# Create Workbench PADER Aggregate Reports Safety Workbench provides U.S. Periodic Adverse Drug Experience Report (PADER) authoring and table generation capabilities. All generated Workbench PADER aggregate reports are unmasked. The following table summarizes the PADER tabulations that Safety Workbench generates: |Tabulation|Description| |-|-| |[_15-Day and Non-15 Day Summary Reports_][5]|This report prints the number of _Case Adverse Events_ that match report criteria. Vault generates tables for both initial reports and follow-up reports.| |[_15-Day Report Line Listing Summary_][15]|This report is a summary listing of _Cases_ that are reportable within 15 days, broken down by initial/follow-up.| |[_Non-Expedited Line Listing Summary_][16]|This report is a summary listing of non-expedited _Cases_ and _Submissions_ broken down by initial/follow-up.| |[_Summary of ADR from Postmarketing Sources_][6]|This report prints the number of _Case Adverse Events_ that match report criteria.| |[_Interval Line Listings_][7]|This report prints the _Case_ listing that matches report criteria. Vault categorizes _Case_ listings by initial and follow-up reports, seriousness, listedness, and whether the report was expedited.| |[_Cases Submitted Under Other NDAs_][8]|This report prints the _Case_ listing that matches report criteria. This report is a summary listing of the _Adverse Events_ in which the drug or biological Product was listed as one of the suspect _Products_, but the report was filed to another New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA) held by the applicant.| |[_Malfunction Line Listing_][9]|For _Cases_ that contain combination products with a _Device_ product type that has malfunctioned, this report prints a listing of device constituent malfunctions.| |[_Line Listing Summary for Combination Products_][10]|This report is a summary listing of _Cases_ that contain combination products with a _Device_ product type that has malfunctioned.| |[_Malfunction Tabulation_][11]|For _Cases_ that contain combination products with a _Device_ product type that has malfunctioned, this report prints the number of _Case Adverse Events_ that match report criteria.| |[_List of Death Cases_][17]|This report lists all the _Cases_ that were transmitted to the FDA during the reporting period as either a 15-day or a non-15-day report, where the patient has died.| |[_List of Nullified Cases_][18]|This report is a listing of nullified _Cases_ during the reporting interval.| |[_Case Series_][19]|This report is a listing of all _Cases_ on the PADER, provided in a flattened Excel format.|
Safety Workbench allows you to generate, run, and download multiple Workbench aggregate reports at once. If this option is relevant to your organization's business processes, see Generate & Run Report Sets. ## Prerequisites To generate Workbench PADERs, consider the following prerequisites: * Your Admin must configure Workbench PADER aggregate reports. * Your Admin must grant you permissions to view and prepare aggregate reports. Typically, these permissions are reserved for the _Aggregate Report Writer role_. * Your Admin must configure US-based local product _Datasheets_ that list expected adverse events for the reporting family _Product_. Workbench uses product _Datasheets_ to classify adverse events as _Labeled_ or _Unlabeled_ in Workbench PADER tables. * To generate table data from _Study_-type _Cases_, your Admin must configure the appropriate _Study Products_. * A _Case_ must have a _Transmission_ record with a _Transmission Date_.
## Create a Workbench PADER Create a Workbench PADER aggregate report and specify the report parameters. ### Add a Workbench PADER Report Set To create a Workbench PADER: 1. Navigate to **Workbench > Report Sets**. 2. Select **Create**. 3. On the _Create Workbench Report Set_ page, enter a name for the report. 4. Select **Save** or **Save + Create** to save the _Workbench Report Set_ and create another. 5. Add _Workbench Report Definitions_ in the _Reports to Generate_ section and filters in the _Filters_ section. Then, see the [section below][4] for completing the required filters for the Workbench PADER. When you create a _Workbench Report Set_, Vault sets the lifecycle state to _Draft_. ### Specify Workbench PADER Filters After adding _Workbench Report Definitions_ to the Workbench PADER report set and selecting **Refresh** in the _Filters_ section, required filters appear in the _Filters_ section. Specify values for the following filters: * _Aggregate Reporting Group_: Select an _Aggregate Reporting Group_ configured for aggregate reporting from the drop-down or use the **Advanced Search** (advanced-search) icon to use filters and refine your search. To learn more about _Aggregate Reporting Groups_, see Configure Workbench PADER Aggregate Reports. * _Transmission > Generation Date_: Enter the start and end date for the reporting period. Vault uses the _Cases_ within the reporting period to generate table data. _Cases_ are included when the _Case Transmission_ is within the reporting period. ### Generate and Run Workbench PADER Reports Review and verify the Workbench PADER report set. Once you have confirmed the report set details are correct, see Generate & Run Report Sets for information on generating and running reports. ## Workbench PADER Table Generation Data Mapping Workbench populates aggregate report tables using _Cases_ within the reporting period specified on the [Workbench PADER][12] and the product registrations configured on the associated _Aggregate Reporting Group_. The following sections describe how Workbench generates PADER tabulations: * [15-Day and Non-15-Day Summary Reports][5] * [15-Day Report Line Listing Summary][15] * [Non-Expedited Line Listing Summary][16] * [Summary of ADR from Postmarketing Sources][6] * [Interval Line Listings][7] * [Cases Submitted Under Other NDAs][8] * [Malfunction Line Listing][9] * [Line Listing Summary for Combination Products][10] * [Malfunction Tabulation][11] * [List of Death Cases][17] * [List of Nullified Cases][18] * [Case Series][19] ### 15-Day and Non-15-Day Summary Reports {#d15-and-non-d15-summary-reports} **Case-Based Report**: This report prints the number of _Cases_ that match report criteria, using the primary _Case Adverse Event_ to categorize the _Case_ into the appropriate column. Vault generates the _15-Day and Non-15-Day Summary Reports_ table for both initial and follow-up reports. The following image displays the _Summary of 15-Day and Non-15-Day Alerts_ table, which includes both initial and follow-up reports: Workbench PADER Summary of 15-Day, Non-15-Day Alerts #### Table Constraints Vault filters _Cases_ to include in the Workbench PADER _15-Day and Non-15-Day Summary Reports_ using the following constraints: ##### Case Not Suppressed The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). `case_version__v.suppress_submission__v ≠ Yes` ##### FDA Transmission in Reporting Period Vault finds _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_.\ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set.\ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_.\ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The registration on the _Transmission_ record matches that listed in the _Aggregate Reporting Group_.\ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ##### Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group A _Case Product_ must meet the following conditions: * The _Product Registration_ field must link to a _Product Registration_ record added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Drug Role_ field must be set to _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ##### Initial vs. Follow-Up Report To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one (1) FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one (1) of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is set to `I` (initial) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one (1) of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not set to `I` (initial) or `1` (nullification) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
#### Table Mapping **Sorting**: _Cases_ are sorted in ascending order by _Worldwide UID_ (WWUID).
Number Name Description
1 No. of Solicited Reports - Study The number of Cases that match one (1) of the following scenarios:
Scenario Report Type Study Type Literature
1
  • Any
2
  • No or blank
COUNT IF
(case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v = 1)
OR
(case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
AND case_version_v.report_type__v.controlled_vocabulary__v.literature__v ≠ Yes
AND case_version__v.study_product_reason__v = blank)
2 No. of Solicited Reports - Other The number of Cases that match one (1) of the following scenarios:
Scenario Report Type Study Type Literature
1
  • Any
2
  • Yes
COUNT IF
(case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
AND case_version__v.study_product_reason__v.controlled_vocabulary__v.e2b_code__v = 2 or 3)
OR
(case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v = 2
AND case_version_v.report_type__v.controlled_vocabulary__v.literature__v = Yes
AND case_version__v.study_product_reason__v = blank)
3 No. of Spontaneous Reports

The number of Cases with the Case > Report Type set to one (1) of the following:

  • Spontaneous
  • Literature (Spontaneous)
  • Other
  • Not Available
  • A custom Report Type with an E2B code of 1, 3, 4, or null (blank)
    case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v ≠ 2
4 Serious, Unlabeled, Non-Fatal (initial and follow-up)

The sum of Cases with primary adverse events that meet the following criteria:

  • Cases with one (1) or more FDA Transmissions within the reporting period where the Local Expedited Criteria field is set to Yes or is blank.
    case_version__v.transmission__v.case_expedited__v = Yes OR Blank
  • Serious (non-fatal): The Case Adverse Event > Seriousness field is set to a value, but the fatal criteria are not met.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlabeled: Vault looks for an Expected value of No in the following priority order:
    1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
    2. The Expectedness field on the primary Case Assessment
    3. The Case Expectedness field
    (case_assessment__v.case_assessment_expectedness__v.expected__v = No
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = No
    WHERE
    case_assessment__v.rank__v = 1)
    ELSE
    (case_version__v.expected__v = No)
5 Serious, Unlabeled, Fatal (initial and follow-up)

The sum of Cases with primary adverse events that meet the following criteria:

  • Cases with one (1) or more FDA Transmissions within the reporting period where the Local Expedited Criteria field is set to Yes or is blank.
    case_version__v.transmission__v.case_expedited__v = Yes OR Blank
  • Meets one (1) of the following conditions to indicate a death occurred:
    • The Date of Death field on the Case is populated.
      case_version__v.dod_normalized__v ≠ Blank
    • The Seriousness field on any Case Adverse Event contains Results in Death.
      case_adverse_event__v.seriousness__v = results_in_death__v
    • The Outcome field on any Case Adverse Event contains Fatal.
      case_adverse_event__v.outcome__v = fatal
    • Any Case Adverse Event has a coded event under the MedDRA HLT of 10011907 (Death and Sudden Death).
      case_adverse_event__v.event_meddra__v.meddra__v.hlt_code__v = 10011907
    • The Autopsy field on the Case is set to Yes.
      case_version__v.autopsy_value__v = Yes
6 Serious, Labeled (initial and follow-up)

The sum of Cases with primary Case Adverse Events that meet the following criteria:

  • Serious: The Case Adverse Event > Seriousness field is populated.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Labeled: Vault looks for an Expected value of Yes in the following priority order:
    1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
    2. The Expectedness field on the primary Case Assessment
    3. The Case Expectedness field
    (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = Yes
    WHERE
    case_assessment__v.rank__v = 1)
    ELSE
    (case_version__v.expected__v = Yes)
7 Serious, Unlabeled, Not Related (initial and follow-up)

The sum of Cases with primary Case Adverse Events that meet the following criteria:

  • Serious: The Case Adverse Event > Seriousness field is populated.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlabeled: Vault looks for an Expected value of No in the following priority order:
    1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
    2. The Expectedness field on the primary Case Assessment
    3. The Case Expectedness field
    (case_assessment__v.case_assessment_expectedness__v.expected__v = No
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = No
    WHERE
    case_assessment__v.rank__v = 1)
    ELSE
    (case_version__v.expected__v = No)
  • Not Related: The Causality Established field in at least two (2) primary Assessment Results is set to No, including one (1) company assessment and one (1) reporter's assessment.
    (case_assessment__v.case_assessment_result__v.causality_established__v = No
    where primary__v = True
    and source_type__v.e2b_code__v = 1 [Investigator],
    5 [Health Care Professional], or 6 [Non-Health Care Professional])
    OR
    (case_assessment__v.case_assessment_result__v.causality_established__v = No
    where primary__v = True
    and source_type__v.e2b_code__v = 2 [Sponsor] or 4 [MAH])
8 Non Serious, Labeled (initial and follow-up)

The sum of Cases with primary Case Adverse Events that meet the following criteria:

  • Non Serious: The Case Adverse Event > Seriousness field is blank.
    case_adverse_event__v.seriousness__v = EMPTY
  • Labeled: Vault looks for an Expected value of Yes in the following priority order:
    1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
    2. The Expectedness field on the primary Case Assessment
    3. The Case Expectedness field
    (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = Yes
    WHERE
    case_assessment__v.rank__v = 1)
    ELSE
    (case_version__v.expected__v = Yes)
9 Non Serious, Unlabeled (initial and follow-up)

The sum of Cases with primary Case Adverse Events that meet the following criteria:

  • Non Serious: The Case Adverse Event > Seriousness field is blank.
    case_adverse_event__v.seriousness__v = EMPTY
  • Unlabeled: Vault looks for an Expected value of No in the following priority order:
    1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
    2. The Expectedness field on the primary Case Assessment
    3. The Case Expectedness field
    (case_assessment__v.case_assessment_expectedness__v.expected__v = No
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = No
    WHERE
    case_assessment__v.rank__v = 1)
    ELSE
    (case_version__v.expected__v = No)
### 15-Day Report Line Listing Summary {#d15-rpt-ll-summary} **Submission-Based Report**: This report prints the number of _Case_ submissions that match report criteria. The following image displays the _15-Day Report Line Listing Summary_ table: Workbench PADER 15-Day Report Line Listing Summary #### Table Constraints Vault filters _Cases_ to include in the PADER _15-Day Report Line Listing Summary_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). \ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_. \ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set. \ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_. \ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The _Reportable Product Registration_ on the _Transmission_ matches that in the _Aggregate Reporting Group_. \ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** If the PADER is run for a non-combination product: A _Case Product_ must meet the following conditions: * The _Product Registration_ field of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` If the PADER is run for a combination product, a different registration field is considered: A _Case Product_ must meet the following conditions: * The _Combination Product Registration_ of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Combination Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ###### **Initial vs. Follow-Up Report** To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is `I` (initial) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not `I` (initial) or `1` (nullification) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
#### Table Mapping
Number Name Description
1 ICSR Initial/ Follow-up

Cases in the Initial category include an initial Transmission in the report interval.

Cases in the Initial with Follow-up category include an initial Transmission and at least one follow-up Transmission in the report interval. This is a subset of the Initial category.

Cases in the Follow-up category do not include any initial Transmissions in the report interval.
2 Submission Count

For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Submissions for Cases in each category.

3 Case Count For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Cases in each category.
### Non-Expedited Line Listing Summary {#non-exp-ll-summary} **Submission-Based Report**: This report prints the number of non-expedited _Case_ submissions that match the report criteria. The following image displays the _Non-Expedited Line Listing Summary_ table: Workbench PADER Non-Expedited Line Listing Summary #### Table Constraints Vault filters _Cases_ to include in the PADER _Non-Expedited Line Listing Summary_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). \ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_. \ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set. \ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_. \ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The _Reportable Product Registration_ on the _Transmission_ matches that in the _Aggregate Reporting Group_. \ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** If the PADER is run for a non-combination product: A _Case Product_ must meet the following conditions: * The _Product Registration_ field of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` If the PADER is run for a combination product a different registration field is considered: A _Case Product_ must meet the following conditions: * The _Combination Product Registration_ of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Combination Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ###### **Initial vs. Follow-Up Report** To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is `I` (initial) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not `I` (initial) or `1` (nullification) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
#### Table Mapping
Number Name Description
1 ICSR Initial/ Follow-up

Cases in the Initial category include an initial Transmission in the report interval.

Cases in the Initial with Follow-up category include an initial Transmission and at least one follow-up Transmission in the report interval. This is a subset of the Initial category.

Cases in the Follow-up category do not include any initial Transmissions in the report interval.
2 Submission Count

For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Submissions for Cases in each category.

3 Case Count For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Cases in each category.
### Summary of ADR from Postmarketing Sources **Event-Based Report**: This report prints the number of _Case Adverse Events_ that match report criteria.
The following image displays the Workbench PADER _Summary of ADR from Postmarketing Sources_ report: Workbench PADER Tabulation by System Organ Class of All Adverse Experiences #### Table Constraints Vault filters _Cases_ to include in the Workbench PADER _Summary of Adverse Drug Reactions from Postmarketing Sources_ using the following constraints: ##### Case Not Suppressed The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed).\ `case_version__v.suppress_submission__v ≠ Yes` ##### FDA Transmission in Reporting Period Vault finds _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_.\ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set.\ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_.\ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The registration on the _Transmission_ record matches that listed in the _Aggregate Reporting Group_.\ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ##### Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group A _Case Product_ must meet the following conditions: * The _Product Registration_ field must link to a _Product Registration_ record added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Drug Role_ field must be set to _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4`
#### Table Mapping **Sorting**: _Cases_ are sorted in ascending order, first by _UID_ and then by _Worldwide UID_.
Number Name Description
1 SOC The MedDRA System Organ Class (SOC) for the Case Adverse Event. The sum of all adverse events under this SOC is listed under each column.
event_meddra__v.soc_term__v
2 Preferred Term The MedDRA Preferred Term (PT) coded on the Case Adverse Event, grouped by the MedDRA SOC.
case_adverse_event__v.event_meddra__v.pt_term__v
3 Domestic The sum of adverse events where the Case Adverse Event > Event Country field is set to a Country where the Agency field is set to FDA.
case_adverse_event__v.event_country__v.agency__v = fda__v
4 Foreign The sum of adverse events where the Case Adverse Event > Event Country field is set to a Country where the Agency field is not set to FDA.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v
5 Serious, Unlabeled

Primary adverse events that meet the following criteria:

  • Serious: The Case Adverse Event > Seriousness field is populated.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlabeled: One (1) of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
      • A Case Assessment Expectedness record must exist with the Expected field set to No.
      • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
    (case_assessment__v.case_assessment_expectedness__v.expected__v = No
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = No or Blank)
6 Serious, Labeled

Primary adverse events that meet the following criteria:

  • Serious: The Case Adverse Event > Seriousness field is populated.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Labeled: One (1) of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
      • A Case Assessment Expectedness record must exist with the Expected field set to Yes.
      • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to Yes to be considered Labeled.
    (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = Yes)
7 Non Serious Unlabeled

Primary adverse events that meet the following criteria:

  • Non Serious: The Case Adverse Event > Seriousness field is blank.
    case_adverse_event__v.seriousness__v = EMPTY
  • Unlabeled: One (1) of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
      • A Case Assessment Expectedness record must exist with the Expected field set to No.
      • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
    (case_assessment__v.case_assessment_expectedness__v.expected__v = No
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = No or Blank)
8 Non Serious Labeled

Primary adverse events that meet the following criteria:

  • Non Serious: The Case Adverse Event > Seriousness field is blank.
    case_adverse_event__v.seriousness__v = EMPTY
  • Labeled: One (1) of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
      • A Case Assessment Expectedness record must exist with the Expected field set to Yes.
      • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to Yes to be considered Labeled.
    (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = Yes)
9 Subtotal The subtotal sum of adverse events for each MedDRA SOC and PT, within domestic or foreign jurisdiction.
10 Total Events The total sum of domestic and foreign adverse events for each MedDRA SOC and PT.
11 Total Cases The total sum of Cases for each MedDRA SOC and PT.
12 Grand Total The total sum of all adverse events and Cases.
### Interval Line Listings {#interval-ll} **Case-Based Report**: This report prints the number of _Cases_ that match report criteria. Workbench generates _Interval Line Listing_ tables for both initial and follow-up reports. The following image displays the Workbench PADER _Interval Line Listing_, which includes both initial and follow-up reports. Workbench PADER Interval Line Listing #### Table Constraints Vault filters _Cases_ to include in the Workbench PADER _Interval Line Listings_ using the following constraints: ##### Case Not Suppressed The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). `case_version__v.suppress_submission__v ≠ Yes` ##### FDA Transmission in Reporting Period Vault finds _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_.\ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set.\ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_.\ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The registration on the _Transmission_ record matches that listed in the _Aggregate Reporting Group_. \ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ##### Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group A _Case Product_ must meet the following conditions: * The _Product Registration_ field must link to a _Product Registration_ record added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Drug Role_ field must be set to _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ##### Initial vs. Follow-Up Report To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one (1) FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one (1) of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is set to `I` (initial) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one (1) of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not set to `I` (initial) or `1` (nullification) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
For each _Case_ included in the report, the Workbench PADER _Interval Line Listings_ displays all _Case Adverse Events_. #### Table Mapping
Number Name Description
1 Category

Vault groups Cases based on the following Case criteria:

  • 15-Day or non-15-Day
  • Serious or non-Serious
  • Initial or Follow-up
  • Labelled or Unlabelled
2 Manufacturer's Report Number Vault maps this value from the Case > UID field.
case_version__v.uid__v
3 Report Type The Report Type of the Case.
case_version__v.report_type__v
4 Expedited

Whether the Case was expedited.

