ID

32753

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
Copyright Holder

German Hodgkin Study Group

Uploaded on

November 14, 2018

DOI

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License

Creative Commons BY-NC 3.0
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German Hodgkin Study Group Study HD16/HD17/HD18 Treatment discontinuation form G6AB DRKS00003455 DRKS00003457

German

Deutsche Hodgkin Studiengruppe: G6AB Therapieabbruchbogen

1 forms  
Formularkopf
Description

Formularkopf

Alias
UMLS CUI-1
C1320722
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

Alias
UMLS CUI [1,1]
C2825181
UMLS CUI [1,2]
C1442065
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

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0457454
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: Progress unter Therapie (PRO)
Description

Bitte Restaging-Bogen ausfüllen.

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0242656
Grund der Abbruchs: Unzureichendes Ansprechen (NC)
Description

Bitte Restagingbogen ausfüllen.

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0521982
UMLS CUI [1,4]
C0231180
Grund der Abbruchs: Toxizität unter Therapie
Description

Bitte ggf. SAE-Bericht ausfüllen

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0600688
UMLS CUI [1,4]
C0087111
Grund der Abbruchs: Patient lehnt weitere Chemotherapie ab
Description

Reason for discontinuation: patient declines Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C1705116
Grund der Abbruchs: Patient lehnt weitere Radiotherapie ab
Description

Reason for discontinuation: patient declines radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1705116
UMLS CUI [1,4]
C1522449
Grund der Abbruchs: Patient zieht Einverständnis zur Studienteilnahme zurück
Description

schriftl. Mitteilung des Pat. einholen und zuschicken

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C2349954
UMLS CUI [1,4]
C0021430
Grund der Abbruchs: Therapierelevante Revision des initialen Stadiums
Description

Reason for discontinuation: Disease stage revision, therapy relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C3665894
UMLS CUI [1,4]
C0699749
UMLS CUI [1,5]
C0439617
Grund der Abbruchs: Hodkin Diagnose referenzpathologisch nicht bestätigt
Description

Reason for discontinuation: Hodgkin not confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0024305
UMLS CUI [1,4]
C0521092
Grund der Abbruchs: Verletzung der Ein-/Ausschlusskriterien
Description

bitte Klartext bei sonstige Bemerkungen

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C1709750
UMLS CUI [1,4]
C1516637
Grund der Abbruchs: Unabhängige Erkrankung
Description

Reason for discontinuation: other disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C2359476
Grund der Abbruchs: sonstige
Description

bitte Klartext bei sonstige Bemerkungen

Data type

boolean

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0205394
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
Sonstige Bemerkungen
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Datum
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Unterschrift
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
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Similar models

Deutsche Hodgkin Studiengruppe: G6AB Therapieabbruchbogen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Formularkopf
C1320722 (UMLS CUI-1)
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
C2825181 (UMLS CUI [1,1])
C1442065 (UMLS CUI [1,2])
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
C0087111 (UMLS CUI-1)
C0457454 (UMLS CUI-2)
Date of discontinuation
Item
Abbruch der Studientherapie am
date
C0457454 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Reason for discontinuation: Progress under therapy
Item
Grund der Abbruchs: Progress unter Therapie (PRO)
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0242656 (UMLS CUI [1,4])
Reason for discontinuation: insufficient response
Item
Grund der Abbruchs: Unzureichendes Ansprechen (NC)
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,3])
C0231180 (UMLS CUI [1,4])
Reason for discontinuation: Treatment toxicity
Item
Grund der Abbruchs: Toxizität unter Therapie
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0600688 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Reason for discontinuation: patient declines Chemotherapy
Item
Grund der Abbruchs: Patient lehnt weitere Chemotherapie ab
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1705116 (UMLS CUI [1,4])
Reason for discontinuation: patient declines radiotherapy
Item
Grund der Abbruchs: Patient lehnt weitere Radiotherapie ab
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
Reason for discontinuation: withdrawal of consent
Item
Grund der Abbruchs: Patient zieht Einverständnis zur Studienteilnahme zurück
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,4])
Reason for discontinuation: Disease stage revision, therapy relevant
Item
Grund der Abbruchs: Therapierelevante Revision des initialen Stadiums
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C3665894 (UMLS CUI [1,3])
C0699749 (UMLS CUI [1,4])
C0439617 (UMLS CUI [1,5])
Reason for discontinuation: Hodgkin not confirmed
Item
Grund der Abbruchs: Hodkin Diagnose referenzpathologisch nicht bestätigt
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0024305 (UMLS CUI [1,3])
C0521092 (UMLS CUI [1,4])
Reason for discontinuation: Eligibility Criteria violation
Item
Grund der Abbruchs: Verletzung der Ein-/Ausschlusskriterien
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C1709750 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,4])
Reason for discontinuation: other disease
Item
Grund der Abbruchs: Unabhängige Erkrankung
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C2359476 (UMLS CUI [1,3])
Reason for discontinuation: other
Item
Grund der Abbruchs: sonstige
boolean
C0566251 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Therapiestatus
integer
C0749659 (UMLS CUI [1])
Treatment status
Code List
Therapiestatus
CL Item
Patient hat keinerlei Studientherapie erhalten (1)
C0087111 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C1272460 (UMLS CUI-3)
(Comment:de)
CL Item
Therapie wurde vor Randomisation, aber nach Therapiebeginn abgebrochen -(HD18-Patient wurde/wird nicht randomisiert) (2)
C0457454 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C0034656 (UMLS CUI-3)
C0032756 (UMLS CUI-4)
C1531783 (UMLS CUI-5)
(Comment:de)
CL Item
randomisierte Therapie wurde begonnen (3)
C1531783 (UMLS CUI-1)
C0034656 (UMLS CUI-2)
(Comment:de)
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])
Comments
Item
Sonstige Bemerkungen
text
C0947611 (UMLS CUI [1])
Date of completion
Item
Datum
date
C0011008 (UMLS CUI [1])
Signature
Item
Unterschrift
text
C1519316 (UMLS CUI [1])
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