ID

17521

Description

Study documentation part: Adverse events, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

Keywords

Versions (1)
  1. 9/21/16 9/21/16 -
Uploaded on

September 21, 2016

DOI

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License

Creative Commons BY-NC 3.0
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End form: Adverse events VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28

German

Adverse events

1 forms  
  1. StudyEvent: ODM
    1. Adverse events
Unerwünschte Ereignisse
Description

Unerwünschte Ereignisse

Alias
UMLS CUI-1
C0877248
Patienten-Nr.:
Description

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C1269815
Beschreibung des unerwünschten Ereignisses
Description

Adverse Events

Data type

text

Alias
UMLS CUI [1]
C0877248
Datum Beginn
Description

Adverse Event Onset Date

Data type

date

Alias
UMLS CUI [1]
C2985916
CTC-Schweregrad
Description

CTC AE grade

Data type

text

Alias
UMLS CUI [1]
C2985911
Auftreten
Description

Adverse Event Occurrence

Data type

text

Alias
UMLS CUI [1]
C2697887
Maßnahmen bzgl . Enoxaparin
Description

therapeutic measures Enoxaparin

Data type

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1879489
UMLS CUI [1,3]
C0206460
Zusammenhang mit Enoxaparin
Description

Conditionally Related to Intervention Enoxaparin

Data type

text

Alias
UMLS CUI [1,1]
C2347854
UMLS CUI [1,2]
C0206460
Klinischer Verlauf
Description

clinical course

Data type

text

Alias
UMLS CUI [1]
C0449259
Datum Ende
Description

Adverse Event End Date

Data type

date

Alias
UMLS CUI [1]
C2697886
schwerwiegendes UE
Description

Serious Adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Sonstiges
Description

Sonstige Ursachen des UEs und weitere Gegenmaßnahmen (z.B. symptomatische Behandlung, Hospitalisierung)

Data type

text

Alias
UMLS CUI [1]
C0205394
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Similar models

Adverse events

1 forms
  1. StudyEvent: ODM
    1. Adverse events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Unerwünschte Ereignisse
C0877248 (UMLS CUI-1)
Patient ID
Item
Patienten-Nr.:
integer
C1269815 (UMLS CUI [1])
Adverse Events
Item
Beschreibung des unerwünschten Ereignisses
text
C0877248 (UMLS CUI [1])
Adverse Event Onset Date
Item
Datum Beginn
date
C2985916 (UMLS CUI [1])
CTC AE grade
Item
CTC-Schweregrad
text
C2985911 (UMLS CUI [1])
Item
Auftreten
text
C2697887 (UMLS CUI [1])
Adverse Event Occurrence
Code List
Auftreten
CL Item
einmalig  (1)
CL Item
mehrmalig  (2)
CL Item
andauernd (3)
Item
Maßnahmen bzgl . Enoxaparin
text
C0087111 (UMLS CUI [1,1])
C1879489 (UMLS CUI [1,2])
C0206460 (UMLS CUI [1,3])
therapeutic measures Enoxaparin
Code List
Maßnahmen bzgl . Enoxaparin
CL Item
keine  (1)
CL Item
Dosiserhöhung  (2)
CL Item
Dosisreduktion  (3)
CL Item
zeitweise abgesetzt  (4)
CL Item
Abbruch (5)
Item
Zusammenhang mit Enoxaparin
text
C2347854 (UMLS CUI [1,1])
C0206460 (UMLS CUI [1,2])
Conditionally Related to Intervention Enoxaparin
Code List
Zusammenhang mit Enoxaparin
CL Item
gesichert  (1)
CL Item
wahrscheinlich  (2)
CL Item
möglich  (3)
CL Item
unwahrscheinlich  (4)
CL Item
keiner (5)
Item
Klinischer Verlauf
text
C0449259 (UMLS CUI [1])
clinical course
Code List
Klinischer Verlauf
CL Item
wiederhergestellt  (1)
CL Item
andauernd  (2)
CL Item
bleibender Schaden  (3)
CL Item
Missbildung (4)
CL Item
Tod (5)
Adverse Event End Date
Item
Datum Ende
date
C2697886 (UMLS CUI [1])
Serious Adverse Event
Item
schwerwiegendes UE
boolean
C1519255 (UMLS CUI [1])
other
Item
Sonstiges
text
C0205394 (UMLS CUI [1])
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