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ID
27966
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 Source: Prof. Dr. med. Georg Heß Universitätsmedizin Mainz
Stichworte
Versionen (3)
- 07.12.17 07.12.17 -
- 07.12.17 07.12.17 -
- 01.01.18 01.01.18 -
Rechteinhaber
Prof. Dr. med. Georg Heß
Hochgeladen am
7. Dezember 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Staging GOAL Trial B-cell Lymphoma NCT02499003
Staging GOAL Trial B-cell Lymphoma NCT02499003
- StudyEvent: ODM
Ähnliche Modelle
Staging GOAL Trial B-cell Lymphoma NCT02499003
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject ID
Item
Subject ID
text
CL Item
Interim Staging (Interim Staging)
CL Item
End of Treatment (End of Treatment)
CL Item
Follow Up 2 (Follow Up 2)
CL Item
Follow Up 4 (Follow Up 4)
CL Item
Follow Up 6 (Follow Up 6)
CL Item
Follow Up 8 (Follow Up 8)
Staging date
Item
Staging date
date
CL Item
Contrast CT (Contrast CT)
CL Item
Non-contrast CT (Non-contrast CT)
CL Item
MRI (MRI)
CL Item
Not done (Not done)
Reason for not using contrast agent
Item
If applicable: Reason for not using contrast agent
text
PET Scan performed
Item
PET Scan performed?
boolean
CL Item
Positive (Positive)
CL Item
Negative (Negative)
PET scan result specification
Item
If PET Scan is positive: please specify
text
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
N: Waldeyer Ring (1)
CL Item
N: cervical (2)
CL Item
N: supraclavicular (3)
CL Item
N: infraclavicular (4)
CL Item
N: axillar (5)
CL Item
N: mediastinal (6)
CL Item
N: hilar (7)
CL Item
N: porta hepatic (8)
CL Item
N: retroperitoneal (9)
CL Item
N: retrocrural (10)
CL Item
N: paraaortic (11)
CL Item
N: mesenteric (12)
CL Item
N: iliac (13)
CL Item
N: inguinal/femoral (14)
CL Item
O: tonsils (15)
CL Item
O: thymus (16)
CL Item
O: lung (17)
CL Item
O: liver (18)
CL Item
O: spleen (19)
CL Item
O: digestive tract (20)
CL Item
O: bone marrow (21)
CL Item
Other (22)
specification localisation
Item
Specification localisation
text
CL Item
Left (Left)
CL Item
Right (Right)
CL Item
N.a. (N.a.)
CL Item
Measurable (Measurable)
CL Item
Not Measurable (Not Measurable)
CL Item
Not Done (Not Done)
Size target lesion
Item
Size
integer
Size target lesion
Item
Size
integer
sum target lesion sizes
Item
Sum
integer
CL Item
01 (1)
CL Item
02 (2)
CL Item
03 (3)
CL Item
04 (4)
CL Item
05 (5)
CL Item
N: Waldeyer Ring (1)
CL Item
N: cervical (2)
CL Item
N: supraclavicular (3)
CL Item
N: infraclavicular (4)
CL Item
N: axillar (5)
CL Item
N: mediastinal (6)
CL Item
N: hilar (7)
CL Item
N: porta hepatic (8)
CL Item
N: retroperitoneal (9)
CL Item
N: retrocrural (10)
CL Item
N: paraaortic (11)
CL Item
N: mesenteric (12)
CL Item
N: iliac (13)
CL Item
N: inguinal/femoral (14)
CL Item
O: tonsils (15)
CL Item
O: thymus (16)
CL Item
O: lung (17)
CL Item
O: liver (18)
CL Item
O: spleen (19)
CL Item
O: digestive tract (20)
CL Item
O: bone marrow (21)
CL Item
Other (22)
Specification lesion localisation
Item
Specification localisation
text
lesion still present
Item
Still present?
boolean
lesion progression
Item
Progression?
boolean
new lesions
Item
Have any new lesions been identified?
boolean
CL Item
N: Waldeyer Ring (1)
CL Item
N: cervical (2)
CL Item
N: supraclavicular (3)
CL Item
N: infraclavicular (4)
CL Item
N: axillar (5)
CL Item
N: mediastinal (6)
CL Item
N: hilar (7)
CL Item
N: porta hepatic (8)
CL Item
N: retroperitoneal (9)
CL Item
N: retrocrural (10)
CL Item
N: paraaortic (11)
CL Item
N: mesenteric (12)
CL Item
N: iliac (13)
CL Item
N: inguinal/femoral (14)
CL Item
O: tonsils (15)
CL Item
O: thymus (16)
CL Item
O: lung (17)
CL Item
O: liver (18)
CL Item
O: spleen (19)
CL Item
O: digestive tract (20)
CL Item
O: bone marrow (21)
CL Item
Other (22)
specification localisation new lesion
Item
If necessary, specify localisation:
text
tumor assessment CR
Item
CR
boolean
tumor assessment CRu
Item
CRu
boolean
tumor assessment PR
Item
PR
boolean
tumor assessment SD
Item
SD
boolean
tumor assessment PD
Item
PD
boolean
tumor assessment Unknown
Item
Unknown
boolean