# Create PBRER Aggregate Reports Safety provides Periodic Benefit-Risk Evaluation Report (PBRER) authoring and table generation capabilities. The Vault Safety PBRER follows the ICH E2C(R2) and GvP Module VII regulatory guidelines. The following table summarizes the PBRER tabulations that Vault Safety generates: | Tabulation | Generated by Default? | Masking Support? | | --- | --- | --- | | [Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources][3] | Yes | No | | [Cumulative Tabulation of Serious Adverse Events (from Clinical Trials)][1] | Yes | Yes | | [Interval Line Listings of Serious Adverse Reactions (from Clinical Trials)][2] | Yes | Yes |

Note: Your Admin can configure custom PBRER templates for your organization.

## Prerequisites Consider the following prerequisites before you generate aggregate report 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. * Your Admin must have already configured: * _Reporting Families_: To identify the _Products_ and _Studies_ to include in reports. * _Study Products_: To generate table data from study _Cases_. * Depending on your business process, your Admin may configure: * A _Datasheet_ for each _Study Product_, _Study_, or _Case Product_ with a list of expected adverse events for the _Reporting Family_. * Criteria Page for Aggregate Reports: Adds a tab at the beginning of aggregate report documents detailing the criteria used to generate the report. * DSUR and PBRER Investigational Product Causality: To consider only causal assessments related to investigational products when generating PBRERs. * DSUR and PBRER Summary Totals and Separate Log Files: * To display totals for each SOC and PT as well as a grand total on Cumulative Tabulation of Serious Adverse Events from Clinical Trials and the Summary Tabulation of Adverse Drug Reactions (ADRs) from Postmarketing Sources. * To generate log files as separate files using the _Log_ document classification type. ## Create a PBRER Aggregate Report Create a PBRER Aggregate Report and specify the report settings. ### Add a PBRER 1. In the Vault primary navigation bar, select **Aggregate Reports > PBRER**, and then select **Create**. 2. In the **Create Aggregate Report** window, under **Select Aggregate Report Type**, select **PBRER**. 3. Complete the fields on the **Create PBRER** page. 4. Save the record. **Result** The Aggregate Report record enters the Pending state. Vault assigns a task to users in the Safety Writer role to review the report details. #### PBRER Fields You can specify the following fields for a PBRER Aggregate Report:

Field	Description
Product Family (Required)	Select the Reporting Family configured for aggregate reporting. The Reporting Family defines which Cases are included in the report: All Cases with a Product in the Reporting Family All Cases with a Study in the Reporting Family All Cases with a blinded Study for a Product in the Reporting Family Note: The Reporting Family object type should be Product Family. 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 filters 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 Approval Date: The date when the Case moved into the Approved state. If the Case was revised for a non-significant follow-up, the most recent approval date is used. If this field is blank, Vault uses the Case Receipt Date/New Info Date.
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)	Select the states that Cases must be in to be included in the report. By default, only Cases in the Approved, Closed, Superseded, and Medical Review states are included. Although Superseded is not listed as an option, it is included within the Closed state. Only system-provided states in the Case Processing lifecycle are supported. Note: If the latest Case version within the aggregate reporting period is in the Nullified or Voided state or in a lifecycle state assigned to the Deleted state type, the Case is excluded from the aggregate report.
Drug Roles to Include	Select one or more Drug Roles from the dropdown list to include in the following tabulations: Interval Line Listings of Serious Adverse Reactions Cumulative Tabulation of Serious Adverse Events From Clinical Trials The Suspect and Interacting Drug Roles are selected by default for PBRERS created with the 23R3 release or later. For PBRERs created from prior releases, update the field to specify or revise which Drug Roles to include in the report. Note: Drug Roles are not considered when generating the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources.
Documents to Generate	You can select which documents to generate. The following options are available: Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources Cumulative Tabulation of Serious Adverse Events from Clinical Trials Interval Line Listings of Serious Adverse Reactions from Clinical Trials If you don't specify this field, by default Vault generates the following documents: Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources Cumulative Tabulation of Serious Adverse Events from Clinical Trials Interval Line Listings of Serious Adverse Reactions from Clinical Trials By default, the documents are unmasked unless you select the Generate Masked Documents option. Depending on when your Vault was originally deployed, an Admin may need to add this field to appear on the layout.
Generate Masked Documents	Select this option to generate a masked copy of the following tables for masked distributions, depending on the tables selected in the Documents to Generate field: Cumulative Tabulation of Serious Adverse Events from Clinical Trials Interval Line Listings of Serious Adverse Reactions (from Clinical Trials) To learn more, see Generate Masked Aggregate Tabulations (CIOMS II, PBRER and DSUR).
Indicate Unexpected Term	Select Yes to display an asterisk beside each unexpected adverse event term in the Interval Line Listings of Serious Adverse Reactions report (masked and unmasked).
Datasheet	This field works alongside the Indicate Unexpected Term setting for evaluating approved terms in Product and Study Product Datasheets. For DSUR and PBRER, Vault always uses Use Approved Version at the beginning of the reporting period, including when this field is left blank. This setting means that the aggregate report Start Date must be within a term's active range to be considered Expected. To learn more, see Manage Datasheets and Auto-Expectedness.

