ID

44070

Description

Study part: Arm B / TACE. 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 (2)
  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 B / TACE SirTac NCT02936388

German

Arm B / TACE

1 forms  
  1. StudyEvent: ODM
    1. Arm B / TACE
Arm B / TACE
Description

Arm B / TACE

Alias
UMLS CUI-1
C1320290
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
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
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
Cisplatin Dosis
Description

dosage cisplatin

Data type

text

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0008838
Dosiseskalation erfolgt?
Description

Dose Escalation

Data type

boolean

Alias
UMLS CUI [1]
C3816728
Wenn nein, warum nicht?
Description

reason

Data type

text

Alias
UMLS CUI [1]
C0566251
EmboCept® S-Dosis:
Description

dosage

Data type

text

Measurement units
  • ml
Alias
UMLS CUI [1]
C0178602
ml
Applikationszeit:
Description

time medication

Data type

text

Measurement units
  • min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013227
min
EmboCept® S - Chemotherapie in Folge
Description

chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
EmboCept® S - Chemotherapie - Gemisch
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
EmboCept® S - als Abschlus
Description

Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
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
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Similar models

Arm B / TACE

1 forms
  1. StudyEvent: ODM
    1. Arm B / TACE
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Arm B / TACE
C1320290 (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 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])
Item
Katheterposition:
text
C1515974 (UMLS CUI [1,1])
C0085590 (UMLS CUI [1,2])
site catheter
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])
liver lobe
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])
Item
Cisplatin Dosis
text
C0178602 (UMLS CUI [1,1])
C0008838 (UMLS CUI [1,2])
dosage cisplatin
Code List
Cisplatin Dosis
CL Item
50mg (50mg)
CL Item
75mg (75mg)
CL Item
100mg (100mg)
Dose Escalation
Item
Dosiseskalation erfolgt?
boolean
C3816728 (UMLS CUI [1])
reason
Item
Wenn nein, warum nicht?
text
C0566251 (UMLS CUI [1])
dosage
Item
EmboCept® S-Dosis:
text
C0178602 (UMLS CUI [1])
time medication
Item
Applikationszeit:
text
C0040223 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
chemotherapy
Item
EmboCept® S - Chemotherapie in Folge
boolean
C0392920 (UMLS CUI [1])
Chemotherapy
Item
EmboCept® S - Chemotherapie - Gemisch
boolean
C0392920 (UMLS CUI [1])
Chemotherapy
Item
EmboCept® S - als Abschlus
boolean
C0392920 (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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