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Elimination Criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Elimination Criteria
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Number
Beskrivning

Visit Number

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Date of Visit
Beskrivning

Date of Visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject Number
Beskrivning

Subject Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Elimination Criteria During the Study
Beskrivning

Elimination Criteria During the Study

Alias
UMLS CUI-1
C0680251
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Beskrivning

Use of investigational or non-registered product other than study vaccine

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C1521826
UMLS CUI [2,3]
C0042210
Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
Beskrivning

Chronic administration of immunosuppressants except topic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0332300
UMLS CUI [2,2]
C1522168
UMLS CUI [2,3]
C0038317
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.
Beskrivning

Administration of other vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0205394
Administration of immunoglobulins and/or any blood products during the study period.
Beskrivning

Administration of immunoglobulins or blood products

Datatyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0371802
Contraindication to Subsequent Vaccination
Beskrivning

Contraindication to Subsequent Vaccination

Alias
UMLS CUI-1
C1301624
UMLS CUI-2
C0042196
Hypersensitivity reaction due to the vaccine.
Beskrivning

Hypersensitivity to vaccine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1521826
UMLS CUI [1,3]
C0042210
IS
Beskrivning

Intussusception

Datatyp

boolean

Alias
UMLS CUI [1]
C0021933
Axillary temperature > 37.5°C or rectal temperature > 38.0°C.
Beskrivning

The following AEs constitute contraindications to administration of HRV vaccine or placebo at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0489749
UMLS CUI [2]
C1531924
°C
GE within 7 days preceding the study vaccine administration
Beskrivning

The following AEs constitute contraindications to administration of HRV vaccine or placebo at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE

Datatyp

boolean

Alias
UMLS CUI [1]
C0017160
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Similar models

Elimination Criteria

1 Formulär
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Item
Visit Number
integer
C1549755 (UMLS CUI [1])
Visit Number
Code List
Visit Number
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI-1)
Use of investigational or non-registered product other than study vaccine
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013230 (UMLS CUI [1])
C0332300 (UMLS CUI [2,1])
C1521826 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Chronic administration of immunosuppressants except topic
Item
Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
C0038317 (UMLS CUI [2,3])
Administration of other vaccine
Item
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])
C0205394 (UMLS CUI [1,2])
Administration of immunoglobulins or blood products
Item
Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
Item Group
Contraindication to Subsequent Vaccination
C1301624 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Hypersensitivity to vaccine
Item
Hypersensitivity reaction due to the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Intussusception
Item
IS
boolean
C0021933 (UMLS CUI [1])
Axillary or rectal temperature
Item
Axillary temperature > 37.5°C or rectal temperature > 38.0°C.
float
C0489749 (UMLS CUI [1])
C1531924 (UMLS CUI [2])
Gastroenteritis
Item
GE within 7 days preceding the study vaccine administration
boolean
C0017160 (UMLS CUI [1])
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