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What Are The Contents Of Ae Dataset? What Is Its Purpose? What Are The Variables In Adverse Event Datasets? |
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Answer» The adverse event data set contains the SUBJID, body system of the event, the preferred term for the event, event severity. The PURPOSE of the AE dataset is to GIVE a summary of the adverse event for all the PATIENTS in the treatment arms to aid in the inferential SAFETY analysis of the drug. The adverse event data set contains the SUBJID, body system of the event, the preferred term for the event, event severity. The purpose of the AE dataset is to give a summary of the adverse event for all the patients in the treatment arms to aid in the inferential safety analysis of the drug. |
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