Subject_SuspectDrug data set
Note:
How you map dosage frequency data depends on your study design.| Data Series Title | Description | Location in Oracle Argus Safety |
|---|---|---|
| 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 Oracle Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in Oracle 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 |
For more information, see: