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Information:
Fel:
ID
28021
Beskrivning
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
Nyckelord
Versioner (2)
- 2017-12-10 2017-12-10 -
- 2018-01-02 2018-01-02 -
Rättsinnehavare
Prof. Dr. med. Georg Heß
Uppladdad den
10 december 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Adverse events GOAL Trial B-cell Lymphoma NCT02499003
Adverse events GOAL Trial B-cell Lymphoma NCT02499003
- StudyEvent: ODM
Similar models
Adverse events GOAL Trial B-cell Lymphoma NCT02499003
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Subject ID
Item
Subject ID
text
C2348585 (UMLS CUI [1])
Page
Item
Page
integer
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)
Adverse event
Item
AE Term (based on CTCAE 4.0)
text
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Yes (Y)
CL Item
No (N)
Start date
Item
Start date
date
Stop date
Item
Stop date
date
Ongoing adverse event at End of Treatment
Item
Ongoing at End of Treatment?
boolean
Maximum CTCAE grade
Item
Max. CTCAE grade
integer
CL Item
Not related (1)
CL Item
Related (2)
CL Item
Not related (1)
CL Item
Related (2)
CL Item
Unchanged (1)
CL Item
Reduced (2)
CL Item
Interrupted (3)
CL Item
Discontinued (4)
CL Item
Not applicable (5)
CL Item
Unchanged (1)
CL Item
Reduced (2)
CL Item
Interrupted (3)
CL Item
Discontinued (4)
CL Item
Not applicable (5)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Recovered (1)
CL Item
Recovered with sequelae (2)
CL Item
Recovering (3)
CL Item
Not recovered (4)
CL Item
Fatal (5)
CL Item
Unknown (6)
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.
Data correct
Item
Data correct?
boolean
Date of signature
Item
Date of signature
date
Name of investigator
Item
Name of investigator
text
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