ID

12240

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). FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients NCT00090051 Roche BO17072

Mots-clés

  1. 30/09/2015 30/09/2015 -
  2. 28/10/2015 28/10/2015 -
Téléchargé le

28 octobre 2015

DOI

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Licence

Creative Commons BY-NC 3.0

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CLL Tumor assessment FCR vs FC BO17072 NCT00090051

Tumor assessment of Chronic Lymphocytic Leukemia NCT00090051 BO17072

Tumor assessment at screening
Description

Tumor assessment at screening

Date of Assessment
Description

Assessment Date

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Indicator lesions
Description

Indicator lesions

Code of origin
Description

Code of origin

Type de données

integer

Alias
UMLS CUI [1]
C2986125
extra nodal or other specification
Description

extra nodal or other specification

Type de données

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Description

Side of lesion

Type de données

text

Alias
UMLS CUI [1]
C0441987
Dimensions
Description

Dimensions

Type de données

text

Unités de mesure
  • mm x mm
Alias
UMLS CUI [1]
C0439534
mm x mm
Method of assessment
Description

Method of assessment

Type de données

text

Alias
UMLS CUI [1]
C2598110
Other specification
Description

Other specification

Type de données

text

Non-indicator lesions
Description

Non-indicator lesions

Alias
UMLS CUI-1
C0221198
Code of origin
Description

Code of origin

Type de données

integer

Alias
UMLS CUI [1]
C2986125
extra nodal or other specification
Description

extra nodal or other specification

Type de données

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Description

Side of lesion

Type de données

text

Alias
UMLS CUI [1]
C0441987
Liver and spleen examination
Description

Liver and spleen examination

Date of Assessment
Description

Date of Assessment

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Examination type
Description

Examination type

Type de données

integer

Alias
UMLS CUI [1]
C0031809
specify other examination
Description

specify other examination

Type de données

text

Alias
UMLS CUI [1]
C0582103
Hepatomegaly
Description

Hepatomegaly

Type de données

boolean

Alias
UMLS CUI [1]
C0019209
Splenomegaly
Description

Splenomegaly

Type de données

boolean

Alias
UMLS CUI [1]
C0038002
Tumor assessment after Cycle 3 and 6
Description

Tumor assessment after Cycle 3 and 6

Assessment Date
Description

Date of Assessment

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Indicator lesions
Description

Indicator lesions

Code of origin
Description

Code of origin

Type de données

text

Alias
UMLS CUI [1]
C2986125
extra nodal or other specification
Description

extra nodal or other specification

Type de données

integer

Alias
UMLS CUI [1]
C1517067
Side of lesion
Description

Side of lesion

Type de données

integer

Alias
UMLS CUI [1]
C1285236
Dimensions
Description

Dimensions

Type de données

integer

Unités de mesure
  • mm x mm
Alias
UMLS CUI [1]
C0439534
mm x mm
Method of assessment
Description

Method of assessment

Type de données

integer

Alias
UMLS CUI [1]
C2598110
Other specification
Description

Other specification

Type de données

integer

Alias
UMLS CUI [1]
C2348235
Non-indicator lesions
Description

Non-indicator lesions

Code of origin
Description

Code of origin

Type de données

text

extra nodal or other specification
Description

extra nodal or other specification

Type de données

text

Alias
UMLS CUI [1]
C1517067
Side of lesion
Description

Side of lesion

Type de données

integer

Alias
UMLS CUI [1]
C1285236
Presence
Description

Presence

Type de données

boolean

Alias
UMLS CUI [1]
C0150312
Liver and spleen examination after Cycle 3 and 6
Description

Liver and spleen examination after Cycle 3 and 6

Date of Assessment
Description

Date of Assessment

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Examination type
Description

Examination type

Type de données

integer

Alias
UMLS CUI [1]
C0031809
specify other examination
Description

specify other examination

Type de données

text

Alias
UMLS CUI [1]
C0260879
Hepatomegaly
Description

Hepatomegaly

Type de données

boolean

Alias
UMLS CUI [1]
C0019209
Status since last visit
Description

Status since last visit

Type de données

integer

Alias
UMLS CUI [1]
C0449438
Splenomegaly
Description

Splenomegaly

Type de données

boolean

Alias
UMLS CUI [1]
C0038002
Status since last visit
Description

Status since last visit

Type de données

integer

Alias
UMLS CUI [1]
C0449438
Response assessment after cycle 3
Description

Response assessment after cycle 3

Date of Assessment
Description

Assessment Date

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Are there any new lesions?
Description

