ID

12250

Beschrijving

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

Trefwoorden

  1. 01-10-15 01-10-15 -
  2. 28-10-15 28-10-15 -
Geüploaded op

28 oktober 2015

DOI

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Licentie

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
Beschrijving

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Beschrijving

Date of examination

Datatype

date

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

Result of Bone marrow examination

normal result
Beschrijving

normal result

Datatype

boolean

Alias
UMLS CUI [1]
C1335065
abnormal result
Beschrijving

abnormal result

Datatype

integer

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

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Beschrijving

Percentage of bone marrow involvement

Datatype

integer

Maateenheden
  • %
Alias
UMLS CUI [1]
C1517677
Bone marrow no involvement
Beschrijving

Bone marrow no involvement

Datatype

boolean

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

Bone marrow uncertain involvement

Datatype

boolean

Alias
UMLS CUI [1]
C0229654
Tumor assessment
Beschrijving

Tumor assessment

Date of Assessment
Beschrijving

Assessment Date

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Indicator lesions
Beschrijving

Indicator lesions

Code of origin
Beschrijving

Code of origin

Datatype

text

extra nodal or other specification
Beschrijving

extra nodal or other specification

Datatype

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Beschrijving

Side of lesion

Datatype

text

Alias
UMLS CUI [1]
C0441987
Dimensions
Beschrijving

Dimensions

Datatype

text

Maateenheden
  • mm x mm
Alias
UMLS CUI [1]
C0439534
mm x mm
Method of assessment
Beschrijving

Method of assessment

Datatype

text

Alias
UMLS CUI [1]
C2598110
Other specification
Beschrijving

Other specification

Datatype

text

Non-indicator lesions
Beschrijving

Non-indicator lesions

Code of origin
Beschrijving

Code of origin

Datatype

integer

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

extra nodal or other specification

Datatype

text

Alias
UMLS CUI [1]
C1517067
Site of lesion
Beschrijving

Site of lesion

Datatype

text

Alias
UMLS CUI [1]
C0449685
Present
Beschrijving

Present

Datatype

boolean

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

Liver and spleen examination

Date of Assessment
Beschrijving

Date of Assessment

Datatype

date

Maateenheden
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Examination type
Beschrijving

Examination type

Datatype

integer

Alias
UMLS CUI [1]
C0031809
specify other examination
Beschrijving

specify other examination

Datatype

text

Alias
UMLS CUI [1]
C0260879
Hepatomegaly
Beschrijving

Hepatomegaly

Datatype

boolean

Alias
UMLS CUI [1]
C0019209
Splenomegaly
Beschrijving

Splenomegaly

Datatype

boolean

Alias
UMLS CUI [1]
C0038002
Response assessment
Beschrijving

Response assessment

Assessment Date
Beschrijving

Date of Assessment

Datatype

date

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

New lesions

Datatype

boolean

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

Non-indicator lesions

Datatype

boolean

Alias
UMLS CUI [1]
C3272925
Overall response
Beschrijving

Overall response

Datatype

integer

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

Complete response

Datatype

integer

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

Partial response

Datatype

integer

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

Partial response

Datatype

boolean

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

Similar models

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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