Person Reporting Serious Adverse Event
Item
Person Reporting Serious Adverse Experience
text
C1519255 (UMLS CUI [1,1])
C0335038 (UMLS CUI [1,2])
Serious Adverse Event
Item
Serious Adverse Experience
text
C1519255 (UMLS CUI [1])
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
integer
C1705586 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Experience Course
integer
C1519255 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
Number of episodes of adverse event
Item
Number of episodes
integer
C1519255 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Intensity (maximum)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Investigational Drug
CL Item
[1] b [2] b [3] b [4] b (1)
CL Item
Dose increased (3)
CL Item
Drug interrupted/restarted (4)
Item
Relationship to Investigational Drug
text
C1519255 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Investigational Drug
CL Item
Possibly related (6)
CL Item
Probably unrelated (7)
Item
Corrective Therapy
integer
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Corrective Therapy
Patient withdrawn due to serious adverse event
Item
Was patient withdrawn due to this specific SAE ?
boolean
C0422727 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS number
Item
AEGIS number
text
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Adverse event results in death
Item
Does the adverse experience result in death?
boolean
C1320832 (UMLS CUI [1])
Adverse experience is life threatening
Item
Is the adverse experience life threatening?
boolean
C1517874 (UMLS CUI [1])
serious adverse experience results in hospitalisation or prolongation of existing hospitalisation?
Item
Does the serious adverse experience results in hospitalisation or prolongation of existing hospitalisation?
boolean
C1519255 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
serious adverse experience result in disability or incapacity
Item
Does the serious adverse experience result in disability or incapacity?
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C3176592 (UMLS CUI [2,2])
serious adverse event result in congenital abnormality or birth defect
Item
Does the serious adverse event result in congenital abnormality or birth defect?
boolean
C1519255 (UMLS CUI [1,1])
C1546948 (UMLS CUI [1,2])
other reason for serious adverse event
Item
Is there another reason for categorisation to serious adverse experience?
boolean
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
other reason for serious adverse event
Item
If there is another reason for categorisation to serious adverse experience, please specify.
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
abatement of adverse event
Item
Did the serious adverse experience abate?
boolean
C1519255 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Item
Was study medication reintroduced (or dose increased)?
integer
C0304229 (UMLS CUI [1,1])
C1611744 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0580673 (UMLS CUI [2,2])
Code List
Was study medication reintroduced (or dose increased)?
CL Item
not applicable (9)
Item
If yes, did the serious adverse experience recur?
integer
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Code List
If yes, did the serious adverse experience recur?
CL Item
not applicable (9)
SAE association with study protocol or procedures
Item
The serious adverse event is probably associated with the protocol design or procedures (but not to study drug).
boolean
C1519255 (UMLS CUI [1,1])
C1514572 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0199171 (UMLS CUI [2,2])
specify association with study protocol or procedures
Item
Please specify association with study protocol or procedures.
text
C1519255 (UMLS CUI [1,1])
C1514572 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0199171 (UMLS CUI [2,2])
SAE associated with another condition
Item
The serious adverse experience is probably associated with another condition.
boolean
C1519255 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other condition associated with SAE
Item
If the serious adverse experience is probably associated with another condition, please specify the condition.
text
C1519255 (UMLS CUI [1,1])
C0348080 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
SAE associated with another drug
Item
The serious adverse experience is associated with another drug.
boolean
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other drug associated with SAE
Item
If the serious adverse experience is associated with another drug, please specify.
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Relevant laboratory test 2
Item
Relevant laboratory test 2
text
C0022885 (UMLS CUI [1])
Date of laboratory test 2
Item
Date of laboratory test 2
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 2
Item
Value of laboratory test 2
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 2
Item
Unit of laboratory test 2
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 2
Item
Normal range of laboratory test 2
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Relevant laboratory test 3
Item
Relevant laboratory test 3
text
C0022885 (UMLS CUI [1])
Date of laboratory test 3
Item
Date of laboratory test 3
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 3
Item
Value of laboratory test 3
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 3
Item
Unit of laboratory test 3
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 3
Item
Normal range of laboratory test 3
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Relevant laboratory test 1
Item
Relevant laboratory test 1
text
C0022885 (UMLS CUI [1])
Relevant laboratory test 4
Item
Relevant laboratory test 4
text
C0022885 (UMLS CUI [1])
Date of laboratory test 1
Item
Date of laboratory test 1
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Laboratory test date 4
Item
Laboratory test date 4
date
C0011008 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
laboratory test result 1
Item
Value of laboratory test 1
float
C0587081 (UMLS CUI [1])
laboratory test result 4
Item
Laboratory test value 4
float
C0587081 (UMLS CUI [1])
Unit of laboratory test 1
Item
Unit of laboratory test 1
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Unit of laboratory test 4
Item
Unit of laboratory test 4
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Normal range of laboratory test 1
Item
Normal range of laboratory test 1
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Normal range of laboratory test 4
Item
Normal range of laboratory test 4
text
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
SAE Remarks
Item
Remarks
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
If applicable, was randomisation code broken at investigational site?
Item
If applicable, was randomisation code broken at investigational site?
boolean
C3897778 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Randomisation Number
Item
Randomisation Number (please do NOT enter the container number):
integer
C2986235 (UMLS CUI [1])
investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
Please PRINT Name
text
C2826892 (UMLS CUI [1])
GSK Medical Monitor’s Signature
Item
GSK Medical Monitor’s Signature
text
C1519316 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Date of GSK Medical Monitor’s Signature
Item
Date of GSK Medical Monitor’s Signature
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1708968 (UMLS CUI [1,3])
GSK Medical Monitor’s name
Item
Please PRINT Name
text
C1547383 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])