Elimination Criteria during the Study

Administrative Data
Descrizione

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Subject Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Descrizione

Date of visit

Tipo di dati

date

Alias
UMLS CUI [1]
C1320303
Visit number
Descrizione

Visit number

Tipo di dati

integer

Alias
UMLS CUI [1]
C1549755
Elimination Criteria during the Study
Descrizione

Elimination Criteria during the Study

Alias
UMLS CUI-1
C0680251
(A) up to visit 3, previous confirmed occurence of RV GE.
Descrizione

previous RV GE

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0035870
UMLS CUI [1,2]
C0017160
(B) Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Descrizione

Diarrhea

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0011991
(C) Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
Descrizione

investigational or non-registered product (drug or vaccine)

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
(D) Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
Descrizione

undefined item

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021081
(E) Administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
Descrizione

Vaccine administration within 14 days before/after study vaccination nor forseen in study protocol

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
(F) Administration of immunoglobulins and/or any blood products during the study period.
Descrizione

Immunoglobulins or blood products during study

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0371802
(G) Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Descrizione

immunosuppressive or immunodeficient condition, including HIV infection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0019693

Similar models

Elimination Criteria during the Study

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])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Code List
Visit number
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
Item Group
Elimination Criteria during the Study
C0680251 (UMLS CUI-1)
previous RV GE
Item
(A) up to visit 3, previous confirmed occurence of RV GE.
boolean
C0035870 (UMLS CUI [1,1])
C0017160 (UMLS CUI [1,2])
Diarrhea
Item
(B) Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
boolean
C0011991 (UMLS CUI [1])
investigational or non-registered product (drug or vaccine)
Item
(C) Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
boolean
C0304229 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
undefined item
Item
(D) Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1])
Vaccine administration within 14 days before/after study vaccination nor forseen in study protocol
Item
(E) Administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Immunoglobulins or blood products during study
Item
(F) Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
immunosuppressive or immunodeficient condition, including HIV infection
Item
(G) Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019693 (UMLS CUI [3])