ID

12234

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

Mots-clés

  1. 30/09/2015 30/09/2015 -
  2. 30/09/2015 30/09/2015 -
  3. 28/10/2015 28/10/2015 -
  4. 27/09/2021 27/09/2021 -
Téléchargé le

28 octobre 2015

DOI

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Licence

Creative Commons BY-NC 3.0 Legacy

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CLL Cycle 1 FCR vs FC BO17072 NCT00090051

Chemotherapy Cycle 1 of Chronic Lymphocytic Leukemia NCT00090051 BO17072

Randomization
Description

Randomization

Alias
UMLS CUI-1
C0034656
Date of visit
Description

Date of visit

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI-1
C1320303
dd/mm/yy
Date of Randomization
Description

Date of Randomization

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
dd/mm/yy
Randomization number
Description

Randomization number

Type de données

integer

Alias
UMLS CUI [1]
C2986235
Treatment arm
Description

Treatment arm

Type de données

integer

Alias
UMLS CUI [1]
C1522541
Reason why randomized but not treated
Description

Reason why randomized but not treated

Type de données

integer

Alias
UMLS CUI [1]
C0746919
Pharmacokinetic assessments
Description

Pharmacokinetic assessments

Participation in pharmacokinetic sampling
Description

Participation in pharmacokinetic sampling

Type de données

boolean

Alias
UMLS CUI [1]
C0031328
Vital signs and physical measurements
Description

Vital signs and physical measurements

Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI-1
C0005910
kg
Height
Description

Height

Type de données

integer

Unités de mesure
  • cm
Alias
UMLS CUI-1
C0005890
cm
Temperature
Description

Temperature

Type de données

float

Unités de mesure
  • °C
Alias
UMLS CUI-1
C0005903
°C
Sitting measurements after al least 5 minutes rest
Description

Sitting measurements after al least 5 minutes rest

Blood pressure systolic
Description

Blood pressure systolic

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure diastolic
Description

Blood pressure diastolic

Type de données

integer

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0428883
kg
Pulse rate
Description

Pulse rate

Type de données

integer

Unités de mesure
  • bpm
Alias
UMLS CUI-1
C0232117
bpm
"B" symptoms
Description

"B" symptoms

Fever
Description

Fever

Type de données

boolean

Alias
UMLS CUI-1
C0015967
Night sweats
Description

Night sweats

Type de données

boolean

Alias
UMLS CUI-1
C0028081
Weight loss
Description

Weight loss

Type de données

boolean

Alias
UMLS CUI-1
C0043096
General physical examination
Description

General physical examination

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

General physical examination

Type de données

text

Alias
UMLS CUI [1]
C0031809
ECG
Description

ECG

Alias
UMLS CUI-1
C1623258
Date ECG performed
Description

Date ECG performed

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI-1
C0011008
dd/mm/yy
Are there any abnormalities noted in the ECG?
Description

Abnormalities in the ECG

Type de données

boolean

Alias
UMLS CUI-1
C1623258
Specification of abnormalities
Description

Specification of abnormalities

Type de données

text

Was ECG performed?
Description

ECG

Type de données

boolean

Alias
UMLS CUI [1]
C1623258
Laboratory analysis
Description

Laboratory analysis

Sample collection date
Description

Sample collection date

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C0011008
dd/mm/yy
Lab ID number
Description

Lab ID number

Type de données

integer

Hematology
Description

Hematology

Alias
UMLS CUI-1
C0474523
Hemoglobin
Description

Hemoglobin

Type de données

integer

Alias
UMLS CUI [1]
C0019046
Hematocrit
Description

Hematocrit

Type de données

integer

Alias
UMLS CUI [1]
C0518014
Red Blood Cells
Description

Red Blood Cells

Type de données

integer

Alias
UMLS CUI [1]
C0362910
Leukocytes (total)
Description

Leukocytes (total)

