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ID
13330
Description
Test Study
Keywords
Versions (2)
- 2/5/16 2/5/16 -
- 2/11/16 2/11/16 -
Copyright Holder
CC BY-NC 3.0
Uploaded on
February 5, 2016
DOI
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License
Creative Commons BY-NC 3.0
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SacBo TI: Case Report Form End Of Study Study Discontinuation
SacBo TI: Case Report Form End Of Study Study Discontinuation
- StudyEvent: ODM
Similar models
SacBo TI: Case Report Form End Of Study Study Discontinuation
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
End of Study
Item
Did the study end regularly?
boolean
C0444496 (UMLS CUI [1])
Early study termination
Item
Did the patient leave the study early?
boolean
C2718058 (UMLS CUI [1])
Date of end of study or of early study termination
Item
What date was the end of study or the study termination
date
C0011008 (UMLS CUI [1])
revocation of written consent
Item
Did the patient revoke written consent?
boolean
C0021430 (UMLS CUI [1,1])
C0680801 (UMLS CUI [1,2])
C0680801 (UMLS CUI [1,2])
Lost to follow up
Item
Was the patient lost to follow up?
boolean
C1302313 (UMLS CUI [1])
Item
Did the patient become retrospectively ineligible for this study and if so what criterion was the reason for becoming ineligible?
integer
C1512714 (UMLS CUI [1])
Code List
Did the patient become retrospectively ineligible for this study and if so what criterion was the reason for becoming ineligible?
CL Item
Adult (Inclusion1 )
CL Item
Patient physically and mentally fit (Inclusion5 )
CL Item
Patient hospitalized in study hospital (Inclusion2 )
CL Item
systemic antiobiotic treatment planned (>= 3 days) (Inclusion3 )
CL Item
Patient contractually capable (Inclusion4 )
CL Item
For women of child-bearing age: contraception (Inclusion6 )
CL Item
Informed consent obtained (Inclusion7 )
CL Item
Hypersensitivity to yeast and/or perenterol (Exclusion1 )
CL Item
Central venous catheterization (Exclusion2 )
CL Item
Immunosuppression (Exclusion3 )
CL Item
Currently having diarrhea and/or frequent diarrhea (Exclusion4 )
CL Item
Frequent use of perenterol or yomogi (7 days before start of study) (Exclusion5 )
CL Item
systemic antifungal treatment (Exclusion6 )
CL Item
systemic antibiotic treatment (6 weeks before start of study) (Exclusion7 )
CL Item
for women: pregnancy (Exclusion8 )
CL Item
for women: lactation (Exclusion9 )
CL Item
currently participating in another trial (Exclusion10 )
any other reason
Item
Was there any other reason for early study termination?
boolean
C2718058 (UMLS CUI [1])