Vault populates Exp (expedited) if one or more FDA Transmissions within the reporting period have their Local Expedited Criteria set to Yes or is blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Vault populates Non-Exp (non-expedited) if all FDA Transmissions within the reporting period have their Local Expedited Criteria set to No.
case_version__v.transmission__v.case_expedited__v = No

5 Initial/Follow-up

Whether the Case is an initial or follow-up Case.

Vault populates Initial if at least one eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault populates Follow-up.
6 Domestic/Foreign

Whether the Case is domestic or foreign.

Vault populates Domestic if the Event Country of the primary adverse event is a Country with FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault populates Foreign if the Event Country of the primary adverse event is a Country other than FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

7 Seriousness

Whether the Case is serious or non-serious.

Vault populates S (serious) if the primary Case Adverse Event is populated with a value.
case_adverse_event__v.seriousness__v ≠ EMPTY

Otherwise, Vault populates NS (non-serious).
8 Listedness

Whether the Case is listed or unlisted.

Vault populates L (listed) if the primary Case Adverse Event is expected. Vault looks for an Expected value in the following priority order:

  1. Case Assessment Expectedness where Country is United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
(case_assessment__v.case_assessment_expectedness__v.expected__v
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v)

Otherwise, Vault populates UL (unlisted).
9 Adverse Experience Reported Term (MedDRA)

Both the reported name and the MedDRA Preferred Term (PT) for the adverse events.
(IF event_reported_english__v ≠ BLANK
THEN case_adverse_event.event_reported_english__v
ELSE case_adverse_event.event_reported__v)
(event_meddra__v.PT)

Vault orders the adverse events by rank, blank values ranking last.
10 Receipt/New Info Date

Vault maps this value from the New Info Date field on the Case. If the New Info Date is blank, Vault maps this value from the Case Receipt date.
IF not blank(case_version__v.new_info_idate__v)
ELSE
case_version__v.receipt_date__v
11 Transmission Generation Date Vault populates this field with all Transmission Dates for Case Transmissions that meet the following criteria:
  • The Transmission lifecycle state is either ACK Accepted or Completed.
    transmission__v.state__v = {E2B ACK Accepted | Completed}
  • The Transmission Reason field is set to one (1) of the following:
    • Initial
    • Follow-up
    • Amendment
    • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
      transmission__v.transmission_reason__v = {I, F, OR 2}
12 Transmission Type

Vault determines the Transmission Type using the Transmission Reason and Local Expedited Criteria fields on Transmissions associated with the Case. For each Transmission date listed in the Transmission Generation Date column, Vault displays one (1) of the following:

  • Exp Initial (expedited initial)
  • Exp Follow-up (expedited follow-up)
  • Non-Exp Initial (non-expedited initial)
  • Non-Exp Follow-up (non-expedited follow-up)


Vault determines a Case is expedited if one (1) or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank
Otherwise, Vault determines the Case is not expedited if all FDA Transmissions within the reporting period have the Local Expedited Criteria field set to No.
case_version__v.transmission__v.case_expedited__v = No
Vault displays the values in the same order as the Transmission Generation Date values.


Vault determines a Case is an initial Case if at least one (1) FDA Transmission within the reporting period has the Transmission Reason set to one (1) of the following:

  • Initial
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial).
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I

Otherwise, Vault determines the Case is a follow-up Case if all FDA Transmissions within the reporting period have the Transmission Reason set to one (1) of the following:

  • Amendment
  • Follow-Up
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is not set to I (initial) or 1 (nullification).
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1
13 Nullified/Voided

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.
14 Case Count

Vault displays the total number of Cases on the report.
### Cases Submitted Under Other NDAs {#cases-under-other-ndas} **Case-Based Report**: This report lists the _Cases_ that match report criteria. The _Cases Submitted Under Other NDAs_ report is a _Case_ line listing in which the drug or biological _Product_ was listed as one (1) of the suspect _Products_ on the _Case_, but the _Case_ was submitted to the FDA under another New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologic License Application (BLA) held by the applicant. If at least one (1) reportable _Product Registration_ on the FDA _Transmission_ for the _Case_ matches that of the _Aggregate Reporting Group_, Vault includes this _Case_ in one (1) of the following reports: * [_15-Day and Non-15-Day Summary Reports_][5] * [_Summary of ADR from Postmarketing Sources_][6] * [_Interval Line Listings_][7] If the reportable _Product Registration_ on the FDA _Transmission_ for the _Case_ does not match that of an _Aggregate Reporting Group_, Vault includes the _Case_ in the _Cases Submitted Under Other NDAs_ report. For more information about how Vault identifies _Cases_ as submitted under another NDA, ANDA, or BLA, see Configure Workbench PADER Aggregate Reports. Workbench PADER Cases Submitted Under Other NDAs #### Table Constraints Vault filters _Cases_ to include in the _Cases Submitted Under Other NDAs_ report using the following constraints: ##### Case Not Suppressed The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). `case_version__v.suppress_submission__v ≠ Yes` ##### FDA Transmission in Reporting Period Vault finds _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_.\ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set.\ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_.\ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The registration on the _Transmission_ record does not match that listed in the _Aggregate Reporting Group_. \ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v != aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ##### Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group A _Case Product_ must meet the following conditions: * The _Product Registration_ field must link to a _Product Registration_ record added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Drug Role_ field must be set to _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` #### Table Mapping **Sorting**: _Cases_ are sorted in ascending order, first by _UID_ and then by _Worldwide UID_.
Number Name Description
1 Case WWID/UID Vault maps these values from the following fields:
  • WWID: Case > Worldwide UID
    case_version__v.worldwide_uid__v
  • UID: Case > UID
    case_version__v.uid__v
2 Generic Name The name of each suspect or interacting Case Product.
case_version__v.case_product__v.product_name__v
AND drug_role__v = Suspect OR Interacting
3 Event Reported (MedDRA) The MedDRA PT of each Case Adverse Event, sorted by the primary event first.
case_adverse_event__v.event_meddra__v.pt_term__v
4 Registration No. The value from the Registration Number field on the Product Registration associated with the Case Product.
case_product__v.product_registration__v.registration_number__v
5 Registration Type The value from the Registration Type field on the Product Registration associated with the Case Product.
case_product__v.product_registration__v.registration_type__v
6 Receipt/New Info Date Vault maps this value from the New Info Date field on the Case. If the New Info Date is blank, Vault maps this value from the Case Receipt date.
IF not blank(case_version__v.new_info_idate__v)
ELSE
case_version__v.receipt_date__v
7 Transmission Generation Date Vault populates this field with the most recent Transmission Date for a Case Transmission that meets the following criteria:
  • The Transmission lifecycle state is either ACK Accepted or Completed.
    transmission__v.state__v = {E2B ACK Accepted | Completed}
  • The Transmission Reason field is set to one (1) of the following:
    • Initial
    • Follow-up
    • Amendment
    • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
      transmission__v.transmission_reason__v = {I, F, OR 2}
8 Transmission Type

