ID

12250

Beskrivning

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

Nyckelord

  1. 2015-10-01 2015-10-01 -
  2. 2015-10-28 2015-10-28 -
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28 oktober 2015

DOI

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Licens

Creative Commons BY-NC 3.0

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CLL Follow-Up Month 9 BO17072 NCT00090051

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

Bone marrow examination
Beskrivning

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Beskrivning

Date of examination

Datatyp

date

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

Result of Bone marrow examination

normal result
Beskrivning

normal result

Datatyp

boolean

Alias
UMLS CUI [1]
C1335065
abnormal result
Beskrivning

abnormal result

Datatyp

integer

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

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Beskrivning

Percentage of bone marrow involvement

Datatyp

integer

Måttenheter
  • %
Alias
UMLS CUI [1]
C1517677
Bone marrow no involvement
Beskrivning

Bone marrow no involvement

Datatyp

boolean

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

Bone marrow uncertain involvement

Datatyp

boolean

Alias
UMLS CUI [1]
C0229654
Tumor assessment
Beskrivning

Tumor assessment

Date of Assessment
Beskrivning

Assessment Date

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Indicator lesions
Beskrivning

Indicator lesions

Code of origin
Beskrivning

Code of origin

Datatyp

text

extra nodal or other specification
Beskrivning

extra nodal or other specification

Datatyp

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Beskrivning

Side of lesion

Datatyp

text

Alias
UMLS CUI [1]
C0441987
Dimensions
Beskrivning

Dimensions

Datatyp

text

Måttenheter
  • mm x mm
Alias
UMLS CUI [1]
C0439534
mm x mm
Method of assessment
Beskrivning

Method of assessment

Datatyp

text

Alias
UMLS CUI [1]
C2598110
Other specification
Beskrivning

Other specification

Datatyp

text

Non-indicator lesions
Beskrivning

Non-indicator lesions

Code of origin
Beskrivning

Code of origin

Datatyp

integer

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

extra nodal or other specification

Datatyp

text

Alias
UMLS CUI [1]
C1517067
Site of lesion
Beskrivning

Site of lesion

Datatyp

text

Alias
UMLS CUI [1]
C0449685
Present
Beskrivning

Present

Datatyp

boolean

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

Liver and spleen examination

Date of Assessment
Beskrivning

Date of Assessment

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Examination type
Beskrivning

Examination type

Datatyp

integer

Alias
UMLS CUI [1]
C0031809
specify other examination
Beskrivning

specify other examination

Datatyp

text

Alias
UMLS CUI [1]
C0260879
Hepatomegaly
Beskrivning

Hepatomegaly

Datatyp

boolean

Alias
UMLS CUI [1]
C0019209
Splenomegaly
Beskrivning

Splenomegaly

Datatyp

boolean

Alias
UMLS CUI [1]
C0038002
Response assessment
Beskrivning

Response assessment

Assessment Date
Beskrivning

Date of Assessment

Datatyp

date

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

New lesions

Datatyp

boolean

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

Non-indicator lesions

Datatyp

boolean

Alias
UMLS CUI [1]
C3272925
Overall response
Beskrivning

Overall response

Datatyp

integer

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

Complete response

Datatyp

integer

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

Partial response

Datatyp

integer

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

Partial response

Datatyp

boolean

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

Similar models

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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])
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])
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])
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])
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])
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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