### Generate PBRER 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 PBRER report tables. ## Mark Unexpected Terms in PBRER Reports You can set the **Indicate Unexpected Term** on a PBRER so that when the Interval Line Listings of Serious Adverse Reactions report (masked and unmasked) report is generated, Vault marks each unexpected adverse event with an asterisk (*). To identify unexpected events, your Admin must have configured Datasheets for the investigational Study Product or Study added to the PBRER Reporting Family. The Datasheet can specify the Active Date Start and, optionally, an Active Date End, which indicates when a term is approved as expected for the Product. If configured, the PBRER Start Date must be within a term's active range to be considered expected. For more information about how to define an active range for expectedness in aggregate reports, see Manage Datasheets and Auto-Expectedness. ## PBRER Table Generation Data Mapping Vault Safety populates aggregate report tables using Cases within the reporting period specified on the [PBRER][4], and the reporting family members configured on the associated Reporting Family. The following sections describe how Vault Safety generates PBRER tabulations: * [Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources][3] * [Cumulative Tabulation of Serious Adverse Events (from Clinical Trials)][1] * [Interval Line Listings of Serious Adverse Reactions (from Clinical Trials)][2]

Note: For blinded studies, Vault populates blinded product information as Blinded in the generated tables.

### Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources The following image map shows how Vault Safety generates the Summary Tabulation of Adverse Drug Reactions from Postmarketing Sources table.

#### Table Constraints Vault filters Cases to include in the Summary Tabulation 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` ##### Case Product in Reporting Family A Case Product must be a member of the Reporting Family. case_version__vr.case_product__v.product__v IN aggregate_report_family__vr.aggregate_report_family_join__vr.products__v ##### Case Data in Cumulative Reporting Period The date must be within the aggregate report cumulative reporting period (Product IBD to Data Period End). How Aggregate Reports Filter by Data Period provides more information. DATE ≤ pbrer__v.data_period_end__v where _DATE_ depends on the option selected in the PBRER **Filter Cases By** (`pbrer__v.filter_cases_by__v`) field: * When **Approval Date**: `case_version__v.approval_date__v` * When blank or **Receipt Date / New Info Date** (Default): * If the Case New Info Date (`new_info_date__v`) is blank, the Receipt Date is used: `case_version__v.receipt_date__v` * Otherwise, the New Info Date is used: `case_version__v.new_info_date__v` If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed. ##### Case Lifecycle State in Aggregate States to Include The latest Case version within the reporting period must be in a state specified in the States to Include field on the PBRER. `case_version__v.state__v CONTAINS pbrer__v.states_to_include__v` Note the following considerations: * Cases in the following states are omitted: * Nullified (`nullified_state__v`) * Voided (`voided_state__v`)

Note: You cannot select these states in the States to Include field. These states are always omitted.

