Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
Early wthdrawal (1)
Item
Did the patient complete the study according to the protocol?
text
C1707478 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
Code List
Did the patient complete the study according to the protocol?
Item
If no completion of study, please mark the primary cause of withdrawal.
integer
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Code List
If no completion of study, please mark the primary cause of withdrawal.
CL Item
Adverse experience (please complete AE page) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
Other reason
Item
If other reason for withdrawal, please specify
text
C3840932 (UMLS CUI [1])
Person Reporting SAE
Item
Person Reporting SAE
text
C0008961 (UMLS CUI [1])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Serious Adverse Experience
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
Results in death
Item
Results in death
boolean
C0392360 (UMLS CUI [1,1])
C0011065 (UMLS CUI [1,2])
Life threatening
Item
Life threatening
boolean
C0392360 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
Results in hospitalisation or prolongation of existing hospitalisation
Item
Results in hospitalisation or prolongation of existing hospitalisation
boolean
C0392360 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Results in disability/incapacity
Item
Results in disability/incapacity
boolean
C0392360 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
Congenital abnormality/birth defect
Item
Congenital abnormality/birth defect
boolean
C0392360 (UMLS CUI [1,1])
C0000768 (UMLS CUI [1,2])
Other reason
Item
Other reason
boolean
C0392360 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other reason, specification
Item
If other reason, please specify
text
C0422727 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Outcome of SAE
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
Number of episodes
Item
Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Investigational Drug
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
Item
Did the SAE abate?
text
C1519255 (UMLS CUI [1,1])
C3853704 (UMLS CUI [1,2])
Code List
Did the SAE abate?
Item
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
text
C0420247 (UMLS CUI [1])
Code List
If study medication was interrupted, stopped or dose reduced: Was study medication reintroduced (or dose increased)?
Item
If yes, did SAE recur?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Code List
If yes, did SAE recur?
Item
Relationship to Investigational Drug
integer
C1518404 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Possibly related (2)
CL Item
Probably unrelated (3)
Item
The SAE is probably associated with:
integer
Code List
The SAE is probably associated with:
CL Item
Protocol design or procedures (1)
CL Item
Another condition (eg, condition under study, intercurrent illness) (2)
Another drug
Item
If another drug, please specify
text
C1115771 (UMLS CUI [1])
Item
Corrective Therapy
text
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Corrective Therapy
Item
Was patient withdrawn due to this specific AE?
text
C0422727 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Code List
Was patient withdrawn due to this specific AE?
Test
Item
Test
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Value
Item
Value
text
C1522609 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
Item
If applicable, was randomisation code broken at investigational site?
text
C3897778 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Code List
If applicable, was randomisation code broken at investigational site?
Randomisation Number
Item
Randomisation Number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Investigators Signature
Item
Investigators Signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C0011008 (UMLS CUI [1])
Investigator's Name
Item
Investigator's Name
text
C2826892 (UMLS CUI [1])
Medical Monitor’s Signature
Item
SB Medical Monitor’s Signature
text
C2346576 (UMLS CUI [1])
Medical Monitor's Name
Item
Medical Monitor's Name
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of signature
Item
Date of signature
date
C0807937 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])