Rebound; 124=Restlessness/Agitation, including fidgety; 125=Sore tongue; 126=Genital discomfort 02/09/2017 16:22 PM
causesdr VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0= No; 1 = At least possibly related VALUE_RANGE: 0::8 NOTES: 0= No; 1 = At least possibly related;2=Dose response; 3=Dechallenge/rechallenge; 4=Timing of onset; 5=Seen in other patients in this trial; 6=Known drug effect; 7=Laboratory data; 8=Other 02/08/2017 16:46 PM
aer_c NEW_DATA_ELEMENT 02/08/2017 14:17 PM
aer_c NEW_MAP_ELEMENT Added data element 'aer_c' to data structure 'adev01'. 02/08/2017 14:17 PM
aer_f NEW_DATA_ELEMENT 02/08/2017 14:17 PM
aer_f NEW_MAP_ELEMENT Added data element 'aer_f' to data structure 'adev01'. 02/08/2017 14:17 PM
aef005 VALUE_RANGE, NOTES VALUE_RANGE: 1::7;9 NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable; VALUE_RANGE: 1::9 NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable;8=Medication Rebound 02/02/2017 16:38 PM
aeout VALUE_RANGE VALUE_RANGE: 1::16; -9 VALUE_RANGE: 1::17; -9 02/02/2017 16:38 PM
aeacn VALUE_RANGE, NOTES VALUE_RANGE: 1::10;99 NOTES: 1 = 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 VALUE_RANGE: 1::11;99 NOTES: 1 = 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 Time 02/02/2017 16:38 PM
version_form ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 100 02/02/2017 16:38 PM
aedur DESCRIPTION DESCRIPTION: AE duration (across all stages) � days DESCRIPTION: AE duration (across all stages) days 02/02/2017 12:08 PM
leastsev DESCRIPTION DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 5 3 6 2 1 02/02/2017 12:08 PM
mostsev DESCRIPTION DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 5 3 6 2 1 02/02/2017 12:08 PM
lab020 DESCRIPTION DESCRIPTION: Date of PI signature DESCRIPTION: Date of PI/clinician signature 01/17/2017 17:54 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 01/03/2017 13:55 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 01/03/2017 13:14 PM
withdrug VALUE_RANGE, NOTES VALUE_RANGE: 0::3 NOTES: 0 = No;1 = Possibly;2 = Probably;3 = Definitely related VALUE_RANGE: 0::4; -9 NOTES: 0 = No;1 = Possibly;2 = Probably;3 = Definitely related; 4=Remotely; -9=NK 12/29/2016 15:31 PM
excour VALUE_RANGE, NOTES VALUE_RANGE: 0::2 NOTES: 0=Intermittent; 1=Persistant; 2=Single occurance VALUE_RANGE: 0::4 NOTES: 0=Intermittent; 1=Persistant; 2=Single occurance;3=Intermittent, infrequently: <10 mins or <2x; 4=intermittent, frequently: >10 mins or >2x; 12/28/2016 17:59 PM
aeacn VALUE_RANGE VALUE_RANGE: 1::10; 99 VALUE_RANGE: 1::10;99 12/28/2016 17:59 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 12/09/2016 15:17 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 12/09/2016 15:09 PM
aeacn VALUE_RANGE, NOTES VALUE_RANGE: 1::8; 99 NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown VALUE_RANGE: 1::10; 99 NOTES: 1 = 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 12/05/2016 17:59 PM
aeout VALUE_RANGE, NOTES VALUE_RANGE: 1::15; -9 NOTES: 1 = 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 VALUE_RANGE: 1::16; -9 NOTES: 1 = 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 baseline 12/05/2016 17:59 PM
visnum NOTES NOTES: -1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; NOTES: -1.5 = Pre-Screening; -1 = Screening; 0 = Baseline; ## = Visit ## (from 1 to 10); Whole numbers = standard monthly visits; #.001 - #.009 = Unscheduled; #.1 = End of Phase 1; #.2 = End of Phase 2; #.3 = End of Phase 3; #.4 = End of Open Choice Phase; #.5 = End of Study; #.6 = Genetic Analysis; 1000=all visits 12/05/2016 17:59 PM
studyrelation_1 VALUE_RANGE, NOTES VALUE_RANGE: 58::62; 69; -888; -999 NOTES: 58=Definite; 59=Probable; 60=Possible; 61=Unlikely; 62=Unrelated; 69=Unknown; -888=Not Applicable; -999=Missing; VALUE_RANGE: 1::5; 9; -888; -999 NOTES: 1=Definite; 2=Probable; 3=Possible; 4=Unlikely; 5=Unrelated; 9=Unknown; -888=Not Applicable; -999=Missing; 12/05/2016 17:53 PM
description_of_sae ELEMENT_SIZE ELEMENT_SIZE: 250 ELEMENT_SIZE: 300 11/30/2016 11:19 AM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 11/07/2016 16:15 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 11/07/2016 16:10 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 11/07/2016 12:09 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 11/07/2016 11:16 AM
aesa14 ELEMENT_SIZE ELEMENT_SIZE: 200 ELEMENT_SIZE: 10/31/2016 13:02 PM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 10/13/2016 13:26 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 10/13/2016 13:26 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 10/13/2016 13:26 PM
gender REQUIRED REQUIRED: Required REQUIRED: Recommended 10/13/2016 13:04 PM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 10/13/2016 13:04 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 10/13/2016 13:04 PM
meddra_status NEW_MAP_ELEMENT Added data element 'meddra_status' to data structure 'adev01'. 10/07/2016 15:56 PM
meddra_status TYPE, ELEMENT_SIZE TYPE: Integer ELEMENT_SIZE: TYPE: String ELEMENT_SIZE: 100 10/07/2016 15:55 PM
meddra_day POSITION POSITION: 368 POSITION: 367 10/07/2016 15:53 PM
meddra_hlgt_term POSITION POSITION: 357 POSITION: 356 10/07/2016 15:53 PM
meddra_hlt_code POSITION POSITION: 358 POSITION: 357 10/07/2016 15:53 PM
meddra_htl_term POSITION POSITION: 359 POSITION: 358 10/07/2016 15:53 PM
meddra_llt_code POSITION POSITION: 360 POSITION: 359 10/07/2016 15:53 PM
meddra_llt_term POSITION POSITION: 361 POSITION: 360 10/07/2016 15:53 PM
meddra_pt_code POSITION POSITION: 362 POSITION: 361 10/07/2016 15:53 PM
meddra_pt_term POSITION POSITION: 363 POSITION: 362 10/07/2016 15:53 PM
meddra_soc_code POSITION POSITION: 364 POSITION: 363 10/07/2016 15:53 PM
meddra_soc_term POSITION POSITION: 365 POSITION: 364 10/07/2016 15:53 PM
meddra_user_id POSITION POSITION: 366 POSITION: 365 10/07/2016 15:53 PM
meddra_version POSITION POSITION: 367 POSITION: 366 10/07/2016 15:53 PM
meddra_comment POSITION POSITION: 355 POSITION: 354 10/07/2016 15:53 PM
meddra_hlgt_code POSITION POSITION: 356 POSITION: 355 10/07/2016 15:53 PM
meddra_day NEW_MAP_ELEMENT Added data element 'meddra_day' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_user_id NEW_MAP_ELEMENT Added data element 'meddra_user_id' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_version NEW_MAP_ELEMENT Added data element 'meddra_version' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_hlgt_term NEW_MAP_ELEMENT Added data element 'meddra_hlgt_term' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_hlt_code NEW_MAP_ELEMENT Added data element 'meddra_hlt_code' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_htl_term NEW_MAP_ELEMENT Added data element 'meddra_htl_term' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_llt_code NEW_MAP_ELEMENT Added data element 'meddra_llt_code' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_llt_term NEW_MAP_ELEMENT Added data element 'meddra_llt_term' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_pt_code NEW_MAP_ELEMENT Added data element 'meddra_pt_code' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_pt_term NEW_MAP_ELEMENT Added data element 'meddra_pt_term' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_soc_code NEW_MAP_ELEMENT Added data element 'meddra_soc_code' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_soc_term NEW_MAP_ELEMENT Added data element 'meddra_soc_term' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_comment NEW_MAP_ELEMENT Added data element 'meddra_comment' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_hlgt_code NEW_MAP_ELEMENT Added data element 'meddra_hlgt_code' to data structure 'adev01'. 10/06/2016 16:35 PM
ae_10 NEW_DATA_ELEMENT 10/06/2016 16:35 PM
ae_10 NEW_MAP_ELEMENT Added data element 'ae_10' to data structure 'adev01'. 10/06/2016 16:35 PM
meddra_comment NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_day NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_hlgt_code NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_hlgt_term NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_hlt_code NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_htl_term NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_llt_code NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_llt_term NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_pt_code NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_pt_term NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_soc_code NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_soc_term NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_status NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_user_id NEW_DATA_ELEMENT 10/06/2016 16:35 PM
meddra_version NEW_DATA_ELEMENT 10/06/2016 16:35 PM
med_nm NEW_MAP_ELEMENT Added data element 'med_nm' to data structure 'adev01'. 09/16/2016 14:37 PM
mtype NEW_MAP_ELEMENT Added data element 'mtype' to data structure 'adev01'. 09/16/2016 14:37 PM
bg_curothmeds NEW_MAP_ELEMENT Added data element 'bg_curothmeds' to data structure 'adev01'. 09/16/2016 14:37 PM
mtype DELETED_MAP_ELEMENT 09/15/2016 18:27 PM
bg_curothmeds DELETED_MAP_ELEMENT 09/15/2016 18:27 PM
med_nm DELETED_MAP_ELEMENT 09/15/2016 18:27 PM
bg_curothmeds NEW_MAP_ELEMENT Added data element 'bg_curothmeds' to data structure 'aapc01'. 09/15/2016 18:24 PM
med_nm NEW_MAP_ELEMENT Added data element 'med_nm' to data structure 'aapc01'. 09/15/2016 18:24 PM
mtype NEW_MAP_ELEMENT Added data element 'mtype' to data structure 'aapc01'. 09/15/2016 18:24 PM