Number Name Description

Spontaneous, including regulatory authority and literature

Cases are listed in this category when the Case Report Type is set to one of the following:

Spontaneous
Literature (Spontaneous)
Other
Not Available

case_version__v.report_type__v = 1, 3, 4 
{Spontaneous | Literature (Spontaneous) | Other | Not available}

Non-interventional

Cases are listed in this category when they match one of the following scenarios:

Scenario	Report Type	Study Type	Causality Established
1	Study Literature (Study) A custom Report Type with an E2B Code of `2`	Individual Patient Use Other Study A custom Study Type where the E2B Code is not set to `1` (Clinical Trial)	Yes Blank
2	Literature (Study) A custom Report Type with both of the following: The E2B Code field set to `2` The Literature field set to Yes	Blank A custom Study Type without a valid E2B Code	Yes 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)
AND case_assessment__v.case_assessment_result__v.causality_established__v = Yes OR Blank
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)
                
AND case_assessment__v.case_assessment_result__v.causality_established__v = Yes OR Blank

Serious Number of adverse events with a value entered in the Case Adverse Event Seriousness field. case_adverse_event__v.seriousness__v ≠ EMPTY

Non-Serious Number of adverse events with an empty Case Adverse Event Seriousness field. case_adverse_event__v.serious__v = EMPTY

SOC The MedDRA System Organ Class (SOC) for the adverse event.
event_meddra__v.soc_term__v

Preferred Term

The MedDRA Preferred Term (PT) for each adverse event, grouped by the MedDRA SOC.
case_adverse_event__v.event_meddra__v.pt_term__v

The report counts Cases depending on category:

Spontaneous: Case Adverse Events do not need an associated Case Assessment to be listed in this report.
Non-interventional: Case Adverse Events must have an associated Case Assessment to be listed in this report.

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.

Interval

Number of adverse events with a Case date within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

DATE ≥ pbrer__v.data_period_start__v AND

            DATE ≤ pbrer__v.data_period_end__v

where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__v.filter_cases_by__v) field:

When Approval Date: case_version__v.approval_date__v
When blank or Receipt Date / New Info Date (Default):
1. If the Case New Info Date is blank, the Receipt Date is used: case_version__v.receipt_date__v
2. Otherwise, the New Info Date is used: case_version__v.new_info_date__v

Cumulative

Number of adverse events with a Case date within the aggregate report cumulative reporting period (up to the Data Period End). How Aggregate Reports Filter by Data Period provides more information.

DATE ≤ pbrer__v.data_period_end__v

where DATE depends on the option selected in the PBRER Filter Cases By (pbrer__v.filter_cases_by__v) field:

When Approval Date: case_version__v.approval_date__v
When blank or Receipt Date / New Info Date (Default):
1. If the Case New Info Date is blank, the Receipt Date is used: case_version__v.receipt_date__v
2. Otherwise, the New Info Date is used: case_version__v.new_info_date__v

Total Spontaneous The total number of all adverse events within the "Spontaneous, including regulatory authority and literature" category, including both serious and non-serious, within the cumulative reporting period.

Total The total number of adverse events for each category within the reporting period.

If the **DSUR and PBRER Summary Totals and Separate Log Files** feature is enabled in your Vault, the Cases in the report are listed in a separate log file once the system generates the report. If the **DSUR and PBRER Summary Totals and Separate Log Files** feature is not enabled in your Vault, the Cases in the report are listed in a separate table as part of the report:

### Cumulative Tabulation of Serious Adverse Events From Clinical Trials Vault generates the Cumulative Tabulation of Serious Adverse Events From Clinical Trials by default for PBRER Aggregate Reports.

#### Table Constraints For Vault to consider a _Case_ for the report, the _Case_ (created from an _Inbox Item_ or imported _Case_) must have a _Case Product_ set to _Primary_. Vault filters _Cases_ to include in the Cumulative Tabulation of Serious Adverse Events From Clinical Trials 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` ##### Case Report and Study Type To filter study cases, the system looks at the Case **Report Type** and **Study Type** fields. A Case is included when it matches one of the following scenarios:

Scenario	Report Type	Study Type
1	Study A custom Report Type with an E2B Code of `2`	Clinical Trial A custom Study Type with an E2B Code of `1`
1	`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`
2	Study A custom Report Type with: The E2B Code field set to `2` The Literature field set to No or Blank	Blank A custom Study Type without a valid E2B Code
2	`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`

##### Case Lifecycle State in Aggregate States to Include The latest Case version within the reporting period must be in a state specified in the States to Include field on the PBRER. `case_version__v.state__v CONTAINS pbrer__v.states_to_include__v` Note the following considerations: * Cases in the following states are omitted: * Nullified (`nullified_state__v`) * Voided (`voided_state__v`)

Note: You cannot select these states in the States to Include field. These states are always omitted.

