Informatie:
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ID
22249
Beschrijving
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
Trefwoorden
Versies (1)
- 25-05-17 25-05-17 -
Geüploaded op
25 mei 2017
DOI
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Licentie
Creative Commons BY 4.0
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CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 End of Treatment
CRFs Cabazitaxel Prostate Cancer NCT01308580 End of Treatment
- StudyEvent: ODM
Similar models
CRFs Cabazitaxel Prostate Cancer NCT01308580 End of Treatment
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
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])
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])
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])
C3538832 (UMLS CUI [1,2])
Date of visit
Item
Date of visit:
date
C1320303 (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])
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)
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)
C0005477 (UMLS CUI-2)
Laboratory Test Biochemistry Date
Item
Date
date
C2826641 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
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])
C1519815 (UMLS CUI [1,2])
Item Group
Ciruclating free plasma DNA - Blood Sampling
C4289789 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
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])
C1317250 (UMLS CUI [1,2])
ECG Date
Item
Date performed:
date
C2826640 (UMLS CUI [1])
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])
C2826279 (UMLS CUI [1,2])