ConMed_SeparateDoseCount

Number of separate dosages.

Case Form / Products / Dosage Regimens / Frequency

ConMed_DosageIntervalUnit Count

Number of units in the dosage interval.

Case Form / Products / Dosage Regimens / Frequency

ConMed_DosageIntervalUnit

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

Case Form / Products / Dosage Regimens / Frequency

ConMed_DosageFrequency

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

Case Form / Products / Dosage Regimens / Frequency

ConMed_Dosage

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

Case Form / Products / Dosage Regimens / Dose Units

ConMed_DosageUnit

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

Case Form / Products / Dosage Regimens / Daily Dosage Units

ConMed_CumulativeDosage

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

Case Form / Products / Total Dose to Primary Event

ConMed_CumulativeDosage Unit

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

Case Form / Products / Total Dose to Primary Event

ConMed_DosageDescription

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

Case Form / Products / Dosage Regimens / Dose Description

ConMed_DosageFormCode

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

Case Form / Products / Product Information / Formulation

ConMed_AdministrationRoute Code

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

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

ConMed_StartDateTime

Start date of the dosing regimen.

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

ConMed_EndDateTime

End date of the dosing regimen.

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

ConMed_RecurReAdministration Code

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

Case Form / Products / Product Details / Rechallenge Results

ConMed_ActionTakenCode

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

Case Form / Products / Product Details / Action Taken

ConMed_AdditionalInformation

Additional information about the concomitant medication.

Case Form / Products / Notes

ConMed_MedicinalProduct Name

Proprietary medicinal name of the concomitant medication.

Case Form / Products / Product Information / Product Name

ConMed_Indication

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

Case Form / Products / Product Indication / Coded Indication

ConMed_IndicationMedDRA Version

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 the Argus Safety.

ConMed_ParentAdministration RouteCode

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

ConMed_FirstDoseToOnset Duration

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 advent.

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

ConMed_FirstDoseToOnset DurationUnit

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

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

ConMed_LastDoseToOnset Duration

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

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

ConMed_LastDoseToOnset DurationUnit

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

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

ConMed_TreatmentDuration

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

Case Form / Products / Dosage Regimens / Duration of Regimen

ConMed_TreatmentDuration Unit

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

Case Form / Products / Dosage Regimens / Duration of Administration

ConMed_OngoingIndicator

Whether the patient is still taking the concomitant medication.

Case Form / Products / Product Detail / Ongoing