mtype VALUE_RANGE, NOTES VALUE_RANGE: 1;2 NOTES: 1=Li; 2=NTP VALUE_RANGE: 1::4 NOTES: 1=Li; 2=NTP; 3 = Other psychiatric medication, 4 = Non-psychiatric medication 09/15/2016 12:03 PM
action VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D; E; F; G;U NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown VALUE_RANGE: A; B; C;D; E; F; G;U; H NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown; H=Dose increased 09/15/2016 12:02 PM
aeacn VALUE_RANGE, NOTES VALUE_RANGE: 1::5; 99 NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other VALUE_RANGE: 1::8; 99 NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other; 6= drug interrupted; 7= not applicable; 8= unknown 08/30/2016 13:30 PM
aeout VALUE_RANGE, NOTES VALUE_RANGE: 1::12; -9 NOTES: 1 = 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 VALUE_RANGE: 1::15; -9 NOTES: 1 = 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 08/30/2016 13:30 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 08/25/2016 15:16 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 08/25/2016 15:08 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 08/19/2016 13:17 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 08/19/2016 13:08 PM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 08/11/2016 12:52 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 08/11/2016 12:52 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 08/11/2016 12:52 PM
gender REQUIRED REQUIRED: Required REQUIRED: Recommended 08/11/2016 12:26 PM
interview_age REQUIRED REQUIRED: Required REQUIRED: Recommended 08/11/2016 12:26 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 08/11/2016 12:26 PM
scid_event_age1 NEW_MAP_ELEMENT Added data element 'scid_event_age1' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age2 NEW_MAP_ELEMENT Added data element 'scid_event_age2' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age3 NEW_MAP_ELEMENT Added data element 'scid_event_age3' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age4 NEW_MAP_ELEMENT Added data element 'scid_event_age4' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age5 NEW_MAP_ELEMENT Added data element 'scid_event_age5' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age6 NEW_MAP_ELEMENT Added data element 'scid_event_age6' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age9 NEW_MAP_ELEMENT Added data element 'scid_event_age9' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_np114 NEW_MAP_ELEMENT Added data element 'scid_np114' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_np116 NEW_MAP_ELEMENT Added data element 'scid_np116' to data structure 'adev01'. 08/10/2016 11:07 AM
behavobs_mood NEW_MAP_ELEMENT Added data element 'behavobs_mood' to data structure 'adev01'. 08/10/2016 11:07 AM
bkgrnd_diag NEW_MAP_ELEMENT Added data element 'bkgrnd_diag' to data structure 'adev01'. 08/10/2016 11:07 AM
chartreview059 NEW_MAP_ELEMENT Added data element 'chartreview059' to data structure 'adev01'. 08/10/2016 11:07 AM
demo_health_condsp NEW_MAP_ELEMENT Added data element 'demo_health_condsp' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age7 NEW_MAP_ELEMENT Added data element 'scid_event_age7' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age8 NEW_MAP_ELEMENT Added data element 'scid_event_age8' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_event_age9 NEW_DATA_ELEMENT 08/10/2016 11:07 AM
scid_np114 NEW_DATA_ELEMENT 08/10/2016 11:07 AM
sped3_11 NEW_MAP_ELEMENT Added data element 'sped3_11' to data structure 'adev01'. 08/10/2016 11:07 AM
scid_np116 NEW_DATA_ELEMENT 08/10/2016 11:07 AM
cbcl1_2_text NEW_MAP_ELEMENT Added data element 'cbcl1_2_text' to data structure 'adev01'. 07/15/2016 15:59 PM
sae_38 NEW_MAP_ELEMENT Added data element 'sae_38' to data structure 'adev01'. 07/15/2016 15:59 PM
aes5 NEW_DATA_ELEMENT 07/15/2016 15:59 PM
aes5 NEW_MAP_ELEMENT Added data element 'aes5' to data structure 'adev01'. 07/15/2016 15:59 PM
sped3_11 ELEMENT_SIZE ELEMENT_SIZE: 100 ELEMENT_SIZE: 500 07/12/2016 15:34 PM
version_form ELEMENT_SIZE ELEMENT_SIZE: 20 ELEMENT_SIZE: 50 07/11/2016 14:45 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/23/2016 18:07 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/23/2016 17:45 PM
ae_maxm TYPE TYPE: Integer TYPE: Float 06/23/2016 17:29 PM
ae_reld NEW_MAP_ELEMENT Added data element 'ae_reld' to data structure 'adev01'. 06/23/2016 15:39 PM
ae_reld NEW_DATA_ELEMENT 06/23/2016 15:39 PM
bg_curothmeds NEW_DATA_ELEMENT 06/21/2016 15:29 PM
ae_maxa NOTES NOTES: 1=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MAX value will be in the range 1 � 4 NOTES: 1=Mild;2=Moderate;3=Severe;4=Very Severe. Calculated MAX value will be in the range 1 - 4 06/20/2016 10:49 AM
ae_maxa ELEMENT_SIZE ELEMENT_SIZE: 8 ELEMENT_SIZE: 06/20/2016 10:48 AM
ae_maxm ELEMENT_SIZE ELEMENT_SIZE: 8 ELEMENT_SIZE: 06/20/2016 10:48 AM
ae_intermit NEW_MAP_ELEMENT Added data element 'ae_intermit' to data structure 'adev01'. 06/20/2016 10:47 AM
ae_maxa NEW_MAP_ELEMENT Added data element 'ae_maxa' to data structure 'adev01'. 06/20/2016 10:47 AM
ae_maxm NEW_MAP_ELEMENT Added data element 'ae_maxm' to data structure 'adev01'. 06/20/2016 10:47 AM
ae_descrip NEW_DATA_ELEMENT 06/20/2016 10:47 AM
ae_descrip NEW_MAP_ELEMENT Added data element 'ae_descrip' to data structure 'adev01'. 06/20/2016 10:47 AM
ae_maxa NEW_DATA_ELEMENT 06/20/2016 10:47 AM
ae_maxm NEW_DATA_ELEMENT 06/20/2016 10:47 AM
rand_num NEW_DATA_ELEMENT 06/20/2016 10:47 AM
rand_num NEW_MAP_ELEMENT Added data element 'rand_num' to data structure 'adev01'. 06/20/2016 10:47 AM
ae_intermit NEW_DATA_ELEMENT 06/20/2016 10:47 AM
gender VALUE_RANGE, NOTES VALUE_RANGE: M;F; T NOTES: M = Male; F = Female; T= Transgender VALUE_RANGE: M;F NOTES: M = Male; F = Female 05/25/2016 11:51 AM
gender DESCRIPTION DESCRIPTION: Gender DESCRIPTION: Sex of the subject 05/25/2016 11:50 AM
scid_event_age1 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
scid_event_age2 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
scid_event_age3 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
scid_event_age4 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
scid_event_age5 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
scid_event_age6 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
scid_event_age7 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
scid_event_age8 NEW_DATA_ELEMENT 05/18/2016 16:53 PM
aeout NOTES NOTES: 1 = 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; 11=Lost to follow up; 12=Other; -9=unknown NOTES: 1 = 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 05/02/2016 10:53 AM
aef001 ELEMENT_SIZE ELEMENT_SIZE: 2 ELEMENT_SIZE: 04/29/2016 11:34 AM
aef005 ELEMENT_SIZE ELEMENT_SIZE: 2 ELEMENT_SIZE: 04/29/2016 11:34 AM
aef008 ELEMENT_SIZE ELEMENT_SIZE: 2 ELEMENT_SIZE: 04/29/2016 11:34 AM
aesa21a1 VALUE_RANGE, NOTES VALUE_RANGE: 0;1;2;3 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe VALUE_RANGE: 0;1;2;3;8;9 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed 04/13/2016 15:23 PM
aesa21b1 VALUE_RANGE, NOTES VALUE_RANGE: 0;1;2;3 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe VALUE_RANGE: 0;1;2;3;8;9 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed 04/13/2016 15:23 PM
aesa21c1 VALUE_RANGE, NOTES VALUE_RANGE: 0;1;2;3 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe VALUE_RANGE: 0;1;2;3;8;9 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed 04/13/2016 15:23 PM
aesa21d1 VALUE_RANGE, NOTES VALUE_RANGE: 0;1;2;3 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe VALUE_RANGE: 0;1;2;3;8;9 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 8=Unknown; 9=Not Assessed 04/13/2016 15:23 PM
saps_ad10 NEW_MAP_ELEMENT Added data element 'saps_ad10' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7cda NEW_MAP_ELEMENT Added data element 'ae7cda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7dda NEW_MAP_ELEMENT Added data element 'ae7dda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7eda NEW_MAP_ELEMENT Added data element 'ae7eda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7fda NEW_MAP_ELEMENT Added data element 'ae7fda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7gda NEW_MAP_ELEMENT Added data element 'ae7gda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7hda NEW_MAP_ELEMENT Added data element 'ae7hda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7ida NEW_MAP_ELEMENT Added data element 'ae7ida' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7jda NEW_MAP_ELEMENT Added data element 'ae7jda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7kda NEW_MAP_ELEMENT Added data element 'ae7kda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7lda NEW_MAP_ELEMENT Added data element 'ae7lda' to data structure 'adev01'. 04/13/2016 15:21 PM
ae7ada NEW_MAP_ELEMENT Added data element 'ae7ada' to data structure 'adev01'. 04/13/2016 15:20 PM
ae7bda NEW_MAP_ELEMENT Added data element 'ae7bda' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21e1 NEW_MAP_ELEMENT Added data element 'aesa21e1' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21f1 NEW_MAP_ELEMENT Added data element 'aesa21f1' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21g1 NEW_MAP_ELEMENT Added data element 'aesa21g1' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21h1 NEW_MAP_ELEMENT Added data element 'aesa21h1' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21i1 NEW_MAP_ELEMENT Added data element 'aesa21i1' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21j1 NEW_MAP_ELEMENT Added data element 'aesa21j1' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21k1 NEW_MAP_ELEMENT Added data element 'aesa21k1' to data structure 'adev01'. 04/13/2016 15:20 PM
aesa21l1 NEW_MAP_ELEMENT Added data element 'aesa21l1' to data structure 'adev01'. 04/13/2016 15:20 PM
ae7ada NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7bda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7cda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7dda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7eda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7fda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7gda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7hda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7ida NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7jda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7kda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
ae7lda NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21e1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21f1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21g1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21h1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21i1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21j1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21k1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
aesa21l1 NEW_DATA_ELEMENT 04/13/2016 15:20 PM
chartreview059 DESCRIPTION DESCRIPTION: Primary ED physician discharge diagnosis DESCRIPTION: Medical inpatient hospitalizations 04/13/2016 14:25 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 03/18/2016 13:48 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 03/18/2016 13:44 PM
corther NEW_MAP_ELEMENT Added data element 'corther' to data structure 'adev01'. 03/18/2016 11:13 AM
excour NEW_MAP_ELEMENT Added data element 'excour' to data structure 'adev01'. 03/18/2016 11:13 AM
freq_increased NEW_MAP_ELEMENT Added data element 'freq_increased' to data structure 'adev01'. 03/18/2016 11:13 AM
rpttp NEW_MAP_ELEMENT Added data element 'rpttp' to data structure 'adev01'. 03/18/2016 11:13 AM
sev_increased NEW_MAP_ELEMENT Added data element 'sev_increased' to data structure 'adev01'. 03/18/2016 11:13 AM
withdrawn NEW_MAP_ELEMENT Added data element 'withdrawn' to data structure 'adev01'. 03/18/2016 11:13 AM
q13_pre NEW_MAP_ELEMENT Added data element 'q13_pre' to data structure 'adev01'. 03/18/2016 11:13 AM
corther NEW_DATA_ELEMENT 03/18/2016 11:13 AM
dayae NEW_MAP_ELEMENT Added data element 'dayae' to data structure 'adev01'. 03/18/2016 11:13 AM
excour NEW_DATA_ELEMENT 03/18/2016 11:13 AM
sev_increased NEW_DATA_ELEMENT 03/18/2016 11:13 AM
withdrawn NEW_DATA_ELEMENT 03/18/2016 11:13 AM
freq_increased NEW_DATA_ELEMENT 03/18/2016 11:13 AM
darsrz DESCRIPTION DESCRIPTION: DESCRIPTION: Days since randomization 03/18/2016 11:12 AM
maxinten VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0 = Moderate 1 = Severe VALUE_RANGE: 0::2 NOTES: 0 = Moderate; 1 = Severe; 2=Mild 03/18/2016 11:10 AM
sefgass16 VALUE_RANGE, NOTES VALUE_RANGE: 0::3 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe VALUE_RANGE: 0::3; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown 12/23/2015 12:02 PM
se_b12 VALUE_RANGE, NOTES VALUE_RANGE: 0::4 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done VALUE_RANGE: 0::4; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done; -9=unknown 12/23/2015 11:47 AM
se_b16 VALUE_RANGE, NOTES VALUE_RANGE: 0::3 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe VALUE_RANGE: 0::3; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown 12/23/2015 11:47 AM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 11/13/2015 15:15 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 11/13/2015 14:19 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 11/09/2015 11:13 AM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 11/09/2015 11:02 AM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 11/02/2015 13:17 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 11/02/2015 12:42 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 10/07/2015 14:37 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 10/07/2015 12:52 PM
saea19 VALUE_RANGE VALUE_RANGE: A;B;C;D: E; F; U VALUE_RANGE: A;B;C;D;E;F;U 10/06/2015 18:04 PM
tx_code VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0=Olanzapine & Placebo; 1=Olanzapine & Sertraline VALUE_RANGE: 0::3 NOTES: 0=Olanzapine + Sertraline Placebo; 1=Olanzapine + Sertraline; 2=Olanzapine + Sertraline + Lithium Placebo; 3=Olanzapine + Sertraline + Lithium 10/06/2015 18:02 PM
ci_enrolled NEW_MAP_ELEMENT Added data element 'ci_enrolled' to data structure 'adev01'. 10/06/2015 16:08 PM
darsrz NEW_DATA_ELEMENT 10/06/2015 16:08 PM
darsrz NEW_MAP_ELEMENT Added data element 'darsrz' to data structure 'adev01'. 10/06/2015 16:08 PM
ae_serious_signific NEW_MAP_ELEMENT Added data element 'ae_serious_signific' to data structure 'adev01'. 09/30/2015 17:13 PM
dsabl NEW_MAP_ELEMENT Added data element 'dsabl' to data structure 'adev01'. 09/30/2015 17:13 PM
hsptl NEW_MAP_ELEMENT Added data element 'hsptl' to data structure 'adev01'. 09/30/2015 17:13 PM
lfthr NEW_MAP_ELEMENT Added data element 'lfthr' to data structure 'adev01'. 09/30/2015 17:13 PM
altillns NEW_MAP_ELEMENT Added data element 'altillns' to data structure 'adev01'. 09/30/2015 17:13 PM
altnone NEW_MAP_ELEMENT Added data element 'altnone' to data structure 'adev01'. 09/30/2015 17:13 PM
altothr NEW_MAP_ELEMENT Added data element 'altothr' to data structure 'adev01'. 09/30/2015 17:13 PM
conspec NEW_MAP_ELEMENT Added data element 'conspec' to data structure 'adev01'. 09/30/2015 17:13 PM
death NEW_MAP_ELEMENT Added data element 'death' to data structure 'adev01'. 09/30/2015 17:13 PM
defect NEW_MAP_ELEMENT Added data element 'defect' to data structure 'adev01'. 09/30/2015 17:13 PM
description_of_sae NEW_MAP_ELEMENT Added data element 'description_of_sae' to data structure 'adev01'. 09/30/2015 17:13 PM
inilspec NEW_MAP_ELEMENT Added data element 'inilspec' to data structure 'adev01'. 09/30/2015 17:13 PM
othspec NEW_MAP_ELEMENT Added data element 'othspec' to data structure 'adev01'. 09/30/2015 17:13 PM
stprspec NEW_MAP_ELEMENT Added data element 'stprspec' to data structure 'adev01'. 09/30/2015 17:13 PM
aespdtm NEW_MAP_ELEMENT Added data element 'aespdtm' to data structure 'adev01'. 09/30/2015 17:13 PM
altproc NEW_MAP_ELEMENT Added data element 'altproc' to data structure 'adev01'. 09/30/2015 17:13 PM
drugrsdt NEW_MAP_ELEMENT Added data element 'drugrsdt' to data structure 'adev01'. 09/30/2015 17:13 PM
ratrel NEW_MAP_ELEMENT Added data element 'ratrel' to data structure 'adev01'. 09/30/2015 17:13 PM
saea19 NEW_MAP_ELEMENT Added data element 'saea19' to data structure 'adev01'. 09/30/2015 17:13 PM
saedimtd NEW_MAP_ELEMENT Added data element 'saedimtd' to data structure 'adev01'. 09/30/2015 17:13 PM
saedinrd NEW_MAP_ELEMENT Added data element 'saedinrd' to data structure 'adev01'. 09/30/2015 17:13 PM
saedispd NEW_MAP_ELEMENT Added data element 'saedispd' to data structure 'adev01'. 09/30/2015 17:13 PM
saerapr NEW_MAP_ELEMENT Added data element 'saerapr' to data structure 'adev01'. 09/30/2015 17:13 PM
stdate NEW_MAP_ELEMENT Added data element 'stdate' to data structure 'adev01'. 09/30/2015 17:13 PM
aespdtm NEW_DATA_ELEMENT 09/30/2015 17:13 PM
aestdtm NEW_DATA_ELEMENT 09/30/2015 17:13 PM
aestdtm NEW_MAP_ELEMENT Added data element 'aestdtm' to data structure 'adev01'. 09/30/2015 17:13 PM
altillns NEW_DATA_ELEMENT 09/30/2015 17:13 PM
altnone NEW_DATA_ELEMENT 09/30/2015 17:13 PM
altothr NEW_DATA_ELEMENT 09/30/2015 17:13 PM
altproc NEW_DATA_ELEMENT 09/30/2015 17:13 PM
conspec NEW_DATA_ELEMENT 09/30/2015 17:13 PM
drugrsdt NEW_DATA_ELEMENT 09/30/2015 17:13 PM
inilspec NEW_DATA_ELEMENT 09/30/2015 17:13 PM
othspec NEW_DATA_ELEMENT 09/30/2015 17:13 PM
ratrel NEW_DATA_ELEMENT 09/30/2015 17:13 PM
saedimtd NEW_DATA_ELEMENT 09/30/2015 17:13 PM
saedinrd NEW_DATA_ELEMENT 09/30/2015 17:13 PM
saedispd NEW_DATA_ELEMENT 09/30/2015 17:13 PM
saerapr NEW_DATA_ELEMENT 09/30/2015 17:13 PM
stprspec NEW_DATA_ELEMENT 09/30/2015 17:13 PM
action VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D; E; F; G NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued VALUE_RANGE: A; B; C;D; E; F; G;U NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued; U=unknown 09/30/2015 17:12 PM
saea19 VALUE_RANGE, NOTES VALUE_RANGE: A;B;C;D NOTES: A=Died; B=Ongoing; C=Recovered; D=Recovered with sequeale VALUE_RANGE: A;B;C;D: E; F; U NOTES: A=Died; B=Ongoing; C=Recovered; D=Recovered with sequelae;E=Not recovered; F=Recovering; U=Unknown 09/30/2015 17:12 PM
days_baseline NEW_MAP_ELEMENT Added data element 'days_baseline' to data structure 'adev01'. 09/24/2015 14:33 PM
hosp NEW_MAP_ELEMENT Added data element 'hosp' to data structure 'adev01'. 09/24/2015 14:33 PM
rev_orthofracture NEW_MAP_ELEMENT Added data element 'rev_orthofracture' to data structure 'adev01'. 09/24/2015 14:33 PM
severityoffall NEW_MAP_ELEMENT Added data element 'severityoffall' to data structure 'adev01'. 09/24/2015 14:33 PM
typeoffall NEW_MAP_ELEMENT Added data element 'typeoffall' to data structure 'adev01'. 09/24/2015 14:33 PM
adverse_event_code NEW_DATA_ELEMENT 09/24/2015 14:33 PM
adverse_event_code NEW_MAP_ELEMENT Added data element 'adverse_event_code' to data structure 'adev01'. 09/24/2015 14:33 PM
agegroup NEW_DATA_ELEMENT 09/24/2015 14:33 PM
agegroup NEW_MAP_ELEMENT Added data element 'agegroup' to data structure 'adev01'. 09/24/2015 14:33 PM
recoverydays NEW_DATA_ELEMENT 09/24/2015 14:33 PM
recoverydays NEW_MAP_ELEMENT Added data element 'recoverydays' to data structure 'adev01'. 09/24/2015 14:33 PM
severityoffall NEW_DATA_ELEMENT 09/24/2015 14:33 PM
study_id NEW_MAP_ELEMENT Added data element 'study_id' to data structure 'adev01'. 09/24/2015 14:33 PM
tx_code NEW_DATA_ELEMENT 09/24/2015 14:33 PM
tx_code NEW_MAP_ELEMENT Added data element 'tx_code' to data structure 'adev01'. 09/24/2015 14:33 PM
typeoffall NEW_DATA_ELEMENT 09/24/2015 14:33 PM
study_id NOTES NOTES: NOTES: 46=Acute Phase; 47=Stabilization Phase 09/24/2015 12:50 PM
ci_enrolled NOTES NOTES: NOTES: 0=No; 1=Yes 09/15/2015 17:24 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 09/04/2015 16:23 PM
trtgroup NEW_MAP_ELEMENT Added data element 'trtgroup' to data structure 'adev01'. 09/04/2015 16:14 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 09/04/2015 16:00 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 08/24/2015 16:03 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 08/24/2015 15:27 PM
visnum NEW_MAP_ELEMENT Added data element 'visnum' to data structure 'adev01'. 08/24/2015 13:31 PM
trtgroup NEW_DATA_ELEMENT 08/21/2015 10:22 AM
ae4t NEW_MAP_ELEMENT Added data element 'ae4t' to data structure 'adev01'. 08/20/2015 10:40 AM
days_visit1 NEW_MAP_ELEMENT Added data element 'days_visit1' to data structure 'adev01'. 08/20/2015 10:40 AM
intrt NEW_MAP_ELEMENT Added data element 'intrt' to data structure 'adev01'. 08/20/2015 10:40 AM
trtgrp_p NEW_MAP_ELEMENT Added data element 'trtgrp_p' to data structure 'adev01'. 08/20/2015 10:40 AM
ae1t NEW_MAP_ELEMENT Added data element 'ae1t' to data structure 'adev01'. 08/20/2015 10:40 AM
ae2t NEW_MAP_ELEMENT Added data element 'ae2t' to data structure 'adev01'. 08/20/2015 10:40 AM
ae3t NEW_MAP_ELEMENT Added data element 'ae3t' to data structure 'adev01'. 08/20/2015 10:40 AM
ae_14 NEW_MAP_ELEMENT Added data element 'ae_14' to data structure 'adev01'. 08/20/2015 10:40 AM
ae_16 NEW_MAP_ELEMENT Added data element 'ae_16' to data structure 'adev01'. 08/20/2015 10:40 AM
ae_20 NEW_MAP_ELEMENT Added data element 'ae_20' to data structure 'adev01'. 08/20/2015 10:40 AM
ae_3 NEW_MAP_ELEMENT Added data element 'ae_3' to data structure 'adev01'. 08/20/2015 10:40 AM
pwc015 NEW_MAP_ELEMENT Added data element 'pwc015' to data structure 'adev01'. 08/20/2015 10:40 AM
aer016a NEW_MAP_ELEMENT Added data element 'aer016a' to data structure 'adev01'. 08/20/2015 10:40 AM
sefcnss30 NEW_MAP_ELEMENT Added data element 'sefcnss30' to data structure 'adev01'. 08/20/2015 10:40 AM
sefgens49 NEW_MAP_ELEMENT Added data element 'sefgens49' to data structure 'adev01'. 08/20/2015 10:40 AM
sefoths61 NEW_MAP_ELEMENT Added data element 'sefoths61' to data structure 'adev01'. 08/20/2015 10:40 AM
sft003 NEW_MAP_ELEMENT Added data element 'sft003' to data structure 'adev01'. 08/20/2015 10:40 AM
sft006 NEW_MAP_ELEMENT Added data element 'sft006' to data structure 'adev01'. 08/20/2015 10:40 AM
sft015 NEW_MAP_ELEMENT Added data element 'sft015' to data structure 'adev01'. 08/20/2015 10:40 AM
ae1t NEW_DATA_ELEMENT 08/20/2015 10:40 AM
ae2t NEW_DATA_ELEMENT 08/20/2015 10:40 AM
ae3t NEW_DATA_ELEMENT 08/20/2015 10:40 AM
ae4t NEW_DATA_ELEMENT 08/20/2015 10:40 AM
ae_16 NEW_DATA_ELEMENT 08/20/2015 10:40 AM
ae_20 NEW_DATA_ELEMENT 08/20/2015 10:40 AM
ae_3 NEW_DATA_ELEMENT 08/20/2015 10:40 AM
safte50 NEW_MAP_ELEMENT Added data element 'safte50' to data structure 'adev01'. 08/20/2015 10:40 AM
ae_14 NEW_DATA_ELEMENT 08/20/2015 10:40 AM
days_visit1 NEW_DATA_ELEMENT 08/19/2015 16:48 PM
intrt NEW_DATA_ELEMENT 08/19/2015 16:48 PM
trtgrp_p NEW_DATA_ELEMENT 08/19/2015 16:48 PM
stage VALUE_RANGE VALUE_RANGE: 0::5; 51::53; 67; -888; - 999 VALUE_RANGE: 0::5; 51::53; 67; -888; -999 08/18/2015 10:11 AM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 08/17/2015 16:02 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 08/17/2015 15:57 PM
otr_actn_02 NEW_MAP_ELEMENT Added data element 'otr_actn_02' to data structure 'adev01'. 08/12/2015 13:40 PM
otr_actn_03 NEW_MAP_ELEMENT Added data element 'otr_actn_03' to data structure 'adev01'. 08/12/2015 13:40 PM
otr_actn_01 NEW_DATA_ELEMENT 08/12/2015 13:40 PM
otr_actn_01 NEW_MAP_ELEMENT Added data element 'otr_actn_01' to data structure 'adev01'. 08/12/2015 13:40 PM
otr_actn_02 NEW_DATA_ELEMENT 08/12/2015 13:40 PM
otr_actn_03 NEW_DATA_ELEMENT 08/12/2015 13:40 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 07/30/2015 12:55 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 07/30/2015 12:48 PM
ham_a_q7 NEW_MAP_ELEMENT Added data element 'ham_a_q7' to data structure 'adev01'. 07/30/2015 11:21 AM
gender REQUIRED REQUIRED: Recommended REQUIRED: Required 07/23/2015 11:32 AM
pwc016 NEW_MAP_ELEMENT Added data element 'pwc016' to data structure 'adev01'. 07/22/2015 15:04 PM
se_b12 NEW_MAP_ELEMENT Added data element 'se_b12' to data structure 'adev01'. 07/22/2015 15:04 PM
se_b16 NEW_MAP_ELEMENT Added data element 'se_b16' to data structure 'adev01'. 07/22/2015 15:04 PM
sefgass16 NEW_MAP_ELEMENT Added data element 'sefgass16' to data structure 'adev01'. 07/22/2015 15:04 PM
sefgass6 NEW_MAP_ELEMENT Added data element 'sefgass6' to data structure 'adev01'. 07/22/2015 15:04 PM
ham_a_q7 NEW_DATA_ELEMENT 07/16/2015 12:08 PM
sefgass6 VALUE_RANGE, NOTES VALUE_RANGE: 0::3; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown VALUE_RANGE: 0::4; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4= not done 07/14/2015 18:17 PM
sefcnss30 VALUE_RANGE, NOTES VALUE_RANGE: 0::3; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown VALUE_RANGE: 0::4; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done 07/14/2015 18:16 PM
se_b16 NOTES NOTES: "0=Absent, 1=Mild, 2=Moderate, 3=Severe" NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe 07/14/2015 18:15 PM
se_b12 VALUE_RANGE, NOTES VALUE_RANGE: 0::3 NOTES: "0=Absent, 1=Mild, 2=Moderate, 3=Severe" VALUE_RANGE: 0::4 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe'; 4= not done 07/14/2015 18:15 PM
aesa20 VALUE_RANGE, NOTES VALUE_RANGE: 0;1;2;3 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe VALUE_RANGE: 0::4 NOTES: 0=Absent; 1=Mild; 2=Moderate; 3=Severe; 4=not done 07/14/2015 18:09 PM
aer016a VALUE_RANGE, NOTES VALUE_RANGE: 0::3;-9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown VALUE_RANGE: 0::4;-9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown; 4=not done 07/14/2015 18:08 PM
cbcl1_2_text ELEMENT_SIZE ELEMENT_SIZE: 62 ELEMENT_SIZE: 500 07/14/2015 13:40 PM
aeout VALUE_RANGE, NOTES VALUE_RANGE: 1::10; -9 NOTES: 1 = 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; -9=unknown VALUE_RANGE: 1::12; -9 NOTES: 1 = 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; 11=Lost to follow up; 12=Other; -9=unknown 07/13/2015 15:12 PM
aeacn VALUE_RANGE, NOTES VALUE_RANGE: 1::3 NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily VALUE_RANGE: 1::5; 99 NOTES: 1 = None; 2 = Discontinued permanently; 3 = Discontinued temporarily; 4=Dose Reduction; 5=Dose suspension; 99=Other 07/13/2015 15:12 PM
session_id NEW_MAP_ELEMENT Added data element 'session_id' to data structure 'adev01'. 07/13/2015 15:11 PM
demo_health_condsp NEW_DATA_ELEMENT 06/26/2015 17:58 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/18/2015 10:25 AM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/18/2015 10:06 AM
sdatothr TYPE, ELEMENT_SIZE TYPE: Integer ELEMENT_SIZE: TYPE: String ELEMENT_SIZE: 60 06/16/2015 13:54 PM
othact1 VALUE_RANGE, NOTES VALUE_RANGE: 1 NOTES: 1 = Yes VALUE_RANGE: 1;0 NOTES: 1 = Yes; 0=No 06/16/2015 11:33 AM
othact2 VALUE_RANGE, NOTES VALUE_RANGE: 1 NOTES: 1 = Yes VALUE_RANGE: 1;0 NOTES: 1 = Yes; 0=No 06/16/2015 11:33 AM
othact3 VALUE_RANGE, NOTES VALUE_RANGE: 1 NOTES: 1 = Yes VALUE_RANGE: 1;0 NOTES: 1 = Yes; 0=No 06/16/2015 11:33 AM
othact4 VALUE_RANGE, NOTES VALUE_RANGE: 1 NOTES: 1 = Yes VALUE_RANGE: 1;0 NOTES: 1 = Yes; 0=No 06/16/2015 11:33 AM
aefther NOTES NOTES: 0 = IE (Independent Evaluator); 1 = PT (Pharmacotherapist); 2 = CBT (Cognitive Behavioral Therapist); 3 = MD (Medical Doctor); 4 = PI (Principal Investigator) NOTES: 0 = IE (Independent Evaluator); 1 = PT (Pharmacotherapist); 2 = CBT (Cognitive Behavioral Therapist); 3 = MD (Medical Doctor); 4 = PI (Principal Investigator) 06/11/2015 16:29 PM
aer016a VALUE_RANGE VALUE_RANGE: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown VALUE_RANGE: 0::3;-9 06/08/2015 10:50 AM
dayae NEW_DATA_ELEMENT 06/05/2015 16:56 PM
sdrugact VALUE_RANGE, NOTES VALUE_RANGE: 1::11 NOTES: 1 = Dose increased; 2 = Dose reduced; 3 = Temporarily discontinued; 4 = Permanently discontinued; 5 = Unblinded; 6 = Unblinded & dose increased; 7 = Unblinded & dose decrease; 8 = Unblinded & temporarily discontinued; 9= Unblinded & permanently discontinued; 10=None; 11=Delayed Dose VALUE_RANGE: 1::12 NOTES: 1 = Dose increased; 2 = Dose reduced; 3 = Temporarily discontinued; 4 = Permanently discontinued; 5 = Unblinded; 6 = Unblinded & dose increased; 7 = Unblinded & dose decrease; 8 = Unblinded & temporarily discontinued; 9= Unblinded & permanently discontinued; 10=None; 11=Delayed Dose; 12= other 06/05/2015 16:36 PM
aecat NEW_MAP_ELEMENT Added data element 'aecat' to data structure 'adev01'. 06/05/2015 16:34 PM
dayresolved NEW_MAP_ELEMENT Added data element 'dayresolved' to data structure 'adev01'. 06/05/2015 16:34 PM
fdacrit NEW_MAP_ELEMENT Added data element 'fdacrit' to data structure 'adev01'. 06/05/2015 16:34 PM
sdatothr NEW_MAP_ELEMENT Added data element 'sdatothr' to data structure 'adev01'. 06/05/2015 16:34 PM
status NEW_MAP_ELEMENT Added data element 'status' to data structure 'adev01'. 06/05/2015 16:34 PM
withdrug NEW_MAP_ELEMENT Added data element 'withdrug' to data structure 'adev01'. 06/05/2015 16:34 PM
aecat NEW_DATA_ELEMENT 06/05/2015 16:34 PM
aefreqnc NEW_DATA_ELEMENT 06/05/2015 16:34 PM
aefreqnc NEW_MAP_ELEMENT Added data element 'aefreqnc' to data structure 'adev01'. 06/05/2015 16:34 PM
aefther NEW_DATA_ELEMENT 06/05/2015 16:34 PM
aefther NEW_MAP_ELEMENT Added data element 'aefther' to data structure 'adev01'. 06/05/2015 16:34 PM
dayonset NEW_DATA_ELEMENT 06/05/2015 16:34 PM
dayonset NEW_MAP_ELEMENT Added data element 'dayonset' to data structure 'adev01'. 06/05/2015 16:34 PM
dayresolved NEW_DATA_ELEMENT 06/05/2015 16:34 PM
fdacrit NEW_DATA_ELEMENT 06/05/2015 16:34 PM
onsetstg NEW_DATA_ELEMENT 06/05/2015 16:34 PM
onsetstg NEW_MAP_ELEMENT Added data element 'onsetstg' to data structure 'adev01'. 06/05/2015 16:34 PM
reportpd NEW_DATA_ELEMENT 06/05/2015 16:34 PM
reportpd NEW_MAP_ELEMENT Added data element 'reportpd' to data structure 'adev01'. 06/05/2015 16:34 PM
sdatothr NEW_DATA_ELEMENT 06/05/2015 16:34 PM
withdrug NEW_DATA_ELEMENT 06/05/2015 16:34 PM
aer016a VALUE_RANGE, NOTES VALUE_RANGE: 0::3 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe VALUE_RANGE: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown 06/05/2015 15:06 PM
sefcnss30 VALUE_RANGE, NOTES VALUE_RANGE: 0::3 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe VALUE_RANGE: 0::3; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown 06/05/2015 15:05 PM
sefgass6 VALUE_RANGE, NOTES VALUE_RANGE: 0::3 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe VALUE_RANGE: 0::3; -9 NOTES: 0=Absent, 1=Mild, 2=Moderate, 3=Severe; -9=unknown 06/05/2015 15:04 PM
sft003 VALUE_RANGE VALUE_RANGE: VALUE_RANGE: 0::3; -9 06/05/2015 11:13 AM
sft006 VALUE_RANGE VALUE_RANGE: VALUE_RANGE: 0::3; -9 06/05/2015 11:13 AM
sft015 VALUE_RANGE VALUE_RANGE: VALUE_RANGE: 0::3; -9 06/05/2015 11:13 AM
sft003 DESCRIPTION, NOTES DESCRIPTION: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown NOTES: DESCRIPTION: Sedation/drowsiness NOTES: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown 06/04/2015 17:31 PM
sft006 DESCRIPTION, NOTES DESCRIPTION: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown NOTES: DESCRIPTION: Malaise NOTES: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown 06/04/2015 17:31 PM
sft015 DESCRIPTION, NOTES DESCRIPTION: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown NOTES: DESCRIPTION: Dizziness/faintness NOTES: 0=Not present; 1=Mild; 2=Moderate; 3=Severe; -9=Unknown 06/04/2015 17:31 PM
sft003 NEW_DATA_ELEMENT 06/04/2015 17:22 PM
sft006 NEW_DATA_ELEMENT 06/04/2015 17:22 PM
sft015 NEW_DATA_ELEMENT 06/04/2015 17:22 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/04/2015 16:35 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/04/2015 16:23 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 06/04/2015 15:13 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 06/04/2015 14:26 PM
aef001 VALUE_RANGE, NOTES VALUE_RANGE: 1::99 NOTES: VALUE_RANGE: 1::99; -9 NOTES: -9=unknown 06/03/2015 16:49 PM
aef008 VALUE_RANGE, NOTES VALUE_RANGE: 1::6 NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); VALUE_RANGE: 1::6; -9 NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); -9=unknown 06/03/2015 16:49 PM
aeout VALUE_RANGE, NOTES VALUE_RANGE: 1::10 NOTES: 1 = 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 VALUE_RANGE: 1::10; -9 NOTES: 1 = 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; -9=unknown 06/03/2015 16:49 PM
aeser VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0 = No; 1 = Yes VALUE_RANGE: 0;1; -9 NOTES: 0 = No; 1 = Yes; -9=unknown 06/03/2015 16:49 PM
aeexp VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: 0 = No; 1 = Yes VALUE_RANGE: 0;1; -9 NOTES: 0 = No; 1 = Yes; -9 =unknown 06/03/2015 16:47 PM
aesev VALUE_RANGE, NOTES VALUE_RANGE: 1::4 NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening VALUE_RANGE: 1::4; -9 NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening; -9=unknown 06/03/2015 16:45 PM
lab020 NEW_MAP_ELEMENT Added data element 'lab020' to data structure 'adev01'. 06/03/2015 16:44 PM
action VALUE_RANGE, NOTES VALUE_RANGE: A; B; C;D NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable VALUE_RANGE: A; B; C;D; E; F; G NOTES: A=None; B=Discontinue; C=Interrupted; D=Not applicable; E=Dose Reduced; F=Stopped Temporarily; G=Phase Discontinued 06/03/2015 16:33 PM
interview_date DESCRIPTION DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYY DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYYY 06/02/2015 17:40 PM
interview_date DESCRIPTION DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed DESCRIPTION: Date on which the interview/genetic test/sampling/imaging was completed. MM/DD/YYY 06/02/2015 17:40 PM
e3_day NEW_MAP_ELEMENT Added data element 'e3_day' to data structure 'adev01'. 06/01/2015 16:49 PM
end_dy NEW_MAP_ELEMENT Added data element 'end_dy' to data structure 'adev01'. 06/01/2015 16:49 PM
eoc_day NEW_MAP_ELEMENT Added data element 'eoc_day' to data structure 'adev01'. 06/01/2015 16:49 PM
start_dy NEW_MAP_ELEMENT Added data element 'start_dy' to data structure 'adev01'. 06/01/2015 16:49 PM
b1_day NEW_MAP_ELEMENT Added data element 'b1_day' to data structure 'adev01'. 06/01/2015 16:49 PM
b2_day NEW_MAP_ELEMENT Added data element 'b2_day' to data structure 'adev01'. 06/01/2015 16:49 PM
b3_day NEW_MAP_ELEMENT Added data element 'b3_day' to data structure 'adev01'. 06/01/2015 16:49 PM
boc_day NEW_MAP_ELEMENT Added data element 'boc_day' to data structure 'adev01'. 06/01/2015 16:49 PM
e1_day NEW_MAP_ELEMENT Added data element 'e1_day' to data structure 'adev01'. 06/01/2015 16:49 PM
e2_day NEW_MAP_ELEMENT Added data element 'e2_day' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp10 NEW_MAP_ELEMENT Added data element 'socgrp10' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp11 NEW_MAP_ELEMENT Added data element 'socgrp11' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp12 NEW_MAP_ELEMENT Added data element 'socgrp12' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp13 NEW_MAP_ELEMENT Added data element 'socgrp13' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp14 NEW_MAP_ELEMENT Added data element 'socgrp14' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp15 NEW_MAP_ELEMENT Added data element 'socgrp15' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp9 NEW_MAP_ELEMENT Added data element 'socgrp9' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp1 NEW_MAP_ELEMENT Added data element 'socgrp1' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp2 NEW_MAP_ELEMENT Added data element 'socgrp2' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp3 NEW_MAP_ELEMENT Added data element 'socgrp3' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp4 NEW_MAP_ELEMENT Added data element 'socgrp4' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp5 NEW_MAP_ELEMENT Added data element 'socgrp5' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp6 NEW_MAP_ELEMENT Added data element 'socgrp6' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp7 NEW_MAP_ELEMENT Added data element 'socgrp7' to data structure 'adev01'. 06/01/2015 16:49 PM
socgrp8 NEW_MAP_ELEMENT Added data element 'socgrp8' to data structure 'adev01'. 06/01/2015 16:49 PM
te1 NEW_MAP_ELEMENT Added data element 'te1' to data structure 'adev01'. 06/01/2015 16:49 PM
te2 NEW_MAP_ELEMENT Added data element 'te2' to data structure 'adev01'. 06/01/2015 16:49 PM
te3 NEW_MAP_ELEMENT Added data element 'te3' to data structure 'adev01'. 06/01/2015 16:49 PM
tebase NEW_MAP_ELEMENT Added data element 'tebase' to data structure 'adev01'. 06/01/2015 16:49 PM
teoc NEW_MAP_ELEMENT Added data element 'teoc' to data structure 'adev01'. 06/01/2015 16:49 PM
phase_ct NEW_MAP_ELEMENT Added data element 'phase_ct' to data structure 'adev01'. 06/01/2015 16:49 PM
prf_term NEW_MAP_ELEMENT Added data element 'prf_term' to data structure 'adev01'. 06/01/2015 16:49 PM
reportid NEW_MAP_ELEMENT Added data element 'reportid' to data structure 'adev01'. 06/01/2015 16:49 PM
soc NEW_MAP_ELEMENT Added data element 'soc' to data structure 'adev01'. 06/01/2015 16:49 PM
action NEW_MAP_ELEMENT Added data element 'action' to data structure 'adev01'. 06/01/2015 16:48 PM
end_dy NEW_DATA_ELEMENT 06/01/2015 16:48 PM
sae NEW_MAP_ELEMENT Added data element 'sae' to data structure 'adev01'. 06/01/2015 16:48 PM
socgrp1 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp10 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp11 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp12 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp13 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp14 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp15 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp2 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp3 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp4 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp5 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp6 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp7 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp8 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
socgrp9 NEW_DATA_ELEMENT 06/01/2015 16:48 PM
start_dy NEW_DATA_ELEMENT 06/01/2015 16:48 PM
tebase NEW_DATA_ELEMENT 06/01/2015 16:48 PM
teoc NEW_DATA_ELEMENT 06/01/2015 16:48 PM
