ID

28276

Beschreibung

NCT02499003 The GOAL Trial: Rescue Treatment With the Monoclonal Anti CD20-antibody Obinutuzumab (GA101) in Combination With Pixantrone for the Treatment of Patients With Relapsed Aggressive B-cell Lymphoma. Visit: All visits. Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz

Stichworte

Versionen (2)
  1. 10.12.17 10.12.17 -
  2. 02.01.18 02.01.18 -
Rechteinhaber

Prof. Dr. med. Georg Heß

Hochgeladen am

2. Januar 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Adverse events GOAL Trial B-cell Lymphoma NCT02499003

Englisch

Adverse events GOAL Trial B-cell Lymphoma NCT02499003

1 Formulare  
Admininstrative data
Beschreibung

Admininstrative data

Alias
UMLS CUI-1
C1320722
Subject ID
Beschreibung

Subject ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Page
Beschreibung

Page

Datentyp

integer

Alias
UMLS CUI [1]
C1704732
Adverse events
Beschreibung

Adverse events

Alias
UMLS CUI-1
C0877248
No.
Beschreibung

adverse event number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
AE Term (based on CTCAE 4.0)
Beschreibung

CTCAE Adverse event

Datentyp

text

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C2826934
SAE?
Beschreibung

Serious adverse event

Datentyp

text

Alias
UMLS CUI [1]
C1519255
Study termination
Beschreibung

Study termination

Datentyp

text

Alias
UMLS CUI [1]
C2718058
Start date
Beschreibung

Start date

Datentyp

date

Alias
UMLS CUI [1]
C0808070
Stop date
Beschreibung

Stop date

Datentyp

date

Alias
UMLS CUI [1]
C0806020
Ongoing at End of Treatment?
Beschreibung

Ongoing adverse event

Datentyp

boolean

Alias
UMLS CUI [1]
C2826663
Max. CTCAE grade
Beschreibung

CTCAE grade

Datentyp

integer

Alias
UMLS CUI [1,1]
C1516728
UMLS CUI [1,2]
C0441800
Causality with Obinutuzumab
Beschreibung

Causality Obinutuzumab

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C2742503
Causality with Pixantrone
Beschreibung

Causality Pixantrone

Datentyp

integer

Alias
UMLS CUI [1,1]
C0015127
UMLS CUI [1,2]
C0253355
Action taken with Obinutuzumab
Beschreibung

Action taken Obinutuzumab

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C2742503
Action taken with Pixantrone
Beschreibung

Action taken Pixantrone

Datentyp

integer

Alias
UMLS CUI [1,1]
C2826626
UMLS CUI [1,2]
C0253355
Treatment given?
Beschreibung

Treatment

Datentyp

text

Alias
UMLS CUI [1]
C0087111
Outcome
Beschreibung

Treatment Outcome

Datentyp

integer

Alias
UMLS CUI [1]
C0085415
I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.
Beschreibung

I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.

Alias
UMLS CUI-1
C2346576
Data correct?
Beschreibung

correct

Datentyp

boolean

Alias
UMLS CUI [1]
C2349182
Date of signature
Beschreibung

Date of signature

Datentyp

date

Alias
UMLS CUI [1]
C0807937
Name of investigator
Beschreibung

Name of investigator

Datentyp

text

Alias
UMLS CUI [1]
C2826892
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Ähnliche Modelle

