SuspectDrug_SeparateDose Count

Number of separate dosages.

Case Form / Products / Dosage Regimens / Frequency

SuspectDrug_DosageInterval UnitCount

Number of units in the dosage interval.

Case Form / Products / Dosage Regimens / Frequency

SuspectDrug_DosageIntervalUnit

Units in which the dosage interval is defined (for example days, months).

Case Form / Products / Dosage Regimens / Frequency

SuspectDrug_Dosage Frequency

Frequency that the dosage was given to the patient (for example, 2 times per day).

Case Form / Products / Dosage Regimens / Frequency

SuspectDrug_Dosage

Number of units in the dosage (for example, 20).

Case Form / Products / Dosage Regimens / Dose Units

SuspectDrug_DosageUnit

Units in which the dosage is defined (for example, mg).

Case Form / Products / Dosage Regimens / Daily Dosage Units

SuspectDrug_Cumulative Dosage

The total dose administered before the first sign, symptom, or reaction occurred.

Case Form / Products / Total Dose to Primary Event

SuspectDrug_Cumulative DosageUnit

Units in the cumulative dosage (for example, mg).

Case Form / Products / Total Dose to Primary Event

SuspectDrug_Dosage Description

Description of the dosage. Use this item if it is not possible to provide structured dosage information.

Case Form / Products / Dosage Regimens / Dose Description

SuspectDrug_DosageForm Code

Pharmaceutical form of the dosage (for example, tablets, capsules, syrup).

Case Form / Products / Product Information / Formulation

SuspectDrug_Administration RouteCode

Route of administration of the drug (for example, intravenous, oral).

Case Form / Products / Dosage Regimens / Patient Route of Administration

SuspectDrug_Gestation PeriodAtExposure

Gestation period at time of exposure to the drug.

Case Form / Patient / Patient Information / Pregnancy / Weeks at Exposure or Trimester of Exposure

SuspectDrug_StartDateTime

Start date of the dosing regimen.

Case Form / Products / Dosage Regimens / Start Date/Time

SuspectDrug_FirstDoseTo OnsetDuration

If the exact start and end dates are not known or the interval is less than one day, the time between the first administration of the drug and the onset of the adverse event.

Case Form / Products / Time Interval Between First Dose/Primary Event

SuspectDrug_FirstDosageTo OnsetDurationUnit

Unit for first dose to onset duration (for example, minutes, hours).

Case Form / Products / Time Interval Between First Dose/Primary Event

SuspectDrug_EndDateTime

End date of the dosing regimen.

Case Form / Products / Dosage Regimens / Stop Date/Time

SuspectDrug_Recur ReAdministrationCode

Indicates whether the adverse event recurred when the drug was readministered (Yes, No, Unknown).

Case Form / Products / Product Details / Rechallenge Results

SuspectDrug_ActionTaken Code

Action taken by the doctor or patient with the drug in response to the adverse event.

Case Form / Products / Product Details / Action Taken

SuspectDrug_Additional Information

Additional information about the drug.

Case Form / Products / Notes

SuspectDrug_Medicinal ProductName

Proprietary name of the medicinal product name. If SuspectDrug_ MedicinalProduct Name is not mapped, the Sponsor Drug Name is transmitted.

Case Form / Products / Product Information / Product Name

SuspectDrug_Indication

Reason that the drug was prescribed. Map to the user-entered verbatim or to the encoded MedDRA lower-level term.

Case Form / Products / Product Indication / Coded Indication

SuspectDrug_Indication MedDRAVersion

Version of MedDRA used to code the indication if the indication is mapped to a lower-level term.

Note: If Indication is mapped to text entered by the user, do not map this field.

For items to be encoded in Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in Argus Safety.

SuspectDrug_BatchNumber

Batch or lot number of the drug.

Case Form / Products / Dosage Regimens / Batch / Lot #

SuspectDrug_Parent AdministrationRouteCode

If the patient is a fetus, the route by which the drug was administered to the parent.

Case Form / Products / Dosage Regimens / Parent Route of Administration

SuspectDrug_Treatment Duration

Duration of the dosing regimen if exact start and dates are not known.

Case Form / Products / Dosage Regimens / Duration of Regimen

SuspectDrug_Treatment DurationUnit

Unit for the treatment duration (for example, days, months).

Case Form / Products / Duration of Administration

SuspectDrug_Overdose Indicator

Whether the patient took more than the prescribed amount of the drug before experiencing the adverse event.

Case Form / Products / Product Detail / Overdoes

SuspectDrug_AbuseIndicator

Whether the patient abused the drug (for example, took pain medication without pain).

Case Form / Products / Product Detail / Abuse

SuspectDrug_Tampering Indicator

Whether the product appeared to be tampered with before it was taken.

Case Form / Products / Product Detail / Tampering

SuspectDrug_TakenPreviously AndToleratedCode

Whether the patient had taken the drug previously and had tolerated it (Yes, No, Unknown).

Case Form / Products / Product Detail / Taken Previously And Tolerated

SuspectDrug_InteractingIndicator

Whether it is believed that the interaction of this non-study co-suspect drug with the study drug(s) caused the adverse event.

Case Form / Products / Product Detail / Interacting

SuspectDrug_Ongoing Indicator

Whether the patient is still taking the drug.

Case Form / Products / Product Detail / Ongoing