Create PADER Aggregate Reports

Learn how to set up PADER aggregate reports and generate PADER report tables.

Sections in This Article

About PADER Reports

Vault Safety provides U.S. Periodic Adverse Drug Experience Report (PADER) authoring and table generation capabilities.

The following table summarizes the PADER tabulations that Vault Safety generates:

Tabulation Generated by Default? Masking Support?
15 Day and Non-15-Day Summary Reports Yes No
Summary of ADR from Postmarketing Sources Yes No
Interval Line Listings Yes No
Appendix: Non-Primary Suspect Product Report Yes No
Appendix: List of Death Cases No No

Tip An administrator can configure custom PADER report templates for your organization.

Prerequisites

Consider the following prerequisites before you generate PADER tables:

  • You must be assigned permissions to view and prepare aggregate reports.
    Typically, these permissions are reserved for the Safety Writer and Head of Safety roles.
  • An administrator must have already configured the Reporting Family with the Products and Studies to include in the report.
  • An administrator must have configured US-based Local Product Datasheets that list expected adverse events for the reporting family product.
    Vault Safety uses Product Datasheets to classify adverse events as labeled or unlabeled in PADER tables.
  • To generate table data from Study-type Cases, an administrator must have configured the appropriate Study Products.

Tip Vault Safety generates PADER tables using controlled vocabularies to determine when causality is not related. An administrator can configure these controlled vocabularies differently. Configure Controlled Vocabularies provides instructions.

Create a PADER Aggregate Report

Create a PADER Aggregate Report and specify the report settings.

Add a PADER

  1. In the vault primary navigation bar, select Aggregate Reports > PADER, and then select Create.

    Note If you do not see PADER as an option, an administrator must update your vault to Enable PADER Authoring and Table Generation.

  2. In the Create Aggregate Report window, under Select Aggregate Report Type, select PADER.
  3. Complete the fields on the Create PADER page.
  4. Save the page.

Result

The PADER record enters the Pending state. The system assigns a task to users in the Safety Writer role to review the report details.

PADER Fields

You can specify the following fields for a PADER Aggregate Report:

Field Description
Product Family (Required)

Select the Reporting Family configured for aggregate reporting.

Note The Reporting Family object type should be Product Family.

To learn more, see Configure Aggregate Reporting Families.
Organization This field is automatically populated with the Organization on the selected Reporting Family.
Data Period Start (Required)

Enter the start date for the reporting period.

The system uses the Cases within the reporting period to generate the table data. Cases are included when the date corresponding to the Filter Cases By setting is within the reporting period.

Cumulative reports do not consider the start date. The data period contains all Cases up to the Data Period End Date.

To learn more, see How Aggregate Reports Filter by Data Period.
Data Period End (Required)

Enter the end date for the reporting period.

To learn more, see How Aggregate Reports Filter by Data Period.
Filter Case By

Regardless of what you select in this field, PADER reports always filter Cases by the Transmission Date on completed FDA Transmissions associated with the Case. Note that when filtering by Transmission Date, the States to Include setting is ignored.

This field is not required for PADER, but this field may appear if it is on the Aggregate Report page layout.

States to Include (Required)

Note This setting is ignored for PADER reports, because PADER reports look for Cases at the Transmission-level, filtering by Transmission Date.

By default, only Cases in the Approved, Closed, Superseded, and Medical Review states are included. Note that while Superseded is not listed as an option, the Closed state includes the Superseded state.

Documents to Generate You can select which documents to generate. The following options are available:
  • Summary Tabulations of ADRs from Postmarketing Sources
  • 15 Day and Non 15 Day Reports
  • Interval Line Listings
  • Non-Primary Suspect Product
  • List of Death Cases

If you don't specify this field, by default the system generates the following documents:

  • Summary Tabulations of ADRs from Postmarketing Sources
  • 15 Day and Non 15 Day Reports
  • Interval Line Listings
  • Non-Primary Suspect Product

Depending on when your vault was originally deployed, an administrator may need to add this field to appear on the page layout.

Generate PADER Tabulations

Review and verify the report settings. Once you have confirmed the report details are correct, use the Generate Aggregate Report Tabulations action to generate PADER report tables.

PADER Table Generation Data Mapping

Vault Safety populates aggregate report tables using Cases within the reporting period specified on the PADER, and the reporting family members configured on the associated Reporting Family.

The following sections describe how Vault Safety generates PADER tabulations:

15 Day and Non-15-Day Summary Reports

Case-Based Report

The 15-Day and Non-15 Day Summary Reports tables are generated for both initial reports and follow-up reports.

The following image shows the Summary of 15 Day and Non-15-Day Reports table. While the following image is of initial report tables, equivalent tables are generated for follow-up reports:

Table Constraints

The system filters Cases to include in the PADER 15-Day and Non-15 Day Summary Reports using the following constraints:

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • FDA Transmission in Reporting Period

    The system filters by the Transmission Date to find Case submitted to the FDA within the reporting period. How Aggregate Reports Filter by Data Period provides more information.

    PADER reports filter by FDA Transmissions regardless of the value in the Filter Cases By field on the aggregate report.

    The Case must have an associated Transmission that meets all of the following conditions:

    1. The Transmission Destination is FDA
      case_version__v.transmission__v.destination__v = fda__v
    2. The Transmission Date is within the interval reporting period specified on the Reporting Family.
      transmission__v.transmission_date__v ≥ data_period_start__v 
      AND transmission__v.transmission_date__v ≤ data_period_end__v
    3. The Transmission is in the E2B ACK Accepted or Completed lifecycle state
      case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v)

    Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.

    Note If the system finds a matching Transmission where the Transmission Reason field is set to "Follow-Up", the Case omitted if the Case is in one of the following states:

    • Voided (voided_state__v)
    • A Lifecycle State assigned a State Type of "Deleted"
  • Suspect or Interacting Product in Reporting Family

    A Case Product must meet both of the following conditions:

    • The Product field must link to a Product record added as a member of the Reporting Family

      Note For Study Products in PADER Reporting Families, you must add both the Study and Product.

      case_version__vr.case_product__v.product__v IN 
          	
      aggregate_report_family__vr.aggregate_report_family_join__vr.products__v
    • The Drug Role field must be set to Suspect (E2B Code=1) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3
  • Initial vs. Follow-Up Report

    To determine whether Cases should be listed in Initial or Follow-Up Reports, the system 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:
      1. Initial
      2. 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 of the following:
      1. Amendment
      2. Follow-Up
      3. 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.

Number Name Description
1 Summary of 15 Day Alerts The Summary of 15 Day Alerts table contains Cases with one 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
2 Serious, Unlabeled - Non-Fatal The sum of all adverse events that meet the following criteria:
  • Serious (Non-Fatal): The Case Adverse Event > Seriousness field is set to a value, but fatal criteria is not met.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlabeled: The system looks for an Expected value of No in the following priority order:
    1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
    2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
    3. If neither of the above are met, fall back to 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)
3 Fatal

One of the following conditions must be met to indicate a death occurred:

  1. A value in the Case Date of Death field
    case_version__v.dod_normalized__v ≠ Blank
  2. Any Case Adverse Event Seriousness field contains Results in Death.
    case_adverse_event__v.seriousness__v = results_in_death__v
  3. Any Case Adverse Event Outcome field contains Fatal
    case_adverse_event__v.outcome__v = fatal
  4. 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
  5. The Case Autopsy field is set to Yes.
    case_version__v.autopsy_value__v = Yes
4 No. of Solicited Reports - Study Number of Cases that match one 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)
5 No. of Solicited Reports - Other Number of Cases that match one 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)
6 No. of Spontaneous Reports Number of adverse events with the Case > Report Type set to one 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
7 Total The total sum of adverse events for each category.
8 Summary of Non 15 Day Alerts The Summary of Non 15 Day Alerts table contains Cases where 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
9 Serious, Unlabeled, Not Related The sum of Cases with primary Case Adverse Events that meet the following criteria:
  • Serious: The Case Adverse Event > Seriousness field is set to a value.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlabeled: The system looks for an Expected value of No in the following priority order:
    1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
    2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
    3. If neither of the above are met, fall back to 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: When the Causality Established field in at least two primary Assessment Results is set to No, including one company assessment and one 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])
10 Serious, Labeled The sum of Cases with primary Case Adverse Events that meet the following criteria:
  • Serious: The Case Adverse Event > Seriousness field is set to a value.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Labeled: The system looks for an Expected value of Yes in the following priority order:
    1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
    2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
    3. If neither of the above are met, fall back to 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)
11 Non Serious, Labeled The sum of Cases with primary Case Adverse Events that meet the following criteria:
  • Non Serious: The Case Adverse Event > Seriousness field is empty.
    case_adverse_event__v.seriousness__v = EMPTY
  • Labeled: The system looks for an Expected value of Yes in the following priority order:
    1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
    2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
    3. If neither of the above are met, fall back to 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)
12 Non Serious, Unlabeled The sum of Cases with primary Case Adverse Events that meet the following criteria:
  • Non Serious: The Case Adverse Event > Seriousness field is empty.
    case_adverse_event__v.seriousness__v = EMPTY
  • Unlabeled: The system looks for an Expected value of No in the following priority order:
    1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
    2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
    3. If neither of the above are met, fall back to 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)

Summary of ADR from Postmarketing Sources

Event-Based Report

The following image shows the PADER Summary of ADR from Postmarketing Sources report:

Table Constraints

The system filters Cases to include in the PADER Summary of Adverse Drug Reactions from Postmarketing Sources using the following constraints:

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • FDA Transmission in Reporting Period

    The system filters by the Transmission Date to find Case submitted to the FDA within the reporting period. How Aggregate Reports Filter by Data Period provides more information.

    PADER reports filter by FDA Transmissions regardless of the value in the Filter Cases By field on the aggregate report.

    The Case must have an associated Transmission that meets all of the following conditions:

    1. The Transmission Destination is FDA
      case_version__v.transmission__v.destination__v = fda__v
    2. The Transmission Date is within the interval reporting period specified on the Reporting Family.
      transmission__v.transmission_date__v ≥ data_period_start__v 
      AND transmission__v.transmission_date__v ≤ data_period_end__v
    3. The Transmission is in the E2B ACK Accepted or Completed lifecycle state
      case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v)

    Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.

    Note If the system finds a matching Transmission where the Transmission Reason field is set to "Follow-Up", the Case omitted if the Case is in one of the following states:

    • Voided (voided_state__v)
    • A Lifecycle State assigned a State Type of "Deleted"
  • Suspect or Interacting Product in Reporting Family

    A Case Product must meet both of the following conditions:

    • The Product field must link to a Product record added as a member of the Reporting Family

      Note For Study Products in PADER Reporting Families, you must add both the Study and Product.

      case_version__vr.case_product__v.product__v IN 
          	
      aggregate_report_family__vr.aggregate_report_family_join__vr.products__v
    • The Drug Role field must be set to Suspect (E2B Code=1) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3

Note The PADER Summary of ADR from Postmarketing Sources report only considers Case Adverse Events with Case Assessments.

Table Mapping

Sorting: Cases are sorted in ascending order, first by UID and then by Worldwide UID.

Number Name Description
1 SOC Class The MedDRA System Organ Class (SOC) for the 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 coded on the Case Adverse Event, grouped by the MedDRA SOC.
case_adverse_event__v.event_meddra__v.pt_term__v

Note Contact Veeva Support to request PT Aggregation in periodic reports, which counts only unique instances of Preferred Terms (PT) in summary tabulations. Once this feature is enabled, when a Case contains multiple Case Adverse Events coded under the same MedDRA Preferred Term (PT), the report counts a single PT event instead of multiple events.

