Center Number
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient number
Item
Patient number
integer
C1830427 (UMLS CUI [1])
GSK Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Person Reporting SAE
Item
Person Reporting SAE (Please print clearly)
text
C0008961 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AEGIS Number
Item
AEGIS Number
integer
C0237753 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
datetime
C2826806 (UMLS CUI [1])
End Date and Time
Item
End Date and Time (If ongoing please leave blank)
datetime
C2826793 (UMLS CUI [1])
Item
Outcome If patient died, please complete Form D
integer
C1705586 (UMLS CUI [1])
Code List
Outcome If patient died, please complete Form D
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
CL Item
Intermittent ( 1)
Experience Course
Item
If intermittent please specify No. of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C1710066 (UMLS CUI [1])
Code List
Intensity (maximum)
CL Item
Mild 2=Moderate 3=Severe (1)
Item
Action Taken with Respect to Investigational Drug
integer
C2826626 (UMLS CUI [1])
Code List
Action Taken with Respect to Investigational Drug
CL Item
None 2=Dose reduced 3=Dose increased 4=Drug interrupted/restarted 5=Drug stopped (1)
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
Related 2=Possibly related 3=Probably unrelated 4=Unrelated (1)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Patient withdrawal
Item
Was patient withdrawn due to this specific AE?
boolean
C1710677 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious AE. Mark all that apply.
integer
C1519255 (UMLS CUI [1])
Code List
Specify reason(s) for considering this a serious AE. Mark all that apply.
CL Item
results in death (1)
CL Item
life threatening (2)
CL Item
results in hospitalization or prolongation of existing hospitalization (3)
CL Item
results in disability/incapacity (4)
CL Item
congenital abnormality/birth defect (5)
CL Item
other (see definition) (6)
Abatement of SAE
Item
Did the SAE abate?
boolean
C1519255 (UMLS CUI [1,1])
C0547047 (UMLS CUI [1,2])
Product reintroduction
Item
Was investigational product reintroduced (or dose increased)?
boolean
C0376495 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Recurrence of SAE
Item
If you answered the previous question with yes, did SAE recur?
boolean
C0877248 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
Item
Assessment The SAE is probably associated with:
integer
C0085978 (UMLS CUI [1,1])
C1710056 (UMLS CUI [1,2])
Code List
Assessment The SAE is probably associated with:
CL Item
Protocol design or procedures (but not to study drug): Please specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ (1)
CL Item
Another condition (eg, condition under study, intercurrent illness): Please specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ (2)
CL Item
Another drug: Please specify _ _ _ _ _ _ _ _ _ _ _ _ _ _ (3)
Laboratory Data
Item
Relevant Laboratory Data: Test
text
C0022885 (UMLS CUI [1])
Laboratory Data
Item
Relevant Laboratory Data: Date
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory Data
Item
Relevant Laboratory Data: Value
float
C0022885 (UMLS CUI [1])
C0587081 (UMLS CUI [2])
Laboratory Data
Item
Relevant Laboratory Data: Units
text
C0022885 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Laboratory Data
Item
Relevant Laboratory Data: Normal Range
float
C0022885 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Remarks
Item
Remarks (Please provide a brief narrative description of the SAE, attaching extra pages eg. hospital discharge summary if necessary)
text
C1519255 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Randomization code
Item
If applicable, was randomization code broken at investigational site?
boolean
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Randomization Number
Item
Randomization Number (please do NOT enter the container number):
integer
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Investigator’s Signature
Item
Investigator’s Signature (confirming that the above data are accurate and complete)
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's 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
Item
Date
date
C0011008 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
C1521743 (UMLS CUI [1,3])
Monitor's Name
Item
Please PRINT Name:
text
C0027365 (UMLS CUI [1,1])
C1708968 (UMLS CUI [1,2])
Cause of Death
Item
Certified Cause of Death
text
C0007465 (UMLS CUI [1])
Date of death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Post-mortem
Item
Was a post-mortem carried out?
boolean
C0004398 (UMLS CUI [1])
Post-mortem findings
Item
If ‘Yes’ please summarise findings (include diagnosis):
text
C0004398 (UMLS CUI [1])
Physician’s Signature
Item
Reporting Physician’s Signature
text
C0807938 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Orthostatic vital signs
integer
C0518766 (UMLS CUI [1])
Code List
Orthostatic vital signs
CL Item
After 10 minutes semi-supine (1)
CL Item
After erect for 1 minute (2)
Time Vitals Taken
Item
Time Vitals Taken
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure
Item
Blood pressure systolic/diastolic
integer
C0005823 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Time of last dose of study medication
Item
Time of last dose of study medication prior to the Week 12 Visit or the Early Withdrawal Visit:
time
C0946444 (UMLS CUI [1])
Date and time of last meal
Item
Date and time of last meal prior to ECG Visit:
datetime
C0578574 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of in-clinic study medication dose
Item
Time of in-clinic study medication dose:
time
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])