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Subject_MedicalHistory data set

in the Subject_MedicalHistory data set

Data Series Title

Description

Location in Argus Safety

MedicalHistory_Name

Condition, disease, or surgical procedure in the patient's medical history. Map to the user-entered verbatim or to the encoded MedDRA lower-level term.

Case Form / Patient / Other Relevant History / Description

MedicalHistory_MedDRA Version

Version of MedDRA used to code the medical history name if the medical history name is mapped to a lower-level term.

Note: If MedicalHistory_Name is mapped to a text field 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.

MedicalHistory_StartDateTime

Start date of the condition, disease, or surgical procedure.

Case Form / Patient / Other Relevant History / Start Date

MedicalHistory_Continuing Indicator

Whether the patient still has the condition or disease (Yes, No, Unknown).

Case Form / Patient / Other Relevant History / Ongoing

MedicalHistory_EndDateTime

End date of the condition, disease, or surgical procedure.

Case Form / Patient / Other Relevant History / Stop Date

MedicalHistory_Comment

Description of the relevant medical history for the patient. Used when more structured information, such as dates and terms, is unknown.

Case Form / Patient / Other Relevant History / Note

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