ID

12155

Descripción

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

Palabras clave

  1. 1/10/15 1/10/15 -
  2. 28/10/15 28/10/15 -
Subido en

1 de octubre de 2015

DOI

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Licencia

Creative Commons BY-NC 3.0 Legacy

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CLL Follow-Up Month 9 NCT00090051 BO17072

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

Bone marrow examination
Descripción

Bone marrow examination

Alias
UMLS CUI-1
C0005957
Date of examination
Descripción

Date of examination

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI-1
C0011008
dd/mm/yy
Result of Bone marrow examination
Descripción

Result of Bone marrow examination

normal result
Descripción

normal result

Tipo de datos

boolean

abnormal result
Descripción

abnormal result

Tipo de datos

integer

Is bone marrow involved with CLL?
Descripción

Is bone marrow involved with CLL?

Percentage of bone marrow involvement
Descripción

Percentage of bone marrow involvement

Tipo de datos

text

no involvement
Descripción

no involvement

Tipo de datos

boolean

Lymphoid nodules in bone marrow?
Descripción

uncertain involvement

Tipo de datos

boolean

Tumor assessment
Descripción

Tumor assessment

Date of Assessment
Descripción

Assessment Date

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Indicator lesions
Descripción

Indicator lesions

Alias
UMLS CUI-1
C0221198
Code of origin
Descripción

Code of origin

Tipo de datos

text

extra nodal or other specification
Descripción

extra nodal or other specification

Tipo de datos

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Descripción

Side of lesion

Tipo de datos

text

Alias
UMLS CUI [1]
C0441987
Dimensions
Descripción

Dimensions

Tipo de datos

text

Unidades de medida
  • mm x mm
Alias
UMLS CUI [1]
C0439534
mm x mm
Method of assessment
Descripción

Method of assessment

Tipo de datos

text

Alias
UMLS CUI [1]
C2598110
Other specification
Descripción

Other specification

Tipo de datos

text

Non-indicator lesions
Descripción

Non-indicator lesions

Alias
UMLS CUI-1
C0221198
Code of origin
Descripción

Code of origin

Tipo de datos

text

extra nodal or other specification
Descripción

extra nodal or other specification

Tipo de datos

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Descripción

Side of lesion

Tipo de datos

text

Alias
UMLS CUI [1]
C0441987
Present
Descripción

Present

Tipo de datos

boolean

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

Liver and spleen examination

Alias
UMLS CUI-1
C2243078
UMLS CUI-2
C2228485
Date of Assessment
Descripción

Date of Assessment

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Examination type
Descripción

Examination type

Tipo de datos

integer

Alias
UMLS CUI [1]
C0031809
specify other examination
Descripción

specify other examination

Tipo de datos

text

Hepatomegaly
Descripción

Hepatomegaly

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019209
Splenomegaly
Descripción

Splenomegaly

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038002
Response assessment
Descripción

Response assessment

Alias
UMLS CUI-1
C0332307
UMLS CUI-2
C0871261
Assessment Date
Descripción

Date of Assessment

Tipo de datos

date

Unidades de medida
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Are there any new lesions?
Descripción

New lesions

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0205314
Was there unequivocal progression in the size of non-indicator lesions?
Descripción

Non-indicator lesions

Tipo de datos

boolean

Overall response
Descripción

Overall response

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1561607
UMLS CUI [1,2]
C0871261
Was complete response confirmed with a bone marrow biopsy?
Descripción

Complete response

Tipo de datos

integer

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

Partial response

Tipo de datos

integer

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

Partial response

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1521726

Similar models

Follow-Up Month 9 Chronic Lymphocytic Leukemia NCT00090051 BO17072

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Bone marrow examination
C0005957 (UMLS CUI-1)
Date
Item
Date of examination
date
C0011008 (UMLS CUI-1)
Item Group
Result of Bone marrow examination
normal result
Item
normal result
boolean
Item
abnormal result
integer
Code List
abnormal result
CL Item
normocellular (1)
CL Item
hypocellular (2)
CL Item
hypercellular (3)
Item Group
Is bone marrow involved with CLL?
Item
Percentage of bone marrow involvement
text
Code List
Percentage of bone marrow involvement
CL Item
Percentage of bone marrow involved with CLL (1)
CL Item
diffude pattern of involvement (2)
CL Item
nodular pattern of involvement (3)
no involvement
Item
no involvement
boolean
uncertain involvement
Item
Lymphoid nodules in bone marrow?
boolean
Item Group
Tumor assessment
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Indicator lesions
C0221198 (UMLS CUI-1)
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
C0221198 (UMLS CUI-1)
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])
Present
Item
Present
boolean
C0150312 (UMLS CUI [1])
Item Group
Liver and spleen examination
C2243078 (UMLS CUI-1)
C2228485 (UMLS CUI-2)
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)
specify other examination
Item
text
Hepatomegaly
Item
Hepatomegaly
boolean
C0019209 (UMLS CUI [1])
Splenomegaly
Item
Splenomegaly
boolean
C0038002 (UMLS CUI [1])
Item Group
Response assessment
C0332307 (UMLS CUI-1)
C0871261 (UMLS CUI-2)
Assessment Date
Item
date
C2985720 (UMLS CUI [1])
New lesions
Item
Are there any new lesions?
boolean
C0221198 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
Non-indicator lesions
Item
Was there unequivocal progression in the size of non-indicator lesions?
boolean
Item
integer
C1561607 (UMLS CUI [1,1])
C0871261 (UMLS CUI [1,2])
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)
CL Item
no (2)
CL Item
not applicable (3)
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)
CL Item
diffude pattern of involvement (2)
CL Item
nodular pattern of involvement (3)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
boolean
C1521726 (UMLS CUI [1])

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