Event
Item
Event (diagnosis only, otherwise sign/symptom)
text
C1519255 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not Recovered/Not Resolved (3)
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Maximum Intensity
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the Serious AE
integer
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the Serious 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Investigational product(s) withdrawn (1)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)
Withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Relationship to investigational products
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0085978 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
integer
C1710056 (UMLS CUI [1])
Code List
Seriousness: Specify reason(s) for considering this a SAE, tick all that apply:
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)
Seriousness Other
Item
Seriousness: If other, specify:
text
C1710056 (UMLS CUI [1])
Item
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
integer
C0304229 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
If Investigational Product(s) was Stopped, Did the Reported Event(s) Recur After Further Investigational Product(s) were Administered?
CL Item
Unknown at this time (3)
CL Item
Not applicable (4)
Item
Possible Cause of SAE other than investigational Product(s), tick all that apply:
integer
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Possible Cause of SAE other than investigational Product(s), tick all that apply:
CL Item
Disease under study (1)
CL Item
Medical Condition(s) (record in nect section) (2)
CL Item
Lack of efficacy (3)
CL Item
Withdrawal of Investigational Product(s) (4)
CL Item
Concomitant medication (record) (5)
CL Item
Activity related to study participation (e.g. procedures) (6)
Possible Cause of SAE Other
Item
Possible Cause of SAE other than investigational Product(s), if other, specify:
text
C0015127 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
medical condition
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc. that can help explain the SAE
text
C0262926 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
medical condition date
Item
Date of Onset
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
medical condition presence
Item
Condition present at the time of the SAE?
boolean
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
medical condition occurence
Item
If no, Date of last occurence:
date
C0012634 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Risk Factors
Item
Other RELEVANT Risk Factors (e.g. smoking, alcohol, diet, drug abuse, accupational hazard) relevant to the SAE
text
C0035648 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Drug name
Item
Drug name (Trade Name preferred)
text
C0013227 (UMLS CUI [1])
Dose
Item
Dose
text
C3174092 (UMLS CUI [1])
Unit
Item
Unit
text
C1519795 (UMLS CUI [1])
Medication frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Taken Prior to Study
Item
Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Ongoing Medication
Item
Ongoing Medication?
boolean
C2826666 (UMLS CUI [1])
Reason for Medication
Item
Reason for Medication (e.g. Gastric Ulcer)
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Investigational Product
Item
Details of Investigational Product(s)
text
C0304229 (UMLS CUI [1])
Item
Was randomisation code broken at investigational site?
integer
C0304229 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Code List
Was randomisation code broken at investigational site?
CL Item
Not applicable (3)
Assessment
Item
Details of RELEVANT assessments.
text
C1516048 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Narrative Remarks
Item
Narrative Remarks (provide a brief narrative description of the SAE and details of tretment given).
text
C0947611 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])