interview_age VALUE_RANGE VALUE_RANGE: 0 :: 1200 VALUE_RANGE: 0 :: 1260 06/01/2015 14:16 PM
prf_term ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 100 06/01/2015 13:22 PM
boc_day NEW_DATA_ELEMENT 05/29/2015 14:51 PM
eoc_day NEW_DATA_ELEMENT 05/29/2015 14:51 PM
aestatuschange_1 NOTES NOTES: 73=No; 74=Yes, Ideation to Attempt; 75=Yes, Ideation to Completed Suicide; 76=Yes, attempt to Completed Suicide; 77=Not Applicable to this AE Type; -888=Not Applicable; -999=Missing; NOTES: 73=No; 74=Yes, Ideation to Attempt; 75=Yes, Ideation to Completed Suicide; 76=Yes, attempt to Completed Suicide; 77=Not Applicable to this AE Type; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
callcenterdatasource_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
crisiscenterdatasource_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
emnetaetype_1 NOTES NOTES: 39=NSSI; 40=Suicide Attempt; 41=Suicide Crisis; 42=Death Clearly not Intentional; 43=Death Unsure if Intentional; 44=Death Probably Intentional; 45=Death Clearly Intentional; 46=Hospitalization; 47=ED; 48=Other Distress Durring Assessment; 65=Other ED visit no documentation available; 66=Other Hospitalization no documentation available; 72=Boys Town Event; 78=Other; -888=Not Applicable; -999=Missing; NOTES: 39=NSSI; 40=Suicide Attempt; 41=Suicide Crisis; 42=Death Clearly not Intentional; 43=Death Unsure if Intentional; 44=Death Probably Intentional; 45=Death Clearly Intentional; 46=Hospitalization; 47=ED; 48=Other Distress Durring Assessment; 65=Other ED visit no documentation available; 66=Other Hospitalization no documentation available; 72=Boys Town Event; 78=Other; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
emnetisdead_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
emnetother_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
noselfharmideationdeath_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
noselfharmideationhospdetox_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
noselfharmideationhosplmed_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
noselfharmideationhosppsych_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
noselfharmideationnohosp_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
noselfharmideationoth_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
noselfharmideationunknown_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideation_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationcrisiscall_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationcrisisedvis_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationdeath_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationhospdetox_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationhospmed_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationhosppsych_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationnohosp_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationother_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationpolice_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationtransfer_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
selfharmideationunknown_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
sitedatasource_1 NOTES NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; NOTES: 0=False; 1=True; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
source_1 NOTES NOTES: 33=RED Cap; 34=Confirm IT; 35=Butler; 70=Baseline Assessment; 71=Vital Statistics; -888=Not Applicable; -999=Missing; NOTES: 33=RED Cap; 34=Confirm IT; 35=Butler; 70=Baseline Assessment; 71=Vital Statistics; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
studyrelation_1 NOTES NOTES: 58=Definite; 59=Probable; 60=Possible; 61=Unlikely; 62=Unrelated; 69=Unknown; -888=Not Applicable; -999=Missing; NOTES: 58=Definite; 59=Probable; 60=Possible; 61=Unlikely; 62=Unrelated; 69=Unknown; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
wk6c11a NOTES NOTES: 1=Yes; 2=No; 98=Refused; -888=Not Applicable; -999=Missing; NOTES: 1=Yes; 2=No; 98=Refused; -888=Not Applicable; -999=Missing; 05/29/2015 13:35 PM
rpttp NOTES NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; 05/29/2015 13:34 PM
comments_misc DESCRIPTION DESCRIPTION: Miscellaneous comments on study, interview, methodology relevant to this form data DESCRIPTION: Miscellaneous comments on study, interview, methodology relevant to this form data 05/29/2015 13:29 PM
phase_ct VALUE_RANGE VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase; Screening; Phase 1 05/28/2015 18:32 PM
visnum NEW_DATA_ELEMENT 05/28/2015 12:48 PM
phase_ct VALUE_RANGE VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B VALUE_RANGE: Pre-Rand; Phase 1/1A; Phase 2; Phase 3; Phase 4; Phase 1B; Open-Choice Phase 05/28/2015 12:11 PM
site ELEMENT_SIZE ELEMENT_SIZE: 20 ELEMENT_SIZE: 100 05/26/2015 11:15 AM
rpttp VALUE_RANGE, NOTES VALUE_RANGE: 1;2 NOTES: "1=Initial, 2=Follow-up" VALUE_RANGE: 1::4 NOTES: "1=Initial, 2=Follow-up"; 3=Unresolved at 1 week; 4=Final Report; 05/21/2015 15:11 PM
week NOTES NOTES: NOTES: 99=week 10-week 14 05/19/2015 18:30 PM
cbcl1_2_text NEW_DATA_ELEMENT 05/04/2015 15:54 PM
safte50 NEW_DATA_ELEMENT 04/29/2015 15:42 PM
ae_serious_signific NEW_DATA_ELEMENT 04/27/2015 17:37 PM
description_of_sae NEW_DATA_ELEMENT 04/27/2015 17:37 PM
interview_age REQUIRED REQUIRED: Recommended REQUIRED: Required 04/23/2015 15:11 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 04/23/2015 15:11 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 04/23/2015 14:40 PM
sdrugact VALUE_RANGE VALUE_RANGE: 1::9 VALUE_RANGE: 1::11 04/23/2015 11:51 AM
aeconmed NEW_MAP_ELEMENT Added data element 'aeconmed' to data structure 'adev01'. 04/23/2015 11:31 AM
aeinit NEW_MAP_ELEMENT Added data element 'aeinit' to data structure 'adev01'. 04/23/2015 11:31 AM
aerisk NEW_MAP_ELEMENT Added data element 'aerisk' to data structure 'adev01'. 04/23/2015 11:31 AM
irbrprt NEW_MAP_ELEMENT Added data element 'irbrprt' to data structure 'adev01'. 04/23/2015 11:31 AM
irbrptdt NEW_MAP_ELEMENT Added data element 'irbrptdt' to data structure 'adev01'. 04/23/2015 11:31 AM
sibre NEW_MAP_ELEMENT Added data element 'sibre' to data structure 'adev01'. 04/23/2015 11:31 AM
sqlatxt NEW_MAP_ELEMENT Added data element 'sqlatxt' to data structure 'adev01'. 04/23/2015 11:31 AM
aechng NEW_DATA_ELEMENT 04/23/2015 11:31 AM
aechng NEW_MAP_ELEMENT Added data element 'aechng' to data structure 'adev01'. 04/23/2015 11:31 AM
aeconmed NEW_DATA_ELEMENT 04/23/2015 11:31 AM
aeinit NEW_DATA_ELEMENT 04/23/2015 11:31 AM
aerisk NEW_DATA_ELEMENT 04/23/2015 11:31 AM
aeterm NEW_DATA_ELEMENT 04/23/2015 11:31 AM
aeterm NEW_MAP_ELEMENT Added data element 'aeterm' to data structure 'adev01'. 04/23/2015 11:31 AM
irbrprt NEW_DATA_ELEMENT 04/23/2015 11:31 AM
irbrptdt NEW_DATA_ELEMENT 04/23/2015 11:31 AM
sibre NEW_DATA_ELEMENT 04/23/2015 11:31 AM
sqlatxt NEW_DATA_ELEMENT 04/23/2015 11:31 AM
aeonstm NEW_DATA_ELEMENT 04/22/2015 18:12 PM
aeonstm NEW_MAP_ELEMENT Added data element 'aeonstm' to data structure 'adev01'. 04/22/2015 18:12 PM
aef002 ELEMENT_SIZE ELEMENT_SIZE: 50 ELEMENT_SIZE: 250 04/22/2015 17:07 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 04/17/2015 15:02 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 04/17/2015 13:06 PM
aesa5 VALUE_RANGE, NOTES VALUE_RANGE: 0;1;2;3 NOTES: Absent=0; Mild=1; Moderate=2; Severe=3 VALUE_RANGE: 0::4 NOTES: Absent=0; Mild=1; Moderate=2; Severe=3; 4=N/A 04/15/2015 15:22 PM
aeact3 NEW_DATA_ELEMENT 04/13/2015 15:27 PM
aeact3 NEW_MAP_ELEMENT Added data element 'aeact3' to data structure 'adev01'. 04/13/2015 15:27 PM
aeany NEW_DATA_ELEMENT 04/13/2015 15:27 PM
aeany NEW_MAP_ELEMENT Added data element 'aeany' to data structure 'adev01'. 04/13/2015 15:27 PM
aedurhr NEW_DATA_ELEMENT 04/13/2015 15:27 PM
aedurhr NEW_MAP_ELEMENT Added data element 'aedurhr' to data structure 'adev01'. 04/13/2015 15:27 PM
aedurmin NEW_DATA_ELEMENT 04/13/2015 15:27 PM
aedurmin NEW_MAP_ELEMENT Added data element 'aedurmin' to data structure 'adev01'. 04/13/2015 15:27 PM
aeonsdt NEW_DATA_ELEMENT 04/13/2015 15:27 PM
aeonsdt NEW_MAP_ELEMENT Added data element 'aeonsdt' to data structure 'adev01'. 04/13/2015 15:27 PM
aerestm NEW_DATA_ELEMENT 04/13/2015 15:27 PM
aerestm NEW_MAP_ELEMENT Added data element 'aerestm' to data structure 'adev01'. 04/13/2015 15:27 PM
aetot NEW_DATA_ELEMENT 04/13/2015 15:27 PM
aetot NEW_MAP_ELEMENT Added data element 'aetot' to data structure 'adev01'. 04/13/2015 15:27 PM
pmmednum NEW_MAP_ELEMENT Added data element 'pmmednum' to data structure 'adev01'. 04/13/2015 15:27 PM
study NEW_MAP_ELEMENT Added data element 'study' to data structure 'adev01'. 04/13/2015 15:27 PM
subtrial_name NEW_MAP_ELEMENT Added data element 'subtrial_name' to data structure 'adev01'. 04/13/2015 15:27 PM
sdrugact NOTES NOTES: 1 = Dose increased; 2 = Dose reduced3 = Temporarily discontinued 4 = Permanently discontinued 5 = Unblinded6 = Unblinded & dose increased 7 = Unblinded & dose decrease 8 = Unblinded & temporarily discontinued 9 = Unblinded & permanently discontinued NOTES: 1 = Dose increased; 2 = Dose reduced; 3 = Temporarily discontinued; 4 = Permanently discontinued; 5 = Unblinded; 6 = Unblinded & dose increased; 7 = Unblinded & dose decrease; 8 = Unblinded & temporarily discontinued; 9= Unblinded & permanently discontinued; 10=None; 11=Delayed Dose 04/13/2015 14:48 PM
aesev VALUE_RANGE, NOTES VALUE_RANGE: 1::3 NOTES: 1 = Mild; 2 = Moderate; 3 = Severe VALUE_RANGE: 1::4 NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 4=Life Threatening 04/13/2015 14:42 PM
aeout VALUE_RANGE, NOTES VALUE_RANGE: 1::5 NOTES: 1 = Resolved without effects; 2 = Resolved with effects; 3 = Ongoing; 4 = Death; 5 = Unknown VALUE_RANGE: 1::10 NOTES: 1 = 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 04/13/2015 14:37 PM
aef005 VALUE_RANGE, NOTES VALUE_RANGE: 1::4;9 NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 9=Not applicable; VALUE_RANGE: 1::7;9 NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 5=Remotely; 6=Definetley Not; 7= Unknown; 9=Not applicable; 04/13/2015 14:08 PM
pmmednum NEW_DATA_ELEMENT 04/13/2015 12:45 PM
subtrial_name NEW_DATA_ELEMENT 04/13/2015 11:51 AM
study NOTES NOTES: CPEA or STAART Study NOTES: 04/13/2015 11:31 AM
aesa12f NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa12f NEW_MAP_ELEMENT Added data element 'aesa12f' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa16 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa16 NEW_MAP_ELEMENT Added data element 'aesa16' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa18 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa18 NEW_MAP_ELEMENT Added data element 'aesa18' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa19 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa19 NEW_MAP_ELEMENT Added data element 'aesa19' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa20 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa20 NEW_MAP_ELEMENT Added data element 'aesa20' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa21a1 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa21a1 NEW_MAP_ELEMENT Added data element 'aesa21a1' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa21b1 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa21b1 NEW_MAP_ELEMENT Added data element 'aesa21b1' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa21c1 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa21c1 NEW_MAP_ELEMENT Added data element 'aesa21c1' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa21d NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa21d NEW_MAP_ELEMENT Added data element 'aesa21d' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa21d1 NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa21d1 NEW_MAP_ELEMENT Added data element 'aesa21d1' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa7f NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa7f NEW_MAP_ELEMENT Added data element 'aesa7f' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa8f NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa8f NEW_MAP_ELEMENT Added data element 'aesa8f' to data structure 'adev01'. 04/10/2015 12:42 PM
aesa9f NEW_DATA_ELEMENT 04/10/2015 12:42 PM
aesa9f NEW_MAP_ELEMENT Added data element 'aesa9f' to data structure 'adev01'. 04/10/2015 12:42 PM
daysrz NEW_MAP_ELEMENT Added data element 'daysrz' to data structure 'adev01'. 04/10/2015 12:42 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 04/07/2015 15:50 PM
interview_date REQUIRED REQUIRED: Required REQUIRED: Recommended 04/07/2015 15:32 PM
aesa14 TYPE TYPE: String TYPE: Float 04/06/2015 08:09 AM
aes3svrt VALUE_RANGE, NOTES VALUE_RANGE: 1::3 NOTES: 1 = Mild; 2 = Moderate; 3 = Severe VALUE_RANGE: 0::3 NOTES: 1 = Mild; 2 = Moderate; 3 = Severe; 0=Absent 04/03/2015 16:54 PM
aesa14 VALUE_RANGE, NOTES VALUE_RANGE: 0;1 NOTES: No=0; Yes=1; VALUE_RANGE: NOTES: 04/03/2015 16:52 PM
saea19 NEW_DATA_ELEMENT 04/02/2015 15:56 PM
aesa10 NEW_MAP_ELEMENT Added data element 'aesa10' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa11 NEW_MAP_ELEMENT Added data element 'aesa11' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa12 NEW_MAP_ELEMENT Added data element 'aesa12' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa13 NEW_MAP_ELEMENT Added data element 'aesa13' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa14 NEW_MAP_ELEMENT Added data element 'aesa14' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa15 NEW_MAP_ELEMENT Added data element 'aesa15' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa7 NEW_MAP_ELEMENT Added data element 'aesa7' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa8 NEW_MAP_ELEMENT Added data element 'aesa8' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa9 NEW_MAP_ELEMENT Added data element 'aesa9' to data structure 'adev01'. 04/02/2015 13:51 PM
version_form NEW_MAP_ELEMENT Added data element 'version_form' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa1 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa1 NEW_MAP_ELEMENT Added data element 'aesa1' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa10 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa11 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa12 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa13 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa14 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa15 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa4 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa4 NEW_MAP_ELEMENT Added data element 'aesa4' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa5 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa5 NEW_MAP_ELEMENT Added data element 'aesa5' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa6 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa6 NEW_MAP_ELEMENT Added data element 'aesa6' to data structure 'adev01'. 04/02/2015 13:51 PM
aesa7 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa8 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
aesa9 NEW_DATA_ELEMENT 04/02/2015 13:51 PM
constisv NEW_MAP_ELEMENT Added data element 'constisv' to data structure 'adev01'. 04/02/2015 13:51 PM
drymthsv NEW_MAP_ELEMENT Added data element 'drymthsv' to data structure 'adev01'. 04/02/2015 13:51 PM
fseqno NEW_MAP_ELEMENT Added data element 'fseqno' to data structure 'adev01'. 04/02/2015 13:51 PM
visday NEW_MAP_ELEMENT Added data element 'visday' to data structure 'adev01'. 04/02/2015 13:51 PM
pwc015 NEW_DATA_ELEMENT 04/01/2015 18:28 PM
pwc016 NEW_DATA_ELEMENT 04/01/2015 18:28 PM
aer016a NEW_DATA_ELEMENT 04/01/2015 18:11 PM
lab020 NEW_DATA_ELEMENT 04/01/2015 17:02 PM
fseqno NEW_DATA_ELEMENT 04/01/2015 12:43 PM
interview_date REQUIRED REQUIRED: Recommended REQUIRED: Required 03/26/2015 12:22 PM
sefgens49 NEW_DATA_ELEMENT 03/24/2015 13:56 PM
sefcnss30 NEW_DATA_ELEMENT 03/24/2015 13:56 PM
sefgass16 NEW_DATA_ELEMENT 03/24/2015 13:56 PM
sefgass6 NEW_DATA_ELEMENT 03/24/2015 13:56 PM
sefoths61 NEW_DATA_ELEMENT 03/24/2015 13:56 PM
wk6c11a NEW_DATA_ELEMENT 03/10/2015 18:33 PM
selfharmideation_1 NEW_MAP_ELEMENT Added data element 'selfharmideation_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationpolice_1 NEW_MAP_ELEMENT Added data element 'selfharmideationpolice_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationtransfer_1 NEW_MAP_ELEMENT Added data element 'selfharmideationtransfer_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationunknown_1 NEW_MAP_ELEMENT Added data element 'selfharmideationunknown_1' to data structure 'adev01'. 03/10/2015 15:47 PM
severity_1 NEW_MAP_ELEMENT Added data element 'severity_1' to data structure 'adev01'. 03/10/2015 15:47 PM
sitedatasource_1 NEW_MAP_ELEMENT Added data element 'sitedatasource_1' to data structure 'adev01'. 03/10/2015 15:47 PM
source_1 NEW_MAP_ELEMENT Added data element 'source_1' to data structure 'adev01'. 03/10/2015 15:47 PM
studyrelation_1 NEW_MAP_ELEMENT Added data element 'studyrelation_1' to data structure 'adev01'. 03/10/2015 15:47 PM
updated_date_1 NEW_MAP_ELEMENT Added data element 'updated_date_1' to data structure 'adev01'. 03/10/2015 15:47 PM
emnetother_1 NEW_MAP_ELEMENT Added data element 'emnetother_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationdeath_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationdeath_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationhospdetox_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationhospdetox_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationhosplmed_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationhosplmed_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationhosppsych_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationhosppsych_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationnohosp_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationnohosp_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationoth_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationoth_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationothval_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationothval_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationunknown_1 NEW_MAP_ELEMENT Added data element 'noselfharmideationunknown_1' to data structure 'adev01'. 03/10/2015 15:47 PM
saenumber_1 NEW_MAP_ELEMENT Added data element 'saenumber_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationcrisiscall_1 NEW_MAP_ELEMENT Added data element 'selfharmideationcrisiscall_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationcrisisedvis_1 NEW_MAP_ELEMENT Added data element 'selfharmideationcrisisedvis_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationdeath_1 NEW_MAP_ELEMENT Added data element 'selfharmideationdeath_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationhospdetox_1 NEW_MAP_ELEMENT Added data element 'selfharmideationhospdetox_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationhospmed_1 NEW_MAP_ELEMENT Added data element 'selfharmideationhospmed_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationhosppsych_1 NEW_MAP_ELEMENT Added data element 'selfharmideationhosppsych_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationnohosp_1 NEW_MAP_ELEMENT Added data element 'selfharmideationnohosp_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationother_1 NEW_MAP_ELEMENT Added data element 'selfharmideationother_1' to data structure 'adev01'. 03/10/2015 15:47 PM
