Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Centre number
Item
Centre number
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Country
Item
Country
text
C0454664 (UMLS CUI [1])
Treatment Number
Item
Treatment Number
integer
C1522541 (UMLS CUI [1])
SAE Report Number
Item
SAE Report Number
integer
C3897642 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
GSK receipt date
Item
GSK receipt date
date
C1519255 (UMLS CUI [1,1])
C2985846 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
Item
Report type
integer
C3897642 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Event
Item
Event
text
C1519255 (UMLS CUI [1])
SAE Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
SAE Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered / resolved with sequelae (4)
SAE End date
Item
End date
date
C0806020 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Maximum intensity
text
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
Code List
Maximum intensity
CL Item
Not applicable (X)
Item
Action taken with investigational product(s) as a result of the SAE
text
C1704758 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
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Investigational product(s) withdrawn (1)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 (X)
Item
Did the subject withdraw from study as a result of SAE?
text
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Code List
Did the subject withdraw from study as a result of SAE?
CL Item
Yes, please complete the Study Conclusion page in the CRF of the subject and tick SAE as reason for withdrawal. (Y)
Item
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Is there a reasonable possibility that the SAE may have been caused by the investigational product?
Item
Medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Medically attended visit
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Doctor (MD)
Item
If fatal, was a post-mortem/autopsy performed?
text
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Code List
If fatal, was a post-mortem/autopsy performed?
CL Item
Yes, summarize findings in Section 11 Narrative Remarks of this SAE form. (Y)
SAE Results in death
Item
Specify reason(s) for considering this a SAE. 1. Results in death
boolean
C1705232 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE is life threatening
Item
Specify reason(s) for considering this a SAE. 2. Is life threatening
boolean
C1517874 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE requires or prolongs hospitalization
Item
Specify reason(s) for considering this a SAE. 3. Requires hospitalisation or prolongation of existing hospitalisation.
boolean
C2826664 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0745041 (UMLS CUI [2,2])
Hospitalisation: Date of admission
Item
Hospitalisation: Date of admission
date
C0806429 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Hospitalisation: Date of discharge
Item
Hospitalisation: Date of discharge
date
C2710998 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
SAE results in disability / incapacity
Item
Specify reason(s) for considering this a SAE. 4. Results in disability / incapacity
boolean
C1519255 (UMLS CUI [1,1])
C0231170 (UMLS CUI [1,2])
SAE causes Congenital anomaly / birth defect in the offspring
Item
Specify reason(s) for considering this a SAE. 5. Congenital anomaly / birth defect in the offspring
boolean
C0000768 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Other Reason for SAE
Item
Specify reason(s) for considering this a SAE. 6. Other reason (clinically significant / intervention required), specify
boolean
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Other Reason for SAE
Item
Specify reason(s) for considering this a SAE. 6. Other reason (clinically significant / intervention required), specify
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
Item
If investigational product was stopped, did the reported event(s) recur after further investigational product(s) were administered?
text
C1519255 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
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 (U)
CL Item
Not applicable (A)
Possible cause of SAE other than investigational product: Disease under study
Item
Possible cause of SAE other than investigational product: Disease under study (not applicable for prophylactic vaccine studies)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0012634 (UMLS CUI [1,5])
C0347984 (UMLS CUI [1,6])
C0008976 (UMLS CUI [1,7])
Possible cause of SAE other than investigational product: Medical condition
Item
Possible cause of SAE other than investigational product: Medical condition(s) (record in Section 6)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C4745084 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Lack of efficacy
Item
Possible cause of SAE other than investigational product: Lack of efficacy
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0235828 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Withdrawal of investigational product
Item
Possible cause of SAE other than investigational product: Withdrawal of investigational product
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2349954 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])
Possible cause of SAE other than investigational product: Concomitant medication
Item
Possible cause of SAE other than investigational product: Concomitant medication (Record in Section 8)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2347852 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Activity related to study participation
Item
Possible cause of SAE other than investigational product: Activity related to study participation (e.g. procedures)
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C2348568 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Other
Item
Possible cause of SAE other than investigational product: Other, specify
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Possible cause of SAE other than investigational product: Other
Item
Possible cause of SAE other than investigational product: Other, specify
text
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1705847 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Medical disorders relevant for SAE
Item
Specify any RELEVANT past or current medical disorders, allergies, surgeries, etc., that can help explain the SAE
text
C0012634 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Date of onset of medical condition
Item
Date of onset
date
C0012634 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Condition present at time of SAE
text
C0012634 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
Code List
Condition present at time of SAE
Date of last occurrence of medical condition
Item
If No, date of last occurrence
date
C0012634 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Family or social history relevant to SAE
Item
Specify any family or social history (smoking, diet, drug abuse, occupational hazard) relevant to the SAE
text
C0241889 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C3714536 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
C1519384 (UMLS CUI [3])
C0013146 (UMLS CUI [4])
C0337074 (UMLS CUI [5])
Drug name Concomitant Medication
Item
Drug name (Trade name preferred)
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Concomitant Medication Dose
Item
Dose
text
C2826811 (UMLS CUI [1])
Concomitant Medication Unit
Item
Unit
text
C2826646 (UMLS CUI [1])
Concomitant Medication Frequency
Item
Frequency
text
C2826654 (UMLS CUI [1])
Concomitant Medication Route
Item
Route
text
C2826730 (UMLS CUI [1])
Item
Taken prior to study?
text
C2826667 (UMLS CUI [1])
Code List
Taken prior to study?
Concomitant Medication Date started
Item
Date started
date
C2826734 (UMLS CUI [1])
Concomitant Medication Date stopped
Item
Date stopped
date
C2826744 (UMLS CUI [1])
Concomitant Medication Reason for medication
Item
Reason for medication
text
C2826696 (UMLS CUI [1])
Vaccine name
Item
Vaccine name (in case of multiple vaccination, please specify if vaccines were administered mixed or separately)
text
C0042210 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
Vaccine Dose Number
Item
Dose N°
text
C0042210 (UMLS CUI [1,1])
C1115464 (UMLS CUI [1,2])
Vaccine Lot Number
Item
Lot N°
text
C0042210 (UMLS CUI [1,1])
C1115660 (UMLS CUI [1,2])
Vaccine Route / site
Item
Route / site
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
Vaccine Date of administration
Item
Date of administration
date
C0011008 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Item
Was treatment blind broken at investigational site?
text
C3897431 (UMLS CUI [1])
Code List
Was treatment blind broken at investigational site?
CL Item
Not applicable (A)
Details of tests/procedures to diagnose/confirm 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
C0022885 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0011900 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE
Item
Narrative remarks: description of signs/symptoms and details of TREATMENT given for SAE
text
C1519255 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2981656 (UMLS CUI [2,2])
SAE additional / follow-up information
Item
Use this page to provide any additional details on the SAE not already captured on the previous pages.
text
C1524062 (UMLS CUI [1,1])
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [2,1])
C1533716 (UMLS CUI [2,2])
C1519255 (UMLS CUI [2,3])
Item
Report Type
integer
C0585733 (UMLS CUI [1])
CL Item
Initial report (1)
CL Item
First follow-up (2)
CL Item
Second follow-up (3)
CL Item
Third follow-up (4)
Investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator's name
Item
Investigator's name (print)
text
C2826892 (UMLS CUI [1])