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Elimination criteria

1 moduli  
  1. StudyEvent: ODM
    1. Elimination criteria
Administrative data
Descrizione

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descrizione

Subject number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Visit number
Descrizione

Visit number

Tipo di dati

text

Alias
UMLS CUI [1]
C1549755
Date of visit
Descrizione

Date of visit

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Elimination criteria during the study
Descrizione

Elimination criteria during the study

Alias
UMLS CUI-1
C0680251
UMLS CUI-2
C2347804
Pregnancy
Descrizione

Pregnancy

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s) during the study period
Descrizione

Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s)

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2347804
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C0205394
UMLS CUI [2,4]
C2347804
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
Descrizione

For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0205191
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study/control vaccine(s) and ending 30 days after (i.e. Days 0-29).
Descrizione

Administration of routine meningococcal, hepatitis B, inactivated influenza, diphteria/tetanus and/or diphteria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed if the subject is outside of the 30 days follow-up period of the previous dose.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C2347804
UMLS CUI [2,1]
C2368628
UMLS CUI [2,2]
C0205547
UMLS CUI [2,3]
C2347804
UMLS CUI [3]
C0700144
UMLS CUI [4]
C2240392
UMLS CUI [5]
C0021403
UMLS CUI [6]
C0058773
Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period.
Descrizione

Enrolment will be deferred until the subject is outside of specified window

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0021027
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0456388
UMLS CUI [3,2]
C1533734
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0456388
UMLS CUI [4,2]
C1533734
UMLS CUI [4,3]
C1301732
Newly diagnosed immunosuppressive condition, including human immunodeficiency virus (HIV) infection.
Descrizione

Newly diagnosed immunosuppressive condition

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C1518321
UMLS CUI [2,1]
C0019693
UMLS CUI [2,2]
C1518321
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Similar models

Elimination criteria

1 moduli
  1. StudyEvent: ODM
    1. Elimination criteria
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 2 (Month 1) (Visit 2)
CL Item
Visit 3 (Month 6) (Visit 3)
CL Item
Visit 4 (Month 7, Post vacc III) (Visit 4)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Elimination criteria during the study
C0680251 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s)
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study/control vaccine(s) during the study period
boolean
C0304229 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C2347804 (UMLS CUI [2,4])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
boolean
C0021081 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Administration of a vaccine not foreseen by the study protocol
Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study/control vaccine(s) and ending 30 days after (i.e. Days 0-29).
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
C2368628 (UMLS CUI [2,1])
C0205547 (UMLS CUI [2,2])
C2347804 (UMLS CUI [2,3])
C0700144 (UMLS CUI [3])
C2240392 (UMLS CUI [4])
C0021403 (UMLS CUI [5])
C0058773 (UMLS CUI [6])
Administration of immunoglobulins and/or any blood product
Item
Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study/ control vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0021027 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0456388 (UMLS CUI [3,1])
C1533734 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0456388 (UMLS CUI [4,1])
C1533734 (UMLS CUI [4,2])
C1301732 (UMLS CUI [4,3])
Newly diagnosed immunosuppressive condition
Item
Newly diagnosed immunosuppressive condition, including human immunodeficiency virus (HIV) infection.
boolean
C0021051 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0019693 (UMLS CUI [2,1])
C1518321 (UMLS CUI [2,2])
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