selfharmideationothervalue_1 NEW_MAP_ELEMENT Added data element 'selfharmideationothervalue_1' to data structure 'adev01'. 03/10/2015 15:47 PM
aestatuschange_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
aestatuschange_1 NEW_MAP_ELEMENT Added data element 'aestatuschange_1' to data structure 'adev01'. 03/10/2015 15:47 PM
callcenterdatasource_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
callcenterdatasource_1 NEW_MAP_ELEMENT Added data element 'callcenterdatasource_1' to data structure 'adev01'. 03/10/2015 15:47 PM
completed NEW_MAP_ELEMENT Added data element 'completed' to data structure 'adev01'. 03/10/2015 15:47 PM
crisiscenterdatasource_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
crisiscenterdatasource_1 NEW_MAP_ELEMENT Added data element 'crisiscenterdatasource_1' to data structure 'adev01'. 03/10/2015 15:47 PM
deathreportnumber_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
deathreportnumber_1 NEW_MAP_ELEMENT Added data element 'deathreportnumber_1' to data structure 'adev01'. 03/10/2015 15:47 PM
discoveryperiod_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
discoveryperiod_1 NEW_MAP_ELEMENT Added data element 'discoveryperiod_1' to data structure 'adev01'. 03/10/2015 15:47 PM
emnetaetype_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
emnetaetype_1 NEW_MAP_ELEMENT Added data element 'emnetaetype_1' to data structure 'adev01'. 03/10/2015 15:47 PM
emnetisdead_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
emnetisdead_1 NEW_MAP_ELEMENT Added data element 'emnetisdead_1' to data structure 'adev01'. 03/10/2015 15:47 PM
emnetother_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
emnetothervalue_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
emnetothervalue_1 NEW_MAP_ELEMENT Added data element 'emnetothervalue_1' to data structure 'adev01'. 03/10/2015 15:47 PM
noselfharmideationdeath_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
noselfharmideationhospdetox_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
noselfharmideationhosplmed_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
noselfharmideationhosppsych_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
noselfharmideationnohosp_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
noselfharmideationoth_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
noselfharmideationothval_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
noselfharmideationunknown_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
saenumber_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideation_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationcrisiscall_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationcrisisedvis_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationdeath_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationhospdetox_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationhospmed_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationhosppsych_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationnohosp_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationother_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationothervalue_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationpolice_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationtransfer_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
selfharmideationunknown_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
sitedatasource_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
source_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
studyrelation_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
updated_date_1 NEW_DATA_ELEMENT 03/10/2015 15:47 PM
stage VALUE_RANGE, NOTES VALUE_RANGE: 0::5 NOTES: 0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD) VALUE_RANGE: 0::5; 51::53; 67; -888; - 999 NOTES: 0 = Pre-Randomization (TADS) 1 = Stage 1 (TADS) 2 = Stage 2 (TADS) 3 = Stage 3 (TADS) 4 = Stage 4 (TADS) 5 = Stage 5 (SOFTAD); 51=Treatmentas Usual; 52=Screening Alone; 53=Intervention; 67=Unknown; -888=Not Applicable; -999=Missing; 03/10/2015 14:39 PM
hand_date DESCRIPTION DESCRIPTION: Date of Exam DESCRIPTION: reported date 03/10/2015 14:35 PM
ae NOTES NOTES: Character text of 18 AEs/side effects that were systematically queried at each visit NOTES: 03/10/2015 14:30 PM
chartreview059 NEW_DATA_ELEMENT 03/03/2015 18:30 PM
sae_38 NEW_DATA_ELEMENT 02/27/2015 15:02 PM
session_id DESCRIPTION DESCRIPTION: session ID DESCRIPTION: session ID/screening ID 02/24/2015 11:04 AM
completed NEW_DATA_ELEMENT 02/13/2015 11:34 AM
aef001 NOTES NOTES: NOTES: 01/13/2015 17:44 PM
aef005 NOTES NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 9=Not applicable; NOTES: 1=Definitely; 2=Probably; 3=Possibly; 4=Unlikely; 9=Not applicable; 01/13/2015 17:44 PM
aef008 NOTES NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); NOTES: 1=None; 2=Stop treatment; 3=Medication; 4=Health care; 5=Hospitalization; 6=Other (specify); 01/13/2015 17:44 PM
sdrugact NOTES NOTES: 1 = Dose increased; 2 = Dose reduced 3 = Temporarily discontinued 4 = Permanently discontinued 5 = Unblinded 6 = Unblinded & dose increased 7 = Unblinded & dose decrease 8 = Unblinded & temporarily discontinued 9 = Unblinded & permanently discontinued NOTES: 1 = Dose increased; 2 = Dose reduced3 = Temporarily discontinued 4 = Permanently discontinued 5 = Unblinded6 = Unblinded & dose increased 7 = Unblinded & dose decrease 8 = Unblinded & temporarily discontinued 9 = Unblinded & permanently discontinued 01/13/2015 17:44 PM
aesuicid DESCRIPTION DESCRIPTION: TADS Rating (not based on Columbia Coding): Adverse Event was a suicide related event DESCRIPTION: TADS Rating (not based on Columbia Coding):Adverse Event was a suicide related event 01/13/2015 17:38 PM
leastsev DESCRIPTION DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review. Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal. Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 DESCRIPTION: Columbia Coded Events: Least severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 01/13/2015 17:38 PM
mostsev DESCRIPTION DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review. Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal. Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 DESCRIPTION: Columbia Coded Events: Most severe Columbia coding for each individual adverse event that was submitted for review.Note: If an event was considered to consist of several separate components, the least severe and most severe coding could differ, otherwise they will be equal.Least Severe to Most Severe Ordering: 7 � 5 � 3 � 6 � 2 � 1 01/13/2015 17:38 PM
othharm DESCRIPTION DESCRIPTION: TADS Rating (not based on Columbia Coding): Adverse Event was classified as harm to others DESCRIPTION: TADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to others 01/13/2015 17:38 PM
selfharm DESCRIPTION DESCRIPTION: TADS Rating (not based on Columbia Coding): Adverse Event was classified as harm to self DESCRIPTION: TADS Rating (not based on Columbia Coding):Adverse Event was classified as harm to self 01/13/2015 17:38 PM
phase_ct DESCRIPTION DESCRIPTION: Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. DESCRIPTION: Current Phase. Phase patient was in at the time of the assessment Phase 4 refers to the follow-up phase. 01/13/2015 17:38 PM
src_subject_id DESCRIPTION DESCRIPTION: The site or study's subject identification DESCRIPTION: Subject ID how it's defined in lab/project 01/12/2015 18:22 PM
med_nm NEW_DATA_ELEMENT 01/07/2015 17:34 PM
version_form NEW_DATA_ELEMENT 01/05/2015 16:36 PM
saps_ad10 NEW_DATA_ELEMENT 01/05/2015 11:30 AM
week DESCRIPTION DESCRIPTION: Week in level DESCRIPTION: Week in level/study 01/05/2015 11:19 AM
aerest0 TYPE TYPE: Integer TYPE: Float 01/02/2015 14:41 PM
aestrt0 TYPE TYPE: Integer TYPE: Float 01/02/2015 13:37 PM
constisv NEW_DATA_ELEMENT 12/15/2014 16:38 PM
drymthsv NEW_DATA_ELEMENT 12/15/2014 16:38 PM
sae NEW_DATA_ELEMENT 12/10/2014 15:04 PM
mtype NEW_DATA_ELEMENT 12/10/2014 14:32 PM
crcid DESCRIPTION DESCRIPTION: CRC ID DESCRIPTION: CRC ID/ROA ID 12/09/2014 16:17 PM
study_id DESCRIPTION DESCRIPTION: Study ID number (assigned by NIMH) DESCRIPTION: Study ID number 12/01/2014 12:48 PM
gender VALUE_RANGE, NOTES VALUE_RANGE: M;F NOTES: M = Male; F = Female VALUE_RANGE: M;F; T NOTES: M = Male; F = Female; T= Transgender 12/01/2014 12:34 PM
comments_misc NEW_MAP_ELEMENT Added data element 'comments_misc' to data structure 'adev01'. 10/20/2014 18:08 PM
comments_misc NEW_MAP_ELEMENT Added data element 'comments_misc' to data structure 'adev01'. 10/20/2014 17:43 PM
comments_misc NEW_MAP_ELEMENT Added data element 'comments_misc' to data structure 'adev01'. 02/25/2013 13:43 PM
Data Structure Change History

This page displays a list of all the changes that have been made to this data structure since its original definition. You can view the element name, the attribute that was changed, previous and subsequent values, and the timestamp of the change. Use the search bar to filter the displayed changes.

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