3 Domestic The sum of adverse events where the Case Adverse Event > Event Country field is set to a Country with the Agency field 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 with the Agency field 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 set to a value.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Unlabeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    1. If Local Product Datasheets are configured, the system looks for Case Assessment Expectedness records under the Case Assessment:
      1. A Case Assessment Expectedness record must exist with the Expected field set to No.
      2. The Local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    2. If there are no Local Datasheets within the FDA's jurisdiction configured, the system 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 set to a value.
    case_adverse_event__v.seriousness__v ≠ EMPTY
  • Labeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    1. If Local Product Datasheets are configured, the system looks for Case Assessment Expectedness records under the Case Assessment:
      1. A Case Assessment Expectedness record must exist with the Expected field set to Yes.
      2. The Local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    2. If there are no Local Datasheets within the FDA's jurisdiction configured, the system 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 empty.
    case_adverse_event__v.seriousness__v = EMPTY
  • Unlabeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    1. If Local Product Datasheets are configured, the system looks for Case Assessment Expectedness records under the Case Assessment:
      1. A Case Assessment Expectedness record must exist with the Expected field set to No.
      2. The Local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    2. If there are no Local Datasheets within the FDA's jurisdiction configured, the system 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 empty.
    case_adverse_event__v.seriousness__v = EMPTY
  • Labeled: One of the following conditions must be met on the Case Assessment for the Case Adverse Event:
    1. If Local Product Datasheets are configured, the system looks for Case Assessment Expectedness records under the Case Assessment:
      1. A Case Assessment Expectedness record must exist with the Expected field set to Yes.
      2. The Local Datasheet used to calculate the Case Assessment Expectedness must specify FDA as the Agency on the Country.
    2. If there are no Local Datasheets within the FDA's jurisdiction configured, the system 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 Subtotal sum of adverse events for each MedDRA SOC and PT, within domestic or foreign jurisdiction.
10 Total Total sum of domestic and foreign adverse events for each MedDRA SOC and PT.
11 Grand Total Total sum of all adverse events.

The Cases contained in the report are listed in a separate table:

Interval Line Listings

Case-Based Report

Vault Safety generates Interval Line Listings tables for both initial and follow-up reports. PADER Interval Line Listings include the following 10 indexes:

  • Index 1: Serious, Labeled Initial Reports
  • Index 2: Serious Unlabeled, Not Related, Initial (Solicited)
  • Index 3: Non-Serious, Labeled, Initial
  • Index 4: Non-Serious, Unlabeled, Initial
  • Index 5: Serious, Labeled Followup
  • Index 6: Serious Unlabeled, Not Related, Followup (Solicited)
  • Index 7: Non-Serious, Labeled, Followup
  • Index 8: Non-Serious, Unlabeled, Followup
  • Index 9: Serious, Unlabeled, Initial
  • Index 10: Serious, Unlabeled, Followup

The following image shows the PADER Interval Line Listings. While the following image is of initial report tables, equivalent tables are generated for follow-up reports:

PADER Interval Line Listings

Table Constraints

The following table describes how the system filters Cases to include in the PADER Interval Line Listings.

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • FDA Transmission in Reporting Period

    The system filters by the Transmission Date to find Case submitted to the FDA within the reporting period. How Aggregate Reports Filter by Data Period provides more information.

    PADER reports filter by FDA Transmissions regardless of the value in the Filter Cases By field on the aggregate report.

    The Case must have an associated Transmission that meets all of the following conditions:

    1. The Transmission Destination is FDA
      case_version__v.transmission__v.destination__v = fda__v
    2. The Transmission Date is within the interval reporting period specified on the Reporting Family.
      transmission__v.transmission_date__v ≥ data_period_start__v 
      AND transmission__v.transmission_date__v ≤ data_period_end__v
    3. The Transmission is in the E2B ACK Accepted or Completed lifecycle state
      case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v)

    Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.

    Note If the system finds a matching Transmission where the Transmission Reason field is set to "Follow-Up", the Case omitted if the Case is in one of the following states:

    • Voided (voided_state__v)
    • A Lifecycle State assigned a State Type of "Deleted"
  • Suspect or Interacting Product in Reporting Family

    A Case Product must meet both of the following conditions:

    • The Product field must link to a Product record added as a member of the Reporting Family

      Note For Study Products in PADER Reporting Families, you must add both the Study and Product.

      case_version__vr.case_product__v.product__v IN 
          	
      aggregate_report_family__vr.aggregate_report_family_join__vr.products__v
    • The Drug Role field must be set to Suspect (E2B Code=1) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3
  • Initial vs. Follow-Up Report

    To determine whether Cases should be listed in Initial or Follow-Up Reports, the system 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:
      1. Initial
      2. 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 of the following:
      1. Amendment
      2. Follow-Up
      3. 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

Note For each Case included in the report, the PADER Interval Line Listings displays all Case Adverse Events.