* If the Case is in a Lifecycle State assigned a State Type of "Deleted", the Case is omitted. * When evaluating the **States to Include** field, the system evaluates Cases in the Superseded (`superseded_state__v`) state as Closed (`closed_state__v`). ##### Case Data in Cumulative Reporting Period The date must be within the aggregate report cumulative reporting period (Product IBD to Data Period End). How Aggregate Reports Filter by Data Period provides more information. DATE ≤ pbrer__v.data_period_end__v where _DATE_ depends on the option selected in the PBRER **Filter Cases By** (`pbrer__v.filter_cases_by__v`) field: * When **Approval Date**: `case_version__v.approval_date__v` * When blank or **Receipt Date / New Info Date** (Default): * If the Case New Info Date (`new_info_date__v`) is blank, the Receipt Date is used: `case_version__v.receipt_date__v` * Otherwise, the New Info Date is used: `case_version__v.new_info_date__v` If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed. ##### Serious Case Adverse Event The _Seriousness_ field on the _Case_ contains a value (is not blank). `case_version__v.seriousness__v ≠ BLANK` If your Admin has enabled DSUR and PBRER Investigational Product Causality: * The _Study Product_ must be blinded or have a _Study Product Role_ of _Investigational_, _Placebo_, or _Active Comparator_. * Vault considers the causality of investigational products when determining the appropriate column for case counting in the Serious Adverse Events (SAE) tabulation. ##### Study Member of Reporting Family The **Study** field links to a Study record that meets any of the following criteria: * A member of the Reporting Family

case_version__v.study__v CONTAINS

  reporting_family__v.reporting_family_member__v.study__v

* Contains a Product that matches a Product Reporting Family Member

case_version__v.product__v CONTAINS

  reporting_family__v.reporting_family_member__v.product__v

* Contains a Blinded Study Product that matches a Product Reporting Family Member

case_version__v.study__v CONTAINS

  reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v WHERE (case.blinded = Yes OR study.blinded = YES)

Note: To ensure Blind Protection, unblinded Cases are counted as blinded until End of Study Reconciliation unblinding is complete for each Case.

##### Unmasked Documents If the Reporting Family includes only Products (no Studies), the report excludes Cases for which the Study's Product is not in the Reporting Family. #### Table Mapping The following table outlines how Vault maps data to populate the Cumulative Tabulation of Serious Adverse Events From Clinical Trials:

Number	Name	Description
	SOC	The MedDRA System Organ Class (SOC) for the adverse event. `case_adverse_event__v.event_meddra__v.soc_term__v`
	Preferred Term	The MedDRA Preferred Term (PT) for each 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.
	Investigational Medicinal Product	The total number of adverse events with suspect investigational products. `COUNT IF case_version__v.case_product__v.primary__v == Yes¹ AND case_product__v.study_product__v ≠ Blank AND case_product__v.study_product__v.study_product_role__v == lead_agent__v (Investigational) AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v`
	Blinded	The total number of adverse events with suspect blinded products. `COUNT IF case_version__v.case_product__v.primary__v == Yes¹ AND case_version__v.case_product__v.study_product__v == Blank AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v`
	Active Comparator	The total number of adverse events with suspect active comparators. `COUNT IF case_version__v.case_product__v.primary__v == Yes¹ AND case_product__v.study_product__v ≠ Blank AND case_product__v.study_product__v.study_product_role__v == active_comparator__v AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v`
	Placebo	The total number of adverse events with suspect placebos. `COUNT IF case_version__v.case_product__v.primary__v == Yes¹ AND case_product__v.study_product__v ≠ Blank AND case_product__v.study_product__v.study_product_role__v == placebo__v AND case_product__v.drug_role__v CONTAINS pbrer__v.drug_roles_to_include__v`
	Total	The sum of the Investigational Medicinal Product, Blinded, Active Comparator, and Placebo SAE occurrences for each SOC and Preferred Term.
	Total	The total number of SAE occurrences for each of the Investigational Medicinal Product, Blinded, Active Comparator, and Placebo categories.
1. If the DSUR and PBRER Investigational Product Causality feature is enabled in your Vault, `case_version__v.case_product__v.primary__v == Yes` is omitted.

