ID
22249
Description
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
Keywords
Versions (1)
- 5/25/17 5/25/17 -
Uploaded on
May 25, 2017
DOI
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License
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
Description
Visit Information
Alias
- UMLS CUI-1
- C0545082
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Assessment Date
Data type
date
Measurement units
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2985720
Description
Body weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Systolic Blood Pressure
Data type
float
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
float
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
float
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
ECOG Performance Status
Data type
integer
Alias
- UMLS CUI [1]
- C1520224
Description
Laboratory Tests Hematology
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0474523
Description
Laboratory Test Date
Data type
date
Measurement units
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2826641
Description
Hemoglobin
Data type
float
Measurement units
- g/dL
Alias
- UMLS CUI [1]
- C0019046
Description
Platelets
Data type
float
Alias
- UMLS CUI [1]
- C0005821
Description
White Blood Cell Count
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0023508
Description
Neutrophils
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0948762
Description
Lymphocytes
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0024264
Description
Monocytes
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophils
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0200638
Description
Basophils
Data type
float
Measurement units
- 10^9/L
Alias
- UMLS CUI [1]
- C0200641
Description
Laboratory Tests Biochemistry
Alias
- UMLS CUI-1
- C0022885
- UMLS CUI-2
- C0005477
Description
Laboratory Test Biochemistry Date
Data type
date
Measurement units
- dd-mmm-yyyy
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0005477
Description
Sodium
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0337443
Description
Potassium
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0202194
Description
Calcium
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0201925
Description
Phosphorus
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0031705
Description
Blood Urea Nitrogen
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0005845
Description
Magnesium
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0373675
Description
Total Proteins
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0555903
Description
Albumin
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0201838
Description
Blood Glucose
Data type
float
Measurement units
- mmol/L
Alias
- UMLS CUI [1]
- C0202042
Description
AST
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201899
Description
AST: Upper Limit
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519815
Description
ALT
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201836
Description
ALT: Upper Limit
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519815
Description
Alkaline Phosphatase
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0201850
Description
Alkaline Phosphatase: Upper Limit
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C1519815
Description
Total Bilirubin
Data type
float
Measurement units
- umol/L
Alias
- UMLS CUI [1]
- C0201913
Description
Total Bilirubin: Upper Limit
Data type
float
Measurement units
- umol/L
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519815
Description
Creatinine
Data type
float
Measurement units
- umol/L
Alias
- UMLS CUI [1]
- C0201976
Description
Creatinine: Upper Limit
Data type
float
Measurement units
- umol/L
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1519815
Description
Lactate Dehydrogenase
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1]
- C0202113
Description
Lactate Dehydrogenase: Upper Limit
Data type
float
Measurement units
- U/L
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C1519815
Description
Ciruclating free plasma DNA - Blood Sampling
Alias
- UMLS CUI-1
- C4289789
- UMLS CUI-2
- C0005834
Description
Electrocardiogram (12 Leads)
Alias
- UMLS CUI-1
- C1623258
Description
ECG Date
Data type
date
Measurement units
- dd-mmm-yyyy
Alias
- UMLS CUI [1]
- C2826640
Description
ECG finding
Data type
text
Alias
- UMLS CUI [1]
- C0438154
Description
Note: If abnormal, clinically significant, record on the AE Form.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0438154
- UMLS CUI [1,2]
- C2826279
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