ID

30405

Beschrijving

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.

Trefwoorden

  1. 03-06-18 03-06-18 -
Houder van rechten

Clinic for Anesthesiology and Intensive care, University Clinic Jena

Geüploaded op

3 juni 2018

DOI

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Licentie

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
Beschrijving

Adverse Events

Alias
UMLS CUI-1
C0877248
Patienten-ID:
Beschrijving

Patient ID

Datatype

text

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

Adverse Events occurence

Datatype

integer

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

Adverse event

Datatype

text

Alias
UMLS CUI [1]
C0877248
Start Zeitpunkt
Beschrijving

Start date and time

Datatype

datetime

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

Start date and time unknown

Datatype

boolean

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

End date and time

Datatype

datetime

Alias
UMLS CUI [1]
C2826793
Stopp Zeitpunkt
Beschrijving

End date and time

Datatype

text

Alias
UMLS CUI [1]
C2826793
SAE?
Beschrijving

serious adverse event

Datatype

integer

Alias
UMLS CUI [1]
C1519255
Intensität
Beschrijving

Severity of Adverse Event

Datatype

integer

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

adverse event drug relationship

Datatype

integer

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

adverse event relationship study

Datatype

integer

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

Therapy

Datatype

integer

Alias
UMLS CUI [1]
C0087111
Ausgang
Beschrijving

outcome

Datatype

integer

Alias
UMLS CUI [1]
C1705586

Similar models

Adverse Events

  1. StudyEvent: ODM
    1. Adverse Events
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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