ID

22249

Descripción

Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

Link

https://clinicaltrials.gov/ct2/show/NCT01308580

Palabras clave

Versiones (1)
  1. 25/5/17 25/5/17 -
Subido en

25 de mayo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 End of Treatment

Inglés

CRFs Cabazitaxel Prostate Cancer NCT01308580 End of Treatment

1 formularios  
End of Treatment
Descripción

End of Treatment

Alias
UMLS CUI-1
C0580352
Did the Subject complete treatment period per protocol?
Descripción

Treatment completed

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0580352
If NO, Main reason for stopping treatment (tick one box only):
Descripción

* Please complete the Adverse event form ** Patient's request should be ticked if the subject withdraws his consent or decide to stop treatment but continue in Follow-up period and none of the above reasons are present especially Adverse Event.

Tipo de datos

text

Alias
UMLS CUI [1]
C3538832
If NO and Main reason is Patient's request, specify:
Descripción

Reason for Treatment Interruption: Patient's request

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1272683
UMLS CUI [1,2]
C3538832
If NO and Other reason, specify:
Descripción

Reason for Treatment Interruption: Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C3538832
Visit Information
Descripción

Visit Information

Alias
UMLS CUI-1
C0545082
Date of visit:
Descripción

Date of visit

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yyyy
Vital Signs
Descripción

Vital Signs

Alias
UMLS CUI-1
C0518766
Date performed:
Descripción

Assessment Date

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2985720
dd-mmm-yyyy
Weight
Descripción

Body weight

Tipo de datos

float

Unidades de medida
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Blood Pressure: Systolic
Descripción

Systolic Blood Pressure

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure: Diastolic
Descripción

Diastolic Blood Pressure

Tipo de datos

float

Unidades de medida
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate:
Descripción

Heart rate

Tipo de datos

float

Unidades de medida
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Performance Status: ECOG
Descripción

ECOG Performance Status

Tipo de datos

integer

Alias
UMLS CUI [1]
C1520224
Laboratory Tests Hematology
Descripción

Laboratory Tests Hematology

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0474523
Date
Descripción

Laboratory Test Date

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2826641
dd-mmm-yyyy
Hemoglobin
Descripción

Hemoglobin

Tipo de datos

float

Unidades de medida
  • g/dL
Alias
UMLS CUI [1]
C0019046
g/dL
Platelet Count (Thrombocyte Count)
Descripción

Platelets

Tipo de datos

float

Alias
UMLS CUI [1]
C0005821
White Blood Cell Count (Leukocyte Count)
Descripción

White Blood Cell Count

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0023508
10^9/L
Neutrophils
Descripción

Neutrophils

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0948762
10^9/L
Lymphocytes
Descripción

Lymphocytes

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0024264
10^9/L
Monocytes
Descripción

Monocytes

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0026473
10^9/L
Eosinophils
Descripción

Eosinophils

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0200638
10^9/L
Basophils
Descripción

Basophils

Tipo de datos

float

Unidades de medida
  • 10^9/L
Alias
UMLS CUI [1]
C0200641
10^9/L
Laboratory Tests Biochemistry
Descripción

Laboratory Tests Biochemistry

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005477
Date
Descripción

Laboratory Test Biochemistry Date

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C2826641
UMLS CUI [1,2]
C0005477
dd-mmm-yyyy
Sodium
Descripción

Sodium

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0337443
mmol/L
Potassium
Descripción

Potassium

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0202194
mmol/L
Calcium
Descripción

Calcium

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0201925
mmol/L
Phosphorus
Descripción

Phosphorus

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0031705
mmol/L
Blood urea nitrogen
Descripción

Blood Urea Nitrogen

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0005845
mmol/L
Magnesium
Descripción

Magnesium

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0373675
mmol/L
Total Proteins
Descripción

Total Proteins

Tipo de datos

float

Unidades de medida
  • g/L
Alias
UMLS CUI [1]
C0555903
g/L
Albumin
Descripción

Albumin

Tipo de datos

float

Unidades de medida
  • g/L
Alias
UMLS CUI [1]
C0201838
g/L
Glucose
Descripción

Blood Glucose

Tipo de datos

float

Unidades de medida
  • mmol/L
Alias
UMLS CUI [1]
C0202042
mmol/L
AST (SGOT)
Descripción

AST

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201899
U/L
AST (SGOT - ASAT): Normal Range - Upper Limit
Descripción

