ID

30405

Description

Study part: Adverse Events. (1,3)-β-D-glucan-based diagnosis of invasive Candida infection versus culture-based diagnosis in patients with severe sepsis or septic shock and at high risk of invasive Candida infection (CandiSep). Provided by PD Dr. med. Frank Bloos, Ph.D. Clinic for Anesthesiology and Intensive care, University Clinic Jena.

Keywords

  1. 6/3/18 6/3/18 -
Copyright Holder

Clinic for Anesthesiology and Intensive care, University Clinic Jena

Uploaded on

June 3, 2018

DOI

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License

Creative Commons BY-NC 3.0

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Adverse Events CandiSep Anesthesiology and Intensive Care NCT02734550

Adverse Events

  1. StudyEvent: ODM
    1. Adverse Events
Adverse Events
Description

Adverse Events

Alias
UMLS CUI-1
C0877248
Patienten-ID:
Description

Patient ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Adverse Events aufgetreten?
Description

Adverse Events occurence

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2745955
Adverse Event Term
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Start Zeitpunkt
Description

Start date and time

Data type

datetime

Alias
UMLS CUI [1]
C3897500
Start Zeitpunkt- unbekannt
Description

Start date and time unknown

Data type

boolean

Alias
UMLS CUI [1,1]
C3897500
UMLS CUI [1,2]
C0439673
Stopp Zeitpunkt
Description

End date and time

Data type

datetime

Alias
UMLS CUI [1]
C2826793
Stopp Zeitpunkt
Description

End date and time

Data type

text

Alias
UMLS CUI [1]
C2826793
SAE?
Description

serious adverse event

Data type

integer

Alias
UMLS CUI [1]
C1519255
Intensität
Description

Severity of Adverse Event

Data type

integer

Alias
UMLS CUI [1]
C1710066
Kausalzusammenhang zum Fungitell®Test
Description

adverse event drug relationship

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0439849
Kausalzusammenhang zur Studienprozedur
Description

adverse event relationship study

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C0008972
Maßnahmen AE
Description

Therapy

Data type

integer

Alias
UMLS CUI [1]
C0087111
Ausgang
Description

outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586

Similar models

Adverse Events

  1. StudyEvent: ODM
    1. Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse Events
C0877248 (UMLS CUI-1)
Patient ID
Item
Patienten-ID:
text
C2348585 (UMLS CUI [1])
Item
Adverse Events aufgetreten?
integer
C0877248 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Code List
Adverse Events aufgetreten?
CL Item
nein (0)
CL Item
ja (1)
Adverse event
Item
Adverse Event Term
text
C0877248 (UMLS CUI [1])
Start date and time
Item
Start Zeitpunkt
datetime
C3897500 (UMLS CUI [1])
Start date and time unknown
Item
Start Zeitpunkt- unbekannt
boolean
C3897500 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
End date and time
Item
Stopp Zeitpunkt
datetime
C2826793 (UMLS CUI [1])
Item
Stopp Zeitpunkt
text
C2826793 (UMLS CUI [1])
Code List
Stopp Zeitpunkt
CL Item
AE andauernd (AE andauernd)
CL Item
Unbekannt (Unbekannt)
Item
SAE?
integer
C1519255 (UMLS CUI [1])
Code List
SAE?
CL Item
nein (0)
CL Item
ja (1)
Item
Intensität
integer
C1710066 (UMLS CUI [1])
Code List
Intensität
CL Item
leicht  (1)
CL Item
mittel  (2)
CL Item
schwer (3)
Item
Kausalzusammenhang zum Fungitell®Test
integer
C0877248 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
Code List
Kausalzusammenhang zum Fungitell®Test
CL Item
nein  (0)
CL Item
ja  (1)
CL Item
möglich (2)
Item
Kausalzusammenhang zur Studienprozedur
integer
C0877248 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
Code List
Kausalzusammenhang zur Studienprozedur
CL Item
nein  (0)
CL Item
ja  (1)
CL Item
möglich (2)
Item
Maßnahmen AE
integer
C0087111 (UMLS CUI [1])
Code List
Maßnahmen AE
CL Item
keine  (0)
CL Item
medikam. Therapie  (1)
CL Item
andere/nicht-medikam. Therapie (2)
Item
Ausgang
integer
C1705586 (UMLS CUI [1])
Code List
Ausgang
CL Item
wiederhergestellt  (1)
CL Item
wiederhergestellt mit bleibendem Schaden  (2)
CL Item
verbessert  (3)
CL Item
unverändert  (4)
CL Item
verschlechtert  (5)
CL Item
tödlich  (6)
CL Item
unbekannt (9)

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