The Investigational Medicinal Products (IMP) Breakdown table contains a breakdown of the _Products_ that appear in the Investigational Medicinal Products column in the main table.

Investigational Medicinal Products Breakdown

The IMP Breakdown table considers only _Cases_ that contain Investigational Product roles and _Products_ that are in the _Reporting Family_. The IMP Breakdown table contains a column for each combination of _Products_ that appear in the _Cases_ included on the main report. Up to a maximum of ten (10) combinations are supported. The sum of these totals corresponds with the total _Adverse Event_ count for the Investigational Medicinal Product on the main report. The Active Comparator Breakdown table contains a breakdown of the adverse events with active comparators that appear in the [Active Comparator][5] column in the main table.

The Active Comparator Breakdown table contains a column for each combination of active comparators that appear in the _Cases_ on the main report. The sum of these totals corresponds with the total _Adverse Event_ count for the Active Comparator on the main report. ### Interval Line Listings of Serious Adverse Reactions By default, Vault generates the Interval Line Listings of Serious Adverse Reactions (from Clinical Trials) for PBRERs.

#### Table Constraints Vault filters Cases to include in the Interval Line Listings of Serious Adverse Reactions 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` ##### Study Member of Reporting Family The **Study** field links to a Study record that meets any of the following criteria: * A member of the Reporting Family

case_version__v.study__v CONTAINS

  reporting_family__v.reporting_family_member__v.study__v

* Contains a Product that matches a Product Reporting Family Member

case_version__v.product__v CONTAINS

  reporting_family__v.reporting_family_member__v.product__v

* Contains a Blinded Study Product that matches a Product Reporting Family Member

case_version__v.study__v CONTAINS

  reporting_family__v.reporting_family_member__v.products__v.study_product__v.study__v WHERE (case.blinded = Yes OR study.blinded = YES)

##### Unmasked Documents If the Reporting Family includes only Products (no Studies), the report excludes Cases for which the Study's Product is not in the Reporting Family. ##### Case Report and Study Type To filter study cases, the system looks at the Case **Report Type** and **Study Type** fields. A Case is included when it matches one of the following scenarios:

Scenario	Report Type	Study Type
1	Study A custom Report Type with an E2B Code of `2`	Clinical Trial A custom Study Type with an E2B Code of `1`
1	`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`
2	Study A custom Report Type with: The E2B Code field set to `2` The Literature field set to No or Blank	Blank A custom Study Type without a valid E2B Code
2	`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`

##### Case Date in Interval Reporting Period The date must be within the aggregate report interval reporting period (Data Period Start to Data Period End). How Aggregate Reports Filter by Data Period provides more information.

