Create Workbench PADER Aggregate Reports

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

• Spontaneous
• Literature (Spontaneous)
• Other
• Not Available
• A custom Report Type with an E2B code of 1, 3, 4, or null (blank)
  case_version_v.report_type__v.controlled_vocabulary__v.e2b_code__v ≠ 2

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

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

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

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

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

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

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

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

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

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

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

• Non Serious: The Case Adverse Event > Seriousness field is blank.
  case_adverse_event__v.seriousness__v = EMPTY
• Unlabeled: Vault looks for an Expected value of No in the following priority order:
  1. Case Assessment Expectedness where the Country is set to United States or another country in the FDA's jurisdiction
  2. The Expectedness field on the primary Case Assessment
  3. The Case Expectedness field
  (case_assessment__v.case_assessment_expectedness__v.expected__v = No
AND
case_assessment_expectedness__v.country__v.agency__v = fda__v)
ELSE
(case_assessment__v.expectedness__v = No
WHERE
case_assessment__v.rank__v = 1)
ELSE
(case_version__v.expected__v = No)

Primary adverse events that meet the following criteria:

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

Primary adverse events that meet the following criteria:

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

Primary adverse events that meet the following criteria:

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

Primary adverse events that meet the following criteria:

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

Whether the Case was expedited.

Vault sets the value to Exp (expedited) if one (1) or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

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

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

Vault sets the value to Initial if at least one (1) eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is set to I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault sets the value to Follow-up.

Whether the Case is domestic or foreign.

Vault sets the value to Domestic if the primary adverse event's Event Country field is set to a Country where the Agency field is set to FDA.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault sets the value to Foreign if the primary adverse event's Event Country field is set to a Country where the Agency field is not set to FDA.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

Whether the Case is serious or non-serious.

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

Otherwise, Vault sets the value to NS (non-serious).

Whether the Case is listed or unlisted.

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

1. Case Assessment Expectedness where Country is set to United States, or another country in the FDA's jurisdiction
2. The Expectedness field on the primary Case Assessment
3. The Case Expectedness field

Otherwise, Vault sets the value to UL (unlisted).

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

Vault orders the adverse events by rank, blank values ranking last.

Vault maps this value from the New Info Date field on the Case. If the New Info Date is blank, Vault maps this value from the Case Receipt date.
IF not blank(case_version__v.new_info_idate__v)
ELSE
case_version__v.receipt_date__v

• The Transmission lifecycle state is either ACK Accepted or Completed.
  transmission__v.state__v = {E2B ACK Accepted | Completed}
• The Transmission Reason field is set to one (1) of the following:
  • Initial
  • Follow-up
  • Amendment
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
    transmission__v.transmission_reason__v = {I, F, OR 2}

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

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

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

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

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

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

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

Vault displays this column only if you choose the report version that includes nullified Cases.

Vault sets the value to Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v_state

Otherwise, Vault leaves this value blank.

• WWID: Case > Worldwide UID
  case_version__v.worldwide_uid__v
• UID: Case > UID
  case_version__v.uid__v

• The Transmission lifecycle state is either ACK Accepted or Completed.
  transmission__v.state__v = {E2B ACK Accepted | Completed}
• The Transmission Reason field is set to one (1) of the following:
  • Initial
  • Follow-up
  • Amendment
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
    transmission__v.transmission_reason__v = {I, F, OR 2}

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

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

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

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

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

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

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

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

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

Otherwise, Vault sets the value to Other Reportable Malfunction.

Whether the Case was expedited.

Vault sets the value to Exp (expedited) if one (1) or more FDA Transmissions within the reporting period have the Local Expedited Criteria field set to Yes or blank.
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

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

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

Vault sets the value to Initial if at least one (1) eligible Transmission for any Case version in the reporting period has a Transmission Reason where the E2B code is set to I (initial).
case_version__v.transmission__v.case_expedited__v = Yes OR Blank

Otherwise, Vault sets the value to Follow-up.

Whether the Case is domestic or foreign.

Vault sets the value to Domestic if the primary adverse event's Event Country field is set to a Country where the Agency field is set to FDA.
case_adverse_event__v.event_country__v.agency__v = fda__v

Vault sets the value to Foreign if the primary adverse event's Event Country field is set to a Country where the Agency field is not set to FDA.
case_adverse_event__v.event_country__v.agency__v ≠ fda__v

Whether the Case is serious or non-serious.

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

Otherwise, Vault sets the value to NS (non-serious).

Whether the Case is listed or unlisted.

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

1. Case Assessment Expectedness where Country is set to United States, or another country in the FDA's jurisdiction
2. The Expectedness field on the primary Case Assessment
3. The Case Expectedness field

Otherwise, Vault sets the value to UL (unlisted).

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

Vault orders the adverse events by rank, blank values ranking last.

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

Vault sets the value using the following logic:

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

Vault maps this value from the New Info Date field on the Case. If the New Info Date is blank, Vault maps this value from the Case Receipt date.
IF not blank(case_version__v.new_info_idate__v)
ELSE
case_version__v.receipt_date__v

• The Transmission lifecycle state is either ACK Accepted or Completed.
  transmission__v.state__v = {E2B ACK Accepted | Completed}
• The Transmission Reason field is set to one (1) of the following:
  • Initial
  • Follow-up
  • Amendment
  • A custom Transmission Reason Controlled Vocabulary where the E2B code is set to I (initial), F (follow-up) or 2 (amendment)
    transmission__v.transmission_reason__v = {I, F, OR 2}

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

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

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

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

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

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

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

Vault displays this column only if you choose the report version that includes nullified Cases.

Vault sets the value to Nullified or Voided if the Case is in the Nullified or Voided lifecycle state, respectively.
case_version__v_state

Otherwise, Vault leaves this value blank.

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

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

Otherwise, Vault sets the value to Other Reportable Malfunction.

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

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

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

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

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

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

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


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

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