New lesions

Type de données

boolean

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

Non-indicator lesions

Type de données

boolean

Alias
UMLS CUI [1]
C3272925
Overall response
Description

Overall response

Type de données

integer

Alias
UMLS CUI [1]
C3272903
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
Description

Partial response

Type de données

boolean

Alias
UMLS CUI [1]
C0741008
Response assessment after Cycle 6
Description

Response assessment after Cycle 6

Assessment Date
Description

Date of Assessment

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C2985720
dd/mm/yy
Are there any new lesions?
Description

New lesions

Type de données

boolean

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

Non-indicator lesions

Type de données

boolean

Overall response
Description

Overall response

Type de données

integer

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

Complete response

Type de données

integer

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

Partial response

Type de données

integer

Alias
UMLS CUI [1]
C0229654
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
Description

Partial response

Type de données

boolean

Alias
UMLS CUI [1]
C0741008

Similar models

Tumor assessment of Chronic Lymphocytic Leukemia NCT00090051 BO17072

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Tumor assessment at screening
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item Group
Indicator lesions
Code of origin
Item
Code of origin
integer
C2986125 (UMLS CUI [1])
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
Code of origin
integer
C2986125 (UMLS CUI [1])
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Side of lesion
Item
text
C0441987 (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
C0582103 (UMLS CUI [1])
Hepatomegaly
Item
Hepatomegaly
boolean
C0019209 (UMLS CUI [1])
Splenomegaly
Item
Splenomegaly
boolean
C0038002 (UMLS CUI [1])
Item Group
Tumor assessment after Cycle 3 and 6
Assessment Date
Item
date
C2985720 (UMLS CUI [1])
Item Group
Indicator lesions
Code of origin
Item
Code of origin
text
C2986125 (UMLS CUI [1])
extra nodal or other specification
Item
extra nodal or other specification
integer
C1517067 (UMLS CUI [1])
Side of lesion
Item
Side of lesion
integer
C1285236 (UMLS CUI [1])
Dimensions
Item
Dimensions
integer
C0439534 (UMLS CUI [1])
Method of assessment
Item
Method of assessment
integer
C2598110 (UMLS CUI [1])
Other specification
Item
Other specification
integer
C2348235 (UMLS CUI [1])
Item Group
Non-indicator lesions
Code of origin
Item
text
extra nodal or other specification
Item
text
C1517067 (UMLS CUI [1])
Side of lesion
Item
Side of lesion
integer
C1285236 (UMLS CUI [1])
Presence
Item
Presence
boolean
C0150312 (UMLS CUI [1])
Item Group
Liver and spleen examination after Cycle 3 and 6
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Examination type
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])
Item
Status since last visit
integer
C0449438 (UMLS CUI [1])
Code List
Status since last visit
CL Item
no change (1)
C0442739 (UMLS CUI-1)
CL Item
decrease (2)
C0547047 (UMLS CUI-1)
CL Item
increase (3)
C0442805 (UMLS CUI-1)
Splenomegaly
Item
boolean
C0038002 (UMLS CUI [1])
Item
integer
C0449438 (UMLS CUI [1])
Code List
Status since last visit
CL Item
no change (1)
C0442739 (UMLS CUI-1)
CL Item
decrease (2)
C0547047 (UMLS CUI-1)
CL Item
increase (3)
C0442805 (UMLS CUI-1)
Item Group
Response assessment after cycle 3
Assessment Date
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
New lesions
Item
Are there any new lesions?
boolean
C0221198 (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)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
boolean
C0741008 (UMLS CUI [1])
Item Group
Response assessment after Cycle 6
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
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
C0229654 (UMLS CUI [1])
Code List
Is patient in complete remission but has bone marrow nodules that can be identified histologically?
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)
Partial response
Item
Does patient fulfill the criteria for a CR but have persistent anemia or thrombocytopenia?
boolean
C0741008 (UMLS CUI [1])

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