Type de données

integer

Alias
UMLS CUI [1]
C0023508
Neutrophils
Description

Neutrophils

Type de données

integer

Alias
UMLS CUI [1]
C0948762
Basophils
Description

Basophils

Type de données

integer

Alias
UMLS CUI [1]
C0200641
Eosinophils
Description

Eosinophils

Type de données

integer

Alias
UMLS CUI [1]
C0362902
Lymphocytes
Description

Lymphocytes

Type de données

integer

Alias
UMLS CUI [1]
C0024264
Monocytes
Description

Monocytes

Type de données

integer

Alias
UMLS CUI [1]
C0026473
Other cells
Description

Other cells

Type de données

integer

Platelets
Description

Platelets

Type de données

integer

Alias
UMLS CUI [1]
C0005821
Prothrombin time
Description

Prothrombin time

Type de données

integer

Alias
UMLS CUI [1]
C0491338
Please comment on any abnormal other cells and specify white cell morphology
Description

Comment

Type de données

text

Alias
UMLS CUI [1]
C0947611
Blood chemistry
Description

Blood chemistry

Alias
UMLS CUI-1
C0005774
Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
Description

Aspartate transaminase (Serum glutamic oxaloacetic transaminase)

Type de données

integer

Alias
UMLS CUI [1]
C0004002
Alanine transaminase (Serum glutamate-pyruvate transaminase)
Description

Alanine transaminase (Serum glutamate-pyruvate transaminase)

Type de données

integer

Alias
UMLS CUI [1]
C0001899
Alk. phosphatase
Description

Alk. phosphatase

Type de données

integer

Alias
UMLS CUI [1]
C0002059
Bilirubin total
Description

Bilirubin total

Type de données

integer

Alias
UMLS CUI [1]
C0201913
Urea (BUN)
Description

Urea (BUN)

Type de données

integer

Alias
UMLS CUI [1]
C0523961
Serum creatinine
Description

Serum creatinine

Type de données

integer

Alias
UMLS CUI [1]
C0201976
Lactate dehydrogenase
Description

Lactate dehydrogenase

Type de données

integer

Alias
UMLS CUI [1]
C0202113
Total protein
Description

Total protein

Type de données

integer

Alias
UMLS CUI [1]
C0555903
Albumin
Description

Albumin

Type de données

integer

Alias
UMLS CUI [1]
C0201838
Blood glucose (random)
Description

Blood glucose (random)

Type de données

integer

Alias
UMLS CUI [1]
C0202042
beta-2-microglobulin
Description

beta-2-microglobulin

Type de données

integer

Electrocytes
Description

Electrocytes

Sodium
Description

Sodium

Type de données

integer

Alias
UMLS CUI [1]
C0037473
Calcium
Description

Calcium

Type de données

integer

Alias
UMLS CUI [1]
C0201925
Potassium
Description

Potassium

Type de données

integer

Alias
UMLS CUI [1]
C0202194
Phosphate
Description

Phosphate

Type de données

integer

Alias
UMLS CUI [1]
C0523826
Administration of Rituximab
Description

Administration of Rituximab

Date of first dose
Description

Date of first dose

Type de données

date

Unités de mesure
  • dd/mm/yy
Alias
UMLS CUI [1]
C3173309
dd/mm/yy
Start time of first dose
Description

Start time of first dose

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI-1
C1301880
hh:mm
End time of first dose
Description

End time of first dose

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI-1
C1522314
hh:mm
Actual Dose of Rituximab
Description

Actual Dose of Rituximab

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1]
C0393022
mg
Interrupted infusion
Description

