Subject_PastDrugHistory data set
Data Series Title | Description | Location in Oracle Argus Safety |
---|---|---|
PastDrugHistory_DrugName | Name of a drug previously taken but not used concomitantly and not potentially involved in the adverse event. | Case Form / Patient / Other Relevant History / Description |
PastDrugHistory_StartDate Time | Date when the previously taken drug was started. | Case Form / Patient / Other Relevant History / Start Date |
PastDrugHistory_EndDate Time | Date when the last dose of the previously taken drug was given. | Case Form / Patient / Other Relevant History / Stop Date |
PastDrugHistory_Drug Indication | Reason for taking the previously taken drug. Map to the user-entered verbatim or to the encoded MedDRA lower-level term. | Case Form / Patient / Other Relevant History / Indication |
PastDrugHistory_Indication MedDRAVersion | Version of MedDRA used to code the indication if the indication is mapped to a lower-level term. | 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. |
PastDrugHistory_Drug Reaction | Adverse event experienced when taking the previously taken drug. Map to the user-entered verbatim or to the encoded MedDRA lower-level term). | Case Form / Patient / Other Relevant History / Reaction |
PastDrugHistory_Reaction MedDRAVersion | Version of MedDRA used to code the indication if the indication is mapped to a lower-level term.
Note: If reaction is mapped to a text field 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. |
Parent topic: Predefined data sets included in the integration