ID

44620

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

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 27, 2021

DOI

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License

Creative Commons BY-NC 3.0
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CLL Completion BO17072 NCT00090051

English

Treatment phase completion Chronic Lymphocytic Leukemia BO17072 NCT00090051

1 forms  
Death of Patient
Description

Death of Patient

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]
C1299658
Was autopsy performed?
Description

Autopsy

Data type

boolean

Alias
UMLS CUI [1]
C4274690
Autopsy findings
Description

Autopsy findings

Data type

text

Alias
UMLS CUI [1]
C1706864
Comments
Description

General comments on patient's death

Data type

text

Alias
UMLS CUI [1]
C0947611
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]
C3173975
dd/mm/yy
Did the patient complete the study up to the end of the treatment phase?
Description

Study completion

Data type

boolean

Alias
UMLS CUI [1]
C2826674
Reason for no completion
Description

Reason for no completion

Data type

integer

Alias
UMLS CUI [1]
C0205197
Specify violation of selection criteria
Description

Specify violation of selection criteria

Data type

text

Alias
UMLS CUI [1]
C1709750
Specify other protocol violation
Description

Specify other protocol violation

Data type

text

Alias
UMLS CUI [1]
C1709750
Specify other reason
Description

Specify other reason

Data type

text

Alias
UMLS CUI [1]
C3840932
Additional observations
Description

Additional observations

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

Alias
UMLS CUI [1]
C0560166
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Similar models

Treatment phase completion Chronic Lymphocytic Leukemia BO17072 NCT00090051

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Death of Patient
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
C1299658 (UMLS CUI [1])
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
C4274690 (UMLS CUI [1])
Autopsy findings
Item
Autopsy findings
text
C1706864 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item Group
Treatment phase completion
Date of last dosing
Item
Date of last dosing
date
C3173975 (UMLS CUI [1])
Study completion
Item
Did the patient complete the study up to the end of the treatment phase?
boolean
C2826674 (UMLS CUI [1])
Item
Reason for no completion
integer
C0205197 (UMLS CUI [1])
Reason for no completion
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)
CL Item
violation of selection criteria at entry (5)
C0242801 (UMLS CUI-1)
CL Item
other protocol violation (6)
C1709750 (UMLS CUI-1)
CL Item
refused treatment/did not cooperate/withdrew consent (7)
C0749657 (UMLS CUI-1)
CL Item
early improvement (8)
C2986411 (UMLS CUI-1)
CL Item
administrative/other (9)
C1292785 (UMLS CUI-1)
Specify violation of selection criteria
Item
Specify violation of selection criteria
text
C1709750 (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
Additional observations
Additional observations
Item
Additional observations
text
C0560166 (UMLS CUI [1])
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