ID

12148

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).

Keywords

Versions (3)
  1. 9/30/15 9/30/15 -
  2. 10/28/15 10/28/15 -
  3. 9/27/21 9/27/21 -
Uploaded on

September 30, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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CLL Completion NCT00090051 BO17072

English

Treatment phase completion Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 forms  
In the case of patient’s death
Description

In the case of patient’s death

Alias
UMLS CUI-1
C0011065
Date of Death
Description

Date of Death

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C1148348
dd/mm/yy
Cause of Death
Description

Primary Cause of Death

Data type

text

Alias
UMLS CUI [1]
C0007465
Cause of death
Description

Underlying cause of death (if applicable)

Data type

text

Alias
UMLS CUI [1]
C0007465
Death related to test drugs
Description

Relationship of death to test drugs

Data type

integer

Alias
UMLS CUI [1,1]
C0439849
UMLS CUI [1,2]
C0007465
Was autopsy performed?
Description

Autopsy

Data type

boolean

Alias
UMLS CUI [1]
C0004398
Autopsy findings
Description

Autopsy findings

Data type

text

Alias
UMLS CUI [1]
C0004398
Comments
Description

General comments on patient's death

Data type

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C1306577
Treatment phase completion
Description

Treatment phase completion

Date of last dosing
Description

Date of last dosing

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1762893
dd/mm/yy
Did the patient complete the study up to the end of the treatment phase?
Description

Study completion

Data type

boolean

Reason for no completion
Description

Reason for no completion

Data type

integer

Specify violation of selection criteria
Description

Specify violation of selection criteria

Data type

text

Specify other protocol violation
Description

Specify other protocol violation

Data type

text

Specify other reason
Description

Specify other reason

Data type

text

Additional observations
Description

Additional observations

Alias
UMLS CUI-1
C1524062
Additional observations
Description

Please record any significant clinical observations related to the trial drug, not reported in other parts of the CRF, including observations toward a possible therapeutic activity outside the studied indication and potential drug interactions.

Data type

text

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Similar models

Treatment phase completion Chronic Lymphocytic Leukemia NCT00090051 BO17072

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
In the case of patient’s death
C0011065 (UMLS CUI-1)
Date of Death
Item
date
C1148348 (UMLS CUI [1])
Cause of Death
Item
text
C0007465 (UMLS CUI [1])
Cause of death
Item
text
C0007465 (UMLS CUI [1])
Item
Death related to test drugs
integer
C0439849 (UMLS CUI [1,1])
C0007465 (UMLS CUI [1,2])
Death related to test drugs
Code List
Death related to test drugs
CL Item
unrelated (1)
C0445356 (UMLS CUI-1)
CL Item
remote (2)
C0205157 (UMLS CUI-1)
CL Item
possible (3)
C0332149 (UMLS CUI-1)
CL Item
probable (4)
C1709683 (UMLS CUI-1)
Autopsy
Item
Was autopsy performed?
boolean
C0004398 (UMLS CUI [1])
Autopsy findings
Item
Autopsy findings
text
C0004398 (UMLS CUI [1])
Comments
Item
text
C0947611 (UMLS CUI [1,1])
C1306577 (UMLS CUI [1,2])
Item Group
Treatment phase completion
Date of last dosing
Item
date
C0011008 (UMLS CUI [1,1])
C1762893 (UMLS CUI [1,2])
Study completion
Item
Did the patient complete the study up to the end of the treatment phase?
boolean
Reason for no completion
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
violation of selection criteria at entry (5)
CL Item
other protocol violation (6)
CL Item
refused treatment/did not cooperate/withdrew consent (7)
CL Item
early improvement (8)
CL Item
administrative/other (9)
Specify violation of selection criteria
Item
text
Specify other protocol violation
Item
text
Specify other reason
Item
text
Item Group
Additional observations
C1524062 (UMLS CUI-1)
Additional observations
Item
text
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