Subject_ConMed data set
| Data Series Title | Description | Location in Oracle Argus Safety |
|---|---|---|
| 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 Oracle Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in the Oracle 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 |
For more information, see: