Anglais

Lab Tests (Blood Sample)

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Type de données

integer

Alias
UMLS CUI [1]
C2348585
Cohort
Description

Cohort

Type de données

integer

Alias
UMLS CUI [1]
C0599755
Visit Type
Description

For all cohorts, antibody determination is to be performed at Visits 1, 4, 5, 6, 8, 9 and 10. Timepoints of HIV-related testing are dependent on Cohort: For Cohort 1 (HIV-pos.), HIV-related testing is to be performed at Visits 1, 5, 8 and 10. For Cohort 2 (HIV-neg., exposed), HIV-related testing is to be performed at Visit 10 (and additionally 2 months post-cessation of breast feeding). For Cohort 3, 4, and 5 (HIV-neg., unexposed infants), HIV-related testing is to be performed at Visits 1 and 10. If clinically indicated, HIV-related testing can also be performed at any other Visit.

Type de données

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Description

Date of Visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Laboratory Tests - Antibody Determination
Description

Laboratory Tests - Antibody Determination

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3833453
Has a blood sample been taken for antibody determination?
Description

If yes, give date in next item if different from visit date In all cohorts, antibody determination is to be performed at Visits 1, 4, 5, 6, 8, 9, 10.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C3833453
Date of antibody blood sample been taken
Description

only if different from visit date

Type de données

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C3833453
UMLS CUI [1,3]
C0011008
Laboratory Tests - HIV
Description

Laboratory Tests - HIV

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0019693
Has a blood sample been taken for HIV related testing?
Description

If yes, give date in next item if different from visit date. For Cohort 1 (HIV-pos.), HIV-related testing is to be performed at Visits 1, 5, 8 and 10. For Cohort 2 (HIV-neg., exposed), HIV-related testing is to be performed at Visit 10 (and additionally 2 months post-cessation of breast feeding). For Cohort 3, 4, and 5 (HIV-neg., unexposed infants), HIV-related testing is to be performed at Visits 1 and 10.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0019693
Date of HIV-related blood sample been taken
Description

only if different from visit date

Type de données

date

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0019693
UMLS CUI [1,3]
C0011008
Laboratory Name
Description

prefilled with "Contract Laboratory Services"

Type de données

text

Alias
UMLS CUI [1]
C3258037
Lab Code
Description

for GSK use only prefilled with "000001"

Type de données

integer

Alias
UMLS CUI [1,1]
C0022877
UMLS CUI [1,2]
C0805701
CD4 test result
Description

to be performed if clinically indicated

Type de données

integer

Unités de mesure
  • cells/mm³
Alias
UMLS CUI [1]
C2698595
cells/mm³
CD4 test result
Description

to be performed if clinically indicated

Type de données

integer

Unités de mesure
  • %
Alias
UMLS CUI [1]
C2698595
%
HIV DNA test result
Description

To be performed if clinically indicated. At Visit 9, the HIV DNA test should only be used for infants < 18 months of age; for older subjects, an HIV antibody test should be used instead.

Type de données

text

Alias
UMLS CUI [1,1]
C1321876
UMLS CUI [1,2]
C0012854
UMLS CUI [1,3]
C1274040
HIV antibody test result
Description

test is mandatory at Visit 1 and 10 in Cohort 5 (= HIV-neg. unexposed, 2+1 schedule).

Type de données

text

Alias
UMLS CUI [1,1]
C2229753
UMLS CUI [1,2]
C1274040
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Similar models

Lab Tests (Blood Sample)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Cohort
integer
C0599755 (UMLS CUI [1])
Cohort
Code List
Cohort
CL Item
HIV-pos. (1)
CL Item
HIV-neg. exposed (2)
CL Item
HIV-neg. unexposed, 3+1 schedule (3)
CL Item
HIV-neg. unexposed, 3+0 schedule (4)
CL Item
HIV-neg. unexposed, 2+1 schedule (5)
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 2 (only if HIV-related testing is clinically indicated) (2)
CL Item
Visit 3 (only if HIV-related testing is clinically indicated) (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
CL Item
Visit 7 (only if HIV-related testing is clinically indicated) (7)
CL Item
Visit 8 (8)
CL Item
Visit 9 (9)
CL Item
Visit 10 (10)
CL Item
Unscheduled (2 months after cessation of breast feeding; HIV-neg., exposed cohort only) (11)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Laboratory Tests - Antibody Determination
C0022885 (UMLS CUI-1)
C3833453 (UMLS CUI-2)
Has a blood sample been taken for antibody determination?
Item
Has a blood sample been taken for antibody determination?
boolean
C0005834 (UMLS CUI [1,1])
C3833453 (UMLS CUI [1,2])
Date of antibody blood sample been taken
Item
Date of antibody blood sample been taken
date
C1277698 (UMLS CUI [1,1])
C3833453 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Laboratory Tests - HIV
C0022885 (UMLS CUI-1)
C0019693 (UMLS CUI-2)
Has a blood sample been taken for HIV related testing?
Item
Has a blood sample been taken for HIV related testing?
boolean
C0005834 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
Date of HIV-related blood sample been taken
Item
Date of HIV-related blood sample been taken
date
C1277698 (UMLS CUI [1,1])
C0019693 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Laboratory Name
Item
Laboratory Name
text
C3258037 (UMLS CUI [1])
Lab Code
Item
Lab Code
integer
C0022877 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
CD4 test result
Item
CD4 test result
integer
C2698595 (UMLS CUI [1])
CD4 test result
Item
CD4 test result
integer
C2698595 (UMLS CUI [1])
Item
HIV DNA test result
text
C1321876 (UMLS CUI [1,1])
C0012854 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
HIV DNA test result
Code List
HIV DNA test result
CL Item
Positive (P)
CL Item
Negative (N)
Item
HIV antibody test result
text
C2229753 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
HIV DNA test result
Code List
HIV antibody test result
CL Item
Positive (P)
CL Item
Negative (N)
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