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(11) 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
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