Date of Visit/Assessment
Item
Date of Visit/Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Study site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Subject No.
Item
Patient No.
text
C2348585 (UMLS CUI [1])
Possible suicidality-related AE
Item
Possible suicidality related AE
text
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
Possible suicidality-related AE start date
Item
Start Date
date
C2697888 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
Suicidality-Related Adverse Event 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])
Possible causes of possible suicidality-related adverse event: Disease under study
Item
Disease under study
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0008976 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Concomitant medications
Item
Concomitant medications
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C2347852 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
Item
Comorbid psychiatric condition(s)
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Medical condition(s)
Item
Medical condition(s)
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
Item
Psycho-social stressors
boolean
C2732635 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0748073 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Investigational product dose change
Item
Investigational product dose change
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2,1])
C1707811 (UMLS CUI [2,2])
Possible causes of possible suicidality-related adverse event: Lack of efficacy
Item
Lack of efficacy
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0235828 (UMLS CUI [2])
Possible causes of possible suicidality-related adverse event: Investigational product(s)
Item
Investigational product(s)
boolean
C0877248 (UMLS CUI [1,1])
C2732635 (UMLS CUI [1,2])
C3166387 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,4])
C0304229 (UMLS CUI [2])
Other possible causes of possible suicidality-related adverse event
Item
Other
boolean
C0205394 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,3])
C3166387 (UMLS CUI [1,4])
C0015127 (UMLS CUI [1,5])
Specify other possible causes of possible suicidality-related adverse event
Item
Other, specify
text
C1521902 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2732635 (UMLS CUI [1,3])
C3166387 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
C0015127 (UMLS CUI [1,6])
History of psychiatric conditions
Item
Has the subject had any psychiatric conditions in the past?
boolean
C0455498 (UMLS CUI [1])
Previous suicidal ideation/behaviour or self-harm
Item
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
boolean
C0424000 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0205156 (UMLS CUI [2,1])
C1760428 (UMLS CUI [2,2])
C0424366 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Current use of iIllicit drugs
Item
Subject's current use of llicit drugs?
boolean
C0086190 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Current alcohol consumption
Item
Subject's current use of alcohol?
boolean
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item
Family history of suicidality?
text
C0241889 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
Code List
Family history of suicidality?
CL Item
Unknown (Unknown)
Item
Family history of psychiatric disorders?
text
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Code List
Family history of psychiatric disorders?
CL Item
Unknown (Unknown)
Current psycho-social stressors
Item
Provide information on the subject's current psycho-social stressors
text
C0748073 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Significant/recent suicidal ideation
Item
Relevant/recent suicidal ideation
text
C0424000 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0424000 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Suicidal behaviour during study
Item
Suicidal behaviour present during study
text
C1760428 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Medical and psychiatric treatment
Item
Comments on medical/psych treatment
text
C0237726 (UMLS CUI [1])
C0204523 (UMLS CUI [2])