Vault determines the Transmission Type using the Transmission Reason and Local Expedited Criteria fields on Transmissions associated with the Case. Vault populates this field with one (1) of the following values:

  • Expedited Initial
  • Expedited Follow-up
  • Non-Expedited Initial
  • Non-Expedited Follow-up


Vault determines a Case is expedited if one (1) or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank
Otherwise, Vault determines the Case is not expedited if all FDA Transmissions within the reporting period have the Local Expedited Criteria field set to No.
case_version__v.transmission__v.case_expedited__v = No


Vault determines a Case is an initial Case if at least one (1) FDA Transmission within the reporting period has the Transmission Reason set to one (1) of the following:

  • Initial
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial)
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I

Otherwise, Vault determines the Case is a follow-up Case if all FDA Transmissions within the reporting period have the Transmission Reason set to one (1) of the following:

  • Amendment
  • Follow-Up
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is not set to I (initial) or 1 (nullification)
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1
9 Nullified/Voided

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.
### Combination Product Reports Workbench PADERs include _Cases_ with combination products. If the combination product contains a device constituent that has malfunctioned and the combination product is in the _Aggregate Reporting Group_ and on the FDA _Transmission_, the _Case_ is eligible for the following PADERs: * [_Malfunction Line Listing_][9] * [_Line Listing Summary for Combination Products_][10] * [_Malfunction Tabulation_][11] See Manage Combination Products for more information about combination products and their constituents. #### Malfunction Line Listing {#malfunction-ll} **Case-Based Report**: This report lists the _Cases_ that match report criteria. The following image displays the _Malfunction Line Listing_ table: Workbench PADER Malfunction Line Listing ##### Table Constraints Vault filters _Cases_ to include in the PADER _Malfunction Line Listing_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed).\ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_.\ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set.\ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_.\ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The registration on the _Transmission_ record matches that listed in the _Aggregate Reporting Group_.\ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** A _Case Product_ must meet the following conditions: * The _Combination_ _Product Registration_ field of a combination product must link to a _Product Registration_ record added as a member of the _Aggregate Reporting Group_.\ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Combination Product Registration_ field of a combination product is on the FDA _Transmission_.\ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The combination product contains at least one (1) device constituent, and the device constituent has a malfunction (_Malfunction_ is set to _Yes_).\ `Case_version__vr.case_product__v.malfunction__v = Yes WHERE Case_version__vr.case_product__v.product_type__v = Device` * The _Drug Role_ field must be set to _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`).\ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ###### **Initial vs. Follow-Up Report** To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one (1) FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one (1) of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is set to `I` (initial)\ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one (1) of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not set to `I` (initial) or `1` (nullification)\ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
##### Table Mapping **Sorting**: _Cases_ are sorted in ascending order, first by _Combination Submission Type and then by_ _Manufacturer's Report Number_.
Number Name Description
1 Category

Vault groups Cases based on the following Case criteria:

  • 15-Day or non-15-Day
  • Serious or non-Serious
  • Initial or Follow-up
  • Labelled or Unlabelled
2 Manufacturer's Report Number Vault maps this value from the Case > UID field.
case_version__v.uid__v
3 Combination Submission Type

Vault maps this value from the Transmission > FDA Report Type.
transmission__v.fda_report_type__v

If the FDA Report Type is 5-Day, Vault sets the value to 5-Day.

Otherwise, Vault sets the value to Other Reportable Malfunction.
4 Report Type The Report Type of the Case.
case_version__v.report_type__v
5 Expedited

Whether the Case was expedited.

Vault populates Exp (expedited) if one or more FDA Transmissions within the reporting period have their Local Expedited Criteria set to Yes or is blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Vault populates Non-Exp (non-expedited) if all FDA Transmissions within the reporting period have their Local Expedited Criteria set to No.
case_version__v.transmission__v.case_expedited__v = No

6 Initial/Follow-up

Whether the Case is an initial or follow-up Case.

Vault populates Initial if at least one eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault populates Follow-up.
7 Domestic/Foreign

Whether the Case is domestic or foreign.

Vault populates Domestic if the Event Country of the primary adverse event is a Country with FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault populates Foreign if the Event Country of the primary adverse event is a Country other than FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

8 Seriousness

Whether the Case is serious or non-serious.

Vault populates S (serious) if the primary Case Adverse Event is populated with a value.
case_adverse_event__v.seriousness__v ≠ EMPTY

Otherwise, Vault populates NS (non-serious).
9 Listedness

Whether the Case is listed or unlisted.

Vault populates L (listed) if the primary Case Adverse Event is expected. Vault looks for an Expected value in the following priority order:

  1. Case Assessment Expectedness where Country is United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
(case_assessment__v.case_assessment_expectedness__v.expected__v
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v)

Otherwise, Vault populates UL (unlisted).
10 Adverse Experience Reported Term (PT)

Both the reported name and the MedDRA Preferred Term (PT) for the adverse events.
(IF event_reported_english__v ≠ BLANK
THEN case_adverse_event.event_reported_english__v
ELSE case_adverse_event.event_reported__v)
(event_meddra__v.PT)
 Vault orders the adverse events by rank, blank values ranking last.

11 Device Problem (Code)

The FDA Device Code: Case product > Device Problem > Device Code> Level x Code, where "x" is the product term level (either 1, 2, or 3).
case_product__v.device_problem__vr.device_code__v.level "x" code

Vault sets the value using the following logic:

  • If the Case Product contains an FDA Device Code of level 3, level 2, or level 1, Vault sets the value to this term and code.
  • If the Case product > Device Problem field is blank, Vault sets the value to -.
  • If a Case has more than one (1) device with a device problem, Vault lists all the Device Codes from the Case.
12 Receipt/New Info Date

Vault maps this value from the New Info Date field on the Case. If the New Info Date is blank, Vault maps this value from the Case Receipt date.
IF not blank(case_version__v.new_info_idate__v)
ELSE
case_version__v.receipt_date__v
13 Transmission Generation Date Vault populates this field with all Transmission Dates for Case Transmissions that meet the following criteria:
  • The Transmission lifecycle state is either ACK Accepted or Completed.
    transmission__v.state__v = {E2B ACK Accepted | Completed}
  • The Transmission Reason field is set to one (1) of the following:
    • Initial
    • Follow-up
    • Amendment
    • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
      transmission__v.transmission_reason__v = {I, F, OR 2}
14 Transmission Type

Vault determines the Transmission Type using the Transmission Reason and Local Expedited Criteria fields on Transmissions associated with the Case. For each Transmission date listed in the Transmission Generation Date column, Vault displays one (1) of the following:

  • Exp Initial (expedited initial)
  • Exp Follow-up (expedited follow-up)
  • Non-Exp Initial (non-expedited initial)
  • Non-Exp Follow-up (non-expedited follow-up)


Vault determines a Case is expedited if one (1) or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank
Otherwise, Vault determines the Case is not expedited if all FDA Transmissions within the reporting period have the Local Expedited Criteria field set to No.
case_version__v.transmission__v.case_expedited__v = No
Vault displays the values in the same order as the Transmission Generation Date values.


Vault determines a Case is an initial Case if at least one (1) FDA Transmission within the reporting period has the Transmission Reason set to one (1) of the following:

  • Initial
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial).
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I

Otherwise, Vault determines the Case is a follow-up Case if all FDA Transmissions within the reporting period have the Transmission Reason set to one (1) of the following:

  • Amendment
  • Follow-Up
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is not set to I (initial) or 1 (nullification).
    transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1
15 Nullified/Voided

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.
##### How Vault Determines Expectedness {#vault-expectedness-1} Vault sets the _Expectedness_ field on a _Case_. To determine whether an _Adverse Event_ is expected for combination products with a device constituent, Vault looks at the non-device constituent and finds all _Expectedness_ records on _Case Assessments_ that meet the following criteria: * Is attached to a _Registration_ record of a combination product. * Lists a country that is supported by the FDA. * Has a datasheet registration that matches the registration in the _Aggregate Reporting Group_. If at least one (1) record has the _Expected_ field set to _No_ or blank, Vault determines an _Adverse Event_ is unexpected. ##### How Vault Determines Listedness Vault sets the _Listedness_ field on a _Case_. For combination products with a device constituent, Vault determines an _Adverse Event_ is listed if the non-device constituent in the _Aggregate Reporting Group_ is associated with an unexpected [_Adverse Event_][1]. #### Line Listing Summary for Combination Products {#ll-summary-for-combo-products} **Case-Based Report**: This report lists the _Cases_ that match report criteria. The _Case_ count in this report will match the _Malfunction Line Listing_ report. The following image displays the _Line Listing Summary for Combination Products_ table: Workbench PADER Line Listing for Combination Products ##### Table Constraints Vault filters _Cases_ to include in the PADER _Line Listing Summary for Combination Products_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed).\ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_.\ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set.\ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_.\ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The registration on the _Transmission_ record matches that listed in the _Aggregate Reporting Group_.\ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** A _Case Product_ must meet the following conditions: * The _Product Registration_ field of a combination product must link to a _Product Registration_ record added as a member of the _Aggregate Reporting Group_.\ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Product Registration_ field of a combination product is on the FDA _Transmission_.\ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The combination product contains at least one (1) device constituent, and the device constituent has a malfunction (_Malfunction_ is set to _Yes_).\ `Case_version__vr.case_product__v.malfunction__v = Yes WHERE Case_version__vr.case_product__v.product_type__v = Device` * The _Drug Role_ field must be set to _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`).\ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ###### **Initial vs. Follow-Up Report** To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one (1) FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one (1) of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is set to `I` (initial)\ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one (1) of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not set to `I` (initial) or `1` (nullification)\ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
##### Table Mapping
Number Name Description
1 Combination Submission Type

Vault maps this value from the Transmission > FDA Report Type.
transmission__v.fda_report_type__v

If the FDA Report Type is 5-Day, Vault sets the value to 5-Day.

Otherwise, Vault sets the value to Other Reportable Malfunction.
2 ICSR Initial/Follow-up

Cases in the Initial category include an initial Transmission in the report interval.

Cases in the Initial with Follow-up category include an initial Transmission and at least one (1) follow-up Transmission in the report interval. This is a subset of the Initial category.

Cases in the Follow-up category do not include any initial Transmissions in the report interval.
3 Submission Count

For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Submissions for Cases in each category.
4 Case Count

For the Initial, Initial with Follow-up, and Follow-up categories, Vault counts the number of Cases in each category.
#### Malfunction Tabulation {#malfunction-tabulation} **Event-Based Report**: This report prints the number of _Case Adverse Events_ that match report criteria. The following image displays the _Malfunction Tabulation_: Workbench PADER Malfunction Tabulation ##### Table Constraints Vault filters _Cases_ to include in the PADER _Malfunction Tabulation_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed).\ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_.\ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set.\ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_.\ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The registration on the _Transmission_ record matches that listed in the _Aggregate Reporting Group_.\ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** A _Case Product_ must meet the following conditions: * The _Product Registration_ field of a combination product must link to a _Product Registration_ record added as a member of the _Aggregate Reporting Group_.\ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registrations__v.registration_number__v` * The _Product Registration_ field of a combination product is on the FDA _Transmission_.\ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The combination product contains at least one (1) device constituent, and the device constituent has a malfunction (_Malfunction_ is set to _Yes_).\ `Case_version__vr.case_product__v.malfunction__v = Yes WHERE Case_version__vr.case_product__v.product_type__v = Device` * The _Drug Role_ field must be set to _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`).\ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ##### Table Mapping **Sorting**: _Cases_ are sorted in ascending order, first by SOC and then by PT.
Number Name Description
1 SOC The MedDRA System Organ Class (SOC) for the Case Adverse Event. The sum of all adverse events under this SOC is listed under each column.
event_meddra__v.soc_term__v
2 PT The MedDRA Preferred Term (PT) coded on the Case Adverse Event, grouped by the MedDRA SOC.
case_adverse_event__v.event_meddra__v.pt_term__v
3 Serious Labeled The sum of adverse events that meet the following criteria:
  • Serious: The Case Adverse Event > Seriousness field is populated.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Labeled: Vault looks for an Expected value of Yes in the following priority order:
    1. Case Assessment Expectedness where the Country is set to United States, or another country in the FDA's jurisdiction
    2. The Expectedness field on the primary Case Assessment
    3. The Case Expectedness field
    (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = Yes
    WHERE
    case_assessment__v.rank__v = 1)
    ELSE
    (case_version__v.expected__v = Yes)
4 Serious Unlabeled The sum of adverse events that meet the following criteria:
  • Serious: The Case Adverse Event > Seriousness field is populated.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlabeled: One (1) of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
      • A Case Assessment Expectedness record must exist with the Expected field set to No.
      • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
      • (case_assessment__v.case_assessment_expectedness__v.expected__v = No
      AND
      case_assessment_expectedness__v.country__v.agency__v = fda__v)
      ELSE
      (case_assessment__v.expectedness__v = No or Blank)
5 Non-Serious Labeled The sum of adverse events that meet the following criteria:
  • Non-Serious: The Case Adverse Event > Seriousness field is blank.
    case_adverse_event__v.seriousness__v = EMPTY
  • Labeled: Vault looks for an Expected value of Yes in the following priority order:
    1. Case Assessment Expectedness where the Country is set to United States, or another country in the FDA's jurisdiction
    2. The Expectedness field on the primary Case Assessment
    3. The Case Expectedness field
    (case_assessment__v.case_assessment_expectedness__v.expected__v = Yes
    AND
    case_assessment_expectedness__v.country__v.agency__v = fda__v)
    ELSE
    (case_assessment__v.expectedness__v = Yes
    WHERE
    case_assessment__v.rank__v = 1)
    ELSE
    (case_version__v.expected__v = Yes)
6 Non-Serious Unlabeled The sum of adverse events that meet the following criteria:
  • Non-Serious: The Case Adverse Event > Seriousness field is blank.
    case_adverse_event__v.seriousness__v = EMPTY
  • Unlabeled: One (1) of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    • If local product Datasheets are configured, the Case Assessment Expectedness records under the Case Assessment must meet the following criteria:
      • A Case Assessment Expectedness record must exist with the Expected field set to No.
      • The local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    • If no local Datasheets within the FDA's jurisdiction are configured, Vault evaluates the Case Assessment for each adverse event. The Case Assessment > Expected field must be set to No or blank to be considered Unlabeled.
      • (case_assessment__v.case_assessment_expectedness__v.expected__v = No
      AND
      case_assessment_expectedness__v.country__v.agency__v = fda__v)
      ELSE
      (case_assessment__v.expectedness__v = No or Blank)
7 Total Events The total sum of adverse events for each MedDRA SOC and PT.
8 Total Cases The total sum of Cases for each MedDRA SOC and PT.
### List of Death Cases {#list-of-death-cases} **Case-Based Report**: This report lists the _Cases_ that match report criteria sorted by WWID/UID. The following image displays the _List of Death Cases_ table: Workbench PADER List of Death Cases #### Table Constraints Vault filters _Cases_ to include in the PADER _List of Death Cases_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). \ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_. \ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set. \ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_. \ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The _Reportable Product Registration_ on the _Transmission_ matches that in the _Aggregate Reporting Group_. \ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** If the PADER is run for a non-combination product: A _Case Product_ must meet the following conditions: * The _Product Registration_ field of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registrations__v` * The _Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` If the PADER is run for a combination product a different registration field is considered: A _Case Product_ must meet the following conditions: * The _Combination Product Registration_ of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.combination_product_registration__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registrations__v` * The _Combination Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ###### **Initial vs. Follow-Up Report** To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is `I` (initial) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not `I` (initial) or `1` (nullification) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
#### Table Mapping
Number Name Description
1 Case WWID/ UID Vault maps these values from the following fields:
  • WWID: Case > Worldwide UID
    case_version__v.worldwide_uid__v
  • UID: Case > UID
    case_version__v.uid__v
2 Country
Gender
Age

Vault maps values from the following fields:

  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Sex: Case > Patient Sex
    case_version__v.gender_value__v.name__v
  • Age: Case > Age and Age (unit)
    IF case_version__v.age_value__v = BLANK
    THEN case_version__v.age_group__v.name__v
    ELSE (case_version__v.age_value__v case_version__v.age_unit__v)
3 Suspect Drug

Vault maps the Product Names of all Case Products on the Case whose Drug Role is set to Suspect, Interacting, or Drug not Administered, ordered by rank.

case_version__v.case_product__v.product_name__v

4 Adverse Events

Vault lists the MedDRA PT of all serious and non-serious adverse events on the Case. If the outcome of an adverse event is fatal, Vault appends the name of the outcome in parentheses. For example, Pyrexia (fatal).

5 Cause of Death (PT)

Both MedDRA PT and reported term entered on the Case > Cause of Death record.

IF case_cause_of_death__v.cause_of_death_meddra_pt__c ≠ Blank
THEN (cause_of_death_meddra_pt__c)
AND IF case_cause_of_death__v.name_reported__v ≠ Blank
THEN (name_reported__v)
ELSE ""-""

6 Autopsy Details

The Autopsy value on the Case:

case_version__v.autopsy_value__v

7 Date of Death

The Date of Death on the Case:

case_version__v.dod_normalized__v

### List of Nullified Cases {#list-of-null-cases} **Case-Based Report**: This report lists the _Cases_ that match report criteria, sorted by WWID/UID. The following image displays the _List of Nullified Cases_ table: Workbench PADER List of Nullified Cases #### Table Constraints Vault filters _Cases_ to include in the PADER _List of Nullified Cases_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). \ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_. \ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set. \ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_. \ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The _Reportable Product Registration_ on the _Transmission_ matches that in the _Aggregate Reporting Group_. \ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** If the PADER is run for a non-combination product: A _Case Product_ must meet the following conditions: * The _Product Registration_ field of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registrations__v` * The _Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` If the PADER is run for a combination product a different registration field is considered: A _Case Product_ must meet the following conditions: * The _Combination Product Registration_ of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Combination Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ###### **Initial vs. Follow-Up Report** To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is `I` (initial) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not `I` (initial) or `1` (nullification) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
#### Table Mapping
Number Name Description
1 Case WWID/ UID Vault maps these values from the following fields:
  • WWID: Case > Worldwide UID
    case_version__v.worldwide_uid__v
  • UID: Case > UID
    case_version__v.uid__v
2 Transmission Date

The Transmission Date on the Transmission where the Reason on the Transmission is Initial, Follow-up, or Amendment.

transmission__v.transmission_date__v
WHERE
transmission__v.reason IN (I,2,F)

3 Nullification Date

The Transmission Date on the Transmission where the Reason on the Transmission is Nullified.

transmission__v.transmission_date__v
WHERE
transmission__v.reason = 1

4 Nullification Reason

The Reason Text on the Transmission where the Reason on the Transmission is Nullified:

transmission__v.transmission_reason_text_long__v
WHERE
transmission__v.reason = 1

### Case Series {#case-series} **Case-Based Report**: This report lists the _Cases_ that match any of the report criteria in the PADER report set, sorted by _Case Name_. The following image displays the _Case Series_ table: Workbench PADER Case Series #### Table Constraints Vault filters _Cases_ to include in the PADER _Case Series_ using the following constraints: ###### **Case Not Suppressed** The _Suppress Submission_ field on the _Case_ must be set to _No_ or blank (not suppressed). \ `case_version__v.suppress_submission__v ≠ Yes` ###### **FDA Transmission in Reporting Period** Vault filters by the _Transmission Date_ to find _Cases_ submitted to the FDA within the reporting period. _Cases_ must have an associated _Transmission_ that meets the following conditions: * The _Transmission Destination_ is _FDA_. \ `case_version__v.transmission__v.destination__v = fda__v` * The _Transmission Date_ is within the interval reporting period specified in the Workbench PADER report set. \ `transmission__v.transmission_date__v >= transmission_generation.filter_start_range AND transmission__v.transmission_date__v <= transmission_generation.filter_end_range` * The _Transmission_ is in the _E2B ACK Accepted_ or _Completed_ lifecycle state, and the _Transmission_ lifecycle state type is not _Deleted_. \ `case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted` * The _Reportable Product Registration_ on the _Transmission_ matches that in the _Aggregate Reporting Group_. \ `case_version__v.transmission__v.reportable_product_registration__v.registration_number__v = aggregate_reporting_group__v.product_registration__v.registration_number__v` The report lists only the latest version of the _Case_ transmitted to the FDA within the reporting period. ###### **Suspect, Interacting, or Drug Not Administered Product in Aggregate Reporting Group** If the PADER is run for a non-combination product: A _Case Product_ must meet the following conditions: * The _Product Registration_ field of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` If the PADER is run for a combination product a different registration field is considered: A _Case Product_ must meet the following conditions: * The _Combination Product Registration_ of a _Case Product_ must link to a _Product Registration_ added as a member of the _Aggregate Reporting Group_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v IN aggregate_reporting_group__vr.aggregate_reporting_group_join__vr.product_registration__v.registration_number__v` * The _Combination Product Registration_ of a _Case Product_ is on the FDA _Transmission_. \ `case_version__vr.case_product__v.combination_product_registration__v.registration_number__v = transmission__v.reportable_product_registration__v.registration_number__v` * The _Drug Role_ must be _Suspect_ (E2B code=`1`), _Interacting_ (E2B code=`3`), or _Drug Not Administered_ (E2B code=`4`). \ `case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3 OR 4` ###### **Initial vs. Follow-Up Report** To determine whether _Cases_ should be listed in initial or follow-up reports, Vault evaluates the _Transmission Reason_ (`transmission_reason__v`) field on FDA _Transmissions_ within the reporting period using the following logic: * **Initial reports**: When there is at least one FDA _Transmission_ within the reporting period with the _Transmission Reason_ set to one of the following: * _Initial_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is `I` (initial) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v = I` * **Follow-up reports**: When all FDA _Transmissions_ within the reporting period have the _Transmission Reason_ set to one of the following: * _Amendment_ * _Follow-Up_ * A custom _Transmission Reason Controlled Vocabulary_ where the E2B code is not `I` (initial) or `1` (nullification) \ `transmission__v.reason__v.controlled_vocabulary__v.e2b_code__v ≠ I OR 1`
#### Table Mapping
Number Name Description
1 Case ID Vault maps these values from the following fields:
  • WWID: Case > Worldwide UID
    case_version__v.worldwide_uid__v
  • UID: Case > UID
    case_version__v.uid__v
2 Case Name

The Name of the Case.

case_version__v.name__v
3 Domestic/Foreign

Whether the Case is domestic or foreign.

Vault populates Domestic if the Event Country of the primary adverse event is a Country with FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault populates Foreign if the Event Country of the primary adverse event is a Country other than FDA in the Agency field.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

4 Expedited

Whether the Case was expedited.

Vault populates Exp (expedited) if one or more FDA Transmissions within the reporting period have their Local Expedited Criteria set to Yes or is blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Vault populates Non-Exp (non-expedited) if all FDA Transmissions within the reporting period have their Local Expedited Criteria set to No.
case_version__v.transmission__v.case_expedited__v = No

5 Initial/ Follow-up

Whether the Case is an initial or follow-up Case.

Vault populates Initial if at least one eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault populates Follow-up.
6 Listedness

Whether the Case is listed or unlisted.

Vault populates L (listed) if the primary Case Adverse Event is expected. Vault looks for an Expected value in the following priority order:

  1. Case Assessment Expectedness where Country is United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
(case_assessment__v.case_assessment_expectedness__v.expected__v
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v)

Otherwise, Vault populates UL (unlisted).
7 Nullified/ Voided

Vault populates Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v.state__v

Otherwise, Vault leaves this value blank.
8 Report Type The Report Type of the Case.
case_version__v.report_type__v
9 Seriousness

Whether the Case is serious or non-serious.

Vault populates S (serious) if the primary Case Adverse Event is populated with a value.
case_adverse_event__v.seriousness__v ≠ EMPTY

Otherwise, Vault populates NS (non-serious).
##### How Vault Determines Listedness Vault evaluates _Listedness_ on _Cases_. Vault determines a _Case Adverse Event_ is listed if the non-device constituent in the _Aggregate Reporting Group_ is associated with an unexpected _Case Adverse Event_. To do this, Vault finds all _Case Assessment Expectedness_ records that: * Are attached to a _Product Registration_ record of a _Product_. * List a country that is supported by the FDA. * Have a datasheet registration that matches the registration in the _Aggregate Reporting Group_. If at least one record has the _Expected_ field set to _No_ or blank, Vault determines a _Case Adverse Event_ is unlisted. If no _Case Assessment Expectedness_ records are found, then Vault uses the _Expectedness_ value on the _Case Assessment_ record to determine _Listedness_. [1]: #vault-expectedness-1 [2]: #combination-products-on-workbench-paders [3]: #deleted [4]: #specify-workbench-pader-filters [5]: #d15-and-non-d15-summary-reports [6]: #summary-of-adr-from-postmarketing-sources [7]: #interval-ll [8]: #cases-under-other-ndas [9]: #malfunction-ll [10]: #ll-summary-for-combo-products [11]: #malfunction-tabulation [12]: #create-a-workbench-pader [13]: #specify-workbench-pader-filters [14]: #vault-expectedness-2 [15]: #d15-rpt-ll-summary [16]: #non-exp-ll-summary [17]: #list-of-death-cases [18]: #list-of-null-cases [19]: #case-series