**Source URL:** https://safety.veevavault.help/en/lr/1125424/ # Workbench Pregnancy Annex 3 Reports Derived Fields The [Workbench Pregnancy Annex 3 Reports](/en/lr/1074914/) use information derived from various fields in Vault. The following sections describe how Vault derives each of these fields. * [_Pregnancy Case_][41] * [_Pregnancy Type (Product Level)_][42] * [_Pregnancy Type (Case Level)_][43] * [_Maternal / Paternal Exposure (Product Level)_][44] * [_Pre-Term Birth Reported_][45] * [_Small for Gestational Age Reported_][46] * [_Low Birth Weight Reported_][48] * [_Exposure (Annex 3)_][411] * [_Pregnancy Outcome (Annex 3)_][412] ## Pregnancy Case {#pregnancy-case} Vault uses the following logic to evaluate _Pregnancy Case_ (`is_pregnancy_case`): If one or more of the following conditions evaluates as TRUE, then `is_pregnancy_case` = TRUE, else `is_pregnancy_case` = FALSE: 1. One or more _Case Adverse Events_ is coded with one of the following MedDRA PT codes: * 10052846 (_Abortion early_) * 10000220 (_Abortion induced_) * 10052847 (_Abortion late_) * 10000230 (_Abortion missed_) * 10000234 (_Abortion spontaneous_) * 10000242 (_Abortion threatened_) * 10014166 (_Ectopic pregnancy_) * 10073513 (_Exposure during pregnancy_) * 10071416 (_Foetal exposure via father_) * 10073300 (_Exposure via body fluid_) * 10055690 (_Foetal death_) * 10071404 (_Foetal exposure during pregnancy_) * 10071406 (_Maternal exposure before pregnancy_) * 10071408 (_Maternal exposure during pregnancy_) * 10071415 (_Maternal exposure timing unspecified_) * 10050353 (_Miscarriage of partner_) * 10028243 (_Multiple pregnancy_) * 10080093 (_Paternal exposure before pregnancy_) * 10080091 (_Paternal exposure during pregnancy_) * 10080092 (_Paternal exposure timing unspecified_) * 10036556 (_Pregnancy_) * 10050192 (_Pregnancy of partner_) * 10067667 (_Pregnancy on contraceptive_) * 10036567 (_Pregnancy on oral contraceptive_) * 10036578 (_Pregnancy test urine positive_) * 10063130 (_Pregnancy with contraceptive device_) * 10053394 (_Pregnancy with injectable contraceptive_) * 10036590 (_Premature baby_) * 10036595 (_Premature delivery_) * 10036600 (_Premature labour_) * 10042062 (_Stillbirth_) * 10045188 (_Twin pregnancy_) * 10045542 (_Unintended pregnancy_) 2. At least `case_product__v > additional_information_coded__v` = `drug_taken_by_the_father__v` AND the _Product/Study_ is in the _Aggregate Reporting Group_ AND its _Drug Role_ is _Suspect_, _Interacting_, or _Drug not Administered_ 3. The `case_version__v.special_situation__v` includes at least one of the following: * `paternal_exposure__v` * `pregnancy__v` * `maternal_exposure__v` * `breast_feeding__v` 4. The `case_version__vr.pregnancy_case__v` = Yes 5. The `case_version__vr.pregnant_at_vaccination__v` = yes 6. The `case_version__vr.fetal_infant_status__v` is not Blank 7. The `case_version__vr.pregnancy_outcome__v` is not null 8. The `sponsor_pregnancy_awareness__v` is not null 9. The `case_version__v > age_group__v > controlled_vocabulary__v > E2B_code` = 0 "Foetus" 10. The `case_product__vr.case_product_dosage__vr.patient_adminroute__vr.route_of_administration__vr. E2B code` = 064 (_Route of Administration = Transplacental_) AND the _Product/Study_ is in the _Aggregate Reporting Group_ AND its _Drug Role_ is _Suspect_, _Interacting_, or _Drug not Administered_ 11. The `case_product__vr.timing_of_exposure_in_pregnancy__v` is not `no_exposure__v` AND is not blank AND the _Product/Study_ is in the _Aggregate Reporting Group_ AND its _Drug Role_ is _Suspect_, _Interacting_, or _Drug not Administered_ ## Pregnancy Type (Product Level) {#pregnancy-type-product} Vault uses the following logic to evaluate _Pregnancy Type (Product Level)_ (`pregnancy_type_product_level`):
Condition Pregnancy Type (Product Level)
At least one Event _PT Code_ = 10050192 (_Pregnancy of partner_) _Father Case_
All of the following four conditions apply: 1. (`case_product__v > additional_information_coded__v` = `drug_taken_by_the_father__v` AND the _Product_ is in the _Aggregate Reporting Group_ AND its _Drug Role_ is _Suspect_) OR `case_version__v > special_situation__v` = `paternal_exposure__v` 2. One of the following two conditions apply: 1. Event _PT Code_ is one of the following: * 10080091 (_Paternal exposure during pregnancy_) * 10080093 (_Paternal exposure before pregnancy_) * 10080092 (_Paternal exposure timing unspecified_) * 10071416 (_Exposure via father_) 2. _LLT Code_ is one of the following: * 10044438 (_Transmission of drug via semen_) * 10050353 (_Miscarriage of partner_) 3. `case_version__v > gender_value__v > Controlled vocabulary > E2B_code` = 2 (_Female_) 4. `case_version__v > pregnancy_case__v` = _Yes_ OR `case_version__v > pregnant_at_vaccination__v` = _Yes_ _Mother Case / Partner Pregnancy_
All of the following five conditions apply: 1. (`case_product__v > additional_information__v` = _Drug taken by the Father_ AND the _Product_ is in the _Aggregate Reporting Group_ AND its _Drug Role_ is _Suspect_) OR `case_version__v > special_situation__v` = `paternal_exposure__v` 2. One of the following two conditions apply: 1. Event _PT Code_ is one of the following: * 10080091 (_Paternal exposure during pregnancy_) * 10080093 (_Paternal exposure before pregnancy_) * 10080092 (_Paternal exposure timing unspecified_) * 10071416 (_Exposure via father_) 2. _LLT Code_ is one of the following: * 10044438 (_Transmission of drug via semen_) * 10050353 (_Miscarriage of partner_) 3. `case_version__vr.parental_info__vr.gender_value__vr > Controlled vocabulary > E2B_code` = 2 (_Female_) 4. `case_version__v > pregnancy_case__v` is not _Yes_ 5. `case_version__v > pregnant_at_vaccination__v` is not _Yes_ _Baby Case / Partner Pregnancy_
At least one of the following four conditions apply: 1. `case_version__vr.parental_info__vr.gender_value__vr > Controlled vocabulary > E2B_code` = 2 (_Female_) AND `case_version__v > pregnancy_case__v` is not _Yes_ AND `case_version__v > pregnant_at_vaccination__v` is not _Yes_ 2. `case_version__v > age_group__v > controlled_vocabulary__v > E2B_code` = 0 (_Foetus_) 3. Any of the events of the case has the following _LLT Codes_: * 10013695 (_Drug exposure in utero_) * 10071421 (_Fetal exposure during pregnancy_) * 10071423 (_Fetal exposure during pregnancy, first trimester_) * 10071425 (_Fetal exposure during pregnancy, second trimester_) * 10071427 (_Fetal exposure during pregnancy, third trimester_) * 10071404 (_Foetal exposure during pregnancy_) * 10071422 (_Foetal exposure during pregnancy, first trimester_) * 10071424 (_Foetal exposure during pregnancy, second trimester_) * 10071426 (_Foetal exposure during pregnancy, third trimester_) 4. Any of the events of the _Case_ is coded to a _PT Code_ within SMQ Code = 20000191 (_Broad 'Neonatal disorders' SMQ_) _Baby Case_
None of the above conditions apply and any of the following three conditions apply: 1. `case_version__v > gender_value__v > Controlled vocabulary > E2B_code` = 2 (_Female_) AND (`case_version__v > pregnancy_case__v` = _Yes_ OR `case_version__v > pregnant_at_vaccination__v` = _Yes_) 2. Any of the events of the _Case_ has the following _LLT Codes_: * 10049193 (_Drug exposure during pregnancy_) * 10071408 (_Maternal exposure during pregnancy_) * 10036556 (_Pregnancy_) * 10079877 (_Maternal cancer in pregnancy_) 3. Any of the events of the _Case_ has the following PT codes: * 10000234 (_Abortion spontaneous_) * 10000220 (_Abortion induced_) _Mother Case_
None of the above conditions apply and either of the following conditions apply: 1. `case_product__v > additional_information_coded__v` = `drug_taken_by_the_father__v` AND the _Product_ is in the _Aggregate Reporting Group_ AND its _Drug Role_ is _Suspect_ 2. `case_version__v > special_situation__v` = `paternal_exposure__v` _Partner Pregnancy_
None of the above conditions apply. _Unknown_
## Pregnancy Type (Case Level) {#pregnancy-type-case} If a _Case_ has multiple _Products_ resulting in multiple values of _Pregnancy Type (Product Level)_, then Vault concatenates all distinct values, separated by a double pipe (\|\|). ## Maternal / Paternal Exposure {#mat-pat-exp-product} Vault uses the following logic to evaluate _Maternal / Paternal Exposure (Product Level)_ (`maternal_paternal_exposure_product`): IF pregnancy_type_product_level_product is one of the following:
mother_case
baby_case
THEN Maternal
ELSEIF pregnancy_type_product_level_product is one of the following:
mother_case_partner_pregnancy
baby_case_partner_pregnancy
partner_pregnancy
THEN Paternal
ELSE Unknown ## Pre-Term Birth Reported {#pre-term-birth-rpt} Vault uses the following logic to evaluate _Pre-Term Birth Reported_ (`pre_term_birth_reported`): IF at least one Event PT Code is one of the following:
(10036590 Premature baby,
10076700 Premature baby death,
10036595 Premature delivery)
OR (If gestation_age_at_outcome_normalized__v IS NOT Null
AND gestation_age_at_outcome_normalized__v <= 259) → 37 weeks or less
THEN "Yes"
ELSEIF (If gestation_age_at_outcome_normalized__v IS NOT Null
AND gestation_age_at_outcome_normalized__v > 259) → more than 37 weeks
THEN "No"
ELSE "Unknown" ## Small for Gestational Age Reported {#small-for-gest-age-rpt} Vault uses the following logic to evaluate _Small for Gestational Age Reported_ (`small_for_gestational_age_reported`): IF at least one Event PT Code is one of the following:
10041092 Small for dates baby
OR at least one 'Event LLT' is one of the following:
10070531 Foetal growth restriction
10070532 Fetal growth restriction
10048489 Intrauterine growth retard
10022819 Intrauterine growth retardation
10048488 Growth intrauterine retard
THEN TRUE
ELSE FALSE ## Low Birth Weight Reported {#low-birth-weight-rpt} Vault uses the following logic to evaluate _Low Birth Weight Reported_ (`low_birth_weight_reported`): IF Pregnancy Type (Case Level) is one of the following:
(Baby Case,
Baby Case / Partner Pregnancy)
AND ((weight_normalized_kg__v is greater than 0 and less than 2.5)
OR (case contains PT code = 10067508 "Low birth weight baby")) THEN Yes
ELSE No ## Exposure (Annex 3) {#exposure-annex-3} Vault uses the following logic to evaluate _Exposure (Annex 3)_ (`exposure_annex_3`) depending on whether the _Case_ is _Maternal Exposure_ or _Paternal Exposure_: |Annex 3 Exposure Category|Value(s) on Case (Multi-select picklist)|Maternal Exposure Priority / Rank|Paternal Exposure Priority / Rank| |-|-|-|-| |During all pregnancy|During all pregnancy OR (1st, 2nd AND 3rd)|1|2| |1st Trimester|First Trimester|2|3| |After 1st Trimester|Second Trimester OR Third Trimester|3|4| |Before Conception|Before Conception|4|1| |Unknown|Exposure with unknown trimester OR Unknown Exposure OR Blank|5|5| |No Exposure|No Exposure|6|6| ## Pregnancy Outcome (Annex 3) {#pregnancy-outcome-annex-3} Vault considers the following _Case_ fields to determine the _Pregnancy Outcome (Annex 3)_ (`pregnancy_outcome_annex_3`) derived field as shown in the table below: 1. _Pregnancy Outcome / Fetal Outcome_ 2. _Fetal Defect_ (from the _Child Information_ record) 3. _Congenital Anomaly Reported_ (for the logic used, see the [Pregnancy Event Line Listing](/en/lr/1074914/#congenital-anomaly-event)) |Pregnancy Outcome / Fetal Outcome|Fetal Defect|Congenital Anomaly Reported|Result: Pregnancy Outcome (Annex 3)| |-|-|-|-| |Ectopic Pregnancy|n/a|n/a|Ectopic pregnancy| |Miscarriage|n/a|n/a|Spontaneous abortion| |Elective termination|_Yes_|n/a|Elective termination (foetal defects)| |Elective termination|Is not _Yes_ (e.g. _No_, _Unknown_, blank, or no record)|n/a|Elective termination (no foetal defects or unknown)| |Medically Indicated Abortion|_Yes_|n/a|Elective termination (foetal defects)| |Medically Indicated Abortion|Is not _Yes_ (e.g. _No_, _Unknown_, blank, or no record)|n/a|Elective termination (no foetal defects or unknown)| |Fetal death / stillborn|_Yes_|n/a|Stillbirth with foetal defects| |Fetal death / stillborn|Is not _Yes_ (e.g. _No_, _Unknown_, blank, or no record)|n/a|Stillbirth without foetal defects| |Live born|n/a|_Yes_|Live birth with congenital anomaly| |Live born|n/a|Is not _Yes_ (e.g. _No_, _Unknown_, _Not reported_, or blank)|Live birth without congenital anomaly| |Termination for a fetal anomaly|_Yes_|n/a|Elective termination (foetal defects)| |Termination for a fetal anomaly|Is not _Yes_ (e.g. _No_, _Unknown_, blank, or no record)|n/a|Elective termination (no foetal defects or unknown)| |Unknown|n/a|n/a|Unknown| |Pregnancy Ongoing|n/a|n/a|Unknown| |Ignore|n/a|n/a|Dropped from tabulation| [41]: #pregnancy-case [42]: #pregnancy-type-product [43]: #pregnancy-type-case [44]: #mat-pat-exp-product [45]: #pre-term-birth-rpt [46]: #small-for-gest-age-rpt [48]: #low-birth-weight-rpt [411]: #exposure-annex-3 [412]: #pregnancy-outcome-annex-3