# Create PADER Aggregate Reports 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
## Prerequisites To be included in a PADER aggregate report, a Case must have a **Transmission** record with a Transmission Date. For more information on Case filtering, see the **FDA Transmission in Reporting** sections within [PADER Table Generation Data Mapping][2]. Consider the following additional prerequisites before you generate PADER tables:
## 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**. If you do not see PADER as an option, an Admin 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.

To learn more, see Configure Aggregate Reporting Families.
Organization Vault populates this field with the Organization on the selected Reporting Family.
Data Period Start (Required)

Enter the start date for the reporting period.

Vault uses the Cases within the reporting period to generate the table data. Cases are included when the date corresponding to the Filter Case 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

To customize how Vault filter Cases within the specified date range, select an option:

  • Case Receipt Date / New Info Date: The latest date when the source provided information, from the most recent available date in the Receipt Date and New Info Date fields.
  • Case Transmission Date (Default): The Transmission Date on E2B ACK Accepted and Completed FDA Transmissions associated with the Case.

If this field is not specified, the Case Transmission Date is used by default.
Include Criteria Page on Documents

Select the checkbox to add a tab at the beginning of the aggregate report document detailing the criteria used to generate the report.

When selected, the criteria page summarizes the following:

  • Report Parameters (including, the Document Name and Organization)
  • Filter Parameters (for example, the Product Family, report period start and end date, and States to Include)
  • Output Parameters (for example, Indicate Unexpected Terms and any additional fields displayed)
  • Legend (for example, an asterisk (*) indicates an Unexpected Event)
States to Include (Required)

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 Vault 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 Admin may need to add this field to appear on the 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][1], 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][3] * [Summary of ADR from Postmarketing Sources][4] * [Interval Line Listings][5] * [Appendix: Non-Primary Suspect Product Report][6] * [Appendix: List of Death Cases][7] ### 15 Day and Non-15-Day 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. 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:

PADER Summary of 15 Day and Non-15-Day 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** Depending on whether the PADER report is set to filter Cases by Transmission Date or Receipt Date / New Info Date, the system finds Cases submitted to the FDA within the reporting period as follows: See How Aggregate Reports Filter by Data Period for more information. #### Filtering Cases by Transmission Date If filtering Cases by Transmission Date, Cases 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, 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
#### Filtering Cases by Receipt Date / New Info Date If filtering Cases by Receipt Date / New Info Date, Cases 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 on or after the reporting period start date specified on the Reporting Family.
    transmission__v.transmission_date__v >= data_period_start__v
    AND transmission__v.transmission_date__v <= today()
  3. The Transmission is in any lifecycle state other than Withdrawn or Inactive, and the Transmission lifecycle state type is not Deleted.
    case_version__v.transmission__v.state__v != (inactive_state__v OR withdrawn_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted
Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.
##### **Suspect, Interacting, or Drug Not Administered Product in Reporting Family** A Case Product must meet both of the following conditions:
##### **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: #### 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 (1) 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 (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)
5 No. of Solicited Reports - Other 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)
6 No. of Spontaneous Reports Number of adverse events 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
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**: This report prints the number of Case Adverse Events that match report criteria. The following image shows the PADER Summary of ADR from Postmarketing Sources report: PADER Summary of ADR from Postmarketing Sources #### 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** Depending on whether the PADER report is set to filter Cases by Transmission Date or Receipt Date / New Info Date, the system finds Cases submitted to the FDA within the reporting period as follows: See How Aggregate Reports Filter by Data Period for more information. #### Filtering Cases by Transmission Date If filtering Cases by Transmission Date, Cases 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, 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
#### Filtering Cases by Receipt Date / New Info Date If filtering Cases by Receipt Date / New Info Date, Cases 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 on or after the reporting period start date specified on the Reporting Family.
    transmission__v.transmission_date__v >= data_period_start__v
    AND transmission__v.transmission_date__v <= today()
  3. The Transmission is in any lifecycle state other than Withdrawn or Inactive, and the Transmission lifecycle state type is not Deleted.
    case_version__v.transmission__v.state__v != (inactive_state__v OR withdrawn_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted
Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.
##### **Suspect, Interacting, or Drug Not Administered Product in Reporting Family** A Case Product must meet both of the following conditions:
#### 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
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: Case Listings Table ### Interval Line Listings **Case-Based Report**: This report prints the number of Cases that match report criteria. Vault Safety generates Interval Line Listings tables for both initial and follow-up reports. PADER Interval Line Listings include the following ten (10) indexes: * Index 1: Serious, Labeled, Initial * Index 2: Serious Unlabeled, Not Related, Initial (Solicited) * Index 3: Non-Serious, Labeled, Initial * Index 4: Non-Serious, Unlabeled, Initial * Index 5: Serious, Labeled, Follow Up * Index 6: Serious, Unlabeled, Not Related, Follow Up (Solicited) * Index 7: Non-Serious, Labeled, Follow Up * Index 8: Non-Serious, Unlabeled, Follow Up * Index 9: Serious, Unlabeled, Initial (15-day) * Index 10: Serious, Unlabeled, Follow Up (15-day) 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** Depending on whether the PADER report is set to filter Cases by Transmission Date or Receipt Date / New Info Date, the system finds Cases submitted to the FDA within the reporting period as follows: See How Aggregate Reports Filter by Data Period for more information. #### Filtering Cases by Transmission Date If filtering Cases by Transmission Date, Cases 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, 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
#### Filtering Cases by Receipt Date / New Info Date If filtering Cases by Receipt Date / New Info Date, Cases 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 on or after the reporting period start date specified on the Reporting Family.
    transmission__v.transmission_date__v >= data_period_start__v
    AND transmission__v.transmission_date__v <= today()
  3. The Transmission is in any lifecycle state other than Withdrawn or Inactive, and the Transmission lifecycle state type is not Deleted.
    case_version__v.transmission__v.state__v != (inactive_state__v OR withdrawn_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted
Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.
##### **Suspect, Interacting, or Drug Not Administered Product in Reporting Family** A Case Product must meet both of the following conditions:
##### **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:
#### Table Mapping
Number Name Description
2 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 (1) 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 the Case, regardless of their Seriousness.
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 Receipt / New Info Date