AST: Upper Limit

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C1519815
U/L
ALT
Descripción

ALT

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201836
U/L
ALT (SGPT - ALAT): Normal Range - Upper Limit
Descripción

ALT: Upper Limit

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C1519815
U/L
Alkaline Phosphatase
Descripción

Alkaline Phosphatase

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0201850
U/L
Alkaline Phosphatase: Normal Range - Upper Limit
Descripción

Alkaline Phosphatase: Upper Limit

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C1519815
U/L
Total Bilirubin
Descripción

Total Bilirubin

Tipo de datos

float

Unidades de medida
  • umol/L
Alias
UMLS CUI [1]
C0201913
umol/L
Total Bilirubin: Normal Range - Upper Limit
Descripción

Total Bilirubin: Upper Limit

Tipo de datos

float

Unidades de medida
  • umol/L
Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C1519815
umol/L
Creatinine
Descripción

Creatinine

Tipo de datos

float

Unidades de medida
  • umol/L
Alias
UMLS CUI [1]
C0201976
umol/L
Creatinine: Normal Range - Upper Limit
Descripción

Creatinine: Upper Limit

Tipo de datos

float

Unidades de medida
  • umol/L
Alias
UMLS CUI [1,1]
C0201976
UMLS CUI [1,2]
C1519815
umol/L
Lactate Dehydrogenase
Descripción

Lactate Dehydrogenase

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1]
C0202113
U/L
Lactate Dehydrogenase: Normal Range - Upper Limit
Descripción

Lactate Dehydrogenase: Upper Limit

Tipo de datos

float

Unidades de medida
  • U/L
Alias
UMLS CUI [1,1]
C0202113
UMLS CUI [1,2]
C1519815
U/L
Ciruclating free plasma DNA - Blood Sampling
Descripción

Ciruclating free plasma DNA - Blood Sampling

Alias
UMLS CUI-1
C4289789
UMLS CUI-2
C0005834
Date of Sample:
Descripción

Sample ID: Z04 - Theoretical time: End of Study Treatment

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1,1]
C4289789
UMLS CUI [1,2]
C1317250
dd-mmm-yyyy
Electrocardiogram (12 Leads)
Descripción

Electrocardiogram (12 Leads)

Alias
UMLS CUI-1
C1623258
Date performed:
Descripción

ECG Date

Tipo de datos

date

Unidades de medida
  • dd-mmm-yyyy
Alias
UMLS CUI [1]
C2826640
dd-mmm-yyyy
Interpretation
Descripción

ECG finding

Tipo de datos

text

Alias
UMLS CUI [1]
C0438154
Interpretation - If abnormal, clinically significant?
Descripción

Note: If abnormal, clinically significant, record on the AE Form.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C2826279
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Similar models

