ID

25672

Descripción

Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity Study ID: 100382 Clinical Study ID: 100382 Study Title: Evaluate the Effect of Several Risk Factors That Are Likely to Influence the Immunogenicity of GSK Biologicals’ Combined Hepatitis A & B Vaccine, vs Separately Administered Monovalent Hepatitis A and Hepatitis B Vaccines Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289731 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Palabras clave

Versiones (3)
  1. 9/9/17 9/9/17 -
  2. 9/9/17 9/9/17 -
  3. 9/9/17 9/9/17 -
Titular de derechos de autor

glaxoSmithKline

Subido en

9 de septiembre de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity

Inglés

Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity

1 formularios  
Check for study continuation
Descripción

Check for study continuation

Alias
UMLS CUI-1
C2348568
Did the subject come at visit 2?
Descripción

study continuation status

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason.
Descripción

Reson for non continuation

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0566251
Please specify SAE N°
Descripción

Number of SAE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Other, please specify
Descripción

e.g.: consent withdrawal, Protocol violation, ...

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Please tick who took the decision.
Descripción

Decision taker

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0679006
Urine sample (Pregnancy test – HCG)
Descripción

Urine sample (Pregnancy test – HCG)

Alias
UMLS CUI-1
C0200354
Has a urine sample been taken?
Descripción

Urine sample pregnancy dipstick

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C1880076
Date of urine sample
Descripción

Please complete only if different from visit date.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C2371162
UMLS CUI [1,2]
C0011008
Result
Descripción

Result of pregnancy dipstick

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0427777
Pre-vaccination assessment
Descripción

Pre-vaccination assessment

Alias
UMLS CUI-1
C0220825
UMLS CUI-2
C0005903
UMLS CUI-3
C0042196
Temperature
Descripción

Temperature

Tipo de datos

float

Unidades de medida
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Route
Descripción

Route of temperature measurement

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Vaccine administration - Twinrix group
Descripción

Vaccine administration - Twinrix group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0593953
Date of vaccination
Descripción

Please complete only if different from visit date.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1115436
UMLS CUI [1,2]
C0593953
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0593953
Has the study vaccine been administered according to protocol?
Descripción

Administration according to Protocol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0593953
Side
Descripción

Side of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0593953
Site
Descripción

Anatomic site of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0593953
Route
Descripción

Route of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0593953
Comments
Descripción

Comments vaccine administration

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0593953
Vaccine administration - Engerix-B and Havrix group
Descripción

Vaccine administration - Engerix-B and Havrix group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0116078
UMLS CUI-3
C0700881
Date of vaccination
Descripción

Please complete only if different from visit date.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1115436
UMLS CUI [1,2]
C0700881
UMLS CUI [1,3]
C0116078
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0116078
Has the study vaccine been administered according to protocol?
Descripción

Left Deltoid I.M.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0116078
Side
Descripción

Side of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0116078
Site
Descripción

Anatomic site of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0116078
Route
Descripción

Route of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0116078
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0700881
Has the study vaccine been administered according to protocol?
Descripción

Right Deltoid I.M.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0700881
Side
Descripción

Side of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0700881
Site
Descripción

Anatomic site of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0700881
Route
Descripción

Route of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0700881
Comments
Descripción

Comments vaccine administration

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0116078
UMLS CUI [1,4]
C0700881
Vaccine administration - Hbvaxpro and Vaqta group
Descripción

Vaccine administration - Hbvaxpro and Vaqta group

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0379473
UMLS CUI-3
C1445761
Date of vaccination
Descripción

Please complete only if different from visit date.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1115436
UMLS CUI [1,2]
C0379473
UMLS CUI [1,3]
C1445761
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1445761
Has the study vaccine been administered according to protocol?
Descripción

Left Deltoid I.M.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C1445761
Side
Descripción

Side of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C1445761
Site
Descripción

Anatomic site of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C1445761
Route
Descripción

Route of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C1445761
Vaccine administration
Descripción

Vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0379473
Has the study vaccine been administered according to protocol?
Descripción

Right Deltoid I.M.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0379473
Side
Descripción

Side of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0441987
UMLS CUI [1,3]
C0379473
Site
Descripción

Anatomic site of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0042210
UMLS CUI [1,3]
C0379473
Route
Descripción

Route of vaccine administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0449444
UMLS CUI [1,3]
C0379473
Comments
Descripción

Comments vaccine administration

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0379473
UMLS CUI [1,4]
C1445761
Vaccine administration - Vaccination 1
Descripción

Vaccine administration - Vaccination 1

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0474232
Why not administered?
Descripción

Please tick the ONE most appropriate category for non administration.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0566251
Please specify SAE N°
Descripción

Number of SAE

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Other, please specify
Descripción

e.g.: consent withdrawal, Protocol violation, ...

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C1521902
Please tick who took the decision
Descripción

decision taker

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C2368628
Serious adverse event - Post-vaccination observation
Descripción

Serious adverse event - Post-vaccination observation

Alias
UMLS CUI-1
C1519255
UMLS CUI-2
C2368628
UMLS CUI-3
C0687676
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
Descripción

IMMEDIATE POST-VACCINATION OBSERVATION If any serious adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0687676
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Similar models

Visit 2 - GSK Study: Hepatitis A & B Vaccine vs. monovalent Hep. A and Hep. B vaccines and risk factors likely to influence their immunogenicity

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Check for study continuation
C2348568 (UMLS CUI-1)
Item
Did the subject come at visit 2?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
study continuation status
Code List
Did the subject come at visit 2?
CL Item
Yes, please complete the following pages. (1)
CL Item
No, please complete below. (2)
Item
Please tick the ONE most appropriate reason.
text
C2348568 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reson for non continuation
Code List
Please tick the ONE most appropriate reason.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Other, please specify (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Other reason for non-participation
Item
Other, please specify
text
C2348568 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision.
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision taker
Code List
Please tick who took the decision.
CL Item
Investigator’s decision  (1)
CL Item
Subject's decision (2)
Item Group
Urine sample (Pregnancy test – HCG)
C0200354 (UMLS CUI-1)
Item
Has a urine sample been taken?
integer
C0200354 (UMLS CUI [1,1])
C1880076 (UMLS CUI [1,2])
Urine sample
Code List
Has a urine sample been taken?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (not of childbearing potential or male) (3)
Date of urine sample
Item
Date of urine sample
date
C2371162 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0430056 (UMLS CUI [1,1])
C0427777 (UMLS CUI [1,2])
Result of pregnancy dipstick
Code List
Result
CL Item
Negative (1)
CL Item
Positive (2)
Item Group
Pre-vaccination assessment
C0220825 (UMLS CUI-1)
C0005903 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route
CL Item
Axillary (A)
CL Item
Oral (O)
Item Group
Vaccine administration - Twinrix group
C2368628 (UMLS CUI-1)
C0593953 (UMLS CUI-2)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0593953 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
CL Item
Twinrix Vaccine (1)
CL Item
Replacement vial (*)  (2)
CL Item
Wrong vial number (*)  (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Anatomic site of vaccine administration
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Route of vaccine administration
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0593953 (UMLS CUI [1,3])
Item Group
Vaccine administration - Engerix-B and Havrix group
C2368628 (UMLS CUI-1)
C0116078 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0700881 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0116078 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
CL Item
Engerix-B Vaccine (1)
CL Item
Replacement vial (*)  (2)
CL Item
Wrong vial number (*)  (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Anatomic site of vaccine administration
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
Route of vaccine administration
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0700881 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
CL Item
Havrix Vaccine (1)
CL Item
Replacement vial (*)  (2)
CL Item
Wrong vial number (*)  (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
Anatomic site of vaccine administration
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0700881 (UMLS CUI [1,3])
Route of vaccine administration
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0116078 (UMLS CUI [1,3])
C0700881 (UMLS CUI [1,4])
Item Group
Vaccine administration - Hbvaxpro and Vaqta group
C2368628 (UMLS CUI-1)
C0379473 (UMLS CUI-2)
C1445761 (UMLS CUI-3)
Date of vaccination
Item
Date of vaccination
date
C1115436 (UMLS CUI [1,1])
C0379473 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C1445761 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
CL Item
HB VAX PRO (1)
CL Item
Replacement vial (*)  (2)
CL Item
Wrong vial number (*)  (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Anatomic site of vaccine administration
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C1445761 (UMLS CUI [1,3])
Route of vaccine administration
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
Vaccine administration
integer
C2368628 (UMLS CUI [1,1])
C0379473 (UMLS CUI [1,2])
Vaccine administration
Code List
Vaccine administration
CL Item
Vaqta Vaccine (1)
CL Item
Replacement vial (*)  (2)
CL Item
Wrong vial number (*)  (3)
CL Item
Not administered (**) (please complete below) (4)
Administration according to Protocol
Item
Has the study vaccine been administered according to protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
Item
Side
integer
C2368628 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
Side of vaccine administration
Code List
Side
CL Item
Left (1)
CL Item
Right (2)
Item
Site
integer
C1515974 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
Anatomic site of vaccine administration
Code List
Site
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
Item
Route
integer
C2368628 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
Route of vaccine administration
Code List
Route
CL Item
I.M. (1)
CL Item
S.C. (2)
Comments vaccine administration
Item
Comments
text
C0947611 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0379473 (UMLS CUI [1,3])
C1445761 (UMLS CUI [1,4])
Item Group
Vaccine administration - Vaccination 1
C2368628 (UMLS CUI-1)
C0474232 (UMLS CUI-2)
Item
Why not administered?
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
vaccine administration
Code List
Why not administered?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Other, please specify (OTH)
Number of SAE
Item
Please specify SAE N°
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Other reason for non administration of vaccine
Item
Other, please specify
text
C2368628 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Item
Please tick who took the decision
integer
C0679006 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
decision taker
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Serious adverse event - Post-vaccination observation
C1519255 (UMLS CUI-1)
C2368628 (UMLS CUI-2)
C0687676 (UMLS CUI-3)
Item
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
text
C1519255 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
undefined item
Code List
Has the subject experienced any serious adverse events within one month (minimum 30 days) post- vaccination?
CL Item
Information not retrievable (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, fill in the Serious Adverse Event form. (Y)
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