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ID
13378
Beschreibung
Test Study
Stichworte
Versionen (3)
- 10.02.16 10.02.16 -
- 10.02.16 10.02.16 - Julian Varghese
- 11.02.16 11.02.16 -
Hochgeladen am
10. Februar 2016
DOI
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Lizenz
Creative Commons BY-NC 3.0
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SacBo PZ: Case Report Form AE Termination Signature Early Study Termination
SacBo PZ: Case Report Form AE Termination Signature Early Study Termination
Ähnliche Modelle
SacBo PZ: Case Report Form AE Termination Signature Early Study Termination
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Date of early study termination
Item
When was the study terminated?
date
C2718058 (UMLS CUI [1])
Repeal of consent
Item
Was the reason for early study termination the repeal of consent?
boolean
C0021430 (UMLS CUI [1])
Item
Did the patient become retrospectively ineligible by failing to meet the inclusion/exclusion criteria and if so what criterion was the reason for becoming ineligible?
text
C1516637 (UMLS CUI [1])
Code List
Did the patient become retrospectively ineligible by failing to meet the inclusion/exclusion criteria 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 )
Central venous catheter
Item
Does the patient receive a central venous catheter?
boolean
C1145640 (UMLS CUI [1])
Immunosuppression
Item
Did any kind of immunosuppression occur?
boolean
C0021079 (UMLS CUI [1])
Termination by the doctor
Item
Was the study early terminated by the doctor due to hypersensitivity reaction or any other severe complications?
boolean
C0020517 (UMLS CUI [1])
C0009566 (UMLS CUI [2])
C0009566 (UMLS CUI [2])
Comment
Item
Comment:
text
C0947611 (UMLS CUI [1])
Any other reason for early study termination
Item
Is there any other reason for early study termination?
boolean
C2718058 (UMLS CUI [1])
Comment
Item
Comment:
text
C0947611 (UMLS CUI [1])