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Elimination criteria during the study

1 Formulários  
Administrative data
Descrição

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descrição

day month year

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Descrição

Workbook number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Descrição

Visit type

Tipo de dados

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Elimination criteria during the study
Descrição

Elimination criteria during the study

Alias
UMLS CUI-1
C0680251
Administration of any other vaccine during the following periods: 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Day 0 up to Day 51; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
Descrição

Administration of other vaccine

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0042210
Chronic administration of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Descrição

chronis is defined as more than 14 days

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0205191
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0021081
UMLS CUI [2,1]
C0205191
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0005525
UMLS CUI [3,1]
C0683607
UMLS CUI [3,2]
C2065041
UMLS CUI [4,1]
C0683607
UMLS CUI [4,2]
C2064827
Administration of immunoglobulins and/or any blood products during the study period.
Descrição

Administration of immunoglobulins and/or any blood products

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0021027
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0456388
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
Descrição

Use of other investigational product

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0304229
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Similar models

Elimination criteria during the study

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Workbook number
Code List
Workbook number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit Day 21 (all WB's)  (1)
CL Item
Visit Day 30 (WB1+2) (2)
CL Item
Visit Day 42 (WB3+4) (3)
CL Item
Visit Day 51 (WB3+4) (4)
CL Item
Visit Month 6 (all WB's)  (5)
CL Item
Visit Month 6+7D (WB1+3) (6)
CL Item
Visit Month 6+21D (WB1+3) (7)
CL Item
Visit Month 6+30D (WB1+)3 (8)
CL Item
Visit Month 12 (all WB's)  (9)
CL Item
Visit Month 12+7D (WB2+4) (10)
CL Item
Visit Month 12+21D (WB2+4) (11)
CL Item
Visit Month 12+30D (WB2+4) (12)
CL Item
Visit Month 18 (all WB's)  (13)
Item Group
Elimination criteria during the study
C0680251 (UMLS CUI-1)
Administration of other vaccine
Item
Administration of any other vaccine during the following periods: 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Day 0 up to Day 51; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days.
boolean
C2368628 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0205191 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0021081 (UMLS CUI [1,3])
C0205191 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0005525 (UMLS CUI [2,3])
C0683607 (UMLS CUI [3,1])
C2065041 (UMLS CUI [3,2])
C0683607 (UMLS CUI [4,1])
C2064827 (UMLS CUI [4,2])
Administration of immunoglobulins and/or any blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C1533734 (UMLS CUI [1,1])
C0021027 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0456388 (UMLS CUI [2,2])
Use of other investigational product
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s).
boolean
C1524063 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
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