| User Defined ID | True | The adverse event user defined ID is an identifier chosen by the data provider to refer to a adverse event. The user defined ID is not shared. |
| Subject ID | True | Please enter either a subject user defined ID or ImmPort accession for the subject for the reported adverse event. |
| Study ID | True | An adverse event may be linked to a single study. |
| Name Reported | True | The adverse event name is a display name that is available when the data is shared, but it is not referenced by other data.. |
| Name Preferred | False | The preferred adverse event name is a term from the MedDRA (www.meddra.org) adverse event classification dictionary. This is an optional term and often updated by ImmPort staff by mapping AE reported names to MedDRA terms. |
| Severity Reported | True | The severity value is chosen from a list of preferred terms. |
| Outcome Reported | True | Describe the outcome of the adverse event. |
| Start Study Day | False | The study day in which the adverse event was initially reported. |
| End Study Day | False | The study day in which the adverse event ceased. |
| Relation To Study Treatment | True | Was the adverse event believed to be related to a study intervention. |
| Organ Or Body System Reported | False | Which portion(s) of the subject was affected by the adverse event. |
| Description | False | A lengthier description of the adverse event. |
| Location Of Reaction Reported | False | Where on/in the subject was the adverse event reported. |
| Study Treatment Action Taken | False | What was done to address the adverse event. |
| Relation To Nonstudy Treatment | False | Was the adverse event related to some non-study intervention. |
| Causality | False | Was the adverse event believed to be casued by a study intervention. |
| Start Time | False | Allows for describing the time during a study day in which an adverse event was reported. |
| End Time | False | Allows for describing the time during a study day in which an adverse event was reported. |