Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item
Did the subject experience a serious adverse event during the study?
text
C1519255 (UMLS CUI [1])
Code List
Did the subject experience a serious adverse event during the study?
Item
If fatal, was a post-mortem/autopsy performed
text
C4274690 (UMLS CUI [1])
Code List
If fatal, was a post-mortem/autopsy performed
Event
Item
Event
text
C0877248 (UMLS CUI [1])
adverse event start date
Item
Start Date
date
C2697888 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
adverse event end date
Item
End Date
date
C2697886 (UMLS CUI [1])
Item
Maximum Intensity
text
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (X)
Item
Action taken with investigational product(s) as a result of the SAE
text
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Investigational Product(s) withdrawn (1)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 (X)
Item
Did the subject withdraw from study as a result of this SAE?
text
C1710677 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Did the subject withdraw from study as a result of this SAE?
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
patient dead
Item
[A] Results in death
boolean
C0011065 (UMLS CUI [1])
life threatening
Item
[B] Is life-threatening
boolean
C2826244 (UMLS CUI [1])
hospitalisation
Item
[C] Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
disability
Item
[D] Results in disability/incapacity
boolean
C0231170 (UMLS CUI [1])
congenital anomaly
Item
[E] Congenital anomaly/birth defect
boolean
C2826727 (UMLS CUI [1])
Other seriousness
Item
[F] Other, specify
boolean
C1710056 (UMLS CUI [1])
Other seriousness
Item
[F] Other, specify
text
C1710056 (UMLS CUI [1])
inadvertant administration
Item
If deliberate or inadvertant administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
text
C1536055 (UMLS CUI [1])
Item
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
integer
C0376495 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
If lnvestigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further lnvestigational Product(s) were Administered?
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Disease under study
Item
Disease under study
boolean
C0012634 (UMLS CUI [1])
Medical condition
Item
Medical condition(s)
boolean
C0012634 (UMLS CUI [1])
Lack of efficacy
Item
Lack of efficacy
boolean
C0235828 (UMLS CUI [1])
Withdrawal of investigational product
Item
Withdrawal of investigational products
boolean
C2349954 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Concomitant medication
Item
Concomitant medication
boolean
C2347852 (UMLS CUI [1])
Activity related to study participation
Item
Activity related to study participation (e.g. procedures)
boolean
C2348568 (UMLS CUI [1])
other cause sae
Item
Other, specify
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
other cause sae
Item
Other, specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
SAE causation
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Onset Date
Item
Date of Onset
date
C0574845 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
Item
Condition Present at Time of the SAE?
text
C3827351 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Condition Present at Time of the SAE?
Date of Last Occurrence
Item
If No, Date of Last Occurrence
date
C2745955 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
risk factor
Item
Other RELEVANT Risk Factors
text
C0035648 (UMLS CUI [1])
Drug Name
Item
Drug Name
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C2348328 (UMLS CUI [1])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
administration route
Item
Route
text
C0013153 (UMLS CUI [1])
Item
Taken Prior to Study?
text
C2826667 (UMLS CUI [1])
Code List
Taken Prior to Study?
concomitant medication start date
Item
Start Date
date
C2826734 (UMLS CUI [1])
concomitant medication end date
Item
Stop Date
date
C2826744 (UMLS CUI [1])
Item
Ongoing Medication?
text
C2826666 (UMLS CUI [1])
Code List
Ongoing Medication?
Reason for Medication
Item
Reason for Medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Double-Blind Therapy Start Date
Item
Double-Blind Therapy Start Date
date
C0013072 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Double-Blind Therapy End Date
Item
Double-Blind Therapy Stop Date
date
C0013072 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Open-Label Treatment Start Date
Item
Open-Label Treatment Start Date
date
C3640652 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Open-Label Treatment End Date
Item
Open-Label Treatment Stop Date
date
C3640652 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
assessment adverse event
Item
Details of RELEVANT Assessments
text
C1161049 (UMLS CUI [1])
SAE description
Item
Provide a brief narrative description of the SAE and details of treatment given
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])