Pre-defined Periodic Report Variables

Oracle Argus Dossier provides a number of pre-defined periodic report variables. When using these variables in your template scripts, be aware of the following:

  • The system only considers encoded events for SOC-based variables; it ignores all unencoded events.
  • For all variables that return a count, return a 0 when the result is NULL.
  • When a variable returns multiple values, those values are separated with a forward slash ( / ) character.
  • For all variables that return a frequency value, print the value with a % sign and round it to two (2) decimal places.
  • All SQL statements for pregnancy cases consider any populated neonate.

The following table lists and describes the pre-defined periodic report variables available for your use.

Variable Description

#REPORT_NUMBER

The Report Number entered in the report header configuration in the Subject Tab.

#TRADE_NAME

The Trade Name entered in the report header configuration.

By default, Oracle Argus Safety pre-populates the configured Trade Name for the ingredients.

You may change these defaults by editing the name.

#GENERIC_NAME

The ingredients that the report has been configured to run against.

#REPORT_START_DATE

The inclusion period start date for the report (Scheduling Tab).

#REPORT_END_DATE

The inclusion period end date for the report (Scheduling Tab).

#IBD

The earliest birth date for the product licenses included in the report.

If configured to do so, Oracle Argus Safety pre-populates this value.

This value can be changed if necessary.

#COUNTRY_IBD

The name of the country with the earliest license date based on the products in the report configuration.

#TOTAL_COUNTRIES_MARKET

The total number of countries where both of the following are true:

The selected products have a marketed license.

The selected products do not have a withdrawn date.

#TOTAL_CASES

The total number of adverse events being reported on. This value is based on the cases selected for the report.

#TOTAL_CASES_SERIOUS

The total number of serious cases included in the generated report.

A case is considered serious if any event in the case has a seriousness check box checked.

#TOTAL_CASES_NON_SERIOUS

The total number of non-serious cases included in the generated report.

A case is considered non-serious if all of the events do not have the Seriousness check box checked.

#TOTAL_CASES_SP

The total number of spontaneous cases included in the generated report.

A case is considered spontaneous when the Report Type is not marked as Include in Clinical Trial in List Maintenance.

#TOTAL_CASES_SP_LIT

The total number of spontaneous literature cases included in the generated report.

A case is considered spontaneous literature when both of the following are true:

The Report Type is not marked as Include in Clinical Trial

Include as Literature is checked in List Maintenance.

#TOTAL_CASES_SOC_PRIMARY("soc_name")

The total number of cases where the primary event has been encoded using the same System Organ Class as specified in soc_name.

#TOTAL_CASES_SOC("soc_name")

The total number of cases where any event has been encoded using the same System Organ Class as specified in soc_name.

#TOTAL_CASES_SOC_SERIOUS("soc_name")

The total number of serious cases where both of the following are true:

Any event has been encoded using the same System Organ Class as specified.

The same event is serious.

#TOTAL_CASES_SOC_NON_SERIOUS ("soc_name")

The total number of non-serious cases where both of the following are true:

Any event has been encoded using the same System Organ Class as specified.

The same event is non-serious.

#TOTAL_CASES_SOC_UNLISTED ("soc_name")

The total number of cases where both of the following are true:

The event assessment for the product is Unlisted.

Any event has been encoded with the specified System Organ Class.

#TOTAL_CASES_SOC_SERIOUS_UNLISTED ("soc_name")

The total numbers of cases where both of the following are true:

The event assessment for the product is Unlisted.

Any serious event has been encoded with the specified System Organ Class.

#LISTOFTERMS_SOC_SERIOUS_UNLISTED ("soc_name")

The Event name as coded for cases where both of the following are true:

The event assessment for the product is Unlisted.

Any serious event has been encoded with the specified System Organ Class.

Multiple Terms must be separated with a forward slash ( / ).

#SUBMISSION_DATE

The date the report is due. The system calculates this date based on the values in the Scheduling tab for the report configuration.

#SOC_NAME_TOP(x)

The System Organ Class with the highest count based on the cases within report and the specified level.