DATE ≥ pbrer__v.data_period_start__v AND

DATE ≤ pbrer__v.data_period_end__v

where _DATE_ depends on the option selected in the PBRER **Filter Cases By** (`pbrer__v.filter_cases_by__v`) field: * When **Approval Date**: `case_version__v.approval_date__v` * When blank or **Receipt Date / New Info Date** (Default): * If the Case New Info Date (`new_info_date__v`) is blank, the Receipt Date is used: `case_version__v.receipt_date__v` * Otherwise, the New Info Date is used: `case_version__v.new_info_date__v` If there are multiple versions of the Case within the reporting period, only the most recent Case version within the reporting period is listed. ##### Serious Case Adverse Event The _Seriousness_ field on the _Case_ contains a value (is not blank). `case_version__v.seriousness__v ≠ BLANK` If your Admin has enabled DSUR and PBRER Investigational Product Causality, the report considers only _Case Adverse Events_ where the _Causality Established_ field on the _Case Assessment Result_ is set to either _Yes_ or blank (unknown) for any _Study Product_ on the _Case_. The _Study Product_ must be blinded or have a _Study Product Role_ of _Investigational_, _Placebo_, and _Active Comparator_. ##### Causality Established is Yes or Blank on Any Case Assessment The _Causality Established_ field must be either _Yes_ or blank (unknown) on any _Case Assessment Result_ to consider the _Case_. `case_assessment_result.causality_established = (Yes OR Blank)` Vault excludes _Cases_ from this report if all serious _Case Adverse Events_ are assessed as unrelated. That is, if all serious _Case Adverse Events_ are linked with at least two (2) _Case Assessment Results_ with the _Causality Established_ field set to _No_, where: * One (1) _Case Assessment Result_ is for the company (Sponsor or MAH). That is, the _Source Type_ maps to E2B Code `2` or `4`. * One (1) other _Case Assessment Result_ where the _Source Type_ does not map to E2B Code `2` or `4`. If your Admin has enabled DSUR and PBRER Investigational Product Causality, the report considers only _Cases_ where the _Study Product_ is blinded or has a _Study Product Role_ of _Investigational_, _Placebo_, or _Active Comparator_. ##### Case Lifecycle State in Aggregate States to Include The latest Case version within the reporting period must be in a state specified in the States to Include field on the PBRER. `case_version__v.state__v CONTAINS pbrer__v.states_to_include__v` Note the following considerations: * Cases in the following states are omitted: * Nullified (`nullified_state__v`) * Voided (`voided_state__v`)

Note: You cannot select these states in the States to Include field. These states are always omitted.

Number	Name	Description
	SOC & Case Total	The MedDRA System Organ Class (SOC) for the adverse event. `case_adverse_event__v.event_meddra__v.soc_term__v` The total number of unique Cases listed under the SOC for the Trial is shown in parentheses.
	Trial Number [EudraCT#]	For studies registered to a country in the European Union, values are mapped from the following fields: Trial Number: Case > Study Number `case_version__v.study_number__v` EudraCT#: Case Study Registration > Registration Number `case_study_registration__v.registration_number_value where country_value__v.agency__v = EMA`
	Case ID/ Subject #	Values from the following fields: Case ID: Case > UID `case_version__v.uid__v` Subject ID: Vault first attempts to map a value from the Case > MRN - Investigation field, but if this field is blank then the value is mapped from the Case > Patient Initials field. `IF case_version__v.mrn_investigation_value__v = Blank SHOW case_version__v.patient_id_value__v ELSE SHOW case_version__v.mrn_investigation_value__v`
	Country, Gender, Age	Values from the following fields: Country: Case > Event Country `case_version__v.event_country__v.name__v` Sex: Case > Patient Sex `case_version__v.gender_value__v.name__v` Age: Case > Age and Age (unit) Vault 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)`
	Serious ADR(s)	The MedDRA Preferred Term for the serious adverse event. `case_adverse_event__v.event_meddra__v.pt_term__v where seriousness__v != null` The primary adverse event is listed first.
	Outcome	The value selected in the Case Adverse Event Outcome field. If there are multiple Case Adverse Event records on a Case, Vault populates the most serious outcome, per E2B guidelines. `case_adverse_event__v.event_outcomes__v.name__v where seriousness__v != null`
	Date of Onset, Time to Onset	Values are mapped for the primary Case Adverse Event as follows: Date of Onset: Case Adverse Event > Onset in the format (DD-MMM-YYYY) `case_adverse_event__v.onset_date__v where primary__v = Yes` Time to Onset: Case Assessment > First Dose Latency (number) and First Dose Latency (unit) `case_assessment__v.first_dose_interval_number__v case_assessment__v.first_dose_interval_unit__v where case_assessment_v.case_product__v.primary__v = Yes AND case_assessment_v.case_adverse_event__v.primary__v = Yes`
	Suspect Drug	The name of the primary Case Product. While the product is blinded, the value is Blinded. If the product is unblinded, the unblinded version of the Interval Line Listings displays the name of the primary Case Product. On the blinded version of the Interval Line Listings, the value remains Blinded. First row (Primary Case Product): `IF [case_version__v.case_product__v.primary__v = Yes AND case_version__v.case_product__v. product_type__v = Study Product AND case_version__v.case_product__v.study_product__v = Blank] THEN "Blinded" ELSE case_version__v.case_product__v.product_name__v where primary__v = Yes` Subsequent rows (non-Primary Case Products): `IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND case_version__v.case_product__v.study_product__v = Blank] THEN "Blinded" ELSE case_version__v.case_product__v.product_name__v where primary__v != Yes`
	Daily Dose, Route, Formulation	If the primary Case Product is blinded, the value is Blinded. First row (Primary Case Product): `IF (case_product__v.primary__v = Yes) AND case_version__v.case_product__v. product_type__v = Study Product AND (case_version__v.case_product__v.study_product__v = Blank) THEN "Blinded"` Subsequent rows (non-Primary Case Products): `IF [case_version__v.case_product__v.primary__v != Yes AND case_version__v.case_product__v. product_type__v = Study Product AND case_version__v.case_product__v.study_product__v = Blank] THEN "Blinded"` If the primary Case Product is not blinded, values are mapped from the primary Case Product > Case Product Dosage as follows: Daily Dose: Values are mapped from the following fields: Dose (number) and Dose (unit) `case_product__v.case_product_dosage__v.dose_number__v AND dose_unit__v` Frequency (number) and Frequency (unit) `case_product__v.case_product_dosage__v.frequency_number__v AND frequency_unit__v` Route: Patient RoA Text `case_product__v.case_product_dosage__v.patient_adminroute_text__v` Formulation: Dose Form Text `case_product__v.case_product_dosage__v.dose_form_text__v` If there are multiple Dosages under the primary Case Product, values from each Dosage record are displayed in a line-separated list.
	Dates of Treatment, Treatment Duration	Values are mapped from the primary Case Product > Case Product Dosage object as follows: Dates of Treatment: First Administration to Last Administration in the format (DD-MMM-YYYY) `(case_product__v.case_product_dosage__v.firstadmin_idate__v) to (case_product__v.case_product_dosage__v.lastadmin_idate__v)` Treatment Duration: Duration (number) and Duration (unit) `(case_product__v.case_product_dosage__v.duration_number__v) (case_product__v.case_product_dosage__v.duration_unit__v)`
	Comments	Values from the following fields: Any text entered in the Case Reporting Summary field. `case_version__v.reporting_summary__v` Any Case Assessment Result Source Type and Assessment Result for the combination of Suspect Drug(s) and Serious ADR(s) listed in the report, with the fields mapped as follows: When the Source Type and the Assessment Result (Override) fields are populated: `case_assessment__v.case_assessment_result__v.source_type__v: case_assessment__v.case_assessment_result__v.assessment_result_override__v` Example: "Sponsor: Not Applicable" When the Assessment Result (Override) field is not populated and the Source Type and the Assessment Result fields are populated: `case_assessment__v.case_assessment_result__v.source_type__v: case_assessment__v.case_assessment_result__v.assessment_result__v` Example: "Sponsor: Related" When the Source Type field is not populated: `[Blank]: case_assessment__v.case_assessment_result__v.assessment_result_override__v` or `[Blank]: case_assessment__v.case_assessment_result__v.assessment_result__v` Example: "[Blank]: Related" Assessment Results are listed in the same row as the suspect drug.
	Trial Number & Case Total	The Trial Number only (excluding the EudraCT#). See row for details. For reports that include multiple trials, this row organizes data under each trial included in the line listings. The total number of distinct Cases listed under the Trial in the report is shown in parentheses.
	Total	The total number of distinct Cases across all Trials in the report.

[1]: #cumulative-tabulation-serious-ae [2]: #interval-line-listings-serious-ar [3]: #cumulative-adrs [4]: #create-pbrer [5]: #active-comparator-sae