Adverse events GOAL Trial B-cell Lymphoma NCT02499003

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Admininstrative data
C1320722 (UMLS CUI-1)
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Page
Item
Page
integer
C1704732 (UMLS CUI [1])
Item Group
Adverse events
C0877248 (UMLS CUI-1)
Item
No.
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
adverse event number
Code List
No.
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
06 (6)
CL Item
07 (7)
CL Item
08 (8)
CL Item
09 (9)
CL Item
10 (10)
CTCAE Adverse event
Item
AE Term (based on CTCAE 4.0)
text
C1516728 (UMLS CUI [1,1])
C2826934 (UMLS CUI [1,2])
Item
SAE?
text
C1519255 (UMLS CUI [1])
Serious adverse event
Code List
SAE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Study termination
text
C2718058 (UMLS CUI [1])
Serious adverse event
Code List
Study termination
CL Item
Yes (Y)
CL Item
No (N)
Start date
Item
Start date
date
C0808070 (UMLS CUI [1])
Stop date
Item
Stop date
date
C0806020 (UMLS CUI [1])
Ongoing adverse event
Item
Ongoing at End of Treatment?
boolean
C2826663 (UMLS CUI [1])
CTCAE grade
Item
Max. CTCAE grade
integer
C1516728 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Item
Causality with Obinutuzumab
integer
C0015127 (UMLS CUI [1,1])
C2742503 (UMLS CUI [1,2])
Causality with Obinutuzumab
Code List
Causality with Obinutuzumab
CL Item
Not related (1)
C1546988 (UMLS CUI-1)
(Comment:en)
CL Item
Related (2)
C1704787 (UMLS CUI-1)
(Comment:en)
Item
Causality with Pixantrone
integer
C0015127 (UMLS CUI [1,1])
C0253355 (UMLS CUI [1,2])
Causality with Obinutuzumab
Code List
Causality with Pixantrone
CL Item
Not related (1)
C1546988 (UMLS CUI-1)
(Comment:en)
CL Item
Related (2)
C1704787 (UMLS CUI-1)
(Comment:en)
Item
Action taken with Obinutuzumab
integer
C2826626 (UMLS CUI [1,1])
C2742503 (UMLS CUI [1,2])
Action taken with Obinutuzumab
Code List
Action taken with Obinutuzumab
CL Item
Unchanged (1)
C0442739 (UMLS CUI-1)
(Comment:en)
CL Item
Reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Interrupted (3)
C1512900 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
(Comment:en)
CL Item
Discontinued (4)
C0558681 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (5)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
Action taken with Pixantrone
integer
C2826626 (UMLS CUI [1,1])
C0253355 (UMLS CUI [1,2])
Action taken with Obinutuzumab
Code List
Action taken with Pixantrone
CL Item
Unchanged (1)
C0442739 (UMLS CUI-1)
(Comment:en)
CL Item
Reduced (2)
C1707814 (UMLS CUI-1)
(Comment:en)
CL Item
Interrupted (3)
C0178602 (UMLS CUI-1)
C0443239 (UMLS CUI-2)
(Comment:en)
CL Item
Discontinued (4)
C0558681 (UMLS CUI-1)
(Comment:en)
CL Item
Not applicable (5)
C1272460 (UMLS CUI-1)
(Comment:en)
Item
Treatment given?
text
C0087111 (UMLS CUI [1])
Serious adverse event
Code List
Treatment given?
CL Item
Yes (Y)
CL Item
No (N)
Item
Outcome
integer
C0085415 (UMLS CUI [1])
Treatment Outcome
Code List
Outcome
CL Item
Recovered (1)
C2004454 (UMLS CUI-1)
(Comment:en)
CL Item
Recovered with sequelae (2)
C1709862 (UMLS CUI-1)
(Comment:en)
CL Item
Recovering (3)
C1709864 (UMLS CUI-1)
(Comment:en)
CL Item
Not recovered (4)
C1709277 (UMLS CUI-1)
(Comment:en)
CL Item
Fatal (5)
C1302234 (UMLS CUI-1)
(Comment:en)
CL Item
Unknown (6)
C0439673 (UMLS CUI-1)
(Comment:en)
Item Group
I have reviewed the AEs on this page and have assessed them for seriousness, causality, severity and outcome and confirm that, to the best of my knowledge, they accurately reflect the study information obtained for this patient.
C2346576 (UMLS CUI-1)
correct
Item
Data correct?
boolean
C2349182 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C0807937 (UMLS CUI [1])
Name of investigator
Item
Name of investigator
text
C2826892 (UMLS CUI [1])
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