ID

12248

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

Mots-clés

  1. 01/10/2015 01/10/2015 -
  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 Follow-Up BO17072 NCT00090051

Follow-Up Study completion Chronic Lymphocytic Leukemia BO17072 NCT00090051

Complete response confirmation
Description

Complete response confirmation

Info
Description

Only for patients achieving a complete response for confirmation of response.

Type de données

text

Bone marrow sampling for molecular response
Description

Bone marrow sampling for molecular response

Date of 1st confirmation
Description

Date of 1st confirmation (Sample number 501)

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C1611825
dd/mm/yy
Remarks of 1st confirmation
Description

Remarks of 1st confirmation (Sample number 501)

Type de données

text

Alias
UMLS CUI [1]
C0282411
Date of 2nd Confirmation
Description

Date of 2nd Confirmation (Sample number 502)

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0750484
dd/mm/yy
Remarks of 2nd confirmation
Description

Remarks of 2nd confirmation (Sample number 502)

Type de données

text

Alias
UMLS CUI [1]
C0282411
Blood sampling for molecular response
Description

Blood sampling for molecular response

Date of 1st confirmation
Description

Date of 1st confirmation (Sample number 601)

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C1611825
dd/mm/yy
Remarks of 1st confirmation
Description

Remarks of 1st confirmation (Sample number 601)

Type de données

text

Alias
UMLS CUI [1]
C0282411
Date of 2nd confirmation
Description

Date of 2nd confirmation (Sample number 602)

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0750484
dd/mm/yy
Remarks of 2nd confirmation
Description

Remarks of 2nd confirmation (Sample number 602)

Type de données

text

Alias
UMLS CUI [1]
C0282411
Completion of follow-up period
Description

Completion of follow-up period

Did the patient complete the study up to the end of 5 year follow-up?
Description

Completion

Type de données

boolean

Study completion
Description

Study completion

Date of last contact
Description

Date of last contact

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0805839
dd/mm/yy
Did the patient complete the study up to the end of the treatment phase?
Description

Study completion

Type de données

boolean

Alias
UMLS CUI [1]
C3274569
Reason for no completion
Description

Reason for no completion

Type de données

integer

Alias
UMLS CUI [1]
C1709849
Specify violation of selection criteria
Description

Specify violation of selection criteria

Type de données

text

Alias
UMLS CUI [1]
C0242801
Specify other protocol violation
Description

Specify other protocol violation

Type de données

text

Alias
UMLS CUI [1]
C1709750
Specify other reason
Description

Specify other reason

Type de données

text

Alias
UMLS CUI [1]
C3840932
Survival visit
Description

Survival visit

Date of contact
Description

Date of contact

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0805839
dd/mm/yy
Survival status
Description

Survival status

Type de données

integer

Alias
UMLS CUI [1]
C0220921
Date of death
Description

Date of Death

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C1148348
dd/mm/yy
Date last contact
Description

Date of last contact

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0805839
dd/mm/yy
Cause of death
Description

Cause of death

Type de données

integer

Alias
UMLS CUI [1]
C0007465
Specify other cause of death
Description

Specify other cause of death

Type de données

text

Alias
UMLS CUI [1]
C0007465
Did the patient’s disease progress after coming off study?
Description

Disease progression

Type de données

integer

Alias
UMLS CUI [1]
C0242656
Date of progressive disease
Description

Date of progressive disease

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy

Similar models

Follow-Up Study completion Chronic Lymphocytic Leukemia BO17072 NCT00090051

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Complete response confirmation
Info
Item
Info
text
Item Group
Bone marrow sampling for molecular response
Date of 1st confirmation
Item
Date of 1st confirmation
date
C1611825 (UMLS CUI [1])
Remarks of 1st confirmation
Item
Remarks of 1st confirmation
text
C0282411 (UMLS CUI [1])
Date of 2nd Confirmation
Item
Date of 2nd Confirmation
date
C0750484 (UMLS CUI [1])
Remarks of 2nd confirmation
Item
Remarks of 2nd confirmation
text
C0282411 (UMLS CUI [1])
Item Group
Blood sampling for molecular response
Date of 1st confimation
Item
Date of 1st confirmation
date
C1611825 (UMLS CUI [1])
Remarks of 1st confirmation
Item
Remarks of 1st confirmation
text
C0282411 (UMLS CUI [1])
Date of 2nd confirmation
Item
Date of 2nd confirmation
date
C0750484 (UMLS CUI [1])
Remarks of 2nd confirmation
Item
Remarks of 2nd confirmation
text
C0282411 (UMLS CUI [1])
Item Group
Completion of follow-up period
Completion
Item
Did the patient complete the study up to the end of 5 year follow-up?
boolean
Item Group
Study completion
Date of last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Study completion
Item
Did the patient complete the study up to the end of the treatment phase?
boolean
C3274569 (UMLS CUI [1])
Item
Reason for no completion
integer
C1709849 (UMLS CUI [1])
Code List
Reason for no completion
CL Item
adverse event/intercurrent illness (1)
C0877248 (UMLS CUI-1)
CL Item
death (complete death page) (2)
C0011065 (UMLS CUI-1)
CL Item
insufficient therapeutic response (3)
C0521982 (UMLS CUI-1)
CL Item
failure to return (4)
C0332156 (UMLS CUI-1)
CL Item
did not cooperate/withdrew consent (5)
C0586888 (UMLS CUI-1)
CL Item
administrative/other (6)
C1320722 (UMLS CUI-1)
Specify violation of selection criteria
Item
Specify violation of selection criteria
text
C0242801 (UMLS CUI [1])
Specify other protocol violation
Item
Specify other protocol violation
text
C1709750 (UMLS CUI [1])
Specify other reason
Item
Specify other reason
text
C3840932 (UMLS CUI [1])
Item Group
Survival visit
Date of contact
Item
Date of contact
date
C0805839 (UMLS CUI [1])
Item
Survival status
integer
C0220921 (UMLS CUI [1])
Code List
Survival status
CL Item
alive (1)
C2584946 (UMLS CUI-1)
CL Item
death (2)
C0011065 (UMLS CUI-1)
CL Item
lost to follow-up (3)
C1302313 (UMLS CUI-1)
Date of Death
Item
Date of death
date
C1148348 (UMLS CUI [1])
Date of last contact
Item
Date last contact
date
C0805839 (UMLS CUI [1])
Item
Cause of death
integer
C0007465 (UMLS CUI [1])
Code List
Cause of death
CL Item
progressive disease (1)
C1335499 (UMLS CUI-1)
CL Item
other (2)
C0205394 (UMLS CUI-1)
CL Item
not known (3)
C0439673 (UMLS CUI-1)
Specify other cause of death
Item
Specify other cause of death
text
C0007465 (UMLS CUI [1])
Item
Did the patient’s disease progress after coming off study?
integer
C0242656 (UMLS CUI [1])
Code List
Did the patient’s disease progress after coming off study?
CL Item
yes (1)
C1705108 (UMLS CUI-1)
CL Item
no (2)
C1298908 (UMLS CUI-1)
CL Item
not known (3)
C0439673 (UMLS CUI-1)
CL Item
not applicable (progressive disease already documented) (4)
C1272460 (UMLS CUI-1)
Date of progressive disease
Item
Date of progressive disease
date
C0011008 (UMLS CUI [1])

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