ID

36040

Beskrivning

Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Nyckelord

Versioner (3)
  1. 2019-03-15 2019-03-15 -
  2. 2019-03-16 2019-03-16 -
  3. 2019-04-10 2019-04-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565)

Engelsk

Concomitant Vaccination; Medication; Non-Serious Adverse Experiences; Serious Adverse Experiences; Study Conclusion;

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Beskrivning

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Trade Name
Beskrivning

Trade Name

Datatyp

text

Alias
UMLS CUI [1]
C2360065
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Medication
Beskrivning

Medication

Alias
UMLS CUI-1
C0013227
Trade/ Generic Name
Beskrivning

Trade/ Generic Name

Datatyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0592502
Medical Indication
Beskrivning

Medical Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Code
Beskrivning

Code

Datatyp

text

Alias
UMLS CUI [1]
C0805701
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Tick box if continuing at end of study
Beskrivning

Tick box if continuing at end of study

Datatyp

integer

Alias
UMLS CUI [1,1]
C1553904
UMLS CUI [1,2]
C2983670
Non-Serious Adverse Experiences
Beskrivning

Non-Serious Adverse Experiences

Alias
UMLS CUI-1
C1518404
Non-Serious Adverse Experiences Description
Beskrivning

Non-Serious Adverse Experiences Description

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0678257
Non-Serious Adverse Experiences location
Beskrivning

Non-Serious Adverse Experiences location

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0450429
Date Non-Serious Adverse Experience Started
Beskrivning

Date Non-Serious Adverse Experience Started

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol
Beskrivning

Non-Serious Adverse Experience Start Date during immediate post-vaccination period specified in protocol

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0808070
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0687676
UMLS CUI [1,5]
C0205253
Date Non-Serious Adverse Experience Stopped
Beskrivning

Date Non-Serious Adverse Experience Stopped

Datatyp

date

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0806020
Non-Serious Adverse Experience Intensity
Beskrivning

Non-Serious Adverse Experience Intensity

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1710066
Non-Serious Adverse Experience Relationship
Beskrivning

Non-Serious Adverse Experience Relationship

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0439849
Non-Serious Adverse Experience Outcome
Beskrivning

Non-Serious Adverse Experience Outcome

Datatyp

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C1705586
Serious Adverse Experiences
Beskrivning

Serious Adverse Experiences

Alias
UMLS CUI-1
C1519255
SB Receipt Date
Beskrivning

SB Receipt Date

Datatyp

date

Alias
UMLS CUI [1]
C2985846
Person Reporting SAE
Beskrivning

Person Reporting SAE

Datatyp

text

Alias
UMLS CUI [1]
C0008961
AEGIS Number
Beskrivning

AEGIS Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C0600091
Serious Adverse Experience
Beskrivning

Serious Adverse Experience

Datatyp

text

Alias
UMLS CUI [1]
C1519255
Date and Time SAE Started
Beskrivning

Date and Time SAE Started

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2697888
Date and Time SAE Stopped
Beskrivning

If ongoing please leave blank

Datatyp

datetime

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1519255
Serious Adverse Experience Intensity
Beskrivning

Serious Adverse Experience Intensity

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0518690
Relationship to Study Vaccine
Beskrivning

Relationship to Study Vaccine

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0439849
Serious Adverse Experience Outcome
Beskrivning

Serious Adverse Experience Outcome

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1705586
Action taken with respect to Study Vaccine
Beskrivning

Action taken with respect to Study Vaccine

Datatyp

integer

Alias
UMLS CUI [1]
C2826626
Corrective Therapy
Beskrivning

If ’yes’, record details in the Concomitant Medication section

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Specify reason(s) for considering this a serious adverse experience.
Beskrivning

Mark all that apply.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0392360
If Serious Adverse Event is fatal, was autopsy performed?
Beskrivning

If Serious Adverse Event is fatal, was autopsy performed?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0004398
The SAE is probably associated with :
Beskrivning

The SAE is probably associated with :

