Workbench Pregnancy Annex 3 Reports Derived Fields

The Workbench Pregnancy Annex 3 Reports use information derived from various fields in Vault. The following sections describe how Vault derives each of these fields.

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)

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)

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

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

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

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

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)

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)

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)
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