Subject_SuspectDrug_ReactionRelatedness data set

in the Subject_SuspectDrug_ReactionRelatedness data set

Data Series Title	Description	Location in Argus Safety
SuspectDrug_AssessmentSource	Source of assessment (for example, investigator).	Case Form / Events / Assessments / Causality / As Reported, As Determined
SuspectDrug_AssessmentMethod	Method of assessment (for example, global introspection).	Case Form / Events / Assessments / Causality / As Reported, As Determined
SuspectDrug_AssessmentResult	Result of assessment (for example, related, possibly related).	Case Form / Events / Assessments / Causality / As Reported, As Determined
SuspectDrug_ReactionID	MedDRA lower-level term (LLT) for the reaction that was assessed for relatedness to the drug.	Case Form / Events / Assessments / Causality / As Reported, As Determined

Note: The value of the item mapped to the SuspectDrug_ AssessmentSource data series for an adverse event that has been coded determines whether the reaction relatedness data for the adverse event specified in the SuspectDrug_ReactionID and SuspectDrug_MedicinalProductName data series appears as Determined Causality or Reported Causality in Argus Safety.

PHARMACEUTICAL COMPANY—As Determined

Any other value—As Reported