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.

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.

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