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification
Beskrivning

SAE is associated with Protocol design or procedures (but not to study vaccine) - Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0184661
UMLS CUI [1,4]
C2348235
SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification
Beskrivning

SAE is associated with Another condition (eg, condition under study, intercurrent illness) - Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0012634
UMLS CUI [1,4]
C2348235
SAE is associated with Another drug - Specification
Beskrivning

SAE is associated with Another drug - Specification

Datatyp

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C2348235
Experience Course
Beskrivning

Experience Course

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
If Experience Course is intermittent, record Number of episodes
Beskrivning

If Experience Course is intermittent, record Number of episodes

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C0205267
UMLS CUI [2]
C4086638
Was subject withdrawn due to this specific SAE?
Beskrivning

Was subject withdrawn due to this specific SAE?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2349954
UMLS CUI [1,2]
C1519255
Serious Adverse Experiences - Relevant Laboratory Data
Beskrivning

Serious Adverse Experiences - Relevant Laboratory Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0022885
Test
Beskrivning

Test

Datatyp

text

Alias
UMLS CUI [1]
C0022885
Date of Test
Beskrivning

Date of Test

Datatyp

date

Alias
UMLS CUI [1]
C2826247
Test Value
Beskrivning

Test Value

Datatyp

text

Alias
UMLS CUI [1]
C0587081
Units
Beskrivning

Units

Datatyp

text

Alias
UMLS CUI [1]
C1519795
Normal Range
Beskrivning

Normal Range

Datatyp

text

Alias
UMLS CUI [1]
C0086715
Serious Adverse Experiences - Relevant Laboratory Data
Beskrivning

Serious Adverse Experiences - Relevant Laboratory Data

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C0022885
Remarks
Beskrivning

Please provide a brief narrative description of the serious adverse experience, attaching extra pages eg, hospital discharge summary if necessary.

Datatyp

text

Alias
UMLS CUI [1]
C0947611
If applicable, was randomisation code broken at study site?
Beskrivning

If applicable, was randomisation code broken at study site?

Datatyp

boolean

Alias
UMLS CUI [1]
C0034656
Randomisation / Study Vaccine Number:
Beskrivning

Randomisation / Study Vaccine Number:

Datatyp

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C0237753
Investigator Signature
Beskrivning

Confirming that the above data are accurate and complete.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Please PRINT name
Beskrivning

Please PRINT name

Datatyp

text

Alias
UMLS CUI [1]
C2826892
Investigator Signature Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
SB Medical Monitor Signature:
Beskrivning

SB Medical Monitor Signature:

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Please PRINT name :
Beskrivning

Please PRINT name :

Datatyp

text

Alias
UMLS CUI [1]
C2826892
SB Medical Monitor Signature Date
Beskrivning

SB Medical Monitor Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Study Conclusion
Beskrivning

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Has the subject dropped out of the study ?
Beskrivning

A drop out is a subject who did not come back for the concluding visit foreseen in the protocol.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0457454
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
Beskrivning

If the subject has dropped out of the study, mark the ONE most appropriate category for drop out

Datatyp

text

Alias
UMLS CUI [1,1]
C1444662
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C2348568
If SAE, please specify AEGIS No.
Beskrivning

If SAE, please specify AEGIS No.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0600091
UMLS CUI [1,4]
C2348235
If Non-Serious Adverse Experience, please specify AE No.
Beskrivning

If Non-Serious Adverse Experience, please specify AE No.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0600091
UMLS CUI [1,4]
C2348235
If Protocol violation, please specify.
Beskrivning

If Protocol violation, please specify.

Datatyp

text

Alias
UMLS CUI [1,1]
C1709750
UMLS CUI [1,2]
C2348235
If others, please specify.
Beskrivning

If others, please specify.

