ID

21514

Description

HD16 NCT Nr.: NCT00736320 HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET. This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). HD17 NCT Nr.: NCT01356680 HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma.This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS). HD18 NCT Nr.: NCT00515554 HD18 for Advanced Stages in Hodgkins Lymphoma. This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS. Permission granted by: Andreas Engert, M.D. Chairman, German Hodgkin Study Group Professor for Internal Medicine Hematology & Oncology University Hospital of Cologne Department of Internal Medicine I Kerpener Str. 62 D-50924 Köln Phone: +49-221-478-5933/5966 Fax: +49-221-478-3778 a.engert@uni-koeln.de

Keywords

Versions (5)
  1. 4/24/17 4/24/17 -
  2. 4/25/17 4/25/17 -
  3. 5/3/17 5/3/17 -
  4. 11/14/18 11/14/18 - Sarah Riepenhausen
  5. 3/15/21 3/15/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 25, 2017

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

German Hodgkin Study Group Study HD16/HD17/HD18 Treatment discontinuation form G6AB

German

Deutsche Hodgkin Studiengruppe: G6AB Therapieabbruchbogen

1 forms  
Formularkopf
Description

Formularkopf

Stempel des einsendenden Instituts
Description

Stamp of participating institution

Data type

text

Alias
UMLS CUI [1]
C2347449
Telefonnummer des einsendenden Instituts (bitte mit Durchwahl)
Description

Phone number of participating institution

Data type

integer

Alias
UMLS CUI [1,1]
C2347449
UMLS CUI [1,2]
C1515258
Adresse der verantwortlichen Studienzentrale
Description

Address of responsible study center

Data type

text

Patientenname
Description

Patient Name

Data type

text

Alias
UMLS CUI [1]
C1299487
Geburtsname
Description

Patient birth name

Data type

text

Alias
UMLS CUI [1]
C1549652
Geburtsdatum
Description

Birth Date

Data type

date

Alias
UMLS CUI [1]
C0421451
Adresse des Patienten
Description

Patient address

Data type

text

Alias
UMLS CUI [1]
C0421449
Studien ID
Description

Study ID

Data type

integer

Alias
UMLS CUI [1]
C2826693
Bogen ID
Description

CRF Indentificator

Data type

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C0600091
Case ID
Description

Case ID

Data type

integer

Alias
UMLS CUI [1,1]
C1698493
UMLS CUI [1,2]
C0600091
Therapieabbruchbogen
Description

Therapieabbruchbogen

Abbruch der Studientherapie am
Description

Date of discontinuation

Data type

date

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0011008
Grund der Abbruchs
Description

Reason for discontinuation

Data type

integer

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
Therapiestatus
Description

Treatment status

Data type

integer

Alias
UMLS CUI [1]
C0749659
Weitere Dokumentation: falls Abbruch weil Hodgkin Diagnose nicht bestätigt wurde-vollständige Dokumentation bis Studienabbruch ohne anschließende Nachsorge. Alle übrigen Fälle- vollständige Dokumentation bis Studienabbruch mit anschließender Nachsorge
Description

Further documentation

Data type

text

Alias
UMLS CUI [1]
C0175636
Datum
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Unterschrift
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Back to the top of the page

Similar models

Deutsche Hodgkin Studiengruppe: G6AB Therapieabbruchbogen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Formularkopf
Stamp of participating institution
Item
Stempel des einsendenden Instituts
text
C2347449 (UMLS CUI [1])
Phone number of participating institution
Item
Telefonnummer des einsendenden Instituts (bitte mit Durchwahl)
integer
C2347449 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Address of responsible study center
Item
Adresse der verantwortlichen Studienzentrale
text
Patient Name
Item
Patientenname
text
C1299487 (UMLS CUI [1])
Patient birth name
Item
Geburtsname
text
C1549652 (UMLS CUI [1])
Birth Date
Item
Geburtsdatum
date
C0421451 (UMLS CUI [1])
Patient address
Item
Adresse des Patienten
text
C0421449 (UMLS CUI [1])
Item
Studien ID
integer
C2826693 (UMLS CUI [1])
Study ID
Code List
Studien ID
CL Item
HD16 (1)
CL Item
HD17 (2)
CL Item
HD18 (3)
CRF Indentificator
Item
Bogen ID
integer
C1516308 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Case ID
Item
Case ID
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
Therapieabbruchbogen
Date of discontinuation
Item
Abbruch der Studientherapie am
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Grund der Abbruchs
integer
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
Reason for discontinuation
Code List
Grund der Abbruchs
CL Item
Progress unter Therapie (PRO) (1)
CL Item
Unzureichendes Ansprechen (NC) (2)
CL Item
Toxizität unter Therapie (3)
CL Item
Patient lehnt weitere Chemotherapie ab (4)
CL Item
Patient lehnt weitere Radiotherapie ab (5)
CL Item
Patient zieht Einverständnis zur Studienteilnahme zurück (schriftl. Mitteilung des Pat. einholen und zuschicken) (6)
CL Item
Therapierelevante Revision des initialen Stadiums (7)
CL Item
Hodkin Diagnose referenzpathologisch nicht bestätigt (8)
CL Item
Verletzung der Ein-/Ausschlusskriterien (bitte Klartext bei sonstige Bemerkungen) (9)
CL Item
Unabhängige Erkrankung (10)
CL Item
sonstige (bitte Klartext bei sonstige Bemerkungen) (11)
Item
Therapiestatus
integer
C0749659 (UMLS CUI [1])
Treatment status
Code List
Therapiestatus
CL Item
Patient hat keinerlei Studientherapie erhalten (1)
CL Item
Therapie wurde vor Randomisation, aber nach Therapiebeginn abgebrochen -(HD18-Patient wurde/wird nicht randomisiert) (2)
CL Item
randomisierte Therapie wurde begonnen (3)
Further documentation
Item
Weitere Dokumentation: falls Abbruch weil Hodgkin Diagnose nicht bestätigt wurde-vollständige Dokumentation bis Studienabbruch ohne anschließende Nachsorge. Alle übrigen Fälle- vollständige Dokumentation bis Studienabbruch mit anschließender Nachsorge
text
C0175636 (UMLS CUI [1])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial