reference date
Item
Reference date
date
C1719096 (UMLS CUI [1])
Visit
Item
Visit Type
text
C0545082 (UMLS CUI [1])
eCRF
Item
electronic case report form
text
C1516308 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item
Are there any adverse events to report?
integer
C0877248 (UMLS CUI [1])
Code List
Are there any adverse events to report?
Description of Event
Item
Description of Event
text
C0678257 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Item
Seriousness of Adverse Event
integer
C1710056 (UMLS CUI [1])
Code List
Seriousness of Adverse Event
CL Item
Yes, complete Serious Adverse Event Form (1)
Item
Severity of adverse event
integer
C1710066 (UMLS CUI [1])
Code List
Severity of adverse event
Item
Relationship to study drug
integer
C0013227 (UMLS CUI [1])
Code List
Relationship to study drug
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Resolved with Sequelae (2)
Item
Action taken (other than with study drug)
integer
C0441472 (UMLS CUI [1])
Code List
Action taken (other than with study drug)
CL Item
Conmed, Complete Concomitant Medications Form (2)
CL Item
Non-Drug Therapy (3)
Item
Action taken with study drug
integer
C0877248 (UMLS CUI [1,1])
C0441472 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Code List
Action taken with study drug
CL Item
Interrupted and later re-started (2)
CL Item
Stopped permanently (4)
Item
In the investigator's judgement, were there any possible suicidality-related adverse events?
integer
C0438696 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
Code List
In the investigator's judgement, were there any possible suicidality-related adverse events?
CL Item
Yes; please fill out adverse events form (1)
Adverse Event number
Item
Please insert adverse event number
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse Event start date
Item
Adverse Event date
date
C2697888 (UMLS CUI [1])
Adverse Event Description
Item
Provide a brief description of the possible suicidality-related adverse event
text
C2699044 (UMLS CUI [1])
Item
Possible causes of possible suicidality-related adverse event: Disease under study
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
Code List
Possible causes of possible suicidality-related adverse event: Disease under study
Item
Possible causes of possible suicidality-related adverse event: Concomitant medications
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
Code List
Possible causes of possible suicidality-related adverse event: Concomitant medications
Item
Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
Code List
Possible causes of possible suicidality-related adverse event: Comorbid psychiatric condition(s)
Item
Possible causes of possible suicidality-related adverse event: Medical condition(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2])
Code List
Possible causes of possible suicidality-related adverse event: Medical condition(s)
Item
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0748073 (UMLS CUI [2])
Code List
Possible causes of possible suicidality-related adverse event: Psycho-social stressors
Item
Possible causes of possible suicidality-related adverse event: Withdrawal of investigationalproduct(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Code List
Possible causes of possible suicidality-related adverse event: Withdrawal of investigationalproduct(s)
Item
Possible causes of possible suicidality-related adverse event: Investigational product dose change
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C1707811 (UMLS CUI [2,2])
Code List
Possible causes of possible suicidality-related adverse event: Investigational product dose change
Item
Possible causes of possible suicidality-related adverse event: Lack of efficacy
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0235828 (UMLS CUI [2])
Code List
Possible causes of possible suicidality-related adverse event: Lack of efficacy
Item
Possible causes of possible suicidality-related adverse event: Investigational product(s)
integer
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2])
Code List
Possible causes of possible suicidality-related adverse event: Investigational product(s)
undefined item
Item
Possible causes of possible suicidality-related adverse event: Other, please specify
text
C1547657 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item
Has the subject had any psychiatric conditions in the past (other than the one under study)?
integer
C0004936 (UMLS CUI [1])
Code List
Has the subject had any psychiatric conditions in the past (other than the one under study)?
CL Item
Yes, provide Information (1)
Item
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
integer
C0424000 (UMLS CUI [1])
Code List
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
CL Item
Yes, provide information (1)
Item
Subject's current use of llicit drugs?
integer
C0086190 (UMLS CUI [1])
Code List
Subject's current use of llicit drugs?
CL Item
Yes, provide information, including results of a drug screen test if one has been obtained (1)
Item
Subject's current use of alcohol?
integer
C0001948 (UMLS CUI [1])
Code List
Subject's current use of alcohol?
CL Item
Yes, provide information, including test results of an alcohol level test if one has been obtained (1)
Item
Family history of suicidality?
integer
C0241889 (UMLS CUI [1,1])
C0438696 (UMLS CUI [1,2])
Code List
Family history of suicidality?
CL Item
Yes, provide information (1)
Item
Family history of psychiatric disorders?
integer
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Code List
Family history of psychiatric disorders?
CL Item
Yes, provide information (1)
psycho-social stressors
Item
Provide information on the subject's current psycho-social stressors
text
C0748073 (UMLS CUI [1])
suicidal ideation
Item
Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event
text
C0424000 (UMLS CUI [1])
suicidal behaviour
Item
Provide information on any suicidal behaviour present during the study, as assessed by the investigator, for this index event
text
C1760428 (UMLS CUI [1])
additional comments
Item
Provide any additional comments or explanation, including, but not limited to, both medical and psychiatric treatment, outcome and follow-up
text
C1830770 (UMLS CUI [1])