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Date of last Contact
Beskrivning

Date of last Contact

Datatyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject in good condition at date of last contact ?
Beskrivning

If no, please give details within the Adverse Experiences section

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1142435
UMLS CUI [1,2]
C0805839
Investigator Signature
Beskrivning

I certify that I have reviewed the data in this case report form and that all information is complete and accurate.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date of Signature
Beskrivning

Date of Signature

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Tillbaka till toppen

Similar models

Concomitant Vaccination; Medication; Non-Serious Adverse Experiences; Serious Adverse Experiences; Study Conclusion;

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Trade Name
Item
Trade Name
text
C2360065 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade/ Generic Name
Item
Trade/ Generic Name
text
C2360065 (UMLS CUI [1,1])
C0592502 (UMLS CUI [1,2])
Medical Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Code
text
C0805701 (UMLS CUI [1])
Code
Code List
Code
CL Item
Prophylactic medication in anticipation of study vaccine reactions (P)
CL Item
Therapeutic (T)
CL Item
Chronic (C)
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])
Tick box if continuing at end of study
Code List
Tick box if continuing at end of study
CL Item
Continuing at end of study (1)
Item Group
Non-Serious Adverse Experiences
C1518404 (UMLS CUI-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])
Non-Serious Adverse Experiences location
Code List
Non-Serious Adverse Experiences location
CL Item
Local (injection site) (1)
CL Item
General (noninjection site) (2)
CL Item
Left (3)
CL Item
Right (4)
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])
Start Date during immediate post-vaccination period specified in protocol
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])
Intensity
Code List
Non-Serious Adverse Experience Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Non-Serious Adverse Experience Relationship
text
C1518404 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
Non-Serious Adverse Experience Relationship
Code List
Non-Serious Adverse Experience Relationship
CL Item
Not related (NR)
CL Item
Unlikely (UL)
CL Item
Suspected (SU)
CL Item
Probable (PB)
Item
Non-Serious Adverse Experience Outcome
text
C1518404 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Non-Serious Adverse Experience Outcome
Code List
Non-Serious Adverse Experience Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item Group
Serious Adverse Experiences
C1519255 (UMLS CUI-1)
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])
Serious Adverse Experience Intensity
Code List
Serious Adverse Experience Intensity
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Relationship to Study Vaccine
text
C0304229 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Relationship to Study Vaccine
Code List
Relationship to Study Vaccine
CL Item
Not related (NR)
CL Item
Unlikely (UL)
CL Item
Suspected (reasonable possibility) (SU)
CL Item
Probable (PB)
Item
Serious Adverse Experience Outcome
integer
C1519255 (UMLS CUI [1,1])
C1705586 (UMLS CUI [1,2])
Serious Adverse Experience Outcome
Code List
Serious Adverse Experience Outcome
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Ongoing at subject study conclusion (3)
CL Item
Died (4)
CL Item
Unknown (5)
Item
Action taken with respect to Study Vaccine
integer
C2826626 (UMLS CUI [1])
Action taken with respect to Study Vaccine
Code List
Action taken with respect to Study Vaccine
CL Item
None (1)
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])
Specify reason(s) for considering this a serious adverse experience.
Code List
Specify reason(s) for considering this a serious adverse experience.
CL Item
Fatal (1)
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])
The SAE is probably associated with :
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])
C2348235 (UMLS CUI [1,4])
Item
Experience Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Experience Course
Code List
Experience Course
CL Item
Intermittent (1)
CL Item
Constant (2)
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])
Item Group
Serious Adverse Experiences - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Test
Item
Test
text
C0022885 (UMLS CUI [1])
Date of Test
Item
Date of Test
date
C2826247 (UMLS CUI [1])
Test Value
Item
Test Value
text
C0587081 (UMLS CUI [1])
Units
Item
Units
text
C1519795 (UMLS CUI [1])
Normal Range
Item
Normal Range
text
C0086715 (UMLS CUI [1])
Item Group
Serious Adverse Experiences - Relevant Laboratory Data
C1519255 (UMLS CUI-1)
C0022885 (UMLS CUI-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])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-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
C1444662 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
If the subject has dropped out of the study, mark the ONE most appropriate category for drop out
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])
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