ID

44069

Description

Study part: Arm A / SIRT. 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

  1. 11/26/17 11/26/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

Charité – University of medicine Berlin

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0

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Arm A / SIRT SirTac NCT02936388

Arm A / SIRT

  1. StudyEvent: ODM
    1. Arm A / SIRT
Prätherapeutische Diagnostik
Description

Prätherapeutische Diagnostik

Alias
UMLS CUI-1
C0430022
Patienten-ID:
Description

Patienten-ID

Data type

text

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

Randomization number

Data type

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
Leber-Angiographie durchgeführt am
Description

date liver angiography

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C4039140
Tc 99 -MAA Scan durchgeführt am
Description

date Technetium Tc 99m

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0039416
SIRT (Selektive Interne Radiotherapie mit Yttrium-90 beladenen SIR-Spheres ® )
Description

SIRT (Selektive Interne Radiotherapie mit Yttrium-90 beladenen SIR-Spheres ® )

Alias
UMLS CUI-1
C1831994
Datum der Behandlung:
Description

date of therapy

Data type

date

Alias
UMLS CUI [1]
C3173309
Nummer der therapeutischen Sitzung:
Description

number of therapy

Data type

integer

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750480
SIR-Spheres ® microspheres vial number:
Description

vial number

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
Kalkulierte Dosis:
Description

dosage

Data type

float

Measurement units
  • GBq
Alias
UMLS CUI [1]
C0178602
GBq
Geplante Dosis:
Description

planned dosage

Data type

float

Measurement units
  • GBq
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C1301732
GBq
Implantinerte Dosis:
Description

dosage implanted

Data type

float

Measurement units
  • GBq
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0021102
GBq
Katheterposition:
Description

site catheter

Data type

text

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0085590
Welche Leberlappen wurde behandelt?
Description

liver lobe

Data type

text

Alias
UMLS CUI [1]
C0447541
Dauer der gesamten Behandlung:
Description

Therapy duration

Data type

text

Measurement units
  • min
Alias
UMLS CUI [1]
C0444921
min
Verabreichte Kontrastmitteldosis:
Description

dosage contrast media

Data type

text

Measurement units
  • ml
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0009924
ml
Art des KM:
Description

type of contrast media

Data type

text

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0009924
Verabreichte Begleitmedikation (z. B. Schmerzmittel, Antiemese, PPI, Steroide, Antibiotika):
Description

concomitant medication

Data type

text

Alias
UMLS CUI [1]
C2347852
Akute Nebenwirkungen
Description

Akute Nebenwirkungen

Alias
UMLS CUI-1
C0877248
Akute Nebenwirkungen:
Description

(innerhalb der ersten 24 Std.)

Data type

boolean

Alias
UMLS CUI [1]
C0877248
Kommentar:
Description

comment

Data type

text

Alias
UMLS CUI [1]
C0947611
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

Similar models

Arm A / SIRT

  1. StudyEvent: ODM
    1. Arm A / SIRT
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Prätherapeutische Diagnostik
C0430022 (UMLS CUI-1)
Patienten-ID
Item
Patienten-ID:
text
C2348585 (UMLS CUI [1])
Randomization number
Item
Random. Nr.:
text
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
date liver angiography
Item
Leber-Angiographie durchgeführt am
date
C0011008 (UMLS CUI [1,1])
C4039140 (UMLS CUI [1,2])
date Technetium Tc 99m
Item
Tc 99 -MAA Scan durchgeführt am
date
C0011008 (UMLS CUI [1,1])
C0039416 (UMLS CUI [1,2])
Item Group
SIRT (Selektive Interne Radiotherapie mit Yttrium-90 beladenen SIR-Spheres ® )
C1831994 (UMLS CUI-1)
date of therapy
Item
Datum der Behandlung:
date
C3173309 (UMLS CUI [1])
number of therapy
Item
Nummer der therapeutischen Sitzung:
integer
C0087111 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
vial number
Item
SIR-Spheres ® microspheres vial number:
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
dosage
Item
Kalkulierte Dosis:
float
C0178602 (UMLS CUI [1])
planned dosage
Item
Geplante Dosis:
float
C0178602 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
dosage implanted
Item
Implantinerte Dosis:
float
C0178602 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Item
Katheterposition:
text
C1515974 (UMLS CUI [1,1])
C0085590 (UMLS CUI [1,2])
Code List
Katheterposition:
CL Item
A. hep. prop. (A. hep. prop.)
C0226301 (UMLS CUI-1)
(Comment:de)
CL Item
A. hep. sin. (A. hep. sin.)
C0226302 (UMLS CUI-1)
(Comment:de)
CL Item
A. hep. dex. (A. hep. dex.)
C0226306 (UMLS CUI-1)
(Comment:de)
CL Item
superselektiv (superselektiv)
C3702378 (UMLS CUI-1)
(Comment:de)
Item
Welche Leberlappen wurde behandelt?
text
C0447541 (UMLS CUI [1])
Code List
Welche Leberlappen wurde behandelt?
CL Item
links (links)
CL Item
rechts (rechts)
CL Item
beide Lappen (beide Lappen)
Therapy duration
Item
Dauer der gesamten Behandlung:
text
C0444921 (UMLS CUI [1])
dosage contrast media
Item
Verabreichte Kontrastmitteldosis:
text
C0178602 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
type of contrast media
Item
Art des KM:
text
C0332307 (UMLS CUI [1,1])
C0009924 (UMLS CUI [1,2])
concomitant medication
Item
Verabreichte Begleitmedikation (z. B. Schmerzmittel, Antiemese, PPI, Steroide, Antibiotika):
text
C2347852 (UMLS CUI [1])
Item Group
Akute Nebenwirkungen
C0877248 (UMLS CUI-1)
Adverse Events
Item
Akute Nebenwirkungen:
boolean
C0877248 (UMLS CUI [1])
comment
Item
Kommentar:
text
C0947611 (UMLS CUI [1])
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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