Interrupted infusion

Type de données

boolean

Alias
UMLS CUI [1]
C0574032
Reason of interruption
Description

Reason of interruption

Type de données

text

Alias
UMLS CUI [1]
C3538832
Decrease of infusion rate
Description

Decrease of infusion rate without interruption

Type de données

boolean

Alias
UMLS CUI [1]
C2964135
Reason of decrease
Description

Reason of decrease

Type de données

text

Alias
UMLS CUI [1]
C0547047
Completion of infusion
Description

Completion of infusion

Type de données

boolean

Alias
UMLS CUI [1]
C0574032
Reason of incomplete infusion
Description

Reason of incomplete infusion

Type de données

text

Alias
UMLS CUI [1]
C0205257
Administration of Fludarabine
Description

Administration of Fludarabine

Delay of Fludarabine medication
Description

Delay of Fludarabine medication

Type de données

boolean

Alias
UMLS CUI [1]
C0059985
Reason for delay
Description

Reason for delay

Type de données

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Description

Specify other reason

Type de données

text

Alias
UMLS CUI [1]
C3840932
Fludarabine Medication
Description

Fludarabine Medication

Date
Description

Date

Type de données

date

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

Start time

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Description

End time

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual dose
Description

Medication Dose

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose adjustment
Description

Dose adjustment

Type de données

boolean

Alias
UMLS CUI [1]
C2826232
Reason for dose adjustment
Description

Reason for dose adjustment

Type de données

integer

Alias
UMLS CUI [1]
C2826286
Specify other reason
Description

Specify other reason

Type de données

text

Alias
UMLS CUI [1]
C2826696
Administration of Cyclophosphamide
Description

Administration of Cyclophosphamide

Delay of Cyclophosphamide
Description

Delay of Cyclophosphamide

Type de données

boolean

Alias
UMLS CUI [1]
C0010583
Reson for delay
Description

Reson for delay

Type de données

integer

Alias
UMLS CUI [1]
C1298642
Specify other reason
Description

Specify other reason

Type de données

text

Alias
UMLS CUI [1]
C2826696
Cyclophosphamide Medication
Description

Cyclophosphamide Medication

Date
Description

Date

Type de données

date

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

Start time

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI [1]
C1301880
hh:mm
End time
Description

End time

Type de données

time

Unités de mesure
  • hh:mm
Alias
UMLS CUI [1]
C1522314
hh:mm
Actual dose
Description

