Adverse Event, Suicidality
Item
Possible suicidality related AE
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
Adverse Event, Suicidality, Start Date
Item
Start Date
date
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Adverse Event, Suicidality, Description
Item
Brief description of possible suicidality-related AE
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Adverse Event, Suicidality, Etiology aspects, Disease
Item
Disease under study
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Concomitant Agent
Item
Concomitant medication(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C2347852 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Mental disorders
Item
Comorbid psychiatric condition(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Other medical condition
Item
Medical condition(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C3843040 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, psychosocial stressor
Item
Psycho-social stressors
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0748073 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Experimental drug, Withdraw
Item
Withdrawal of investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2349954 (UMLS CUI [1,5])
Adverse Event, Suicidality, Etiology aspects, Experimental drug, Medication dose changed
Item
Investigational product dose change
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1608430 (UMLS CUI [1,5])
Adverse Event, Suicidality, Etiology aspects, Lack of Efficacy
Item
Lack of efficacy
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0235828 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Experimental drug
Item
Investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Other
Item
Other
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Adverse Event, Suicidality, Etiology aspects, Other
Item
Yes, specify
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Adverse Event, Suicidality, Medical History, Mental disorders
Item
Has the subject had any psychiatric conditions in the past?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
Adverse Event, Suicidality, Medical History, Active suicidal ideation; Adverse Event, Suicidality, Medical History, Suicidal behavior; Adverse Event, Suicidality, Medical History, Self-injurious Behavior
Item
Has the subject had any suicidal ideation, behavior or self-harm in the past?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0749133 (UMLS CUI [1,4])
C0877248 (UMLS CUI [2,1])
C3166387 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C1760428 (UMLS CUI [2,4])
C0877248 (UMLS CUI [3,1])
C3166387 (UMLS CUI [3,2])
C0262926 (UMLS CUI [3,3])
C0085271 (UMLS CUI [3,4])
Adverse Event, Suicidality, Illicit medication use, Current
Item
Subject's current use of illicit drugs?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0281875 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Adverse Event, Suicidality, Alcohol consumption, Current
Item
Subject's current use of alcohol?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0001948 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Item
Family history of suicidality?
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
Code List
Family history of suicidality?
Item
Family history of psychiatric disorders?
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0241889 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,4])
Code List
Family history of psychiatric disorders?
Adverse event, Suicidality, Psychosocial stressor, Current
Item
Information of subject's current psycho-social stressors.
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0748073 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Adverse Event, Suicidality, Feeling suicidal
Item
Relevant/recent suicidal ideation
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0424000 (UMLS CUI [1,3])
Adverse Event, Suicidality, Suicidal behavior, During, Clinical Trials
Item
Suicide behavior present during study
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C1760428 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,4])
C0008976 (UMLS CUI [1,5])
Adverse Event, Suicidality, Therapeutic procedure, Comment
Item
Comments on medical/psych treatment
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])