ID

27864

Description

Study part: Adverse Event- Report. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

Keywords

Versions (1)
  1. 12/3/17 12/3/17 -
Copyright Holder

Charité – University of medicine Berlin

Uploaded on

December 3, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Event- Report SirTac NCT02936388

German

Adverse Event- Report

1 forms  
  1. StudyEvent: ODM
    1. Adverse Event- Report
ADVERSE EVENT REPORT
Description

ADVERSE EVENT REPORT

Alias
UMLS CUI-1
C0684224
UMLS CUI-2
C0877248
Patienten-ID:
Description

Patienten-ID

Data type

text

Alias
UMLS CUI [1]
C2348585
Random. Nr.:
Description

Random. Nr.

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
Adverse Event Beschreibung
Description

Adverse Event

Data type

text

Alias
UMLS CUI [1]
C0877248
Dauer des AE- Datum Beginn
Description

adverse event start date

Data type

date

Alias
UMLS CUI [1]
C2697888
Dauer des AE- Datum Ende
Description

adverse event end date

Data type

date

Alias
UMLS CUI [1]
C2697886
Weiter bestehend nach Studienende?
Description

ongoing

Data type

boolean

Alias
UMLS CUI [1]
C2826663
Schwerwiegend?
Description

severe

Data type

boolean

Alias
UMLS CUI [1]
C0205082
Intensität
Description

Intensity

Data type

integer

Alias
UMLS CUI [1]
C0522510
Therapie des Ereignisses?
Description

therapy adverse event

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0877248
Wenn ja, bitte kommentieren
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Ausgang des AE?
Description

outcome

Data type

integer

Alias
UMLS CUI [1]
C1705586
Kausalität
Description

relation

Data type

integer

Alias
UMLS CUI [1]
C0869014
Maßnahmen Prüfpräparat
Description

measures

Data type

integer

Alias
UMLS CUI [1]
C0087111
Ausgefüllt/bestätigt am:
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Name Prüfarzt
Description

investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift Prüfarzt
Description

investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Adverse Event- Report

1 forms
  1. StudyEvent: ODM
    1. Adverse Event- Report
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ADVERSE EVENT REPORT
C0684224 (UMLS CUI-1)
C0877248 (UMLS CUI-2)
Patienten-ID
Item
Patienten-ID:
text
C2348585 (UMLS CUI [1])
Random. Nr.
Item
Random. Nr.:
text
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Adverse Event
Item
Adverse Event Beschreibung
text
C0877248 (UMLS CUI [1])
adverse event start date
Item
Dauer des AE- Datum Beginn
date
C2697888 (UMLS CUI [1])
adverse event end date
Item
Dauer des AE- Datum Ende
date
C2697886 (UMLS CUI [1])
ongoing
Item
Weiter bestehend nach Studienende?
boolean
C2826663 (UMLS CUI [1])
severe
Item
Schwerwiegend?
boolean
C0205082 (UMLS CUI [1])
Item
Intensität
integer
C0522510 (UMLS CUI [1])
Intensity
Code List
Intensität
CL Item
leicht (1)
CL Item
mittel (3)
CL Item
schwer (3)
therapy adverse event
Item
Therapie des Ereignisses?
boolean
C0087111 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
comment
Item
Wenn ja, bitte kommentieren
text
C0947611 (UMLS CUI [1])
Item
Ausgang des AE?
integer
C1705586 (UMLS CUI [1])
outcome
Code List
Ausgang des AE?
CL Item
wiederhergestellt (1)
CL Item
im Begriff, wiederhergestellt (2)
CL Item
noch nicht wiederhergestellt (3)
CL Item
wiederhergestellt mit Folgeschäden (4)
CL Item
Tod (5)
CL Item
Unbekannt (6)
Item
Kausalität
integer
C0869014 (UMLS CUI [1])
relation
Code List
Kausalität
CL Item
gesichert (1)
CL Item
wahrscheinlich (2)
CL Item
möglich (3)
CL Item
unwahrscheinlich (4)
CL Item
kein Zusammenhang (5)
CL Item
nicht zu beurteilen (6)
Item
Maßnahmen Prüfpräparat
integer
C0087111 (UMLS CUI [1])
measures
Code List
Maßnahmen Prüfpräparat
CL Item
Prüfpräparat abgesetzt (1)
CL Item
Dosis verringert (2)
CL Item
Dosis erhöht (3)
CL Item
Keine Dosis- Änderung (4)
CL Item
Unbekannt (5)
CL Item
Nicht anwendbar (6)
date
Item
Ausgefüllt/bestätigt am:
date
C0011008 (UMLS CUI [1])
investigator name
Item
Name Prüfarzt
text
C2826892 (UMLS CUI [1])
investigator signature
Item
Unterschrift Prüfarzt
text
C2346576 (UMLS CUI [1])
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