Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Receipt Date
Item
GSK Receipt Date
date
C2985846 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
SAE number
Item
SAE N°:
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
SAE number
Item
SAE N°:
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Initial report
Item
1 Initial report
boolean
C0684224 (UMLS CUI [1])
Additional information
Item
2 Additional info
boolean
C1546922 (UMLS CUI [1])
Additional information
Item
3 Additional info
boolean
C1546922 (UMLS CUI [1])
Additional information
Item
4 Additional info
boolean
C1546922 (UMLS CUI [1])
Event
Item
Event
text
C0877248 (UMLS CUI [1])
Start date
Item
Start date
date
C0808070 (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 /resolved with sequelae (4)
End date
Item
End date
date
C0806020 (UMLS CUI [1])
Item
Maximum intensity
integer
C0518690 (UMLS CUI [1,1])
C0877248 (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 SAE
integer
C2826626 (UMLS CUI [1])
Code List
Action taken with investigational product(s) as a result of the SAE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose not changed (2)
CL Item
Dose Interrupted (3)
CL Item
Not applicable (4)
subject withdrawal
Item
Did the subject withdraw from study as a result of this SAE?
boolean
C0422727 (UMLS CUI [1])
SAE study drug
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
boolean
C3828190 (UMLS CUI [1])
Item
Medical advice
integer
C1386497 (UMLS CUI [1])
CL Item
HO Hospitalisation (1)
CL Item
ER Emergency room (2)
CL Item
MD Medical doctor (3)
autopsy
Item
Was a post-mortem / autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Results in death
Item
Results in death
boolean
C0011065 (UMLS CUI [1])
life threatening
Item
Is life threatening
boolean
C2826244 (UMLS CUI [1])
hospitalisation
Item
Requires hospitalisation or prolongation of existing hospitalisation
boolean
C0019993 (UMLS CUI [1])
incapacity
Item
Results in disability / incapacity
boolean
C3176592 (UMLS CUI [1])
Congenital anomaly
Item
Congenital anomaly / birth defect in the offspring
boolean
C2826727 (UMLS CUI [1])
Other
Item
Other, specify:
text
C0205394 (UMLS CUI [1])
Item
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C0035020 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Code List
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
CL Item
Unknown at this time (Unknown at this time)
CL Item
Not applicable (Not applicable)
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])
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
Item
Other, specify:
text
C0205394 (UMLS CUI [1])
medical disorders allergies surgeries
Item
Specify any relevant past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Date of onset
Item
Date of onset
date
C0574845 (UMLS CUI [1])
Medical Condition SAE
Item
Condition present at time of SAE
boolean
C0012634 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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 factors family history occupation substance abuse disorder
Item
Specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE:
text
C0035648 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0028811 (UMLS CUI [1,3])
C0740858 (UMLS CUI [1,4])
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])
Frequency
Item
Frequency
text
C3476109 (UMLS CUI [1])
Route
Item
Route
text
C0013153 (UMLS CUI [1])
Concomitant Medications
Item
Taken prior to study?
boolean
C2347852 (UMLS CUI [1])
Date started
Item
Date started
date
C3173309 (UMLS CUI [1])
Date stopped
Item
Date stopped
date
C1531784 (UMLS CUI [1])
Ongoing medication
Item
Ongoing medication?
boolean
C2826666 (UMLS CUI [1])
Reason for medication
Item
Reason for medication
text
C0392360 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Vaccine
Item
Vaccine (specify mixed or separate)
text
C0042210 (UMLS CUI [1])
Dose
Item
Dose N°
text
C0178602 (UMLS CUI [1])
Lot
Item
Lot N°
text
C1115660 (UMLS CUI [1])
Route
Item
Route / site
text
C0013153 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Was randomization code broken at investigational site?
text
C0034656 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Code List
Was randomization code broken at investigational site?
CL Item
Not applicable (Not applicable)
test diagnosis SAE
Item
Provide details of any other tests/procedures which were carried out to diagnose or confirm the SAE, e.g. laboratory data with units and normal range:
text
C0392366 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
SAE treatment
Item
Provide a brief narrative description of the SAE and details of treatment given:
text
C1519255 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
follow-up information SAE
Item
Use this page to provide any additional details on the SAE not already captured on the previous pages:
text
C0807975 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Investigator signature
Item
Investigator’s signature:
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])