ID

12250

Description

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

Keywords

Versions (2)
  1. 10/1/15 10/1/15 -
  2. 10/28/15 10/28/15 -
Uploaded on

October 28, 2015

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

English

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 forms  
Bone marrow examination
Description

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Description

Date of examination

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2826643
dd/mm/yy
Result of Bone marrow examination
Description

Result of Bone marrow examination

normal result
Description

normal result

Data type

boolean

Alias
UMLS CUI [1]
C1335065
abnormal result
Description

abnormal result

Data type

integer

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

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Description

Percentage of bone marrow involvement

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C1517677
Bone marrow no involvement
Description

Bone marrow no involvement

Data type

boolean

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

Bone marrow uncertain involvement

Data type

boolean

Alias
UMLS CUI [1]
C0229654
Tumor assessment
Description

Tumor assessment

Date of Assessment
Description

Assessment Date

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Indicator lesions
Description

Indicator lesions

Code of origin
Description

Code of origin

Data type

text

extra nodal or other specification
Description

extra nodal or other specification

Data type

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Description

Side of lesion

Data type

text

Alias
UMLS CUI [1]
C0441987
Dimensions
Description

Dimensions

Data type

text

Measurement units
  • mm x mm
Alias
UMLS CUI [1]
C0439534
mm x mm
Method of assessment
Description

Method of assessment

Data type

text

Alias
UMLS CUI [1]
C2598110
Other specification
Description

Other specification

Data type

text

Non-indicator lesions
Description

Non-indicator lesions

Code of origin
Description

Code of origin

Data type

integer

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

extra nodal or other specification

Data type

text

Alias
UMLS CUI [1]
C1517067
Site of lesion
Description

Site of lesion

Data type

text

Alias
UMLS CUI [1]
C0449685
Present
Description

Present

Data type

boolean

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

Liver and spleen examination

Date of Assessment
Description

Date of Assessment

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Examination type
Description

Examination type

Data type

integer

Alias
UMLS CUI [1]
C0031809
specify other examination
Description

specify other examination

Data type

text

Alias
UMLS CUI [1]
C0260879
Hepatomegaly
Description

Hepatomegaly

Data type

boolean

Alias
UMLS CUI [1]
C0019209
Splenomegaly
Description

Splenomegaly

Data type

boolean

Alias
UMLS CUI [1]
C0038002
Response assessment
Description

Response assessment

Assessment Date
Description

Date of Assessment

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Are there any new lesions?
Description

New lesions

Data type

boolean

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

Non-indicator lesions

Data type

boolean

Alias
UMLS CUI [1]
C3272925
Overall response
Description

Overall response

Data type

integer

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

Complete response

Data type

integer

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

Partial response

Data type

integer

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

Partial response

Data type

boolean

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

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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