Table Mapping

Number Name Description
1 Non 15-Day Report
Serious Labeled
  1. The system first filters Cases that meet the following criteria:
    • Non-15 Day: When 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
    • Labeled: The system looks for an Expected value of Yes in the following priority order:
      1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
      2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
      3. If neither of the above are met, fall back to 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)
  2. Then, the system displays all Case Adverse Events under that Case with the Seriousness field set to a value.
    case_adverse_event__v.seriousness__v ≠ EMPTY
2 Non 15-Day Report
Serious, Unlabeled, Not Related (solicited)
  1. The system first filters Cases that meet the following criteria:
    • Non-15 Day: When 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
    • Unlabeled: The system looks for an Expected value of No in the following priority order:
      1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
      2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
      3. If neither of the above are met, fall back to 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: When the Causality Established field in at least two primary Assessment Results is set to No, including one company assessment and one 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])
    • Solicited: The Case > Report Type (report_type__v) field is set to one of the following:
      1. Study
      2. Literature (Study)
      3. A custom Report Type with an E2B Code of 2
  2. Then, the system displays all Case Adverse Events under that Case with the Seriousness field set to a value.
    case_adverse_event__v.seriousness__v ≠ EMPTY
3 Non 15-Day Report
Non Serious Labeled
  1. The system first filters Cases that meet the following criteria:
    • Non-15 Day: When 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
    • Labeled: The system looks for an Expected value of Yes in the following priority order:
      1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
      2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
      3. If neither of the above are met, fall back to 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)
  2. Then, the system displays all Case Adverse Events under that Case with the Seriousness field empty.
    case_adverse_event__v.seriousness__v = EMPTY
4 Non 15-Day Report Non Serious Unlabeled
  1. The system first filters Cases that meet the following criteria:
    • Non-15 Day: When 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
    • Unlabeled: The system looks for an Expected value of No in the following priority order:
      1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
      2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
      3. If neither of the above are met, fall back to 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)
  2. Then, the system displays all Case Adverse Events under that Case with the Seriousness field empty.
    case_adverse_event__v.seriousness__v = EMPTY
5 15 Day Report Serious Unlabeled
  1. The system first filters Cases that meet the following criteria:
    • 15 Day: When one or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or is blank.
      case_version__v.transmission__v.case_expedited__v = Yes OR Blank
    • Unlabeled: The system looks for an Expected value of No in the following priority order:
      1. Look for Case Assessment Expectedness where Country is set to the United States, or another country in the FDA's jurisdiction.
      2. If no local US Case Assessment Expectedness is found, look at the Expectedness field on the primary Case Assessment.
      3. If neither of the above are met, fall back to 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)
  2. Then, the system displays all Case Adverse Events under that Case with the Seriousness field set to a value.
    case_adverse_event__v.seriousness__v ≠ EMPTY
6 Manufacturer Report Number This value is mapped from the Case > UID field.
case_version__v.uid__v
7 Adverse Experience Reported Term (MedDRA Term) Both the reported name and the MedDRA Preferred Term for the adverse event.
(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)
8 Initial Report Date or Latest Follow-Up Report Date The latest FDA transmission date. This value is mapped from the Transmission Date field for the most recent FDA Transmission within the reporting period.
case_version__v.transmission__v.transmission_date__v

Appendix: Non-Primary Suspect Product Report

Case-Based Report

The Non-Primary Suspect Drug 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 NDA, ANDA, or BLA held by the applicant.

Note Starting in 21R1, the Non-Primary Suspect Product Report is generated for PADER reports by default. For vaults originally deployed before 21R1, an administrator must upload the Non-Primary Suspect Product Report template, otherwise the system cannot generate this report.

Table Constraints

The system filters Cases to include in the PADER Non-Primary Suspect Product Report using the following constraints:

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • FDA Transmission in Reporting Period

    The system filters by the Transmission Date to find Case submitted to the FDA within the reporting period. How Aggregate Reports Filter by Data Period provides more information.