CRFs Cabazitaxel Prostate Cancer NCT01308580 End of Treatment

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
End of Treatment
C0580352 (UMLS CUI-1)
Treatment completed
Item
Did the Subject complete treatment period per protocol?
boolean
C0580352 (UMLS CUI [1])
Item
If NO, Main reason for stopping treatment (tick one box only):
text
C3538832 (UMLS CUI [1])
Reason for Treatment Interruption
Code List
If NO, Main reason for stopping treatment (tick one box only):
CL Item
Adverse event* (Adverse event*)
CL Item
Poor compliance to protocol (Poor compliance to protocol)
CL Item
Disease progression (Disease progression)
CL Item
Lost to follow-up (Lost to follow-up)
CL Item
Patient's request** (Patient's request**)
CL Item
Other reason (Other reason)
Reason for Treatment Interruption: Patient's request
Item
If NO and Main reason is Patient's request, specify:
text
C1272683 (UMLS CUI [1,1])
C3538832 (UMLS CUI [1,2])
Reason for Treatment Interruption: Specification
Item
If NO and Other reason, specify:
text
C2348235 (UMLS CUI [1,1])
C3538832 (UMLS CUI [1,2])
Item Group
Visit Information
C0545082 (UMLS CUI-1)
Date of visit
Item
Date of visit:
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Assessment Date
Item
Date performed:
date
C2985720 (UMLS CUI [1])
Body weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Blood Pressure: Systolic
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Blood Pressure: Diastolic
float
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate:
float
C0018810 (UMLS CUI [1])
Item
Performance Status: ECOG
integer
C1520224 (UMLS CUI [1])
ECOG Performance Status
Code List
Performance Status: ECOG
CL Item
0 (1)
CL Item
1 (2)
CL Item
2 (3)
CL Item
3 (4)
CL Item
4 (5)
Item Group
Laboratory Tests Hematology
C0022885 (UMLS CUI-1)
C0474523 (UMLS CUI-2)
Laboratory Test Date
Item
Date
date
C2826641 (UMLS CUI [1])
Hemoglobin
Item
Hemoglobin
float
C0019046 (UMLS CUI [1])
Platelets
Item
Platelet Count (Thrombocyte Count)
float
C0005821 (UMLS CUI [1])
White Blood Cell Count
Item
White Blood Cell Count (Leukocyte Count)
float
C0023508 (UMLS CUI [1])
Neutrophils
Item
Neutrophils
float
C0948762 (UMLS CUI [1])
Lymphocytes
Item
Lymphocytes
float
C0024264 (UMLS CUI [1])
Monocytes
Item
Monocytes
float
C0026473 (UMLS CUI [1])
Eosinophils
Item
Eosinophils
float
C0200638 (UMLS CUI [1])
Basophils
Item
Basophils
float
C0200641 (UMLS CUI [1])
Item Group
Laboratory Tests Biochemistry
C0022885 (UMLS CUI-1)
C0005477 (UMLS CUI-2)
Laboratory Test Biochemistry Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
Sodium
Item
Sodium
float
C0337443 (UMLS CUI [1])
Potassium
Item
Potassium
float
C0202194 (UMLS CUI [1])
Calcium
Item
Calcium
float
C0201925 (UMLS CUI [1])
Phosphorus
Item
Phosphorus
float
C0031705 (UMLS CUI [1])
Blood Urea Nitrogen
Item
Blood urea nitrogen
float
C0005845 (UMLS CUI [1])
Magnesium
Item
Magnesium
float
C0373675 (UMLS CUI [1])
Total Proteins
Item
Total Proteins
float
C0555903 (UMLS CUI [1])
Albumin
Item
Albumin
float
C0201838 (UMLS CUI [1])
Blood Glucose
Item
Glucose
float
C0202042 (UMLS CUI [1])
AST
Item
AST (SGOT)
float
C0201899 (UMLS CUI [1])
AST: Upper Limit
Item
AST (SGOT - ASAT): Normal Range - Upper Limit
float
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
ALT
Item
ALT
float
C0201836 (UMLS CUI [1])
ALT: Upper Limit
Item
ALT (SGPT - ALAT): Normal Range - Upper Limit
float
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Alkaline Phosphatase
Item
Alkaline Phosphatase
float
C0201850 (UMLS CUI [1])
Alkaline Phosphatase: Upper Limit
Item
Alkaline Phosphatase: Normal Range - Upper Limit
float
C0201850 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Total Bilirubin
Item
Total Bilirubin
float
C0201913 (UMLS CUI [1])
Total Bilirubin: Upper Limit
Item
Total Bilirubin: Normal Range - Upper Limit
float
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Creatinine
Item
Creatinine
float
C0201976 (UMLS CUI [1])
Creatinine: Upper Limit
Item
Creatinine: Normal Range - Upper Limit
float
C0201976 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Lactate Dehydrogenase
Item
Lactate Dehydrogenase
float
C0202113 (UMLS CUI [1])
Lactate Dehydrogenase: Upper Limit
Item
Lactate Dehydrogenase: Normal Range - Upper Limit
float
C0202113 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
Item Group
Ciruclating free plasma DNA - Blood Sampling
C4289789 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
Ciruclating free plasma DNA: Date of Sample
Item
Date of Sample:
date
C4289789 (UMLS CUI [1,1])
C1317250 (UMLS CUI [1,2])
Item Group
Electrocardiogram (12 Leads)
C1623258 (UMLS CUI-1)
ECG Date
Item
Date performed:
date
C2826640 (UMLS CUI [1])
Item
Interpretation
text
C0438154 (UMLS CUI [1])
ECG finding
Code List
Interpretation
CL Item
Abnormal (Abnormal)
CL Item
Normal (Normal)
ECG finding abnormal
Item
Interpretation - If abnormal, clinically significant?
boolean
C0438154 (UMLS CUI [1,1])
C2826279 (UMLS CUI [1,2])
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