Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Code
text
C0805701 (UMLS CUI [1])
CL Item
Prophylactic medication in anticipation of study vaccine reactions (P)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Tick box if continuing at end of study
integer
C1553904 (UMLS CUI [1,1])
C2983670 (UMLS CUI [1,2])
Code List
Tick box if continuing at end of study
CL Item
Continuing at end of study (1)
Non-Serious Adverse Experiences Description
Item
Non-Serious Adverse Experiences Description
text
C1518404 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experiences location
integer
C1518404 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Experiences location
CL Item
Local (injection site) (1)
CL Item
General (noninjection site) (2)
Date Non-Serious Adverse Experience Started
Item
Date Non-Serious Adverse Experience Started
date
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
integer
C1518404 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0687676 (UMLS CUI [1,4])
C0205253 (UMLS CUI [1,5])
Code List
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
CL Item
Start Date during immediate post-vaccination period specified in protocol (1)
Date Non-Serious Adverse Experience Stopped
Item
Date Non-Serious Adverse Experience Stopped
date
C1518404 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Non-Serious Adverse Experience Intensity
integer
C1518404 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Experience Intensity
Item
Non-Serious Adverse Experience Relationship
text
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Experience Relationship
Item
Non-Serious Adverse Experience Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Non-Serious Adverse Experience Outcome
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
SB Receipt Date
Item
SB Receipt Date
date
C2985846 (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])
Date and Time SAE Started
Item
Date and Time SAE Started
datetime
C1519255 (UMLS CUI [1,1])
C2697888 (UMLS CUI [1,2])
Date and Time SAE Stopped
Item
Date and Time SAE Stopped
datetime
C1519255 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Serious Adverse Experience Intensity
integer
C1519255 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Serious Adverse Experience Intensity
Item
Relationship to Study Vaccine
text
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Relationship to Study Vaccine
CL Item
Suspected (reasonable possibility) (SU)
Item
Serious Adverse Experience Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Code List
Serious Adverse Experience Outcome
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
Item
Action taken with respect to Study Vaccine
integer
C2826626 (UMLS CUI [1])
Code List
Action taken with respect to Study Vaccine
CL Item
Vaccination course interrupted/ restarted (2)
CL Item
Vaccination course stopped (3)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item
Specify reason(s) for considering this a serious adverse experience.
integer
C1519255 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Specify reason(s) for considering this a serious adverse experience.
CL Item
Life threatening (2)
CL Item
Disabling/incapacitating (3)
CL Item
Results in hospitalisation (excluding elective surgery or routine clinical procedures that are not the result of an adverse experience) (4)
CL Item
Results in prolonged hospitalisation (5)
CL Item
Congenital abnormality in offspring (6)
CL Item
Associated with cancer (7)
CL Item
Associated with overdose (8)
CL Item
Any event which is regarded by the investigator as serious or which would suggest any significant hazard, contra-indication, side effect or precaution that may be associated with the use of the study vaccine should be reported as serious adverse experience. (9)
If Serious Adverse Event is fatal, was autopsy performed?
Item
If Serious Adverse Event is fatal, was autopsy performed?
boolean
C1519255 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0004398 (UMLS CUI [1,3])
Item
The SAE is probably associated with :
integer
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
Code List
The SAE is probably associated with :
CL Item
Protocol design or procedures (but not to study vaccine), please specify (1)
CL Item
Another condition (eg, condition under study, intercurrent illness), please specify (2)
CL Item
Another drug, please specify (3)
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
Item
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
Item
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
SAE is associated with Another drug - Specification
Item
SAE is associated with Another drug - Specification
text
C1519255 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C234823 (UMLS CUI [1,4])
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Experience Course
If Experience Course is intermittent, record Number of episodes
Item
If Experience Course is intermittent, record Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C0205267 (UMLS CUI [1,3])
C4086638 (UMLS CUI [2])
Was subject withdrawn due to this specific SAE?
Item
Was subject withdrawn due to this specific SAE?
boolean
C2349954 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Remarks
Item
Remarks
text
C0947611 (UMLS CUI [1])
If applicable, was randomisation code broken at study site?
Item
If applicable, was randomisation code broken at study site?
boolean
C0034656 (UMLS CUI [1])
Randomisation / Study Vaccine Number:
Item
Randomisation / Study Vaccine Number:
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C0237753 (UMLS CUI [2,3])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Please PRINT name
Item
Please PRINT name
text
C2826892 (UMLS CUI [1])
Investigator Signature Date
Item
Investigator Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
SB Medical Monitor Signature:
Item
SB Medical Monitor Signature:
text
C2346576 (UMLS CUI [1])
Please PRINT name :
Item
Please PRINT name :
text
C2826892 (UMLS CUI [1])
SB Medical Monitor Signature Date
Item
SB Medical Monitor Signature Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Has the subject dropped out of the study ?
Item
Has the subject dropped out of the study ?
boolean
C2348568 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Item
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
text
Code List
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
CL Item
Serious adverse experience (complete the Serious Adverse Experience form), please specify AEGIS No. (SAE)
CL Item
Non-serious adverse experience (complete the Non-Serious Adverse Experiences section), please specify AE No. (AEX)
CL Item
Protocol violation, please specify (PTV)
CL Item
Consent withdrawal, not due to adverse experiences (CWS)
CL Item
Migration from study area (MIG)
CL Item
Lost to follow-up (LFU)
CL Item
Others, please specify (OTH)
If SAE, please specify AEGIS No.
Item
If SAE, please specify AEGIS No.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If Non-Serious Adverse Experience, please specify AE No.
Item
If Non-Serious Adverse Experience, please specify AE No.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
If Protocol violation, please specify.
Item
If Protocol violation, please specify.
text
C1709750 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
If others, please specify.
Item
If others, please specify.
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Date of last Contact
Item
Date of last Contact
date
C0805839 (UMLS CUI [1])
Was the subject in good condition at date of last contact ?
Item
Was the subject in good condition at date of last contact ?
boolean
C1142435 (UMLS CUI [1,1])
C0805839 (UMLS CUI [1,2])
Investigator Signature
Item
Investigator Signature
text
C2346576 (UMLS CUI [1])
Date of Signature
Item
Date of Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])