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.