SOC term name with the xth highest occurrence in the case series. For example; #SOC_NAME_TOP(2) returns the name of the SOC with the second highest occurrence in the line listings.

If there is more than one SOC at this level, the application uses a forward slash ( / ) to separate them when it prints the report.

#SOC_COUNT_TOP(x)

The total count of the System Organ Class that has the highest count based on the cases within the PSUR Report and the level as specified.

SOC term count that has the xth highest occurrence in the case series. For example, #SOC_COUNT_TOP(2) returns the total number of occurrences for the SOC with the second highest occurrence in the line listings".

#SOC_FREQUENCY_TOP(x)

The frequency of occurrence (across all cases in the report) of the System Organ Class that has the xth highest count based on the cases in the report.

Frequency of occurrence of events in the SOC that has the xth highest occurrence. For example, #SOC_FREQUENCY_TOP(2) = #SOC_COUNT_TOP(2) / #TOTAL_CASES

#SOC_PT_NAME_TOP(x,y)

The PT term name with the yth highest occurrence in the xth highest SOC occurrence.

For example; #SOC_PT_NAME_TOP(2,3) returns the third most frequent Preferred Term name of the second most frequent SOC for the cases in the PSUR.

#SOC_PT_COUNT_TOP(x,y)

The number of occurrences of the PT name with the yth highest occurrence in the xth highest SOC occurrence.

For example; #SOC_PT_COUNT_TOP(2,3) returns the number of the third most frequent Preferred Term of the second most frequent SOC for the line listings.

#TOTAL_COUNTRIES_COUNT__REPORT

The total number of countries from the Country of Incidence field (in the Case Form) based on the cases in the report.

#TOTAL_CASES_COUNT_DRUGINTERACTIONS

The total number of cases where any product on the Case Form (Product tab) has Yes specified for Interactions

#TOTAL_CASES_COUNT_DRUGABUSE

The total number of cases where any product on the Case Form (Product Tab) has True specified for Abuse

#TOTAL_CASES_COUNT_PROSPECTPREGNANCY

The total number of cases where both of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective. (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_RETROPREGNANCY

The total number of cases where the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective. (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_PENDINGDELIVERY_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type Prospective.

The delivery date is greater than the current date. (Case Form | Patient Tab | Pregnancy Details).

If you do not enter a delivery date, the application ignores the case.

#TOTAL_CASES_COUNT_ELECTIVETERMINATIONS__PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The birth type is Elective Termination (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_SPONTANEOUSABORTIONS__PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The birth type is Spontaneous Abortions (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_SPONTANEOUSABORTIONS__PROSPECT

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant

The pregnancy type is Prospective

The birth type is Spontaneous Abortions and the pregnancy type is either Prospective or Retrospective.

Computed as:

('= #TOTAL_CASES_COUNT_SPONTANEOUSABORTIONS / (#TOTAL_CASES_PROSPECT_PREGNANCY+#TOTAL_CASES_RETRO_PREGNANCY)"

#TOTAL_CASES_COUNT_NORMALOUTCOME__PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The fetal outcome is Normal. (Case Form | Patient Tab | Pregnancy Details)

#TOTAL_CASES_COUNT_FOLLOWUPLOST_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The birth type is Lost to F/U (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_FOLLOWUPDONE_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The birth type is not Lost to F/U (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_ABNORMALOUTCOME_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type Prospective.

The fetal outcome is not Normal. (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_CAMAJOR_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The fetal outcome is CA Major (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_CAMAJOR_PROSPECT

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The fetal outcome is CA Major and is not Normal (Case Form | Patient Tab | Pregnancy Details)

#TOTAL_CASES_COUNT_CAMINOR_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The fetal outcome is CA Minor (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_CAMINOR_PROSPECT

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The fetal outcome is CA Minor and is not Normal (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_PREMATURE_PROSPECT

Total # of Cases w/ProsPregnancy with premature birth type.

#TOTAL_CASES_FREQUENCY_PREMATURE_PROSPECT

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The birth type is Premature and the pregnancy type is Prospective (Case Form | Patient Tab | Pregnancy Details)

#TOTAL_CASES_COUNT_STILLBIRTH_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The birth type is Still Birth (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_STILLBIRTH_PROSPECT

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The birth type is Still Birth and the pregnancy type is Prospective (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_PENDINGDELIVERY_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The delivery date is greater than the current date. (Case Form | Patient Tab | Pregnancy Details)

If delivery date is not entered, the application ignores the case.

#TOTAL_CASES_COUNT_ELECTIVETERMINATIONS_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Elective Termination (Case Form | Patient Tab | Pregnancy Details)".

#TOTAL_CASES_COUNT_SPONTANEOUSABORTIONS_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Spontaneous Abortion (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_SPONTANEOUSABORTIONS_RETRO

The frequency of occurrence in cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Spontaneous and the pregnancy type is either Prospective or Retrospective.

Computed as:

('= #TOTAL_CASES_COUNT_SPONTANEOUSABORTIONS_RETRO / (#TOTAL_CASES_PROSPECT_PREGNANCY+#TOTAL_CASES_RETRO_PREGNANCY)".

#TOTAL_CASES_COUNT_NORMALOUTCOME_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is Normal (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_FOLLOWUPLOST_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Lost to F/U (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_FOLLOWUPDONE_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is not Lost to F/U (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_ABNORMALOUTCOME_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is not Normal (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_CAMAJOR_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is CA Major (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_CAMAJOR_RETRO

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is CA Major and is not Normal (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_CAMINOR_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is CA Minor (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_CAMINOR_RETRO

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is CA Minor and is not Normal (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_PREMATURE_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Premature (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_PREMATURE_RETRO

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Premature and the pregnancy type is Prospective (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_STILLBIRTH_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Still Birth (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_FREQUENCY_STILLBIRTH_RETRO

The frequency of occurrence of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The birth type is Still Birth and the pregnancy type is Prospective (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_CA_ALL

The total number of cases where both of the following are true:

The patient is Pregnant.

The fetal outcome is either CA Major OR CA Minor (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_PERINATAL_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The fetal outcome is Perinatal complication (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_PERINATAL_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is Perinatal complication (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_POSTNATAL_PROSPECT

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Prospective.

The fetal outcome is Post-perinatal complication (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_POSTNATAL_RETRO

The total number of cases where all of the following are true:

The patient is Pregnant.

The pregnancy type is Retrospective.

The fetal outcome is Post-perinatal complication (Case Form | Patient Tab | Pregnancy Details).

#TOTAL_CASES_COUNT_PEDIATRICS

The total number of cases where both of the following are true:

The patient's age group has been selected

The group has been configured with the E2B codes of either 1,2 or 3 in list maintenance.

#SOC_NAME_TOP_PEDIATRICS(x)

The SOC with the largest number based on the level specified where the patient's age group is with the E2B code value of 1,2 or 3 in list maintenance.

#SOC_COUNT_TOP_PEDIATRICS(x)

The largest number of SOC based on the level specified where the patient's age group is with the E2B code value of 1,2 or 3 in list maintenance.

#SOC_FREQUENCY_TOP_PEDIATRICS(x)

The frequency of occurrence of events in the SOC that has the xth highest occurrence in pediatrics (E2B code of 1, 2 or 3 in list maintenance).

#TOTAL_CASES_COUNT_ELDERLY

The total number of cases where both of the following are true:

The patient's age group has been selected

The group has been configured with the E2B codes of 6 in list maintenance.

#SOC_NAME_TOP_ELDERLY(x)

The SOC with the largest number based on the level specified where the patient's age group is with the E2B code value of 6 in list maintenance.

#SOC_COUNT_TOP_ELDERLY(x)

The largest number of SOC based on the level specified where the patient's age group is with the of 6 in list maintenance.

#SOC_FREQUENCY_TOP_ELDERLY(x)

The frequency of occurrence of events in the SOC that has the xth highest occurrence in pediatrics (E2B code of 6 in list maintenance).

#DEV_INTERNATIONAL_BIRTHDATE

The DIBD date of the product.