ID

12250

Beschreibung

An open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) versus fludarabine and cyclophosphamide alone (FC) in previously treated patients with CD20 positive B-cell chronic lymphocytic leukemia (CLL). NCT00090051 BO17072

Stichworte

Versionen (2)
  1. 01.10.15 01.10.15 -
  2. 28.10.15 28.10.15 -
Hochgeladen am

28. Oktober 2015

DOI

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Lizenz

Creative Commons BY-NC 3.0
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CLL Follow-Up Month 9 BO17072 NCT00090051

Englisch

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulare  
Bone marrow examination
Beschreibung

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Beschreibung

Date of examination

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C2826643
dd/mm/yy
Result of Bone marrow examination
Beschreibung

Result of Bone marrow examination

normal result
Beschreibung

normal result

Datentyp

boolean

Alias
UMLS CUI [1]
C1335065
abnormal result
Beschreibung

abnormal result

Datentyp

integer

Alias
UMLS CUI [1]
C0741594
Is bone marrow involved with CLL?
Beschreibung

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Beschreibung

Percentage of bone marrow involvement

Datentyp

integer

Maßeinheiten
  • %
Alias
UMLS CUI [1]
C1517677
Bone marrow no involvement
Beschreibung

Bone marrow no involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C1517677
Lymphoid nodules in bone marrow?
Beschreibung

Bone marrow uncertain involvement

Datentyp

boolean

Alias
UMLS CUI [1]
C0229654
Tumor assessment
Beschreibung

Tumor assessment

Date of Assessment
Beschreibung

Assessment Date

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Indicator lesions
Beschreibung

Indicator lesions

Code of origin
Beschreibung

Code of origin

Datentyp

text

extra nodal or other specification
Beschreibung

extra nodal or other specification

Datentyp

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Beschreibung

Side of lesion

Datentyp

text

Alias
UMLS CUI [1]
C0441987
Dimensions
Beschreibung

Dimensions

Datentyp

text

Maßeinheiten
  • mm x mm
Alias
UMLS CUI [1]
C0439534
mm x mm
Method of assessment
Beschreibung

Method of assessment

Datentyp

text

Alias
UMLS CUI [1]
C2598110
Other specification
Beschreibung

Other specification

Datentyp

text

Non-indicator lesions
Beschreibung

Non-indicator lesions

Code of origin
Beschreibung

Code of origin

Datentyp

integer

Alias
UMLS CUI [1]
C0449409
extra nodal or other specification
Beschreibung

extra nodal or other specification

Datentyp

text

Alias
UMLS CUI [1]
C1517067
Site of lesion
Beschreibung

Site of lesion

Datentyp

text

Alias
UMLS CUI [1]
C0449685
Present
Beschreibung

Present

Datentyp

boolean

Alias
UMLS CUI [1]
C0150312
Liver and spleen examination
Beschreibung

Liver and spleen examination

Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Examination type
Beschreibung

Examination type

Datentyp

integer

Alias
UMLS CUI [1]
C0031809
specify other examination
Beschreibung

specify other examination

Datentyp

text

Alias
UMLS CUI [1]
C0260879
Hepatomegaly
Beschreibung

Hepatomegaly

Datentyp

boolean

Alias
UMLS CUI [1]
C0019209
Splenomegaly
Beschreibung

Splenomegaly

Datentyp

boolean

Alias
UMLS CUI [1]
C0038002
Response assessment
Beschreibung

Response assessment

Assessment Date
Beschreibung

Date of Assessment

Datentyp

date

Maßeinheiten
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Are there any new lesions?
Beschreibung

New lesions

Datentyp

boolean

Alias
UMLS CUI [1]
C2986548
Was there unequivocal progression in the size of non-indicator lesions?
Beschreibung

Non-indicator lesions

Datentyp

boolean

Alias
UMLS CUI [1]
C3272925
Overall response
Beschreibung

Overall response

Datentyp

integer

Alias
UMLS CUI [1]
C3272903
Was complete response confirmed with a bone marrow biopsy?
Beschreibung

Complete response

Datentyp

integer

Alias
UMLS CUI [1]
C0677874
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
Beschreibung

Partial response

Datentyp

integer

Alias
UMLS CUI [1]
C1521726
Does patient fulfill the criteria for a CR but have persistent anemia or Thrombocytopenia?
Beschreibung

