ID

44584

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

Keywords

  1. 9/30/15 9/30/15 -
  2. 10/27/15 10/27/15 -
  3. 9/27/21 9/27/21 -
Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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CLL History BO17072 NCT00090051

History of Chronic lymphocytic leukemia NCT0090051

Vital signs and physical measurements
Description

Vital signs and physical measurements

Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI-1
C0005910
kg
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI-1
C0005890
cm
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI-1
C0005903
°C
after al least 5 minutes rest
Description

after al least 5 minutes rest

systolic
Description

systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI-1
C0871470
mmHg
diastolic
Description

diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI-1
C0428883
mmHg
Pulse rate
Description

Pulse rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI-1
C0232117
bpm
"B" symptoms
Description

"B" symptoms

Fever
Description

Fever

Data type

boolean

Alias
UMLS CUI-1
C0015967
Night sweats
Description

Night sweats

Data type

boolean

Alias
UMLS CUI-1
C0028081
Weight loss
Description

Weight loss

Data type

boolean

Alias
UMLS CUI-1
C1262477
General physical examination
Description

General physical examination

Perform a standard physical examination but specify only abnormalities not related to CLL.
Description

General physical examination

Data type

text

Alias
UMLS CUI-1
C0031809
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
Date ECG performed
Description

Date ECG performed

Data type

date

Measurement units
  • dd/mm/yy
Alias
UMLS CUI [1]
C2826846
dd/mm/yy
Are there any abnormalities noted in the ECG?
Description

Abnormalities in the ECG

Data type

boolean

Alias
UMLS CUI [1]
C0236140
Specification of abnormalities
Description

Specification of abnormalities

Data type

text

Alias
UMLS CUI [1]
C0205161

Similar models

History of Chronic lymphocytic leukemia NCT0090051

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Vital signs and physical measurements
Weight
Item
Weight
float
C0005910 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI-1)
Temperature
Item
Temperature
float
C0005903 (UMLS CUI-1)
Item Group
after al least 5 minutes rest
Blood pressure
Item
systolic
integer
C0871470 (UMLS CUI-1)
Blood pressure
Item
diastolic
integer
C0428883 (UMLS CUI-1)
Pulse rate
Item
Pulse rate
integer
C0232117 (UMLS CUI-1)
Item Group
"B" symptoms
Fever
Item
Fever
boolean
C0015967 (UMLS CUI-1)
Night sweats
Item
Night sweats
boolean
C0028081 (UMLS CUI-1)
Weight loss
Item
Weight loss
boolean
C1262477 (UMLS CUI-1)
Item Group
General physical examination
General physical examination
Item
Perform a standard physical examination but specify only abnormalities not related to CLL.
text
C0031809 (UMLS CUI-1)
Item Group
ECG
C1623258 (UMLS CUI-1)
Date
Item
Date ECG performed
date
C2826846 (UMLS CUI [1])
Abnormalities in the ECG
Item
Are there any abnormalities noted in the ECG?
boolean
C0236140 (UMLS CUI [1])
Abnormalities
Item
Specification of abnormalities
text
C0205161 (UMLS CUI [1])

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