ID

12152

Beskrivning

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

Nyckelord

  1. 2015-10-01 2015-10-01 -
  2. 2015-10-28 2015-10-28 -
Uppladdad den

1 oktober 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0 Legacy

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

CLL Follow-Up NCT00090051 BO17072

Follow-Up Study completion Chronic Lymphocytic Leukemia NCT00090051 BO17072

Complete response confirmation
Beskrivning

Complete response confirmation

Info
Beskrivning

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

Datatyp

text

Bone marrow sampling for molecular response
Beskrivning

Bone marrow sampling for molecular response

Alias
UMLS CUI-1
C0005953
Date of 1st confimation
Beskrivning

Date of 1st confirmation (Sample number 501)

Datatyp

date

Måttenheter
  • dd/mm/yy
dd/mm/yy
Remarks of 1st confirmation
Beskrivning

Remarks of 1st confirmation (Sample number 501)

Datatyp

text

Date of 2nd confirmation
Beskrivning

Date of 2nd confirmation (Sample number 502)

Datatyp

date

Måttenheter
  • dd/mm/yy
dd/mm/yy
Remarks of 2nd confirmation
Beskrivning

Remarks of 2nd confirmation (Sample number 502)

Datatyp

text

Blood sampling for molecular response
Beskrivning

Blood sampling for molecular response

Alias
UMLS CUI-1
C0005953
Date of 1st confirmation
Beskrivning

Date of 1st confirmation (Sample number 601)

Datatyp

date

Måttenheter
  • dd/mm/yy
dd/mm/yy
Remarks of 1st confirmation
Beskrivning

Remarks of 1st confirmation (Sample number 601)

Datatyp

text

Date of 2nd confirmation
Beskrivning

Date of 2nd confirmation (Sample number 602)

Datatyp

date

Måttenheter
  • dd/mm/yy
dd/mm/yy
Remarks of 2nd confirmation
Beskrivning

Remarks of 2nd confirmation (Sample number 602)

Datatyp

text

Completion of follow-up period
Beskrivning

Completion of follow-up period

Alias
UMLS CUI-1
C0016441
Did the patient complete the study up to the end of 5 year follow-up?
Beskrivning

Completion

Datatyp

boolean

Study completion
Beskrivning

Study completion

Date of last contact
Beskrivning

Date of last contact

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Did the patient complete the study up to the end of the treatment phase?
Beskrivning

Study completion

Datatyp

boolean

Reason for no completion
Beskrivning

Reason for no completion

Datatyp

integer

Specify violation of selection criteria
Beskrivning

Specify violation of selection criteria

Datatyp

text

Specify other protocol violation
Beskrivning

Specify other protocol violation

Datatyp

text

Specify other reason
Beskrivning

Specify other reason

Datatyp

text

Survival visit
Beskrivning

Survival visit

Date of contact
Beskrivning

Date of contact

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1705415
dd/mm/yy
Survival status
Beskrivning

Survival status

Datatyp

integer

Date of death
Beskrivning

Date of Death

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C1148348
dd/mm/yy
Date last contact
Beskrivning

Date of last contact

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1]
C0805839
dd/mm/yy
Cause of death
Beskrivning

Cause of death

Datatyp

integer

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

Specify other cause of death

Datatyp

text

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

Disease progression

Datatyp

integer

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

Date of progressive disease

Datatyp

date

Måttenheter
  • dd/mm/yy
Alias
UMLS CUI [1,1]
C1335499
UMLS CUI [1,2]
C0011008
dd/mm/yy

Similar models

Follow-Up Study completion Chronic Lymphocytic Leukemia NCT00090051 BO17072

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Complete response confirmation
Info
Item
text
Item Group
Bone marrow sampling for molecular response
C0005953 (UMLS CUI-1)
Date of 1st confirmation
Item
Date of 1st confimation
date
Remarks of 1st confirmation
Item
text
Date of 2nd confirmation
Item
Date of 2nd confirmation
date
Remarks of 2nd confirmation
Item
text
Item Group
Blood sampling for molecular response
C0005953 (UMLS CUI-1)
Date of 1st confimation
Item
Date of 1st confirmation
date
Remarks of 1st confirmation
Item
text
Date of 2nd confirmation
Item
Date of 2nd confirmation
date
Remarks of 2nd confirmation
Item
text
Item Group
Completion of follow-up period
C0016441 (UMLS CUI-1)
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
C0011008 (UMLS CUI [1])
Study completion
Item
Did the patient complete the study up to the end of the treatment phase?
boolean
Item
Reason for no completion
integer
Code List
Reason for no completion
CL Item
adverse event/intercurrent illness (1)
CL Item
death (complete death page) (2)
CL Item
insufficient therapeutic response (3)
CL Item
failure to return (4)
CL Item
did not cooperate/withdrew consent (5)
CL Item
administrative/other (6)
Specify violation of selection criteria
Item
text
Specify other protocol violation
Item
text
Specify other reason
Item
text
Item Group
Survival visit
Date of contact
Item
Date of contact
date
C0011008 (UMLS CUI [1,1])
C1705415 (UMLS CUI [1,2])
Item
Survival status
integer
Code List
Survival status
CL Item
alive (1)
CL Item
death (2)
CL Item
lost to follow-up (3)
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)
CL Item
other (2)
CL Item
not known (3)
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)
CL Item
no (2)
CL Item
not known (3)
CL Item
not applicable (progressive disease already documented) (4)
Date of progressive disease
Item
Date of progressive disease
date
C1335499 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial