NameInitials

Patient initials.

Case Form / Patient / Patient Information / Initials

BirthDateTime

Patient date of birth.

Case Form / Patient / Patient Information / Date of Birth

OnsetAge

Age at the time of onset of the reaction.

Case Form / Patient / Patient Information / Age

OnsetAgeUnit

Unit for the age at time of onset of the reaction (for example, years, months).

Case Form / Patient / Patient Information / Age Units

GestationPeriod

Gestation period when the adverse event was observed in the fetus.

Case Form / Patient / Patient Information / Pregnancy Details / Weeks at Onset If a valid value is entered, the Pregnant field is selected as well.

GestationPeriodUnit

Unit for the gestation period (weeks, months, trimester).

Case Form/ Patient / Patient Pregnancy Details / Weeks at Onset

If a value is entered, the Pregnant field is selected.

AgeGroupCode

Patient age group (for example, adolescent, adult).

Case Form / Patient / Patient Age Group

Weight

Patient weight.

Case Form / Patient / Weight

WeightUnit

Unit for the patient weight (for lb, kg).

Case Form / Patient / Patient Weight

Argus Safety requires kg. If you collect weight in pounds, set the study design to perform the conversion to kg. See the Central Designer User Guide.

Height

Patient height.

Case Form / Patient / Patient Height

HeightUnit

Unit for the patient height (for in, cm).

Case Form / Patient / Patient Height

Argus Safety requires cm. If you collect height in inches, set the study design to perform the conversion to cm. See the Central Designer User Guide.

SexCode

Patient gender

Case Form / Patient / Patient Gender

LastMenstrualDateTime

Date of the last menstrual period the adverse event occurred.

Case Form / Patient / Patient Date of LMP

MedicalHistory

Text item used to summarize the history and concurrent conditions of patient.

Case Form / Patient / Notes

InvestigationResult

Results of tests and procedures to the investigation of the patient. Map this data series when structured information is not available.

Case Form / Patient / Relevant Test

RaceCode

Patient race.

Case Form / Patient / Patient Ethnicity

BreastFeedingIndicator

Indicates whether the patient breast feeds an infant.

Case Form / Patient / Patient Details / Breastfeeding

OccupationCode

Occupation of the patient.

Case Form / Patient / Patient Details / Occupation

PregnancyDueDateTime

Due date for the pregnancy.

Case Form / Patient / Pregnancy Due Date

ProspectiveIndicator

Whether the sponsor was aware of the pregnancy before the birth.

Case Form / Patient / Pregnancy Prospective

RetrospectiveIndicator

Whether the sponsor became aware of the pregnancy after the birth.

Case Form / Patient / Pregnancy Retrospective

FetusCount

Number of fetuses in the pregnancy.

Case Form / Patient / Pregnancy Fetus Count