Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Did the subject experience any adverse events during the study?
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Were any repeat haematology or clinical chemistry samples taken?
Item
Were any repeat haematology or clinical chemistry samples taken?
boolean
C0018941 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Were any repeat urinalysis samples taken?
Item
Were any repeat urinalysis samples taken?
boolean
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
Were any repeat PK samples taken?
Item
Were any repeat PK samples taken?
boolean
C1277698 (UMLS CUI [1,1])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
Adverse Event - Sequence Number
Item
Adverse Event - Sequence Number
integer
C0877248 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Adverse Event - Modified term
Item
Adverse Event - Modified term
text
C0877248 (UMLS CUI [1,1])
Adverse Event - MedDRA synonym
Item
Adverse Event - MedDRA synonym
text
C0877248 (UMLS CUI [1,1])
C1140263 (UMLS CUI [1,2])
Adverse Event - MedDRA lower level term code
Item
Adverse Event - MedDRA lower level term code
text
C0877248 (UMLS CUI [1,1])
C3898442 (UMLS CUI [1,2])
Adverse Event - Failed coding
Item
Adverse Event - Failed coding
text
C0877248 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Adverse Event Start Date and Time
Item
Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
Item
Adverse Event Outcome
integer
C1705586 (UMLS CUI [1])
Code List
Adverse Event Outcome
CL Item
Recovered/Resolved, provide End Date and Time (1)
(Comment:en)
CL Item
Recovering/Resolving (2)
(Comment:en)
CL Item
Not recovered/Not resolved (3)
(Comment:en)
CL Item
Recovered/Resolved with sequelae, provide End Date and Time (4)
(Comment:en)
CL Item
Fatal, record Date and Time of Death (5 )
(Comment:en)
Adverse Event End Date and Time
Item
Adverse Event End Date and Time
datetime
C2826793 (UMLS CUI [1])
Adverse Event - Date and Time of Death
Item
Adverse Event - Date and Time of Death
datetime
C0877248 (UMLS CUI [1,1])
C1148348 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C1301931 (UMLS CUI [2,2])
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
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
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])
C1518404 (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])
C1518404 (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
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Item
Does this Adverse Event meet the definition of serious?
text
C1519255 (UMLS CUI [1])
Code List
Does this Adverse Event meet the definition of serious?
Item
Serious Adverse event Outcome
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Serious Adverse event Outcome
CL Item
Results in death (A)
CL Item
Is life-threatening (B)
CL Item
Requires hospitalisation or prolongati.on of existing hospitalisation (C)
CL Item
Results in disability/incapacity (D)
CL Item
Congenital anomaly/birth defect (E)
If other Serious Adverse Event Outcome, specify
Item
If other Serious Adverse Event Outcome, specify
text
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Item
Was this SAE caused by an activity related to study participation (e.g., procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])