Partial response

Datentyp

boolean

Alias
UMLS CUI [1]
C0741008
UMLS CUI [2]
C0040034
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Ähnliche Modelle

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Bone marrow examination
C0005957 (UMLS CUI-1)
Date
Item
Date of examination
date
C2826643 (UMLS CUI [1])
Item Group
Result of Bone marrow examination
normal result
Item
normal result
boolean
C1335065 (UMLS CUI [1])
Item
abnormal result
integer
C0741594 (UMLS CUI [1])
abnormal result
Code List
abnormal result
CL Item
normocellular (1)
C2960424 (UMLS CUI-1)
CL Item
hypocellular (2)
C1855710 (UMLS CUI-1)
CL Item
hypercellular (3)
C0542080 (UMLS CUI-1)
Item Group
Is bone marrow involved with CLL?
Item
Percentage of bone marrow involvement
integer
C1517677 (UMLS CUI [1])
Percentage of bone marrow involvement
Code List
Percentage of bone marrow involvement
CL Item
Percentage of bone marrow involved with CLL (1)
C1517677 (UMLS CUI-1)
CL Item
diffuse pattern of involvement (2)
C1333299 (UMLS CUI-1)
CL Item
nodular pattern of involvement (3)
C1334973 (UMLS CUI-1)
Bone marrow no involvement
Item
Bone marrow no involvement
boolean
C1517677 (UMLS CUI [1])
Bone marrow uncertain involvement
Item
Lymphoid nodules in bone marrow?
boolean
C0229654 (UMLS CUI [1])
Item Group
Tumor assessment
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Indicator lesions
Code of origin
Item
text
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Side of lesion
Item
text
C0441987 (UMLS CUI [1])
Dimensions
Item
text
C0439534 (UMLS CUI [1])
Method of assessment
Item
text
C2598110 (UMLS CUI [1])
Other specification
Item
text
Item Group
Non-indicator lesions
Code of origin
Item
Code of origin
integer
C0449409 (UMLS CUI [1])
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Site of lesion
Item
Site of lesion
text
C0449685 (UMLS CUI [1])
Present
Item
Present
boolean
C0150312 (UMLS CUI [1])
Item Group
Liver and spleen examination
Date of Assessment
Item
date
C2985720 (UMLS CUI [1])
Item
integer
C0031809 (UMLS CUI [1])
Examination type
Code List
Examination type
CL Item
CT scan (1)
C0040405 (UMLS CUI-1)
CL Item
physical examination (2)
C0031809 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
specify other examination
Item
specify other examination
text
C0260879 (UMLS CUI [1])
Hepatomegaly
Item
Hepatomegaly
boolean
C0019209 (UMLS CUI [1])
Splenomegaly
Item
Splenomegaly
boolean
C0038002 (UMLS CUI [1])
Item Group
Response assessment
Assessment Date
Item
date
C2985720 (UMLS CUI [1])
New lesions
Item
Are there any new lesions?
boolean
C2986548 (UMLS CUI [1])
Non-indicator lesions
Item
Was there unequivocal progression in the size of non-indicator lesions?
boolean
C3272925 (UMLS CUI [1])
Item
Overall response
integer
C3272903 (UMLS CUI [1])
Overall response
Code List
Overall response
CL Item
complete response (1)
C0677874 (UMLS CUI-1)
CL Item
partial response (2)
C1521726 (UMLS CUI-1)
CL Item
stable disease (3)
C0677946 (UMLS CUI-1)
CL Item
pregressive disease (4)
C1335499 (UMLS CUI-1)
Item
Was complete response confirmed with a bone marrow biopsy?
integer
C0677874 (UMLS CUI [1])
Complete response
Code List
Was complete response confirmed with a bone marrow biopsy?
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
no (2)
C1298908 (UMLS CUI-1)
CL Item
not applicable (3)
C1272460 (UMLS CUI-1)
Item
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
integer
C1521726 (UMLS CUI [1])
Percentage of bone marrow involvement
Code List
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
CL Item
Percentage of bone marrow involved with CLL (1)
C1517677 (UMLS CUI-1)
CL Item
diffuse pattern of involvement (2)
C1333299 (UMLS CUI-1)
CL Item
nodular pattern of involvement (3)
C1334973 (UMLS CUI-1)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or Thrombocytopenia?
boolean
C0741008 (UMLS CUI [1])
C0040034 (UMLS CUI [2])
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