Event
Item
Event
text
C0877248 (UMLS CUI [1])
Item
Adverse Event start date - Complete Date Unknown
integer
C2697888 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
Adverse Event start date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Adverse Event - Start date and time
Item
Adverse Event - Start date and time
datetime
C2826806 (UMLS CUI [1])
Item
Adverse Event - Outcome, End date and time
integer
C1705586 (UMLS CUI [1])
C2826793 (UMLS CUI [2])
Code List
Adverse Event - Outcome, End date and time
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
Item
Adverse Event end date - Complete Date Unknown
text
C2826793 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Code List
Adverse Event end date - Complete Date Unknown
CL Item
Complete Date Unknown (1)
Adverse Event - End date/ time
Item
Adverse Event - End date/ time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Event - Frequency
integer
C0877248 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Code List
Adverse Event - Frequency
CL Item
Single Episode (1)
Item
Adverse Event - Maximum Intensity
integer
C1710066 (UMLS CUI [1])
Code List
Adverse Event - Maximum Intensity
CL Item
Not applicable (4)
Item
Action taken with Investigational Product(s) as a result of the AE
integer
C1704758 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
Action taken with Investigational Product(s) as a result of the AE
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Start date and time of event segment change
Item
Start date and time of event segment change
datetime
C2826806 (UMLS CUI [1,1])
C0443172 (UMLS CUI [1,2])
Item
Intensity of event segment
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Intensity of event segment
Was this event serious?
Item
Was this event serious?
boolean
C1519255 (UMLS CUI [1])
Was this event determined by the investigator to be possibly suicidality-related?
Item
Was this event determined by the investigator to be possibly suicidality-related?
boolean
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
SAE number
Item
SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Did SAE occur after initiation of study medication?
Item
Did SAE occur after initiation of study medication?
boolean
C1519255 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Item
Intensity at onset of event
integer
C0518690 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Code List
Intensity at onset of event
CL Item
Not applicable (4)
Item
Action taken with Investigational Product(s) as a result of the SAE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action taken with Investigational Product(s) as a result of the SAE
CL Item
Investigational Product(s) withdrawn (1)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this SAE?
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Duration of AE if <24 hours
Item
Duration of AE if <24 hours
integer
C0449238 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Duration of AE if <24 hours
Item
Duration of AE if <24 hours
integer
C0449238 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Time to onset since last dose
Item
Time to onset since last dose
integer
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Time to onset since last dose
Item
Time to onset since last dose
integer
C0332162 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
Item
Was the SAE caused by activities related to study participation other than investigational product e.g. procedures, blood draws, washout, etc.?
boolean
C1519255 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C0304229 (UMLS CUI [3])
C2700391 (UMLS CUI [4])
C0005834 (UMLS CUI [5])
C1710661 (UMLS CUI [6])
C0439849 (UMLS CUI [7])
Item
Specify the reason for considering this an SAE
integer
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Specify the reason for considering this an SAE
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/incapacity (4)
CL Item
Congenital anomaly/birth defect (5)
CL Item
Possible drug-induced liver injury (see definition in SAE section of protocol) (7)
Specify reason for considering this an SAE with general narrative comment
Item
Specify reason for considering this an SAE with general narrative comment
text
C1710056 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
Relevant Concomitant/Treatment Medications - Drug Name
Item
Relevant Concomitant/Treatment Medications - Drug Name
text
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
Relevant Concomitant/Treatment Medications - Total daily dose
Item
Relevant Concomitant/Treatment Medications - Total daily dose
float
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C2348070 (UMLS CUI [3,1])
C0439810 (UMLS CUI [3,2])
Relevant Concomitant/Treatment Medications - Unit
Item
Relevant Concomitant/Treatment Medications - Unit
text
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0439148 (UMLS CUI [3])
Relevant Concomitant/Treatment Medications - Indication
Item
Relevant Concomitant/Treatment Medications - Indication
text
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3])
Relevant Concomitant/Treatment Medications - Start date/time
Item
Relevant Concomitant/Treatment Medications - Start date/time
datetime
C2826734 (UMLS CUI [1])
C1301880 (UMLS CUI [2,1])
C2347852 (UMLS CUI [2,2])
C0013227 (UMLS CUI [3,1])
C0808070 (UMLS CUI [3,2])
C0013227 (UMLS CUI [4,1])
C1301880 (UMLS CUI [4,2])
Item
Relevant Concomitant/Treatment Medications - Drug type
integer
C2347852 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0457591 (UMLS CUI [3])
Code List
Relevant Concomitant/Treatment Medications - Drug type
Lab Sequence Number
Item
Lab Sequence Number
text
C0022885 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Test name
Item
Test name
text
C0022885 (UMLS CUI [1])
Test date
Item
Test date
date
C2826247 (UMLS CUI [1])
Test results
Item
Test results
text
C0456984 (UMLS CUI [1])
Test units
Item
Test units
text
C1519795 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Normal low range
Item
Normal low range
text
C0086715 (UMLS CUI [1,1])
C0205251 (UMLS CUI [1,2])
Normal high range
Item
Normal high range
text
C0086715 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
Relevant diagnostic results not noted above
Item
Relevant diagnostic results not noted above
text
C0430022 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
integer
C0304229 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0580673 (UMLS CUI [2,3])
Code List
If investigational product(s) were stopped temporarily, did the reported event(s) recur after investigational products were restarted?
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
General Narrative Comments
Item
General Narrative Comments
text
C0947611 (UMLS CUI [1,1])
C1135957 (UMLS CUI [1,2])
Provide a brief description of the possible suicidality-related AE/SAE
Item
Provide a brief description of the possible suicidality-related AE/SAE
text
C0877248 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C3166387 (UMLS CUI [2,2])
C0678257 (UMLS CUI [2,3])
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Concomitant medication(s)
Item
Concomitant medication(s)
boolean
C2347852 (UMLS CUI [1])
Comorbid psychiatric condition(s)
Item
Comorbid psychiatric condition(s)
boolean
C0004936 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
Medical condition(s)
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
Psycho-social stressors
Item
Psycho-social stressors
boolean
C0748073 (UMLS CUI [1])
Withdrawal of investigational product(s)
Item
Withdrawal of investigational product(s)
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Investigational product dose change
Item
Investigational product dose change
boolean
C0304229 (UMLS CUI [1,1])
C1707811 (UMLS CUI [1,2])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Investigational product(s)
Item
Investigational product(s)
boolean
C0304229 (UMLS CUI [1])
Other cause
Item
Other cause
boolean
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Specify other cause
Item
Specify other cause
text
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Has the subject had any psychiatric conditions in the past (other than the one under study)?
Item
Has the subject had any psychiatric conditions in the past (other than the one under study)?
boolean
C0004936 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
If subject has had any psychiatric conditions in the past, provide informations
Item
If subject has had any psychiatric conditions in the past, provide informations
text
C0004936 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
Has the subject had any suicidal ideation, behaviour or self-harm in the past?
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])
C1760428 (UMLS CUI [1,3])
C0424366 (UMLS CUI [1,4])
If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
Item
If the subject had any suicidal ideation, behaviour or self-harm in the past, provide information
text
C0424000 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1760428 (UMLS CUI [1,3])
C0424366 (UMLS CUI [1,4])
C1533716 (UMLS CUI [2])
Subject's current use of illicit drugs?
Item
Subject's current use of illicit drugs?
boolean
C0281875 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
Item
If current use of illicit drugs, provide information, including results of a drug screen test if one has been obtained
text
C0281875 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
C0373483 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
Subject's current use of alcohol?
Item
Subject's current use of alcohol?
boolean
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
Item
If current use of alcohol, provide information, including results of an alcohol level test if one has been obtained.
text
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
C0202304 (UMLS CUI [3,1])
C1274040 (UMLS CUI [3,2])
Family history of suicidality?
Item
Family history of suicidality?
boolean
C0241889 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
If family history of suicidality, provide information
Item
If family history of suicidality, provide information
text
C0241889 (UMLS CUI [1,1])
C3166387 (UMLS CUI [1,2])
C1533716 (UMLS CUI [2])
Family history of psychiatric disorders?
Item
Family history of psychiatric disorders?
boolean
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
If family history of psychiatric disorders, provide information
Item
If family history of psychiatric disorders, provide information
text
C0241889 (UMLS CUI [1,1])
C0004936 (UMLS CUI [1,2])
Provide information on the subject's current psycho-social stressors
Item
Provide information on the subject's current psycho-social stressors. For example, isolation, problems with family, relationships, work, finances, stress, etc.
text
C0748073 (UMLS CUI [1])
C0205409 (UMLS CUI [2])
C0424960 (UMLS CUI [3])
C0439849 (UMLS CUI [4])
C0043227 (UMLS CUI [5])
C0557159 (UMLS CUI [6])
C0038435 (UMLS CUI [7])
Provide information on any relevant and/or recent suicidal ideation, not associated with suicidal behaviour, as assessed by the investigator, for this index event
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. For example, suicidal thoughts, associated frequency, severity and duration as well as likelihood of the subject acting upon these thoughts.
text
C0424000 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1760428 (UMLS CUI [2])
C0439603 (UMLS CUI [3])
C0439793 (UMLS CUI [4])
C0449238 (UMLS CUI [5])
C0033204 (UMLS CUI [6])
Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
Item
Provide information on any suicidal behavior present during the study, as assessed by the investigator, for this index event.
text
C1760428 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C0347984 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Provide any additional comments or explanation, including but not limited to, both medical and psychiatric treatment, outcome and follow-up.
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])
C0681841 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
C0237726 (UMLS CUI [3])
C0204523 (UMLS CUI [4])
C1547647 (UMLS CUI [5])
C1522577 (UMLS CUI [6])