    PADER reports filter by FDA Transmissions regardless of the value in the Filter Cases By field on the aggregate report.

    The Case must have an associated Transmission that meets all of the following conditions:

    1. The Transmission Destination is FDA
      case_version__v.transmission__v.destination__v = fda__v
    2. The Transmission Date is within the interval reporting period specified on the Reporting Family.
      transmission__v.transmission_date__v ≥ data_period_start__v 
      AND transmission__v.transmission_date__v ≤ data_period_end__v
    3. The Transmission is in the E2B ACK Accepted or Completed lifecycle state
      case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v)

    Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.

    Note If the system finds a matching Transmission where the Transmission Reason field is set to "Follow-Up", the Case omitted if the Case is in one of the following states:

    • Voided (voided_state__v)
    • A Lifecycle State assigned a State Type of "Deleted"
  • Non-Primary Case Product in Reporting Family

    The Case must contain a Case Product that meets the following conditions:

    • The Product field must link to a Product record added as a member of the Reporting Family

      Note For Study Products in PADER Reporting Families, you must add both the Study and Product.

    • The Drug Role field must be set to Suspect or Interacting
    • The Case Product must not be designated as the primary product (Primary is No and Rank does not equal 1)
    case_version__vr.case_product__v.product__v 
    where primary__v ≠ True (Rank ≠1)
    AND drug_role__v = Suspect OR Interacting
    IN aggregate_report_family__vr.aggregate_report_family_join__vr.products__v

Table Mapping

Sorting: Cases are sorted in ascending order, first by UID and then by Worldwide UID.

Number Name Description
1 Case WWID / UID Values are mapped from the following fields:
  • UID: Case > UID
    case_version__v.uid__v
  • WWID: Case > Worldwide UID
    case_version__v.worldwide_uid__v
2 Non-Primary Suspect Product Name of each non-primary suspect or interacting Case Product.
case_version__v.case_product__v.product_name__v 
where primary__v ≠ True (Rank ≠1)
AND drug_role__v = Suspect OR Interacting
3 Adverse Events MedDRA PT of each Case Adverse Event, sorted by primary first.
case_adverse_event__v.event_meddra__v.pt_term__v
4 Approval Number 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 Approval Type 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 Submission Date 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 of the following:
    1. Initial
    2. Follow-up
    3. Amendment
    4. 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}
7 Submission Type The type is determined using the Transmission Reason and Local Expedited Criteria fields on Transmissions associated with the Case.
  • Expedited: When one or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or is blank.
    case_version__v.transmission__v.case_expedited__v = Yes OR Blank
  • Non-Expedited: When 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
  • Initial: When at least one FDA Transmission within the reporting period has the Transmission Reason set to one of the following:
    1. Initial
    2. 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: When all FDA Transmissions within the reporting period have the Transmission Reason set to one of the following:
    1. Amendment
    2. Follow-Up
    3. 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

Appendix: List of Death Cases

Case-Based Report

The List of Death Cases for PADER lists all cases that were transmitted to the FDA during the reporting period as a 15 or non-15 day report, where the patient has died.

Note For vaults originally deployed before 21R1, an administrator must upload the List of Death Cases report template before you can generate this report.

Table Constraints

The system filters Cases to include in the PADER List of Death Cases using the following constraints:

  • Case Not Suppressed
    The Case Suppress Submission field must be set to No or blank (not suppressed).
    case_version__v.suppress_submission__v ≠ Yes
  • FDA Transmission in Reporting Period

    The system filters by the Transmission Date to find Case submitted to the FDA within the reporting period. How Aggregate Reports Filter by Data Period provides more information.

    PADER reports filter by FDA Transmissions regardless of the value in the Filter Cases By field on the aggregate report.