If the Cases on the report are filtered by Transmission Date, the latest FDA transmission date is populated. 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

If the Cases on the report are filtered by Receipt Date / New Info Date, the New Info Date is populated. This value is mapped from the New Info Date field on the Case.

case_version__v.new_info_idate__v
9 Transmission Generation Date

If Cases on the report are filtered by Transmission Date, this field is populated 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:
    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}
### Appendix: Non-Primary Suspect Product Report **Case-Based Report**: This report prints the number of Cases that match report criteria. 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 (1) of the suspect products, but the report was filed to another NDA, ANDA, or BLA held by the applicant.
PADER Non-Primary Suspect Product 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** Depending on whether the PADER report is set to filter Cases by Transmission Date or Receipt Date / New Info Date, the system finds Cases submitted to the FDA within the reporting period as follows: See How Aggregate Reports Filter by Data Period for more information. #### Filtering Cases by Transmission Date If filtering Cases by Transmission Date, Cases 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, 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
#### Filtering Cases by Receipt Date / New Info Date If filtering Cases by Receipt Date / New Info Date, Cases 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 on or after the reporting period start date specified on the Reporting Family.
    transmission__v.transmission_date__v >= data_period_start__v
    AND transmission__v.transmission_date__v <= today()
  3. The Transmission is in any lifecycle state other than Withdrawn or Inactive, and the Transmission lifecycle state type is not Deleted.
    case_version__v.transmission__v.state__v != (inactive_state__v OR withdrawn_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted
Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.
##### **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
* 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` * 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 OR Drug Not Administered
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 The 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 The MedDRA PT of each Case Adverse Event, sorted by primary first.
case_adverse_event__v.event_meddra__v.pt_term__v
4 Registration Number 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

The New Info Date is populated. This value is mapped from the New Info Date field on the Case.
case_version__v.new_info_idate__v

If Cases on the report are filtered by Receipt Date / New Info Date, this field is populated with the New Info Date for a Case with a Transmission record that meets the following criteria:

  • The Transmission Lifecycle State is not Inactive or Withdrawn.
    case_version__v.transmission__v.state__v != (inactive_state__v OR withdrawn_state__v)
7 Transmission Generation Date

If Cases on the report are filtered by Transmission Date, this field is populated 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:
    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}
8 Transmission 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 (1) 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 (1) 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**: This report prints the number of Cases that match report criteria. 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.
PADER List of Death Cases #### 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** Depending on whether the PADER report is set to filter Cases by Transmission Date or Receipt Date / New Info Date, the system finds Cases submitted to the FDA within the reporting period as follows: See How Aggregate Reports Filter by Data Period for more information. #### Filtering Cases by Transmission Date If filtering Cases by Transmission Date, Cases 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, 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
#### Filtering Cases by Receipt Date / New Info Date If filtering Cases by Receipt Date / New Info Date, Cases 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 on or after the reporting period start date specified on the Reporting Family.
    transmission__v.transmission_date__v >= data_period_start__v
    AND transmission__v.transmission_date__v <= today()
  3. The Transmission is in any lifecycle state other than Withdrawn or Inactive, and the Transmission lifecycle state type is not Deleted.
    case_version__v.transmission__v.state__v != (inactive_state__v OR withdrawn_state__v) AND case_version__v.transmission__v.state__v.statetype__v != Deleted
Only the latest version of the Case Transmitted to the FDA within the reporting period is listed in the report.
##### **Suspect, Interacting, or Drug Not Administered Product in Reporting Family** A Case Product must meet both of the following conditions:
##### **Case Indicates a Death Occurred** One (1) 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 Sex: Case > Patient Sex
    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, Interacting, or Drug Not Administered.
case_version__v.case_product__v.product_name__v
where drug_role__v = Suspect OR Interacting OR Drug Not Administered
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 To review examples of PADER generation based on Case filtering, see Sample PADER Generation When Filtering by Transmission Date and Sample PADER Generation When Filtering by Receipt Date / New Info Date. [1]: #create-pader [2]: #data-mapping [3]: #15-day-and-non-15-day-summary-reports [4]: #summary-adr-postmarket [5]: #interval-line-listings [6]: #non-primary-suspect-product [7]: #list-of-death-cases