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Elimination Criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Elimination Criteria
Note
Beskrivning

Note

Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
Beskrivning

Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis

Datatyp

text

Elimination Criteria
Beskrivning

Elimination Criteria

Check all that apply
Beskrivning

Check all that apply

Datatyp

text

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Elimination Criteria

1 Formulär
  1. StudyEvent: ODM
    1. Elimination Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Note
Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
Item
Check the following criteria at each visit. If any criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis
text
Item Group
Elimination Criteria
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period. (1)
CL Item
Newly diagnosed immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, during the study period (2)
CL Item
Administration of a licensed vaaccine not foreseen in the study protocol during the study (30 days prior to the first vaccicnation until study end(Week 12)). (3)
CL Item
Chronic administration (defined as more than 14 days) of immunosuppresants 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.) (4)
CL Item
Administration of immunoglobulins and/or any blood products during the study period. (5)
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