Medication Dose

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose adjustment
Description

Dose adjustment

Type de données

boolean

Alias
UMLS CUI [1]
C2826232
Reason for dose adjustment
Description

Reason for dose adjustment

Type de données

integer

Alias
UMLS CUI [1]
C2826286
Specify other reason
Description

Specify other reason

Type de données

text

Alias
UMLS CUI [1]
C3840932

Similar models

Chemotherapy Cycle 1 of Chronic Lymphocytic Leukemia NCT00090051 BO17072

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Randomization
C0034656 (UMLS CUI-1)
Visit date
Item
Date of visit
date
C1320303 (UMLS CUI-1)
Date of Randomization
Item
Date of Randomization
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Randomization number
Item
Randomization number
integer
C2986235 (UMLS CUI [1])
Item
Treatment arm
integer
C1522541 (UMLS CUI [1])
Code List
Treatment arm
CL Item
FCR (1)
C1880650 (UMLS CUI-1)
CL Item
FC (2)
C0280920 (UMLS CUI-1)
No treatment
Item
Reason why randomized but not treated
integer
C0746919 (UMLS CUI [1])
Participation in pharmacokinetic sampling
Item
Participation in pharmacokinetic sampling
boolean
C0031328 (UMLS CUI [1])
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
Sitting measurements after al least 5 minutes rest
Blood pressure
Item
Blood pressure systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure
Item
Blood pressure 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
C0043096 (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
C0011008 (UMLS CUI-1)
Abnormalities in the ECG
Item
Are there any abnormalities noted in the ECG?
boolean
C1623258 (UMLS CUI-1)
Abnormalities
Item
Specification of abnormalities
text
ECG
Item
Was ECG performed?
boolean
C1623258 (UMLS CUI [1])
Item Group
Laboratory analysis
Date
Item
Sample collection date
date
C0011008 (UMLS CUI [1])
Lab ID number
Item
Lab ID number
integer
Item Group
Hematology
C0474523 (UMLS CUI-1)
Hemoglobin
Item
Hemoglobin
integer
C0019046 (UMLS CUI [1])
Hematocrit
Item
Hematocrit
integer
C0518014 (UMLS CUI [1])
RBC
Item
Red Blood Cells
integer
C0362910 (UMLS CUI [1])
Leukocytes
Item
Leukocytes (total)
integer
C0023508 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
integer
C0948762 (UMLS CUI [1])
Basophils
Item
Basophils
integer
C0200641 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
integer
C0362902 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
integer
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
integer
C0026473 (UMLS CUI [1])
Other cells
Item
Other cells
integer
Platelets
Item
Platelets
integer
C0005821 (UMLS CUI [1])
Prothrombin time
Item
Prothrombin time
integer
C0491338 (UMLS CUI [1])
Comment
Item
Please comment on any abnormal other cells and specify white cell morphology
text
C0947611 (UMLS CUI [1])
Item Group
Blood chemistry
C0005774 (UMLS CUI-1)
AST (SGOT)
Item
Aspartate transaminase (Serum glutamic oxaloacetic transaminase)
integer
C0004002 (UMLS CUI [1])
ALT (SGPT)
Item
Alanine transaminase (Serum glutamate-pyruvate transaminase)
integer
C0001899 (UMLS CUI [1])
Alk. phosphatase
Item
Alk. phosphatase
integer
C0002059 (UMLS CUI [1])
Bilirubin total
Item
Bilirubin total
integer
C0201913 (UMLS CUI [1])
Urea (BUN)
Item
Urea (BUN)
integer
C0523961 (UMLS CUI [1])
Serum creatinine
Item
Serum creatinine
integer
C0201976 (UMLS CUI [1])
LDH
Item
Lactate dehydrogenase
integer
C0202113 (UMLS CUI [1])
Total protein
Item
Total protein
integer
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
integer
C0201838 (UMLS CUI [1])
Blood glucose
Item
Blood glucose (random)
integer
C0202042 (UMLS CUI [1])
beta-2-microglobulin
Item
beta-2-microglobulin
integer
Item Group
Electrocytes
Sodium
Item
Sodium
integer
C0037473 (UMLS CUI [1])
Calcium
Item
Calcium
integer
C0201925 (UMLS CUI [1])
Potassium
Item
Potassium
integer
C0202194 (UMLS CUI [1])
Phosphate
Item
Phosphate
integer
C0523826 (UMLS CUI [1])
Date of first dose
Item
Date of first dose
date
C3173309 (UMLS CUI [1])
Start time of first dose
Item
Start time of first dose
time
C1301880 (UMLS CUI-1)
End time of first dose
Item
End time of first dose
time
C1522314 (UMLS CUI-1)
Actual Dose of Rituximab
Item
Actual Dose of Rituximab
float
C0393022 (UMLS CUI [1])
Interrupted infusion
Item
Interrupted infusion
boolean
C0574032 (UMLS CUI [1])
Reason of interruption
Item
Reason of interruption
text
C3538832 (UMLS CUI [1])
Decrease of infusion rate
Item
Decrease of infusion rate
boolean
C2964135 (UMLS CUI [1])
Reason of decrease
Item
Reason of decrease
text
C0547047 (UMLS CUI [1])
Completion of infusion
Item
Completion of infusion
boolean
C0574032 (UMLS CUI [1])
Reason of incomplete infusion
Item
Reason of incomplete infusion
text
C0205257 (UMLS CUI [1])
Delay of Fludarabine medication
Item
Delay of Fludarabine medication
boolean
C0059985 (UMLS CUI [1])
Item
Reason for delay
integer
C1298642 (UMLS CUI [1])
Code List
Reason for delay
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C3840932 (UMLS CUI [1])
Item Group
Fludarabine Medication
Date
Item
date
C0011008 (UMLS CUI [1])
Start time
Item
time
C1301880 (UMLS CUI [1])
End time
Item
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual dose
float
C3174092 (UMLS CUI [1])
Dose adjustment
Item
boolean
C2826232 (UMLS CUI [1])
Item
Reason for dose adjustment
integer
C2826286 (UMLS CUI [1])
Code List
Reason for dose adjustment
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Item Group
Administration of Cyclophosphamide
Delay of Cyclophosphamide
Item
Delay of Cyclophosphamide
boolean
C0010583 (UMLS CUI [1])
Item
Reson for delay
integer
C1298642 (UMLS CUI [1])
Code List
Reson for delay
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C2826696 (UMLS CUI [1])
Item Group
Cyclophosphamide Medication
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Start time
Item
Start time
time
C1301880 (UMLS CUI [1])
End time
Item
End time
time
C1522314 (UMLS CUI [1])
Medication Dose
Item
Actual dose
float
C3174092 (UMLS CUI [1])
Dose adjustment
Item
Dose adjustment
boolean
C2826232 (UMLS CUI [1])
Item
Reason for dose adjustment
integer
C2826286 (UMLS CUI [1])
Code List
Reason for dose adjustment
CL Item
laboratory (1)
C0022877 (UMLS CUI-1)
CL Item
adverse event (2)
C0877248 (UMLS CUI-1)
CL Item
other (3)
C0205394 (UMLS CUI-1)
Specify other reason
Item
Specify other reason
text
C3840932 (UMLS CUI [1])

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