Adverse_Event

Records all information typically collected for adverse events. If the adverse event is detected as part of a planned subject assessment, then the Assessment_Acc_Num foreign key will be non-null. If that key is null then the adverse event is detected through unplanned means such as subject self-reporting or clinician observation.

Columns

Name	Type	Description	Foreign Key
adverse_event_accession	varchar(15)	Primary Key.
causality	varchar(250)	CDISC term for relation of Adverse Event to study (NOT RELATED, UNLIKELY RELATED, POSSIBLY RELATED, PROBABLY RELATED, DEFINITELY RELATED).
description	varchar(4000)	Free text to expand upon details
end_study_day	float	End of a duration
end_time	varchar(40)	End of a duration
location_of_reaction_preferred	varchar(126)	Standardized name or code for the location where reaction to adverse event occurred
location_of_reaction_reported	varchar(126)	Location where reaction to adverse event occurred.
name_preferred	varchar(126)	Standardized name or identifier
name_reported	varchar(126)	Name or identifier
organ_or_body_system_preferred	varchar(126)	Standardized name or code for the body system in the organism
organ_or_body_system_reported	varchar(126)	Reported name or code for the body system in the organism
other_action_taken	varchar(250)	Treatment or action applied other than planned
outcome_preferred	varchar(40)	Standardized code of the outcome
outcome_reported	varchar(40)	Reported outcome
relation_to_nonstudy_treatment	varchar(250)	Determination of whether the adverse event was related to a non-planned treatment
relation_to_study_treatment	varchar(250)	Determination of whether the adverse event was related to the study treatment
severity_preferred	varchar(60)	Standardized value in LK_ADVERSE_EVENT_SEVERITY table	lk_adverse_event_severity.name
severity_reported	varchar(60)	Reported value
start_study_day	float	Start day
start_time	varchar(40)	Start time
study_accession	varchar(15)	Foreign key reference to STUDY table	study.study_accession
study_treatment_action_taken	varchar(250)	Planned treatment applied as a response
subject_accession	varchar(15)	Foreign key reference to SUBJECT table	subject.subject_accession
workspace_id	int	Foreign key reference to WORKSPACE table	workspace.workspace_id

Indexes

Name	Column	Description
PRIMARY	adverse_event_accession	BTREE
idx_adverse_event_subject	subject_accession	BTREE
idx_adverse_event_study	study_accession	BTREE
idx_adverse_event_workspace	workspace_id	BTREE
fk_adverse_event_4	severity_preferred	BTREE

Tables that Reference this Table

Name	Column	Table Reference	Column Reference