    The Case must have an associated Transmission that meets all of the following conditions:

    1. The Transmission Destination is FDA
      case_version__v.transmission__v.destination__v = fda__v
    2. The Transmission Date is within the interval reporting period specified on the Reporting Family.
      transmission__v.transmission_date__v ≥ data_period_start__v 
      AND transmission__v.transmission_date__v ≤ data_period_end__v
    3. The Transmission is in the E2B ACK Accepted or Completed lifecycle state
      case_version__v.transmission__v.state__v = (e2b_ack_accepted_state__v OR completed_state__v)

    Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.

    Note If the system finds a matching Transmission where the Transmission Reason field is set to "Follow-Up", the Case omitted if the Case is in one of the following states:

    • Voided (voided_state__v)
    • A Lifecycle State assigned a State Type of "Deleted"
  • Suspect or Interacting Product in Reporting Family

    A Case Product must meet both of the following conditions:

    • The Product field must link to a Product record added as a member of the Reporting Family

      Note For Study Products in PADER Reporting Families, you must add both the Study and Product.

      case_version__vr.case_product__v.product__v IN 
          	
      aggregate_report_family__vr.aggregate_report_family_join__vr.products__v
    • The Drug Role field must be set to Suspect (E2B Code=1) or Interacting (E2B Code=3)
      case_product__v.drug_role__v.controlled_vocabulary__v.e2b_code__v = 1 OR 3
  • Case Indicates a Death Occurred

    One of the following conditions must be met to indicate a death occurred:

    1. A value in the Case Date of Death field
      case_version__v.dod_normalized__v ≠ Blank
    2. Any Case Adverse Event Seriousness field contains Results in Death.
      case_adverse_event__v.seriousness__v = results_in_death__v
    3. Any Case Adverse Event Outcome field contains Fatal
      case_adverse_event__v.outcome__v = fatal
    4. 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
    5. The Case Autopsy field is set to Yes.
      case_version__v.autopsy_value__v = Yes

Table Mapping

Sorting: Cases are sorted in ascending order, first by UID and then by Worldwide UID.

Number Name Description
1 Case WWID / UID Values are mapped from the following fields:
  • UID: Case > UID
    case_version__v.uid__v
  • WWID: Case > Worldwide UID
    case_version__v.worldwide_uid__v
2 Country / Patient Gender / Age Values from the following fields:
  • Country: Case > Event Country
    case_version__v.event_country__v.name__v
  • Patient Gender: Case > Patient Gender
    case_version__v.gender_value__v.name__v
  • Age: Case > Age and Age (unit)
    The system automatically calculates the age to the closest full number in years
    (case_version__v.age_value__v case_version__v.age_unit__v) 
                         
    OR
    (case_version__v.age_normalized_year__v case_version__v.age_unit__v)
3 Suspect Drug The Case Product name, where the Drug Role is Suspect or Interacting.
case_version__v.case_product__v.product_name__v 
where drug_role__v = Suspect OR Interacting
4 Cause of Death 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 ""-""

Example PADER Generation

Consider the following example, where a Vault contains four Cases for the product Cholecap. Toggle through the following tabs to see details of each of these Cases and their versions:

Toggle the following tabs to view how Vault Safety generates PADER reports with this data set for two different reporting periods.

  • Cholecap PADER 000001

    PADER 000001 Report Information

    PADER Summary ADR

    PADER Summary ADR

    15 and Non-15 Day Summary Reports

    PADER 15 and Non-15 Day Reports

    Interval Line Listings

    Index 8: Non-Serious, Unlabeled, Follow-up
    Index 8: Interval Line Listings
    Index 9: Serious, Unlabeled, Initial
    Index 9: Interval Line Listings

    Non-Primary Suspect Report

    Not Applicable: Empty Table Generated

    List of Death Cases

    Appendix List of Death Cases
  • Cholecap PADER 000002

    PADER 000002 Report Information

    PADER Summary ADR

    PADER Summary ADR

    15 and Non-15 Day Summary Reports

    PADER 15 and Non-15 Day Reports

    Interval Line Listings

    Index 10: Serious, Unlabeled, Follow-up
    Index 10: Interval Line Listings

    Non-Primary Suspect Report

    Not Applicable: Empty Table Generated

    List of Death Cases

    Appendix List of Death Cases

Note The colored highlighting in the above reports is added to illustrate the Case from which data originates. Actual reports are not highlighted.


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